NCT00259636

Brief Summary

Patients with fibromyalgia \& migraine are randomized to receive zonisamide or placebo.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2004

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 26, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 29, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

June 1, 2011

Status Verified

May 1, 2011

Enrollment Period

3.4 years

First QC Date

November 26, 2005

Last Update Submit

May 31, 2011

Conditions

FibromyalgiaMigraine

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Sleep efficiency

    assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment

Interventions

zonisamideDRUG

zonisamide 100 mg -300 mg daily vs placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • with fibromyalgia \& migraine

You may not qualify if:

  • allergy sulfa, liver or kidney disease, pregnant or not using contraception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15206, United States

Location

MeSH Terms

Conditions

FibromyalgiaMigraine Disorders

Interventions

Zonisamide

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsIsoxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Dawn Marcus, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 26, 2005

First Posted

November 29, 2005

Study Start

August 1, 2004

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

June 1, 2011

Record last verified: 2011-05

Locations

US(1)