Treatment of Pain Associated With Fibromyalgia

NCT02187159 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: DS5565-A-E3112013-005163-10
• Study Type: interventional
• Target: 1,270
• Locations: 12 countries
• Sites: 176

Brief Summary

The main objective of this trial is to compare change in weekly average daily pain score (ADPS) from baseline to Week 13 in participants receiving either dose of DS-5565 versus placebo. Weekly ADPS is based on daily pain scores reported by the participant that best describes his or her worst pain over the previous 24 hours.

Conditions

Pain Associated With Fibromyalgia

Keywords

pain; fibromyalgia

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 13 in Average Daily Pain Score (ADPS) in Participants Receiving DS-5565, Pregabalin, or Placebo

  The patient reported pain intensity daily (over the past 24 hours) on a scale of 0 = no pain to 10 = worst possible pain. The daily pain scores were averaged over 7 days to calculate the weekly ADPS.

  Baseline up to Week 13 postdose

Secondary Outcomes (11)

• Number of Participants Who Answered "Much Improved or Better" on the Patient Global Impression of Change (PGIC) Scale at Week 13 in Participants Receiving DS-5565, Pregabalin, or Placebo

  Week 13 postdose

• Change From Baseline to Week 13 in Fibromyalgia Index Questionnaire (FIQ) Total Score in Participants Receiving DS-5565, Pregabalin, or Placebo

  Baseline up to Week 13 postdose

• Number of Responders at Week 13 Among Participants Receiving DS-5565, Pregabalin, or Placebo

  Week 13 postdose

• Change From Baseline to Week 13 in Multidimensional Fatigue Inventory (MFI-20) General Fatigue Score in Participants Receiving DS-5565, Pregabalin, or Placebo

  Baseline up to Week 13 postdose

• Change From Baseline to Week 13 in Hospital Anxiety and Depression Scale (HADS) in Participants Receiving DS-5565, Pregabalin, or Placebo

  Baseline up to Week 13 postdose

Study Arms (4)

DS-5565 QD

EXPERIMENTAL

Participants take one each of placebo tablet and capsule in the morning, and one DS-5565 tablet once daily (QD) with a placebo capsule in the evening

Drug: DS-5565; Drug: Placebo tablet; Drug: Placebo capsule

DS-5565 BID

EXPERIMENTAL

Participants take one DS-5565 tablet and one placebo capsule, twice daily (BID)

Drug: DS-5565; Drug: Placebo capsule

Pregabalin

ACTIVE COMPARATOR

Participants take one pregabalin capsule and one placebo tablet BID

Drug: Pregabalin; Drug: Placebo tablet

Placebo

PLACEBO COMPARATOR

Participants take one each of placebo tablet and capsule BID

Drug: Placebo tablet; Drug: Placebo capsule

Interventions

DS-5565 DRUG

DS-5565 15 mg tablet for oral administration

Also known as: mirogabalin

DS-5565 BID; DS-5565 QD

Pregabalin DRUG

Pregabalin 150 mg capsule for oral administration

Also known as: Lyrica

Pregabalin

Placebo tablet DRUG

Placebo tablet (matching DS5565) for oral administration

Also known as: Placebo matching DS-5565

DS-5565 QD; Placebo; Pregabalin

Placebo capsule DRUG

Placebo capsule (matching pregabalin) for oral administration

Also known as: Placebo matching pregabalin

DS-5565 BID; DS-5565 QD; Placebo

Eligibility Criteria

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

You may qualify if:

• 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 randomization (based on completion of at least 4 daily pain diaries during the 7-day baseline period prior to randomization)
• Subject must have documented evidence of a fundoscopic examination (with pupil dilation) within 12 months prior to screening or at screening.
• 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.

