Treatment of Pain Associated With Fibromyalgia

NCT ID: NCT02187159

Last Updated: 2020-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-07-07

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

Study Design

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

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 DS5565) 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 DS5565) 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 DS5565) 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 DS5565) 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 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.

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
• 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.
• 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 subjects 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

Mobile, Alabama, United States

Phoenix, Arizona, United States

Scottsdale, Arizona, United States

Little Rock, Arkansas, United States

Fresno, California, United States

Glendale, California, United States

Orange, California, United States

Oxnard, California, United States

Richmond, California, United States

Sacramento, California, United States

San Diego, California, United States

Santa Ana, California, United States

Santa Barbara, California, United States

Simi Valley, California, United States

New London, Connecticut, United States

Bradenton, Florida, United States

Brandon, Florida, United States

DeBary, Florida, United States

Fort Myers, Florida, United States

Hialeah, Florida, United States

Homestead, Florida, United States

Lake Mary, Florida, United States

Miami, Florida, United States

North Miami, Florida, United States

Ocala, Florida, United States

Plant City, Florida, United States

Tampa, Florida, United States

Alpharetta, Georgia, United States

Atlanta, Georgia, United States

Atlanta, Georgia, United States

Columbus, Georgia, United States

Savannah, Georgia, United States

Boise, Idaho, United States

Meridian, Idaho, United States

Chicago, Illinois, United States

Gurnee, Illinois, United States

Naperville, Illinois, United States

Evansville, Indiana, United States

West Des Moines, Iowa, United States

Shawnee Mission, Kansas, United States

Wichita, Kansas, United States

Lexington, Kentucky, United States

Monroe, Louisiana, United States

Traverse City, Michigan, United States

Jackson, Mississippi, United States

Omaha, Nebraska, United States

Las Vegas, Nevada, United States

Brooklyn, New York, United States

Manhasset, New York, United States

New York, New York, United States

Staten Island, New York, United States

Benson, North Carolina, United States

Greensboro, North Carolina, United States

Raleigh, North Carolina, United States

Salisbury, North Carolina, United States

Fargo, North Dakota, United States

Cleveland, Ohio, United States

Columbus, Ohio, United States

Dayton, Ohio, United States

Garfield Heights, Ohio, United States

Middleburg Heights, Ohio, United States

Tiffin, Ohio, United States

Oklahoma City, Oklahoma, United States

Tulsa, Oklahoma, United States

Salem, Oregon, United States

Duncansville, Pennsylvania, United States

Warwick, Rhode Island, United States

Anderson, South Carolina, United States

Charleston, South Carolina, United States

Greer, South Carolina, United States

Rock Hill, South Carolina, United States

Bristol, Tennessee, United States

Knoxville, Tennessee, United States

New Tazewell, Tennessee, United States

Austin, Texas, United States

Dallas, Texas, United States

Houston, Texas, United States

Houston, Texas, United States

San Antonio, Texas, United States

Sealy, Texas, United States

Sugar Land, Texas, United States

Salt Lake City, Utah, United States

Norfolk, Virginia, United States

Richmond, Virginia, United States

Kirkland, Washington, United States

Charleston, West Virginia, United States

Camperdown, New South Wales, Australia

Campsie, New South Wales, Australia

Coffs Harbour, New South Wales, Australia

St Leonards, New South Wales, Australia

Maroochydore, Queensland, Australia

Sherwood, Queensland, Australia

Southport, Queensland, Australia

Woodsville, South Australia, Australia

Hobart, Tasmania, Australia

Clayton, Victoria, Australia

Malvern East, Victoria, Australia

Burgas, , Bulgaria

Pleven, , Bulgaria

Plovdiv, , Bulgaria

Rousse, , Bulgaria

Sevlievo, , Bulgaria

Sofia, , Bulgaria

Targovishte, , Bulgaria

Varna, , Bulgaria

Tallinn, , Estonia

Tartu, , Estonia

Balassagyarmat, , Hungary

Budapest, , Hungary

Debrecen, , Hungary

Esztergom, , Hungary

Kistarcsa, , Hungary

Nyíregyháza, , Hungary

Szeged, , Hungary

Veszprém, , Hungary

Ahmedabad, Gujarat, India

Surat, Gujarat, India

Bangalore, Karnataka, India

Hubli, Karnataka, India

Pune, Maharashtra, India

Jaipur, Rajasthan, India

Lucknow, VP, India

Baldone, , Latvia

Balvi, , Latvia

Jēkabpils, , Latvia

Liepāja, , Latvia

Ogre, , Latvia

Riga, , Latvia

Ventspils, , Latvia

Auckland, , New Zealand

Hamilton, , New Zealand

Nelson, , New Zealand

Tauranga, , New Zealand

Wellington, , New Zealand

Bacau, , Romania

Bucharest, , Romania

Cluj-Napoca, , Romania

Oradea, , Romania

Târgu Mureş, , Romania

Ivanovo, , Russia

Krasnoyarsk, , Russia

Moscow, , Russia

Nizhny Novgorod, , Russia

Orenburgsky, , Russia

Pyatigorski, , Russia

Saint Petersburg, , Russia

Stavropol, , Russia

Vladikavkaz, , Russia

Yaroslav, , Russia

Banská Bystrica, , Slovakia

Bratislava, , Slovakia

Dubnica nad Váhom, , Slovakia

Galanta, , Slovakia

Krompachy, , Slovakia

Piešťany, , Slovakia

Prešov, , Slovakia

Reading, Berkshire, United Kingdom

Penzance, Cornwall, United Kingdom

Chesterfield, Derbyshire, United Kingdom

Poole, Dorset, United Kingdom

Romford, Essex, United Kingdom

Blackpool, Lancashire, United Kingdom

Thornton-Cleveleys, Lancashire, United Kingdom

Wigan, Lancashire, United Kingdom

Salford, Manchester, United Kingdom

Southport, Merseyside, United Kingdom

Wellingborough, Northamptonshire, United Kingdom

Barnsley, South Yorkshire, United Kingdom

Cannock, Staffordshire, United Kingdom

North Shields, TYNE and WEAR, United Kingdom

Atherstone, Warwickshire, United Kingdom

Dudley, WEST Midlands, United Kingdom

Belfast, , United Kingdom

Leeds, , United Kingdom

Manchester, , United Kingdom

Torpoint, , United Kingdom

Countries

United States; Australia; Bulgaria; Estonia; Hungary; India; Latvia; New Zealand; Romania; Russia; Slovakia; United Kingdom

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

2013-005163-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

DS5565-A-E311

Identifier Type: -

Identifier Source: org_study_id