An Open-Label Extension Study of DS-5565 for 52 Weeks in Pain Associated With Fibromyalgia

NCT ID: NCT02234583

Last Updated: 2020-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2485 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-04
• Study Completion Date: 2017-04-19

Brief Summary

This is an open-label study of DS-5565 in subjects who either completed participation in a preceding Phase 3 study of DS-5565 in fibromyalgia (FM); i.e. DS5565-A-E309 (NCT02146430), DS5565-A-E310 (NCT02187471), or DS5565-A-E311 (NCT02187159) or are de novo subjects. Eligible subjects will be assigned to receive open-label DS-5565 for 52 weeks. All subjects will receive DS-5565 15 mg once daily (QD) for the first three weeks of the treatment period. After three weeks, subjects may be titrated to 15 mg twice daily (BID) based on protocol-specified criteria.

Conditions

Pain Associated With Fibromyalgia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DS-5565

Participants receive 15 mg DS-5565 administered once or twice daily. Each participant's dose can be titrated up or down based on the investigator's decision. Analysis will be based on the dose modality at the time of data collection.

Group Type: EXPERIMENTAL

DS-5565

Intervention Type: DRUG

DS-5565 15 mg tablet for oral administration

Interventions

DS-5565

DS-5565 15 mg tablet for oral administration

Intervention Type: DRUG

Other Intervention Names

Investigational product

Eligibility Criteria

Inclusion Criteria

• Able to give written informed consent
• Completed participation (i.e. completed the End-of-Tapering visit) in a preceding study of DS 5565 in FM (DS5565-A-E309, DS5565-A-E310, or DS5565-A-E311)
• 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
• Able to complete subject-reported questionaires per the investigator's judgement
• The subject must not have experienced any significant safety issues during the preceding study that, in the investigator's judgment, would adversely impact the subject's well-being in the long-term extension

De Novo Subjects

• 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 first dose (based on completion of at least 4 daily pain diaries during the 7-day baseline period)
• 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 during the preceding study (for rollover subjects) or within 12 months prior to screening (for de novo subjects) that in the opinion of the investigator would interfere with study participation or assessment of safety and tolerability
• Subjects who are at risk of suicide as defined by their responses to the C-SSRS or in the opinion of the investigator.
• Subjects with severe or uncontrolled depression that, in the judgment of the investigator, makes the subject inappropriate for entry into the study
• Subjects with pain due to other conditions (e.g. DPNP 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
• A diagnosis of untreated sleep apnea or initiation of treatment for sleep apnea within the past 3 months
• Known hypersensitivity to α2δ ligands or other components of the study medications
• Pregnancy or breast-feeding, or intent to become pregnant during the study period
• Abnormal investigative tests (i.e. ECGs) and laboratory values judged by the investigator to be clinically significant at the End-of-Treatment visit (Visit - Week 13) in the preceding study (for rollover subjects) or at screening (for de novo subjects), with particular focus on:

For De Novo Subjects Only

• Unable to undergo pre-study washout of prohibited concomitant medications (as listed in Section 5.2.1 of the protocol)
• Current severe or uncontrolled major depressive disorder or anxiety disorders as assessed by the Mini-international Neuropsychiatric Interview (MINI) interview (Version 6.0) at screening are excluded, but 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
• 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
• Subject is an employee of the study center, an immediate family member* of an employee of the study center, or an employee of Daiichi Sankyo, INC Research, or any of the study vendors supporting this study. *(spouse, parent, child, or sibling, whether biological or legally adopted)