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 within 12 months prior to screening that in the opinion of the investigator would interfere with study participation or assessment of safety and tolerability
• Anticipation of initiation or significant change to normal daily exercise routines or need for ongoing use of concomitant medications or non-pharmacological pain management techniques that may confound assessments of efficacy and/or safety
• Unable to undergo pre-study washout of prohibited concomitant medications
• Subjects who are at risk of suicide as defined by their responses to the Columbia-Suicide Severity Rating Scale (C-SSRS) or in the opinion of the investigator. Note: Patients answering "yes" to any of the questions about active suicidal ideation/intent/behaviors occurring within the past 12 months must be excluded (C-SSRS Suicide Ideation section - Questions 3, 4, or 5; C-SSRS Suicidal Behavior section, any of the suicide behaviors questions). Such patients should be referred immediately to a mental health professional for appropriate evaluation.
• Current severe or uncontrolled major depressive disorder or anxiety disorders as assessed by the Mini-international Neuropsychiatric Interview (MINI) 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
• Subjects with pain due to other conditions (e.g. diabetic peripheral neuropathic pain 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
• Any history of a malignancy other than basal cell carcinoma within the past 5 years
• A diagnosis of untreated sleep apnea or initiation of treatment for sleep apnea within the past 3 months
• Pregnancy or breast-feeding, or intent to become pregnant during the study period
• 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.
• Known hypersensitivity to alpha2-delta (α2δ) ligands or other components of the study medications. Note: Prior exposure to DS-5565 is allowed, as long as hypersensitivity to DS-5565 was not observed.
• Subjects who are unlikely to comply with the protocol (e.g. uncooperative attitude, inability to return for subsequent visits) and/or otherwise considered by the investigator to be unlikely to complete the study.

Sponsors & Collaborators

• Daiichi Sankyo: lead
• Syneos Health: collaborator

Study Sites (176)

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Mobile, Alabama, 36608, United States

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Phoenix, Arizona, 85027, United States

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Scottsdale, Arizona, United States

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Little Rock, Arkansas, 72205, United States

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Fresno, California, 93710, United States

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Glendale, California, 91204, United States

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Orange, California, 92868, United States

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Oxnard, California, United States

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Richmond, California, 94806, United States

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Sacramento, California, 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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Simi Valley, California, 93065, United States

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New London, Connecticut, United States

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Bradenton, Florida, 34208, United States

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Brandon, Florida, 33511, United States

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DeBary, Florida, 32713, United States

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Fort Myers, Florida, 33916, United States

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Hialeah, Florida, 33013, United States

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Homestead, Florida, 33030, United States

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Lake Mary, Florida, United States

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Miami, Florida, 33126, United States

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North Miami, Florida, 33161, United States

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Ocala, Florida, 34471, United States

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Plant City, Florida, 33563, United States

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Tampa, Florida, 33614, United States

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Alpharetta, Georgia, 30005, United States

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Atlanta, Georgia, 30328, United States

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Atlanta, Georgia, 30342, United States

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Columbus, Georgia, 31904, United States

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Savannah, Georgia, 31405, United States

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Boise, Idaho, 83713, United States

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Meridian, Idaho, 83642, United States

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Chicago, Illinois, 60611, United States

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Gurnee, Illinois, 60031, United States

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Naperville, Illinois, 60563, United States

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Evansville, Indiana, 47714, United States

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West Des Moines, Iowa, 50266, 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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Lexington, Kentucky, 40509, United States

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Monroe, Louisiana, 71201, United States

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Traverse City, Michigan, 49684, United States

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Jackson, Mississippi, 39202, United States

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Omaha, Nebraska, 68134, United States

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Las Vegas, Nevada, 89123, United States

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Brooklyn, New York, 11229, United States

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Manhasset, New York, United States

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New York, New York, 10128, United States

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Staten Island, New York, 10312, United States

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Benson, North Carolina, United States

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Greensboro, North Carolina, 27408, United States

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Raleigh, North Carolina, 27609, United States

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Salisbury, North Carolina, United States

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Fargo, North Dakota, 58103, United States

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Cleveland, Ohio, 44122, United States

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Columbus, Ohio, United States

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Dayton, Ohio, 45424, United States

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Garfield Heights, Ohio, 44125, United States

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Middleburg Heights, Ohio, United States

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Tiffin, Ohio, 44883, 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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Salem, Oregon, 97301, United States

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Duncansville, Pennsylvania, 16635, United States

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Warwick, Rhode Island, United States

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Anderson, South Carolina, 29621, United States

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Charleston, South Carolina, 29406, United States

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Greer, South Carolina, 29650, United States

