FibromyalgiaPhase 4NCT00259636
Zonisamide for Fibromyalgia & Migraine
A Phase 4 study testing zonisamide in people with Fibromyalgia and Migraine, run by University of Pittsburgh at 1 site in United States.
Trial summary
Patients with fibromyalgia \& migraine are randomized to receive zonisamide or placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia, Migraine
- What is being tested?
- zonisamide
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Jan 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 with fibromyalgia \& migraine
Who cannot join
- allergy sulfa, liver or kidney disease, pregnant or not using contraception
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15206
About this study
Patients with fibromyalgia \& migraine are randomized to receive zonisamide or placebo.
Read the detailed description
Study was not conducted due to logistical problems
- Conditions
- Fibromyalgia, Migraine
- Being tested
- zonisamide
- Medical subject headings
- Fibromyalgia, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zonisamideDrug
zonisamide 100 mg -300 mg daily vs placebo
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue score
assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment
Measured: 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
Measured: 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
Measured: assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment
Secondary outcomes (1)
Sleep efficiency
assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment
Measured: assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2005 (estimated)
- Study startAug 2004
- Primary completionJan 2008
- Study completionJan 2008
Why it stopped: Logistical problems prevented enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Eisai Inc.
- Investigators
- Dawn Marcus, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00259636
- Sponsor's protocol ID
- EISAI 51-345-749
- Status last verified
- May 2011
- First submitted
- 26 Nov 2005
- Last updated
- 1 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zonisamide for Fibromyalgia & Migraine
- ClinicalTrials.gov ID
- NCT00259636
- Acronym / sponsor ID
- EISAI 51-345-749
- Conditions
- Fibromyalgia, Migraine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Logistical problems prevented enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Eisai Inc.
- Study start
- Aug 2004
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 29 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with fibromyalgia \& migraine are randomized to receive zonisamide or placebo.
Detailed description
Study was not conducted due to logistical problems
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18-65 with fibromyalgia \& migraine
Key exclusion criteria (1 listed)
- allergy sulfa, liver or kidney disease, pregnant or not using contraception
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zonisamidezonisamide 100 mg -300 mg daily vs placebo | Drug | – |
Primary outcome
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
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
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
1 secondary outcome
Sleep efficiency
Time frame: assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dawn Marcus, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing zonisamide in people with Fibromyalgia and Migraine, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue score (time frame: assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2011.