Treatment of Pain Associated With Fibromyalgia

NCT ID: NCT02146430

Last Updated: 2020-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1293 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-27
• Study Completion Date: 2016-07-14

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 subjects 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

DS-5565 QD

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

Group Type: EXPERIMENTAL

DS-5565

Intervention Type: DRUG

DS-5565 15 mg tablet for oral administration

Placebo tablet

Intervention Type: DRUG

Placebo tablet (matching DS-5565) for oral administration

Placebo capsule

Intervention Type: DRUG

Placebo capsule (matching pregabalin) for oral administration

DS-5565 BID

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

Group Type: EXPERIMENTAL

DS-5565

Intervention Type: DRUG

DS-5565 15 mg tablet for oral administration

Placebo capsule

Intervention Type: DRUG

Placebo capsule (matching pregabalin) for oral administration

Pregabalin

Participants take one pregabalin capsule and one placebo tablet BID

Group Type: ACTIVE_COMPARATOR

Pregabalin

Intervention Type: DRUG

Pregabalin 150 mg capsule for oral administration

Placebo tablet

Intervention Type: DRUG

Placebo tablet (matching DS-5565) for oral administration

Placebo

Participants take one each of placebo tablet and capsule BID

Group Type: PLACEBO_COMPARATOR

Placebo tablet

Intervention Type: DRUG

Placebo tablet (matching DS-5565) for oral administration

Placebo capsule

Intervention Type: DRUG

Placebo capsule (matching pregabalin) for oral administration

Interventions

DS-5565

DS-5565 15 mg tablet for oral administration

Intervention Type: DRUG

Pregabalin

Pregabalin 150 mg capsule for oral administration

Intervention Type: DRUG

Placebo tablet

Placebo tablet (matching DS-5565) for oral administration

Intervention Type: DRUG

Placebo capsule

Placebo capsule (matching pregabalin) for oral administration

Intervention Type: DRUG

Other Intervention Names

mirogabalin; Lyrica; Placebo matching DS-5565; Placebo matching pregabalin

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years
• Able to give written informed consent
• Able to complete participant-reported questionnaires per the investigator's judgment
• At screening, participants must meet the 1990 American College of Rheumatology (ACR) criteria for fibromyalgia (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.

Exclusion Criteria

• 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
• Participants 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.
• Participants 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
• Participant 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.
• Participants 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.
• Abnormal investigative tests (i.e. electrocardiograms [ECGs]) and laboratory values judged by the investigator to be clinically significant at screening, with particular focus on: a. Abnormal renal function defined as calculated creatinine clearance (CrCl) < 60 mL/min determined by the central laboratory using the modified Cockcroft-Gault equation; blood urea nitrogen> 1.5 × upper limit of normal (ULN); creatine kinase > 3.0 × ULN; serum creatinine > 1.6 mg/dL (> 141.4 μmol/L); b. Abnormal liver function defined as aspartate aminotransferase (AST) > 2.0 × ULN, alanine aminotransferase (ALT) > 2.0 × ULN; alkaline phosphatase > 1.5 × ULN; total bilirubin> 1.2 × ULN. If a subject has total bilirubin > 1.2 ULN, unconjugated and conjugated bilirubin fractions should be analyzed and only participants documented to have Gilbert's syndrome may be enrolled.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Syneos Health

