A Multicentre Trial to Determine the Efficacy and Safety of AD-337 in the Treatment of Fibromyalgia
Phase 2
Completed
- Conditions
- Fibromyalgia
- Registration Number
- NCT00377039
- Lead Sponsor
- Sosei
- Brief Summary
This is a multicentre, randomized, double-blind, placebo controlled, parallel group exploratory study to investigate the efficacy, safety and tolerability of AD 337 in the treatment of fibromyalgia in female subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 100
Inclusion Criteria
- Female
- Age 18-65
- Meet ACR 1990 criteria for classification of Fibromyalgia
- Able and willing to discontinue CNS active therapies
Exclusion Criteria
- If pain is NOT primarily due to Fibromyalgia
- Current or prior history of serious psychiatric disorder
- Pregnant/breastfeeding
- QTc > 470ms
- Failure to respond to 2 or more adequate regimes of different classes of antidepressants.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The Fibromyalgia Impact Questionnaire total score after 4 weeks treatment
- Secondary Outcome Measures
Name Time Method These will be FIQ Total score at weeks 1, 2, 3, at end of study and overall FIQ subscales at weeks 1, 2, 3, 4 at end of study and overall Short form McGill Pain questionnaire subscales at weeks 1, 2, 3, 4 at end of study and overall Tender point assessment (ACR 1990 criteria) scores at weeks 2, 4 at end of study and overall Hospital Anxiety and Depression Scale subscales at weeks 2, 4 and overall Fibromyalgia Health Assessment Questionnaire total score at weeks 1, 2, 3, 4 at end of study and overall
Trial Locations
- Locations (1)
David L Scott
🇬🇧London, United Kingdom