Treatment of Pain Associated With Fibromyalgia
A Randomized, Double-Blind, Placebo- and Active-Controlled Study of DS-5565 for Treatment of Pain Associated With Fibromyalgia
2 other identifiers
interventional
1,301
13 countries
150
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 subject that best describes his or her worst pain over the previous 24 hours.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2015
150 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2014
CompletedFirst Posted
Study publicly available on registry
July 11, 2014
CompletedStudy Start
First participant enrolled
January 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 6, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 12, 2017
CompletedResults Posted
Study results publicly available
November 9, 2020
CompletedNovember 9, 2020
November 1, 2020
2 years
July 8, 2014
August 24, 2020
November 5, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline to Week 13 in Average Daily Pain Score (ADPS) Among Participants Receiving DS-5565, Pregabalin, or Placebo
Average daily pain scores (ADPS) reported by the participant that best describes his or her worst pain over the previous 24 hours. A daily pain score has a scale where 0 = no pain to 10 = worst possible pain. Higher scores indicate a worse outcome. For participants with no Week 13 data, the baseline observation was carried forward (BOCF). The mean (multiple imputation estimate) and standard error (multiple imputation) are reported.
Baseline up to Week 13 postdose
Secondary Outcomes (11)
Number of Participants Who Answered "Much Improved or Better" in Patient Global Impression of Change at Week 13 Receiving DS-5565, Pregabalin, or Placebo
Baseline up to Week 13 postdose
Change From Baseline to Week 13 in Average Score on the Fibromyalgia Index Questionnaire (FIQ) in Participants Receiving DS-5565, Pregabalin, or Placebo
Baseline up to Week 13 postdose
Number of Participants Classified As 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 Among 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) Measure Among Participants Receiving DS-5565, Pregabalin, or Placebo
Baseline up to Week 13 postdose
- +6 more secondary outcomes
Study Arms (4)
Placebo
PLACEBO COMPARATORParticipants take one each of placebo tablet and capsule, twice daily (BID)
Pregabalin
OTHERParticipants take one pregabalin capsule and one placebo tablet BID
DS-5565 15 mg QD
EXPERIMENTALParticipants take one each of placebo tablet and capsule in the morning and one placebo capsule in the evening with one DS-5565 tablet once daily (QD)
DS-5565 15 mg BID
EXPERIMENTALParticipants take one placebo capsule with one DS-5565 tablet BID
Interventions
DS-5565 15 mg QD or BID; tablet for oral use
Pregabalin capsule for oral use; 75 mg capsule for one week, then 150 mg capsule
Placebo tablet for oral use, matching DS-5565 tablet
Placebo capsule for oral use, matching pregabalin capsule
Eligibility Criteria
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 C-SSRS questions at screening must be excluded. 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
- Syneos Healthcollaborator
Study Sites (154)
Unknown Facility
Birmingham, Alabama, 35242, United States
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Huntsville, Alabama, United States
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Phoenix, Arizona, 85020, United States
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Scottsdale, Arizona, United States
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Tempe, Arizona, United States
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Tucson, Arizona, United States
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Anaheim, California, United States
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Covina, California, 91723, United States
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El Cajon, California, 92020, United States
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Encino, California, United States
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Huntington Beach, California, 92646, United States
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Lakewood, California, 90712, United States
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Lomita, California, 90717, United States
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Los Angeles, California, United States
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National City, California, 91950, United States
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Northridge, California, 91324, United States
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Oceanside, California, United States
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Sacramento, California, United States
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Upland, California, 91786, United States
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Walnut Creek, California, United States
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Boca Raton, Florida, 33486, United States
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DeLand, Florida, 32720, United States
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Edgewater, Florida, 32132, United States
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Fort Lauderdale, Florida, United States
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Fort Myers, Florida, United States
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Hialeah, Florida, 33016, United States
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Largo, Florida, 33774, United States
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Lauderdale Lakes, Florida, 33319, United States
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Maitland, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, 32807, United States
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Sunrise, Florida, United States
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Tamarac, Florida, United States
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Tampa, Florida, United States
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Vero Beach, Florida, 32960, United States
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West Palm Beach, Florida, United States
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Winter Haven, Florida, United States
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Winter Park, Florida, United States
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Dawsonville, Georgia, United States
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Marietta, Georgia, 30060, United States
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Smyrna, Georgia, United States
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Chicago, Illinois, United States
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Evansville, Indiana, United States
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Granger, Indiana, United States
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Overland Park, Kansas, United States
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Owensboro, Kentucky, 423303, United States
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Lake Charles, Louisiana, United States
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New Orleans, Louisiana, 70119, United States
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Frederick, Maryland, United States
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Brockton, Massachusetts, United States
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North Dartmouth, Massachusetts, United States
