Fibromyalgia
Conditions
Keywords
ACR 1990 Fibromyalgia, Fibromyalgia Impact Questionnaire
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.
Interventions
DRUGAD 337
Sponsors
Sosei
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Fibromyalgia Impact Questionnaire total score after 4 weeks treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
| These will be | — |
| 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 | — |
| Tender point assessment (ACR 1990 criteria) scores at weeks 2, 4 at end of study and overall | — |
Countries
United Kingdom
Outcome results
None listed