- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00259636
Zonisamide for Fibromyalgia & Migraine
May 31, 2011 updated by: University of Pittsburgh
Patients with fibromyalgia & migraine are randomized to receive zonisamide or placebo.
Study Overview
Detailed Description
Study was not conducted due to logistical problems
Study Type
Interventional
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15206
- University of Pittsburgh
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18-65 with fibromyalgia & migraine
Exclusion Criteria:
- allergy sulfa, liver or kidney disease, pregnant or not using contraception
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual analogue score
Time Frame: 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
|
assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment
|
Tender point count
Time Frame: 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
|
assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment
|
Headache index
Time Frame: 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
|
assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep efficiency
Time Frame: 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
|
assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2004
Primary Completion (ACTUAL)
January 1, 2008
Study Completion (ACTUAL)
January 1, 2008
Study Registration Dates
First Submitted
November 26, 2005
First Submitted That Met QC Criteria
November 26, 2005
First Posted (ESTIMATE)
November 29, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
June 1, 2011
Last Update Submitted That Met QC Criteria
May 31, 2011
Last Verified
May 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Headache Disorders, Primary
- Headache Disorders
- Fibromyalgia
- Myofascial Pain Syndromes
- Migraine Disorders
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Membrane Transport Modulators
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Zonisamide
Other Study ID Numbers
- EISAI 51-345-749
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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