Fibromyalgia
Conditions
Interventions
Product Name: AD 337 20 mg Capsule
Product Code: AD 337
Pharmaceutical Form: Capsule, hard
CAS Number: 23327-57-3
Current Sponsor code:
Sponsors
Arakis Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who meet all the following criteria will be eligible to participate in the study: Female subjects. Subjects aged 18 - 65 years. Subjects who meet ACR 1990 criteria for the classification of fibromyalgia and have a history of widespread musculoskeletal pain for at least 3 months. Subjects who have pain in 11 or more of 18 tender point sites on digital palpation. Subjects who are able and willing to discontinue central nervous system active therapies, including antidepressants; sedative-hypnotic agents; muscle relaxants and centrally-acting analgesics during the study. Subjects who are able to read, speak and understand English, capable of understanding the study requirements. and willing to cooperate with the study instructions. Subjects who are able and willing to provide written informed consent. Subjects who complete the FIQ questionnaire at visit 1. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects who are pregnant or breast feeding or unable or unwilling to use an adequate method of contraception as defined by the protocol. Subjects whose primary pain originates from traumatic injury. Subjects with concurrent inflammatory diseases including rheumatic disease, rheumatoid arthritis and inflammatory arthritis; hypothyroidism, hyperparathyroidism, autoimmune disease or unstable metabolic disease. Subjects with current or recent history of psychosis, hypomania, mania, dementia or other serious psychiatric disorder which, in the opinion of the investigator, would make then unsuitable to participate in the study. Subjects with an average QTc. interval greater than 470ms at their screening visit. Evidence of alcohol or substance abuse by the subject in past 6 months. Use of an investigational drug within 30 days of the subject's screening visit. Subjects who are intolerant to serotonin and noradrenaline reuptake inhibitors (SNRIs) or nefopam. Subjects with clinically significant condition(s) such as (but not limited to) convulsive disorders, stroke, cardiac arrhythmia or cancers (all), that in the opinion of the Investigator, may compromise their safety or compliance, interfere with evaluation, or preclude completion of the study. Subjects with a history of glaucoma or urinary retention. Subjects with serum creatinine >1.5 x upper limit of normal [ULN] or liver function tests > 3 x ULN or other abnormal laboratory values at screening which indicates an underlying unknown concomitant disease that requires further evaluation. Subjects who have failed to respond to 2 or more adequate regimens of 2 different classes of antidepressants for depression or fibromyalgia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of AD 337 in the treatment of fibromyalgia when administered orally 3 times daily for 28 days.; Secondary Objective: To determine the safety and tolerability of AD 337 over 4 weeks of treatment. To explore the relationship between AD 337 plasma exposure and individual efficacy and safety criteria. ;Primary end point(s): The primary endpoint will be the fibromyalgia Impact Questionnaire (FIQ) total score after 4 weeks treatment. | — |
Countries
United Kingdom
Outcome results
None listed