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

Sponsors

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

Mobile, Alabama, United States

Phoenix, Arizona, United States

Anaheim, California, United States

Fresno, California, United States

Fresno, California, United States

Los Alamitos, California, United States

Los Angeles, California, United States

Newport Beach, California, United States

Rancho Mirage, California, United States

Roseville, California, United States

San Diego, California, United States

Santa Ana, California, United States

Santa Barbara, California, United States

Santa Monica, California, United States

Spring Valley, California, United States

Thousand Oaks, California, United States

Tustin, California, United States

Walnut Creek, California, United States

Cromwell, Connecticut, United States

Bradenton, Florida, United States

Brandon, Florida, United States

Brooksville, Florida, United States

Clearwater, Florida, United States

Clearwater, Florida, United States

Coral Springs, Florida, United States

Fort Lauderdale, Florida, United States

Fort Myers, Florida, United States

Hialeah, Florida, United States

Jacksonville, Florida, United States

Kissimmee, Florida, United States

Lakeland, Florida, United States

Leesburg, Florida, United States

Miami, Florida, United States

New Port Richey, Florida, United States

Ocala, Florida, United States

Orlando, Florida, United States

Ormond Beach, Florida, United States

Royal Palm Beach, Florida, United States

St. Petersburg, Florida, United States

Sunrise, Florida, United States

Tampa, Florida, United States

Alpharetta, Georgia, United States

Atlanta, Georgia, United States

Columbus, Georgia, United States

Savannah, Georgia, United States

Smyrna, Georgia, United States

Bolingbrook, Illinois, United States

Chicago, Illinois, United States

Gurnee, Illinois, United States

Melrose Park, Illinois, United States

Oak Brook, Illinois, United States

Evansville, Indiana, United States

Indianapolis, Indiana, United States

West Des Moines, Iowa, United States

Newton, Kansas, United States

Shawnee Mission, Kansas, United States

Wichita, Kansas, United States

Wichita, Kansas, United States

Lexington, Kentucky, United States

Paducah, Kentucky, United States

Lake Charles, Louisiana, United States

Boston, Massachusetts, United States

Fall River, Massachusetts, United States

New Bedford, Massachusetts, United States

Watertown, Massachusetts, United States

Biloxi, Mississippi, United States

Hazelwood, Missouri, United States

Kansas City, Missouri, United States

Springfield, Missouri, United States

St Louis, Missouri, United States

Billings, Montana, United States

Omaha, Nebraska, United States

Las Vegas, Nevada, United States

Berlin, New Jersey, United States

Blackwood, New Jersey, United States

Albuquerque, New Mexico, United States

Brooklyn, New York, United States

Manhasset, New York, United States

New York, New York, United States

North Massapequa, New York, United States

Charlotte, 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

Fargo, North Dakota, United States

Cincinnati, Ohio, United States

Dayton, Ohio, United States

Kettering, Ohio, United States

Tiffin, Ohio, United States

Willoughby, Ohio, United States

Oklahoma City, Oklahoma, United States

Tulsa, Oklahoma, United States

Eugene, Oregon, United States

Medford, Oregon, United States

Portland, Oregon, United States

Salem, Oregon, United States

Tipton, Pennsylvania, United States

Wyomissing, Pennsylvania, United States

Anderson, South Carolina, United States

Fountain Inn, South Carolina, United States

Greer, South Carolina, United States

Dakota Dunes, South Dakota, United States

Rapid City, South Dakota, United States

Knoxville, Tennessee, United States

New Tazewell, Tennessee, United States

Tullahoma, Tennessee, United States

Dallas, Texas, United States

Lubbock, Texas, United States

Plano, Texas, United States

San Antonio, Texas, United States

Salt Lake City, Utah, United States

Virginia Beach, Virginia, United States

Bellevue, Washington, United States

Seattle, Washington, United States

Wenatchee, Washington, 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

Sherwood, Queensland, Australia

Southport, Queensland, Australia