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Ann Arbor, Michigan, 48104, United States
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Ann Arbor, Michigan, United States
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Lansing, Michigan, United States
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Rochester Hills, Michigan, United States
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Florissant, Missouri, United States
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Hazelwood, Missouri, United States
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O'Fallon, Missouri, United States
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Bellevue, Nebraska, United States
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Newington, New Hampshire, United States
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Albuquerque, New Mexico, United States
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Brooklyn, New York, 11230, United States
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Cedarhurst, New York, United States
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Rochester, New York, United States
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Charlotte, North Carolina, United States
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Raleigh, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Minot, North Dakota, 58701, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Middleburg Heights, Ohio, 44130, United States
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Oklahoma City, Oklahoma, United States
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Portland, Oregon, United States
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Altoona, Pennsylvania, United States
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Media, Pennsylvania, United States
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Wyomissing, Pennsylvania, United States
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Greenville, South Carolina, United States
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Mt. Pleasant, South Carolina, United States
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Chattanooga, Tennessee, 37421, United States
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Franklin, Tennessee, 37064, United States
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Knoxville, Tennessee, 37912, United States
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Memphis, Tennessee, United States
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Austin, Texas, 78756, United States
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Houston, Texas, 77024, United States
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Lake Jackson, Texas, United States
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San Antonio, Texas, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, 23235, United States
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Bellevue, Washington, 98007, United States
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Richland, Washington, 99352, United States
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CABA, Buenos Aires, Argentina
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La Plata, Buenos Aires, Argentina
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Lanús, Buenos Aires, Argentina
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Mar del Plata, Buenos Aires, Argentina
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Quilmes, Buenos Aires, Argentina
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San Fernando, Buenos Aires, Argentina
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Rosario, Santa Fe Province, Argentina
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Córdoba, Argentina
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San Miguel de Tucumán, Argentina
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Santa Fe, Argentina
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Klagenfurt, Austria
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Senftenberg, 3541, Austria
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Vienna, 1090, Austria
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Minsk, Belarus
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Vitebsk, Belarus
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Brussels, Belgium
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Edegem, Belgium
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Gozée, Belgium
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Oostham, Belgium
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Antofagasta, Chile
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Providencia, Chile
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Puerto Varas, Chile
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Viña del Mar, Chile
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Barranquilla, Colombia
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Bogotá, Colombia
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Haifa, Israel
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Kfar Saba, Israel
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Ramat Gan, Israel
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Tel Aviv, Israel
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Cuautitlán Izcalli, Mexico
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Durango, Mexico
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Guadalajara, Mexico
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León, Mexico
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Mexico City, Mexico
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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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Aveiro, Portugal
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Braga, Portugal
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Guimarães, Portugal
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Lisbon, Portugal
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Ponte de Lima, Portugal
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Porto, Portugal
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Vila Nova de Gaia, Portugal
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Ljubljana, Slovenia
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Slovenj Gradec, Slovenia
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Alicante, Spain
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Barcelona, Spain
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Elche, Spain
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Granada, Spain
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Guadalajara, Spain
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Madrid, Spain
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Santiago de Compostela, Spain
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Seville, Spain
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Geneva, Switzerland
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Sankt Gallen, Switzerland
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: 31284771DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Daiichi Sankyo US Contact for Clinical Trial Results
- Organization
- Daiichi Sankyo, Inc.
Study Officials
- STUDY DIRECTOR
Global Clinical Leader
Daiichi Sankyo
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 11, 2014
Study Start
January 16, 2015
Primary Completion
January 6, 2017
Study Completion
January 12, 2017
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.
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/