Fibromyalgia, Migraine
Conditions
Brief summary
Patients with fibromyalgia & migraine are randomized to receive zonisamide or placebo.
Detailed description
Study was not conducted due to logistical problems
Interventions
DRUGzonisamide
zonisamide 100 mg -300 mg daily vs placebo
Sponsors
Eisai Inc.
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 18-65 with fibromyalgia & migraine
Exclusion criteria
* allergy sulfa, liver or kidney disease, pregnant or not using contraception
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual analogue score | assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment | assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment |
| Tender point count | assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment | assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment |
| Headache index | assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment | assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep efficiency | assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment | assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment |
Countries
United States
Outcome results
None listed