An Open-Label Extension Study of DS-5565 for 52 Weeks in Pain Associated With Fibromyalgia

NCT02234583 | Completed Phase 3 Results DMC

• 2 other identifiers: DS5565-A-E3122013-005164-26
• Study Type: interventional
• Target: 2,485
• Locations: 26 countries
• Sites: 253

Brief Summary

This is an open-label study of DS-5565 in subjects who either completed participation in a preceding Phase 3 study of DS-5565 in fibromyalgia (FM); i.e. DS5565-A-E309 (NCT02146430), DS5565-A-E310 (NCT02187471), or DS5565-A-E311 (NCT02187159) or are de novo subjects. Eligible subjects will be assigned to receive open-label DS-5565 for 52 weeks. All subjects will receive DS-5565 15 mg once daily (QD) for the first three weeks of the treatment period. After three weeks, subjects may be titrated to 15 mg twice daily (BID) based on protocol-specified criteria.

Conditions

Pain Associated With Fibromyalgia

Keywords

pain; fibromyalgia

Outcome Measures

Primary Outcomes (1)

• Average Daily Pain Score (ADPS) for DS-5565

  Average of daily pain scores are reported by the participant and best describes his or her worst pain over the previous 24 hours. A daily pain score has a scale of 0 = no pain to 10 = worst possible pain.

  Day 0 (baseline) up to to Week 52 postdose

Secondary Outcomes (5)

• Number of Participants With Much Improved or Better (≤2) Status in Status at Week 52 As Assessed by the Patient-Rated Global Impression of Change

  Week 52 postdose

• Hospital Anxiety Depression Scale (HADS) Depression and Anxiety Scores for DS-5565

  Day 0 (baseline) up to Week 52 postdose

• EuroQol Five Dimensions Questionnaire (EQ-5D) Measure for DS-5565

  Day 0 (baseline) up to Week 52 postdose

• Short Form-36 (SF-36) Measure for DS-5565

  Day 0 (baseline) to Week 52 postdose

• Pain-Associated Sleep Interference as Assessed by Average Daily Sleep Interference Score (ADSIS) for DS-5565

  Day 0 (baseline) up to Week 52 postdose

Study Arms (1)

DS-5565

EXPERIMENTAL

Participants receive 15 mg DS-5565 administered once or twice daily. Each participant's dose can be titrated up or down based on the investigator's decision. Analysis will be based on the dose modality at the time of data collection.

Drug: DS-5565

Interventions

DS-5565 DRUG

DS-5565 15 mg tablet for oral administration

Also known as: Investigational product

DS-5565

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to give written informed consent
• Completed participation (i.e. completed the End-of-Tapering visit) in a preceding study of DS 5565 in FM (DS5565-A-E309, DS5565-A-E310, or DS5565-A-E311)
• Women of child-bearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy during the study and for 4 weeks after study completion
• Able to complete subject-reported questionaires per the investigator's judgement
• The subject must not have experienced any significant safety issues during the preceding study that, in the investigator's judgment, would adversely impact the subject's well-being in the long-term extension
• De Novo Subjects
• Age ≥ 18 years
• Able to give written informed consent
• Able to complete subject-reported questionnaires per the investigator's judgment
• At screening, subjects must meet the 1990 American College of Rheumatology (ACR) criteria for FM, i.e. widespread pain present for at least 3 months and pain in at least 11 of 18 specific tender point sites. In addition, the 2010 ACR criteria must be met:
• Widespread pain index (WPI) ≥ 7 and symptom severity (SS) scale score ≥ 5, or WPI 3 to 6 and SS scale score ≥ 9
• Symptoms have been present at a similar level for at least 3 months
• The subject does not have a disorder that would otherwise explain the pain
• ADPS of ≥ 4 on the 11-point numeric rating scale (NRS) over the past 7 days prior to first dose (based on completion of at least 4 daily pain diaries during the 7-day baseline period)
• Subject must have documented evidence of a fundoscopic examination (with pupil dilation) within 12 months prior to screening or at screening

You may not qualify if:

• Clinically significant unstable neurologic, psychiatric, ophthalmologic, hepatobiliary, respiratory, or hematologic illness or unstable cardiovascular disease (e.g. severe hypotension, uncontrolled cardiac arrhythmia, or myocardial infarction) or any other concurrent disease during the preceding study (for rollover subjects) or within 12 months prior to screening (for de novo subjects) that in the opinion of the investigator would interfere with study participation or assessment of safety and tolerability
• Subjects who are at risk of suicide as defined by their responses to the C-SSRS or in the opinion of the investigator.
• Subjects with severe or uncontrolled depression that, in the judgment of the investigator, makes the subject inappropriate for entry into the study
• Subjects with pain due to other conditions (e.g. DPNP or post-herpetic neuralgia) that, in the opinion of the investigator, would confound assessment or self-evaluation of the pain associated with FM
• Subjects with pain due to any widespread inflammatory musculoskeletal disorder (e.g. rheumatoid arthritis, lupus) or widespread rheumatic disease other than FM.
• Abuse or dependence of prescription medications, street drugs, or alcohol within the last 1 year
• A diagnosis of untreated sleep apnea or initiation of treatment for sleep apnea within the past 3 months
• Known hypersensitivity to α2δ ligands or other components of the study medications
• Pregnancy or breast-feeding, or intent to become pregnant during the study period
• Abnormal investigative tests (i.e. ECGs) and laboratory values judged by the investigator to be clinically significant at the End-of-Treatment visit (Visit - Week 13) in the preceding study (for rollover subjects) or at screening (for de novo subjects), with particular focus on:
• For De Novo Subjects Only
• Unable to undergo pre-study washout of prohibited concomitant medications (as listed in Section 5.2.1 of the protocol)
• Current severe or uncontrolled major depressive disorder or anxiety disorders as assessed by the Mini-international Neuropsychiatric Interview (MINI) interview (Version 6.0) at screening are excluded, but mild to moderate major depression or anxiety disorders are permitted provided that the investigator assesses the patient as clinically stable and appropriate for entry into the study
• Any diagnosis of lifetime bipolar disorder or psychotic disorder
• Subject is currently enrolled in or has not yet completed at least 30 days since ending another investigational device or drug study or is receiving other investigational agents

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (276)

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Birmingham, Alabama, 35242, United States

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Mobile, Alabama, 36608, United States

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Phoenix, Arizona, 85018, United States

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Anaheim, California, 92801, United States

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Fresno, California, 93710, United States

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Fresno, California, 93720, United States

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Los Alamitos, California, 90720, United States

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Los Angeles, California, 90036, United States

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Newport Beach, California, 92660, United States

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Rancho Mirage, California, 92270, United States

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Roseville, California, 95661, United States

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San Diego, California, 92103, United States

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Santa Ana, California, 92705, United States

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Santa Barbara, California, 93108, United States

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Santa Monica, California, 90404, United States

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Spring Valley, California, 91978, United States

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Thousand Oaks, California, 91360, United States

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Tustin, California, 92780, United States

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Walnut Creek, California, 94598, United States

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Cromwell, Connecticut, 06416, United States

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Bradenton, Florida, 34201, United States

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Brandon, Florida, 33511, United States

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Brooksville, Florida, 34601, United States

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Clearwater, Florida, 33761, United States

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Clearwater, Florida, 33765, United States

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Coral Springs, Florida, 33067, United States

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Fort Lauderdale, Florida, 33308, United States

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Fort Myers, Florida, 33912, United States

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Hialeah, Florida, 33013, United States

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Jacksonville, Florida, 32256, United States

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Kissimmee, Florida, 34744, United States

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Lakeland, Florida, 33805, United States

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Leesburg, Florida, 34748, United States

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Miami, Florida, 33140, United States

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New Port Richey, Florida, 34652, United States

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Ocala, Florida, 34471, United States

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Orlando, Florida, 32801, United States

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Ormond Beach, Florida, 32174, United States

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Royal Palm Beach, Florida, 33411, United States

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St. Petersburg, Florida, 33709, United States

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Sunrise, Florida, 33351, United States

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Tampa, Florida, 33606, United States

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Alpharetta, Georgia, 30005, United States

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Atlanta, Georgia, 30342, United States

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Columbus, Georgia, 31909, United States

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Savannah, Georgia, 31405, United States

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Smyrna, Georgia, 30080, United States

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Bolingbrook, Illinois, 60490, United States

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Chicago, Illinois, 60634, United States

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Gurnee, Illinois, 60031, United States

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Melrose Park, Illinois, 60160, United States

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Oak Brook, Illinois, 60523, United States

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Evansville, Indiana, 47714, United States

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Indianapolis, Indiana, 46260, United States

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West Des Moines, Iowa, 50265, United States

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Newton, Kansas, 67114, United States

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Shawnee Mission, Kansas, 66218, United States

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Wichita, Kansas, 67205, United States

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Wichita, Kansas, 67207, United States

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Lexington, Kentucky, 40509, United States

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Paducah, Kentucky, 42003, United States

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Lake Charles, Louisiana, 70601, United States

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Boston, Massachusetts, 02131, United States

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Fall River, Massachusetts, 02720, United States

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New Bedford, Massachusetts, 02740, United States

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Watertown, Massachusetts, 02472, United States

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Biloxi, Mississippi, 39531, United States