OTHER

Sponsor Role: collaborator

Daiichi Sankyo

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Leader

Role: STUDY_DIRECTOR

Daiichi Sankyo

Locations

Glendale, Arizona, United States

Phoenix, Arizona, United States

Anaheim, California, United States

Beverly Hills, California, United States

Los Alamitos, California, United States

Newport Beach, California, United States

Oakland, California, United States

Rancho Mirage, California, United States

Roseville, California, United States

San Diego, California, United States

Sherman Oaks, California, United States

Torrance, California, United States

Tustin, California, United States

Colorado Springs, Colorado, United States

Denver, Colorado, United States

Cromwell, Connecticut, United States

Danbury, Connecticut, United States

Boynton Beach, Florida, United States

Bradenton, Florida, United States

Brooksville, Florida, United States

Coral Springs, Florida, United States

Gainesville, Florida, United States

Jacksonville, Florida, United States

Lakeland, Florida, United States

Miami, Florida, United States

Ocala, Florida, United States

Orlando, Florida, United States

Port Orange, Florida, United States

Royal Palm Beach, Florida, United States

Sanford, Florida, United States

St. Petersburg, Florida, United States

Savannah, Georgia, United States

Chicago, Illinois, United States

Elwood, Indiana, United States

Indianapolis, Indiana, United States

Newton, Kansas, United States

Wichita, Kansas, United States

Wheaton, Maryland, United States

Boston, Massachusetts, United States

Fall River, Massachusetts, United States

Methuen, Massachusetts, United States

New Bedford, Massachusetts, United States

Southfield, Michigan, United States

Biloxi, Mississippi, United States

Hattiesburg, Mississippi, United States

Kansas City, Missouri, United States

Springfield, Missouri, United States

St Louis, Missouri, United States

Omaha, Nebraska, United States

Las Vegas, Nevada, United States

Berlin, New Jersey, United States

Princeton, New Jersey, United States

Stratford, New Jersey, United States

West Long Branch, New Jersey, United States

Hartsdale, New York, United States

New York, New York, United States

Valley Stream, New York, United States

Williamsville, New York, United States

Charlotte, North Carolina, United States

Durham, North Carolina, United States

Greensboro, North Carolina, United States

High Point, North Carolina, United States

Raleigh, North Carolina, United States

Winston-Salem, North Carolina, United States

Cincinnati, Ohio, United States

Middleburg Heights, Ohio, United States

Toledo, Ohio, United States

Oklahoma City, Oklahoma, United States

Medford, Oregon, United States

Allentown, Pennsylvania, United States

Mechanicsburg, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Anderson, South Carolina, United States

Fountain Inn, South Carolina, United States

Greenville, South Carolina, United States

Summerville, South Carolina, United States

Dakota Dunes, South Dakota, United States

Tullahoma, Tennessee, United States

Allen, Texas, United States

Austin, Texas, United States

Carrollton, Texas, United States

Dallas, Texas, United States

DeSoto, Texas, United States

Houston, Texas, United States

Lubbock, Texas, United States

Mesquite, Texas, United States

Plano, Texas, United States

Richardson, Texas, United States

Sugar Land, Texas, United States

Bountiful, Utah, United States

Seattle, Washington, United States

Morgantown, West Virginia, United States

Burlington, , Canada

Edmonton, , Canada

Kentville, , Canada

Kitchener, , Canada

London, , Canada

Markham, , Canada

Mississauga, , Canada

Newmarket, , Canada

Oshawa, , Canada

Penticton, , Canada

Pointe-Claire, , Canada

Sarnia, , Canada

Sherbrooke, , Canada

Toronto, , Canada

Vancouver, , Canada

Winnipeg, , Canada

Choceň, , Czechia

Prague, , Czechia

Rychnov nad Kněžnou, , Czechia

Říčany, , Czechia

Aalborg, , Denmark

Odense, , Denmark

Hyvinkää, , Finland

Kokkola, , Finland

Amiens, , France

Cubray, , France

Élancourt, , France

Grenoble, , France

Paris, , France

Saint-Etienne, , France

Toulouse, , France

Bad Doberan, , Germany

Berlin, , Germany

Böhlen, , Germany

Chemnitz, , Germany

Cologne, , Germany

Cottbus, , Germany

Dresden, , Germany

Eichstätt, , Germany

Essen, , Germany

Fellbach, , Germany

Frankfurt, , Germany

Hamburg, , Germany

Jena, , Germany

Leipzig, , Germany

Mainz, , Germany

Marburg, , Germany

Mönchengladbach, , Germany

Munich, , Germany

Rodgau, , Germany

Stadtroda, , Germany

Wallerfing, , Germany

Weinheim, , Germany

Westerstede, , Germany

Wiesbaden, , Germany

Würzburg, , Germany

Beek, , Netherlands

Leiden, , Netherlands

Sneek, , Netherlands

Ålesund, , Norway

Hamar, , Norway

Hønefoss, , Norway

Kløfta, , Norway

Lier, , Norway

Lillehammer, , Norway

Stavanger, , Norway

Belgrade, , Serbia

Kragujevac, , Serbia

Niš, , Serbia

Novi Sad, , Serbia

Borås, , Sweden

Mölndal, , Sweden

Stockholm, , Sweden

Countries

United States; Canada; Czechia; Denmark; Finland; France; Germany; Netherlands; Norway; Serbia; Sweden

References

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.

Reference Type: DERIVED

PMID: 31284771 (View on PubMed)

Other Identifiers

2013-005161-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

DS5565-A-E309

Identifier Type: -

Identifier Source: org_study_id