Treatment of Pain Associated With Fibromyalgia

NCT ID: NCT02187471

Last Updated: 2020-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1301 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-16
• Study Completion Date: 2017-01-12

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.

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

Placebo

Participants take one each of placebo tablet and capsule, twice daily (BID)

Group Type: PLACEBO_COMPARATOR

Placebo tablet

Intervention Type: DRUG

Placebo tablet for oral use, matching DS-5565 tablet

Placebo capsule

Intervention Type: DRUG

Placebo capsule for oral use, matching pregabalin capsule

Pregabalin

Participants take one pregabalin capsule and one placebo tablet BID

Group Type: OTHER

Pregabalin

Intervention Type: DRUG

Pregabalin capsule for oral use; 75 mg capsule for one week, then 150 mg capsule

Placebo tablet

Intervention Type: DRUG

Placebo tablet for oral use, matching DS-5565 tablet

DS-5565 15 mg QD

Participants 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)

Group Type: EXPERIMENTAL

DS-5565

Intervention Type: DRUG

DS-5565 15 mg QD or BID; tablet for oral use

Placebo tablet

Intervention Type: DRUG

Placebo tablet for oral use, matching DS-5565 tablet

Placebo capsule

Intervention Type: DRUG

Placebo capsule for oral use, matching pregabalin capsule

DS-5565 15 mg BID

Participants take one placebo capsule with one DS-5565 tablet BID

Group Type: EXPERIMENTAL

DS-5565

Intervention Type: DRUG

DS-5565 15 mg QD or BID; tablet for oral use

Placebo capsule

Intervention Type: DRUG

Placebo capsule for oral use, matching pregabalin capsule

Interventions

DS-5565

DS-5565 15 mg QD or BID; tablet for oral use

Intervention Type: DRUG

Pregabalin

Pregabalin capsule for oral use; 75 mg capsule for one week, then 150 mg capsule

Intervention Type: DRUG

Placebo tablet

Placebo tablet for oral use, matching DS-5565 tablet

Intervention Type: DRUG

Placebo capsule

Placebo capsule for oral use, matching pregabalin capsule

Intervention Type: DRUG

Other Intervention Names

Mirogabalin; Other treatment - not comparator; Tablet Control; Capsule Control

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 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.
• 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

Birmingham, Alabama, United States

Huntsville, Alabama, United States

Phoenix, Arizona, United States

Scottsdale, Arizona, United States

Tempe, Arizona, United States

Tucson, Arizona, United States

Anaheim, California, United States

Covina, California, United States

El Cajon, California, United States

Encino, California, United States

Huntington Beach, California, United States

Lakewood, California, United States

Lomita, California, United States

Los Angeles, California, United States

National City, California, United States

Northridge, California, United States

Oceanside, California, United States

Sacramento, California, United States

Upland, California, United States

Walnut Creek, California, United States

Boca Raton, Florida, United States

DeLand, Florida, United States

Edgewater, Florida, United States

Fort Lauderdale, Florida, United States

Fort Myers, Florida, United States

Hialeah, Florida, United States

Largo, Florida, United States

Lauderdale Lakes, Florida, United States

Maitland, Florida, United States

Miami, Florida, United States

Orlando, Florida, United States

Sunrise, Florida, United States

Tamarac, Florida, United States

Tampa, Florida, United States

Vero Beach, Florida, United States

West Palm Beach, Florida, United States

Winter Haven, Florida, United States

Winter Park, Florida, United States

Dawsonville, Georgia, United States

Marietta, Georgia, United States

Smyrna, Georgia, United States

Chicago, Illinois, United States

Evansville, Indiana, United States

Granger, Indiana, United States

Overland Park, Kansas, United States

Owensboro, Kentucky, United States

Lake Charles, Louisiana, United States

New Orleans, Louisiana, United States

Frederick, Maryland, United States

Brockton, Massachusetts, United States

North Dartmouth, Massachusetts, United States

Ann Arbor, Michigan, United States

Ann Arbor, Michigan, United States

Lansing, Michigan, United States

Rochester Hills, Michigan, United States

Florissant, Missouri, United States

Hazelwood, Missouri, United States

O'Fallon, Missouri, United States

Bellevue, Nebraska, United States

Newington, New Hampshire, United States

Albuquerque, New Mexico, United States

Brooklyn, New York, United States

Cedarhurst, New York, United States

Rochester, New York, United States

Charlotte, North Carolina, United States

Raleigh, North Carolina, United States

Winston-Salem, North Carolina, United States

Minot, North Dakota, United States

Cincinnati, Ohio, United States

Columbus, Ohio, United States

Dayton, Ohio, United States

Middleburg Heights, Ohio, United States

Oklahoma City, Oklahoma, United States

Portland, Oregon, United States

Altoona, Pennsylvania, United States

Media, Pennsylvania, United States

Wyomissing, Pennsylvania, United States

Greenville, South Carolina, United States

Mt. Pleasant, South Carolina, United States

Chattanooga, Tennessee, United States

Franklin, Tennessee, United States

Knoxville, Tennessee, United States

Memphis, Tennessee, United States

Austin, Texas, United States

Houston, Texas, United States

Lake Jackson, Texas, United States

San Antonio, Texas, United States

Norfolk, Virginia, United States

Richmond, Virginia, United States

Bellevue, Washington, United States

Richland, Washington, United States

CABA, Buenos Aires, Argentina

La Plata, Buenos Aires, Argentina

Lanús, Buenos Aires, Argentina

Mar del Plata, Buenos Aires, Argentina

Quilmes, Buenos Aires, Argentina

San Fernando, Buenos Aires, Argentina

Rosario, Santa Fe Province, Argentina

Córdoba, , Argentina

San Miguel de Tucumán, , Argentina

Santa Fe, , Argentina

Klagenfurt, , Austria

Senftenberg, , Austria

Vienna, , Austria

Minsk, , Belarus

Vitebsk, , Belarus

Brussels, , Belgium

Edegem, , Belgium

Gozée, , Belgium

Oostham, , Belgium

Antofagasta, , Chile

Providencia, , Chile

Puerto Varas, , Chile

Viña del Mar, , Chile

Barranquilla, , Colombia

Bogotá, , Colombia

Haifa, , Israel

Kfar Saba, , Israel

Ramat Gan, , Israel

Tel Aviv, , Israel

Cuautitlán Izcalli, , Mexico

Durango, , Mexico

Guadalajara, , Mexico

León, , Mexico

Mexico City, , Mexico

Elblag, , Poland

Gdansk, , Poland

Katowice, , Poland

Krakow, , Poland

Lublin, , Poland

Nadarzyn, , Poland

Nowa Sól, , Poland

Torun, , Poland

Tychy, , Poland

Warsaw, , Poland

Aveiro, , Portugal

Braga, , Portugal

Guimarães, , Portugal

Lisbon, , Portugal

Ponte de Lima, , Portugal

Porto, , Portugal

Vila Nova de Gaia, , Portugal

Ljubljana, , Slovenia

Slovenj Gradec, , Slovenia

Alicante, , Spain

Barcelona, , Spain

Elche, , Spain

Granada, , Spain

Guadalajara, , Spain

Madrid, , Spain

Santiago de Compostela, , Spain

Seville, , Spain

Geneva, , Switzerland

Sankt Gallen, , Switzerland

Countries

United States; Argentina; Austria; Belarus; Belgium; Chile; Colombia; Israel; Mexico; Poland; Portugal; Slovenia; Spain; Switzerland

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

2013-005162-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

DS5565-A-E310

Identifier Type: -

Identifier Source: org_study_id