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Hazelwood, Missouri, 63042, United States

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Kansas City, Missouri, 64114, United States

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Springfield, Missouri, 65807, United States

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St Louis, Missouri, 63141, United States

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Billings, Montana, 59102, United States

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Omaha, Nebraska, 68114, United States

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Las Vegas, Nevada, 89123, United States

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Berlin, New Jersey, 08009, United States

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Blackwood, New Jersey, 08012, United States

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Albuquerque, New Mexico, 87109, United States

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Brooklyn, New York, 11230, United States

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Manhasset, New York, 11030, United States

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New York, New York, 10168, United States

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North Massapequa, New York, 11758, United States

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Charlotte, North Carolina, 28210, United States

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Greensboro, North Carolina, 27408, United States

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High Point, North Carolina, 27262, United States

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Raleigh, North Carolina, 27612, United States

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Winston-Salem, North Carolina, 27103, United States

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Fargo, North Dakota, 58103, United States

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Cincinnati, Ohio, 45242, United States

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Dayton, Ohio, 45417, United States

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Kettering, Ohio, 45429, United States

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Tiffin, Ohio, 44863, United States

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Willoughby, Ohio, 44094, United States

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Oklahoma City, Oklahoma, 73103, United States

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Tulsa, Oklahoma, 74104, United States

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Eugene, Oregon, 97404, United States

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Medford, Oregon, 97504, United States

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Portland, Oregon, 97210, United States

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Salem, Oregon, 97301, United States

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Tipton, Pennsylvania, 16684, United States

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Wyomissing, Pennsylvania, 19610, United States

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Anderson, South Carolina, 29621, United States

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Fountain Inn, South Carolina, 29644, United States

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Greer, South Carolina, 29651, United States

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Dakota Dunes, South Dakota, 57049, United States

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Rapid City, South Dakota, 57702, United States

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Knoxville, Tennessee, 37919, United States

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New Tazewell, Tennessee, 37836, United States

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Tullahoma, Tennessee, 37388, United States

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Dallas, Texas, 75230, United States

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Lubbock, Texas, 79424, United States

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Plano, Texas, 75093, United States

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San Antonio, Texas, 78232, United States

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Salt Lake City, Utah, 84102, United States

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Virginia Beach, Virginia, 23454, United States

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Bellevue, Washington, 98007, United States

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Seattle, Washington, 98104, United States

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Wenatchee, Washington, 98801, United States

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Camperdown, New South Wales, Australia

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Campsie, New South Wales, Australia

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Coffs Harbour, New South Wales, Australia

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St Leonards, New South Wales, Australia

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Maroochydore, Queensland, Australia

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Sherwood, Queensland, 4075, Australia

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Sherwood, Queensland, Australia

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Southport, Queensland, Australia

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Woodville, South Australia, Australia

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Hobart, Tasmania, Australia

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Clayton, Victoria, Australia

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Malvern East, Victoria, Australia

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Klagenfurt, Austria

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Senftenberg, Austria

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Vienna, 1090, Austria

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Burgas, Bulgaria

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Pleven, Bulgaria

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Plovdiv, Bulgaria

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Rousse, Bulgaria

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Sevlievo, Bulgaria

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Sofia, Bulgaria

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Targovishte, Bulgaria

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Varna, Bulgaria

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Penticton, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Burlington, Ontario, Canada

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Kitchener, Ontario, Canada

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London, Ontario, Canada

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Markham, Ontario, L3R 9W9, Canada

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Markham, Ontario, Canada

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Mississauga, Ontario, Canada

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Newmarket, Ontario, Canada

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Oshawa, Ontario, Canada

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Sarnia, Ontario, N7T 4X3, Canada

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Sarnia, Ontario, Canada

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Toronto, Ontario, M3J 2C5, Canada

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Toronto, Ontario, Canada

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Pointe-Claire, Quebec, H9R 3J1, Canada

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Québec, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Antofagasta, Region 11, Chile

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Puerto Varas, Region X, Chile

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Choceň, Czechia

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Pilsen, Czechia

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Prague, Czechia

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Rychnov nad Kněžnou, Czechia

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Říčany, Czechia

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Aalborg, Denmark

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Odense, Denmark

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Tallinn, Estonia

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Tartu, Estonia

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Hyvinkää, Finland

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Kuopio, Finland

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Saint-Etienne, Cedex, France