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Rock Hill, South Carolina, 28209, United States

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Bristol, Tennessee, 37620, United States

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Knoxville, Tennessee, 37919, United States

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New Tazewell, Tennessee, 37825, United States

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Austin, Texas, 78705, United States

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Dallas, Texas, 75231, United States

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Houston, Texas, 77070, United States

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Houston, Texas, 77089, United States

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San Antonio, Texas, 78229, United States

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Sealy, Texas, 77474, United States

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Sugar Land, Texas, 77479, United States

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Salt Lake City, Utah, 84102, United States

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Norfolk, Virginia, 23507, United States

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Richmond, Virginia, 23294, United States

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Kirkland, Washington, 98033, United States

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Charleston, West Virginia, 25304, United States

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Camperdown, New South Wales, Australia

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Campsie, New South Wales, 2194, Australia

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Coffs Harbour, New South Wales, 2450, Australia

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St Leonards, New South Wales, Australia

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Maroochydore, Queensland, 4558, Australia

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Sherwood, Queensland, Australia

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Southport, Queensland, 4215, Australia

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Woodsville, South Australia, Australia

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Hobart, Tasmania, 7000, Australia

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Clayton, Victoria, Australia

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Malvern East, Victoria, 3145, Australia

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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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Tallinn, Estonia

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Tartu, 51013, Estonia

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Balassagyarmat, Hungary

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Budapest, Hungary

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Debrecen, Hungary

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Esztergom, Hungary

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Kistarcsa, Hungary

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Nyíregyháza, Hungary

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Szeged, Hungary

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Veszprém, Hungary

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Ahmedabad, Gujarat, India

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Surat, Gujarat, India

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Bangalore, Karnataka, India

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Hubli, Karnataka, India

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Pune, Maharashtra, India

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Jaipur, Rajasthan, India

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Lucknow, VP, India

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Baldone, LV-2155, Latvia

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Balvi, Latvia

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Jēkabpils, LV-5201, Latvia

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Liepāja, LV-3401, Latvia

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Ogre, LV-5001, Latvia

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Riga, Latvia

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Ventspils, Latvia

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Auckland, 2025, New Zealand

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Hamilton, 3204, New Zealand

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Nelson, 7010, New Zealand

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Tauranga, 3110, New Zealand

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Wellington, 6242, New Zealand

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Bacau, Romania

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Bucharest, Romania

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Cluj-Napoca, Romania

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Oradea, Romania

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Târgu Mureş, Romania

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Ivanovo, Russia

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Krasnoyarsk, Russia

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Moscow, Russia

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Nizhny Novgorod, Russia

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Orenburgsky, Russia

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Pyatigorski, Russia

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Saint Petersburg, Russia

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Stavropol, Russia

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Vladikavkaz, Russia

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Yaroslav, Russia

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Banská Bystrica, 974 04, Slovakia

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Bratislava, 821 08, Slovakia

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Dubnica nad Váhom, 018 41, Slovakia

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Galanta, Slovakia

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Krompachy, Slovakia

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Piešťany, Slovakia

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Prešov, Slovakia

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Reading, Berkshire, RG7 3SQ, United Kingdom

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Penzance, Cornwall, United Kingdom

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Chesterfield, Derbyshire, S40 4AA, United Kingdom

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Poole, Dorset, United Kingdom

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Romford, Essex, 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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Salford, Manchester, United Kingdom

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Southport, Merseyside, United Kingdom

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Wellingborough, Northamptonshire, NN8 4RW, United Kingdom

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Barnsley, South Yorkshire, 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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Dudley, WEST Midlands, United Kingdom

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Belfast, BT7 2EB, United Kingdom

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Leeds, United Kingdom

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Manchester, 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; Pregabalin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2014
• First Posted: July 10, 2014
• Study Start: November 1, 2014
• Primary Completion: July 7, 2016
• Study Completion: July 7, 2016
• Last Updated: November 9, 2020
• Results First Posted: November 9, 2020

Record last verified: 2020-11

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

LA (7); GB (20); RU (10); SL (7); IN (7); AU (11); BU (8); RO (5); ES (2); US (86); NZ (5); HU (8)