Woodville, South Australia, Australia

Hobart, Tasmania, Australia

Clayton, Victoria, Australia

Malvern East, Victoria, Australia

Klagenfurt, , Austria

Senftenberg, , Austria

Vienna, , Austria

Burgas, , Bulgaria

Pleven, , Bulgaria

Plovdiv, , Bulgaria

Rousse, , Bulgaria

Sevlievo, , Bulgaria

Sofia, , Bulgaria

Targovishte, , Bulgaria

Varna, , Bulgaria

Penticton, British Columbia, Canada

Vancouver, British Columbia, Canada

Winnipeg, Manitoba, Canada

Burlington, Ontario, Canada

Kitchener, Ontario, Canada

London, Ontario, Canada

Markham, Ontario, Canada

Markham, Ontario, Canada

Mississauga, Ontario, Canada

Newmarket, Ontario, Canada

Oshawa, Ontario, Canada

Sarnia, Ontario, Canada

Sarnia, Ontario, Canada

Toronto, Ontario, Canada

Toronto, Ontario, Canada

Pointe-Claire, Quebec, Canada

Québec, Quebec, Canada

Sherbrooke, Quebec, Canada

Antofagasta, Region 11, Chile

Puerto Varas, Region X, Chile

Choceň, , Czechia

Pilsen, , Czechia

Prague, , Czechia

Rychnov nad Kněžnou, , Czechia

Říčany, , Czechia

Aalborg, , Denmark

Odense, , Denmark

Tallinn, , Estonia

Tartu, , Estonia

Hyvinkää, , Finland

Kuopio, , Finland

Saint-Etienne, Cedex, France

Douai, Nord, France

Élancourt, , France

Berlin, , Germany

Böhlen, , Germany

Dresden, , Germany

Hanover, , Germany

Leipzig, , Germany

Magdeburg, , Germany

Mainz, , Germany

Stadtroda, , Germany

Balassagyarmat, , Hungary

Budapest, , Hungary

Debrecen, , Hungary

Nyíregyháza, , Hungary

Baldone, , Latvia

Balvi, , Latvia

Jēkabpils, , Latvia

Liepāja, , Latvia

Ogre, , Latvia

Riga, , Latvia

Ventspils, , Latvia

Kaunas, , Lithuania

Klaipėda, , Lithuania

Vilnius, , Lithuania

Auckland, , New Zealand

Hamilton, , New Zealand

Nelson, , New Zealand

Tauranga, , New Zealand

Wellington, , New Zealand

Ålesund, , Norway

Hamar, , Norway

Hønefoss, , Norway

Kløfta, , Norway

Lillehammer, , Norway

Stavanger, , Norway

Elblag, , Poland

Gdansk, , Poland

Katowice, , Poland

Krakow, , Poland

Lublin, , Poland

Nadarzyn, , Poland

Nowa Sól, , Poland

Torun, , Poland

Tychy, , Poland

Warsaw, , Poland

Wroclaw, , Poland

Aveiro, , Portugal

Guimarães, , Portugal

Porto, , Portugal

Vila Nova de Gaia, , Portugal

Ponce, , Puerto Rico

San Juan, , Puerto Rico

Bacau, , Romania

Bucharest, , Romania

Târgu Mureş, , Romania

Krasnoyarsk, , Russia

Moscow, , Russia

Nizhniy Novgarad, , Russia

Stavropol, , Russia

Belgrade, , Serbia

Banská Bystrica, , Slovakia

Bratislava, , Slovakia

Dubnica nad Váhom, , Slovakia

Galanta, , Slovakia

Krompachy, , Slovakia

Piešťany, , Slovakia

Prešov, , Slovakia

Ljubljana, , Slovenia

Slovenj Gradec, , Slovenia

Bayview, Chatsworth, South Africa

Johannesburg, Gautang, South Africa

Pretoria, Gautang, South Africa

Durban, KwaZulu-Natal, South Africa

Cape Town, Western Cape, South Africa

Somerset West, Western Cape, South Africa

Stellenbosch, , South Africa

Santiago de Compostela, A Coruna, Spain

Barcelona, , Spain

Granada, , Spain

Madrid, , Spain

Dnipropetrovsk, , Ukraine

Ivano-Frankivsk, , Ukraine

Kharkiv, , Ukraine

Kherson, , Ukraine

Kyiv, , Ukraine

Lviv, , Ukraine

Vinnytsia, , Ukraine

Zaporizhzhia, , Ukraine

Penzance, Cornwall, United Kingdom

Chesterfield, Derbyshire, United Kingdom

Romford, Essex, United Kingdom

Manchester, Greater Manchester, United Kingdom

Blackpool, Lancashire, United Kingdom

Thornton-Cleveleys, Lancashire, United Kingdom

Wigan, Lancashire, United Kingdom

Stourton, Leeds, United Kingdom

Salford, Manchester, United Kingdom

Southport, Merseyside, United Kingdom

Wellingborough, Northamptonshire, United Kingdom

Belfast, Northern Ireland, United Kingdom

Cannock, Staffordshire, United Kingdom

North Shields, Tyne and Wear, United Kingdom

Atherstone, Warwickshire, United Kingdom

Torpoint, , United Kingdom

Countries

United States; Australia; Austria; Bulgaria; Canada; Chile; Czechia; Denmark; Estonia; Finland; France; Germany; Hungary; Latvia; Lithuania; New Zealand; Norway; Poland; Portugal; Puerto Rico; Romania; Russia; Serbia; Slovakia; Slovenia; South Africa; Spain; Ukraine; 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)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2013-005164-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

DS5565-A-E312

Identifier Type: -

Identifier Source: org_study_id