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Douai, Nord, France

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Élancourt, France

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Berlin, Germany

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Böhlen, Germany

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Dresden, Germany

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Hanover, Germany

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Leipzig, Germany

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Magdeburg, Germany

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Mainz, Germany

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Stadtroda, Germany

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Balassagyarmat, Hungary

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Budapest, Hungary

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Debrecen, Hungary

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Nyíregyháza, Hungary

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Baldone, Latvia

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Balvi, Latvia

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Jēkabpils, Latvia

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Liepāja, Latvia

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Ogre, Latvia

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Riga, Latvia

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Ventspils, Latvia

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Kaunas, Lithuania

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Klaipėda, Lithuania

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Vilnius, Lithuania

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Auckland, New Zealand

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Hamilton, New Zealand

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Nelson, New Zealand

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Tauranga, New Zealand

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Wellington, New Zealand

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Ålesund, Norway

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Hamar, Norway

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Hønefoss, Norway

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Kløfta, Norway

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Lillehammer, Norway

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Stavanger, Norway

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Elblag, Poland

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Gdansk, Poland

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Katowice, Poland

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Krakow, Poland

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Lublin, Poland

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Nadarzyn, Poland

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Nowa Sól, Poland

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Torun, Poland

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Tychy, Poland

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Warsaw, Poland

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Wroclaw, Poland

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Aveiro, Portugal

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Guimarães, Portugal

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Porto, Portugal

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Vila Nova de Gaia, Portugal

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Ponce, 00716, Puerto Rico

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San Juan, 00909, Puerto Rico

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Bacau, Romania

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Bucharest, Romania

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Târgu Mureş, Romania

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Krasnoyarsk, Russia

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Moscow, Russia

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Nizhniy Novgarad, Russia

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Stavropol, Russia

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Belgrade, Serbia

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Banská Bystrica, Slovakia

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Bratislava, Slovakia

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Dubnica nad Váhom, Slovakia

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Galanta, Slovakia

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Krompachy, 05342, Slovakia

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Piešťany, Slovakia

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Prešov, Slovakia

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Ljubljana, Slovenia

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Slovenj Gradec, Slovenia

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Bayview, Chatsworth, South Africa

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Johannesburg, Gautang, South Africa

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Pretoria, Gautang, South Africa

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Durban, KwaZulu-Natal, South Africa

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Cape Town, Western Cape, South Africa

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Somerset West, Western Cape, South Africa

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Stellenbosch, South Africa

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Santiago de Compostela, A Coruna, Spain

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Barcelona, Spain

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Granada, Spain

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Madrid, Spain

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Dnipropetrovsk, Ukraine

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Ivano-Frankivsk, Ukraine

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Kharkiv, Ukraine

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Kherson, Ukraine

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Kyiv, Ukraine

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Lviv, Ukraine

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Vinnytsia, Ukraine

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Zaporizhzhia, Ukraine

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Penzance, Cornwall, United Kingdom

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Chesterfield, Derbyshire, United Kingdom

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Romford, Essex, United Kingdom

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Manchester, Greater Manchester, United Kingdom

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Blackpool, Lancashire, United Kingdom

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Thornton-Cleveleys, Lancashire, United Kingdom

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Wigan, Lancashire, United Kingdom

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Stourton, Leeds, United Kingdom

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Salford, Manchester, United Kingdom

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Southport, Merseyside, United Kingdom

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Wellingborough, Northamptonshire, United Kingdom

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Belfast, Northern Ireland, United Kingdom

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Cannock, Staffordshire, United Kingdom

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North Shields, Tyne and Wear, United Kingdom

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Atherstone, Warwickshire, CV9 1EU, United Kingdom

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Torpoint, United Kingdom

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Related Publications (1)

• Arnold LM, Whitaker S, Hsu C, Jacobs D, Merante D. Efficacy and safety of mirogabalin for the treatment of fibromyalgia: results from three 13-week randomized, double-blind, placebo- and active-controlled, parallel-group studies and a 52-week open-label extension study. Curr Med Res Opin. 2019 Oct;35(10):1825-1835. doi: 10.1080/03007995.2019.1629757. Epub 2019 Jul 9.

  PMID: 31284771 DERIVED

MeSH Terms

Conditions

Pain; Fibromyalgia

Interventions

mirogabalin

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Results Point of Contact

• Title: Daiichi Sankyo US Contact for Clinical Trial Results
• Organization: Daiichi Sankyo, Inc.

CTRinfo@DSI.com

1-908-992-6400

Study Officials

• Global Clinical Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2014
• First Posted: September 9, 2014
• Study Start: February 4, 2015
• Primary Completion: April 19, 2017
• Study Completion: April 19, 2017
• Last Updated: July 23, 2020
• Results First Posted: July 23, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Locations

SL (2); AU (3); GB (16); PT (4); US (117); PR (2); FI (2); HU (4); NO (6); PL (11); LI (3); DK (2); ZA (7); UA (8); RU (4); BU (8); CL (2); ES (2); CZ (5); FR (3); RO (3); NZ (5); CA (18); SE (1); LA (7); DE (8)