Clinical Trials Logo
  1. Home
  2. Fibromyalgia
  3. NCT00259636
  4. Details
NCT00259636 Clinical Trial

Zonisamide for Fibromyalgia & Migraine

Fibromyalgia Clinical Trial

Official title:
Zonisamide for Fibromyalgia & Migraine

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00259636
Other study ID # EISAI 51-345-749
Secondary ID
Status Withdrawn
Phase Phase 4
First received November 26, 2005
Last updated May 31, 2011
Start date August 2004
Est. completion date January 2008

Study information
Verified date May 2011
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Description:

Study was not conducted due to logistical problems

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date January 2008
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- 18-65 with fibromyalgia & migraine

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• zonisamide
zonisamide 100 mg -300 mg daily vs placebo

Locations
Country Name City State
United States University of Pittsburgh Pittsburgh Pennsylvania

Sponsors (2)
Lead Sponsor Collaborator
University of Pittsburgh Eisai Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Primary 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 No
Primary 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 No
Secondary 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 No
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05659862 - Digitally Assisted Behavioral Physical Activity Intervention in Fibromyalgia N/A
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Completed NCT03042728 - Impact of Inclusion of a Therapy Dog Visit as Part of the Fibromyalgia Treatment Program N/A
Recruiting NCT06097091 - Effects and Mechanisms of Pain Neuroscience Education in Patients With Fibromyalgia N/A
Recruiting NCT04554784 - Effectiveness of Bowen Therapy for Pain Management in Patients With Fibromyalgia N/A
Completed NCT03300635 - Metabolism, Muscle Function and Psychological Factors in Fibromyalgia N/A
Recruiting NCT06166563 - Exercise, Irritable Bowel Syndrome and Fibromyalgia N/A
Completed NCT03166995 - Postural Exercises in Women With Fibromyalgia N/A
Completed NCT03227952 - Sensory Stimulation in Fibromyalgia N/A
Recruiting NCT06237595 - Vagus Nerve Stimulation in Fibromyalgia N/A
Completed NCT01888640 - Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation (FAST) N/A
Completed NCT03641495 - Pain Education and Therapeutic Exercise for Fibromyalgia N/A
Recruiting NCT05581628 - FREQUENCY OF FIBROMYALGIA IN PATIENTS WITH CELIAC DISEASE
Active, not recruiting NCT05128162 - Open-label Study to Assess the Safety and Efficacy of Psilocybin With Psychotherapy in Adult Participants With Fibromyalgia Phase 2
Completed NCT04674878 - Comparison of Muscle Energy Techniques and Breathing Exercises for Functional Improvement in Fibromyalgia N/A
Active, not recruiting NCT04084795 - Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia N/A
Completed NCT03129906 - Impact of the Restriction of Sources of Gluten in Fibromyalgia Patients N/A
Completed NCT05058911 - Exposure-based Cognitive Behavior Therapy vs Traditional Cognitive Behavior Therapy for Fibromyalgia N/A
Recruiting NCT04571528 - Effectiveness of VIRTUAL FIBROWALK STUDY N/A
Recruiting NCT04571853 - New Educational Tool for FM N/A