Treatment of Pain Associated With Fibromyalgia | NCT02187159 | Trialant

Treatment of Pain Associated With Fibromyalgia | NCT02187159 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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.

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Mobile, Alabama 36608, United States

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Phoenix, Arizona 85027, United States

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Scottsdale, Arizona, United States

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Little Rock, Arkansas 72205, United States

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Fresno, California 93710, United States

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Glendale, California 91204, United States

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Orange, California 92868, United States

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Oxnard, California, United States

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Richmond, California 94806, United States

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Sacramento, California, United States

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San Diego, California 92103, United States

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Santa Ana, California 92705, United States

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Santa Barbara, California 93108, United States

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Simi Valley, California 93065, United States

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New London, Connecticut, United States

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Bradenton, Florida 34208, United States

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Brandon, Florida 33511, United States

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DeBary, Florida 32713, United States

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Fort Myers, Florida 33916, United States

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Hialeah, Florida 33013, United States

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Homestead, Florida 33030, United States

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Lake Mary, Florida, United States

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Miami, Florida 33126, United States

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North Miami, Florida 33161, United States

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Ocala, Florida 34471, United States

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Plant City, Florida 33563, United States

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Tampa, Florida 33614, United States

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Alpharetta, Georgia 30005, United States

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Atlanta, Georgia 30328, United States

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Atlanta, Georgia 30342, United States

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Columbus, Georgia 31904, United States

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Savannah, Georgia 31405, United States

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Boise, Idaho 83713, United States

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Meridian, Idaho 83642, United States

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Chicago, Illinois 60611, United States

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Gurnee, Illinois 60031, United States

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Naperville, Illinois 60563, United States

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Evansville, Indiana 47714, United States

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West Des Moines, Iowa 50266, United States

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Shawnee Mission, Kansas 66218, United States

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Wichita, Kansas 67205, United States

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Lexington, Kentucky 40509, United States

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Monroe, Louisiana 71201, United States

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Traverse City, Michigan 49684, United States

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Jackson, Mississippi 39202, United States

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Omaha, Nebraska 68134, United States

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Las Vegas, Nevada 89123, United States

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Brooklyn, New York 11229, United States

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Manhasset, New York, United States

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New York, New York 10128, United States

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Staten Island, New York 10312, United States

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Benson, North Carolina, United States

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Greensboro, North Carolina 27408, United States

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Raleigh, North Carolina 27609, United States

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Salisbury, North Carolina, United States

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Fargo, North Dakota 58103, United States

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Cleveland, Ohio 44122, United States

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Columbus, Ohio, United States

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Dayton, Ohio 45424, United States

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Garfield Heights, Ohio 44125, United States

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Middleburg Heights, Ohio, United States

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Tiffin, Ohio 44883, United States

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Oklahoma City, Oklahoma 73103, United States

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Tulsa, Oklahoma 74104, United States

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Salem, Oregon 97301, United States

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Duncansville, Pennsylvania 16635, United States

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Warwick, Rhode Island, United States

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Anderson, South Carolina 29621, United States

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Charleston, South Carolina 29406, United States

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Greer, South Carolina 29650, United States

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Rock Hill, South Carolina 28209, United States

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Bristol, Tennessee 37620, United States

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Knoxville, Tennessee 37919, United States

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New Tazewell, Tennessee 37825, United States

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Austin, Texas 78705, United States

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Dallas, Texas 75231, United States

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Houston, Texas 77070, United States

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Houston, Texas 77089, United States

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San Antonio, Texas 78229, United States

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Sealy, Texas 77474, United States

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Sugar Land, Texas 77479, United States

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Salt Lake City, Utah 84102, United States

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Norfolk, Virginia 23507, United States

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Richmond, Virginia 23294, United States

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Kirkland, Washington 98033, United States

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Charleston, West Virginia 25304, United States

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Camperdown, New South Wales, Australia

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Campsie, New South Wales 2194, Australia

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Coffs Harbour, New South Wales 2450, Australia

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St Leonards, New South Wales, Australia

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Maroochydore, Queensland 4558, Australia

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Sherwood, Queensland, Australia

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Southport, Queensland 4215, Australia

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Woodsville, South Australia, Australia

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Hobart, Tasmania 7000, Australia

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Clayton, Victoria, Australia

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Malvern East, Victoria 3145, Australia

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Burgas, Bulgaria

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Pleven, Bulgaria

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Plovdiv, Bulgaria

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Rousse, Bulgaria

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Sevlievo, Bulgaria

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Sofia, Bulgaria

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Targovishte, Bulgaria

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Varna, Bulgaria

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Tallinn, Estonia

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Tartu, 51013, Estonia

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Balassagyarmat, Hungary

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Budapest, Hungary

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Debrecen, Hungary

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Esztergom, Hungary

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Kistarcsa, Hungary

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Nyíregyháza, Hungary

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Szeged, Hungary

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Veszprém, Hungary

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Ahmedabad, Gujarat, India

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Surat, Gujarat, India

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Bangalore, Karnataka, India

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Hubli, Karnataka, India

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Pune, Maharashtra, India

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Jaipur, Rajasthan, India

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Lucknow, VP, India

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Baldone, LV-2155, Latvia

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Balvi, Latvia

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Jēkabpils, LV-5201, Latvia

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Liepāja, LV-3401, Latvia

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Ogre, LV-5001, Latvia

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Riga, Latvia

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Ventspils, Latvia

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Auckland, 2025, New Zealand

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Hamilton, 3204, New Zealand

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Nelson, 7010, New Zealand

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Tauranga, 3110, New Zealand

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Wellington, 6242, New Zealand

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Bacau, Romania

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Bucharest, Romania

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Cluj-Napoca, Romania

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Oradea, Romania

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Târgu Mureş, Romania

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Ivanovo, Russia

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Moscow, Russia

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Orenburgsky, Russia

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Pyatigorski, Russia

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Saint Petersburg, Russia

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Stavropol, Russia

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Vladikavkaz, Russia

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Yaroslav, Russia

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Banská Bystrica, 974 04, Slovakia

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Bratislava, 821 08, Slovakia

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Dubnica nad Váhom, 018 41, Slovakia

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Galanta, Slovakia

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Krompachy, Slovakia

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Piešťany, Slovakia

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Prešov, Slovakia

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Reading, Berkshire RG7 3SQ, United Kingdom

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Penzance, Cornwall, United Kingdom

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Chesterfield, Derbyshire S40 4AA, United Kingdom

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Poole, Dorset, United Kingdom

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Romford, Essex, United Kingdom

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Blackpool, Lancashire, United Kingdom

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Thornton-Cleveleys, Lancashire, United Kingdom

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Wigan, Lancashire, United Kingdom

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Salford, Manchester, United Kingdom

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Southport, Merseyside, United Kingdom

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Wellingborough, Northamptonshire NN8 4RW, United Kingdom

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Barnsley, South Yorkshire, United Kingdom

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Cannock, Staffordshire, United Kingdom

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North Shields, TYNE and WEAR, United Kingdom

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Atherstone, Warwickshire CV9 1EU, United Kingdom

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Dudley, WEST Midlands, United Kingdom

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Belfast, BT7 2EB, United Kingdom

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Leeds, United Kingdom

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Manchester, United Kingdom

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Torpoint, United Kingdom