Clinical Trials Logo
  1. Home
  2. Migraine Headache
  3. NCT00055484

A Study to Measure the Safety and Effectiveness of Zonisamide in Subjects With Migraine Headache

Migraine Headache Clinical Trial

Official title:
A Double-Blind, Randomized, Multicenter, Parallel Dose Study to Evaluate the Safety and Efficacy of Zonisamide 150 mg and 300 mg Per Day and Placebo in Subjects With Migraine Headache

Clinical Trial Summary

The purpose of this study is to determine if zonisamide is effective as a preventative medication for individuals with migraine headache.

Clinical Trial Description

The pharmacologic treatment of migraine may be acute (abortive, symptomatic) or preventive (prophylactic). Preventive medication is usually given daily for months or years; however, treatment may also be given in an intermittent regimen. Most migraine prophylactic medications were designed to treat other disorders, and they can be divided into three groups:

1. Serotonergic or monoaminergic agents such as methysergide, which have demonstrated high degrees of effectiveness;

2. Non-serotonergic drugs such as beta-blockers, tricyclic antidepressants, valproate; and

3. Drugs with lesser demonstrated effectiveness, such as selective serotonin reuptake inhibitors, calcium channel antagonists, and non-steroidal anti-inflammatory drugs.

The choice of treatment must be individualized, and is influenced by contraindications, potential side effects, the need to treat associated symptoms like tension-type headache and insomnia, and drug cost.

Anticonvulsants, such as valproate, have shown significant degrees of efficacy in migraine prophylaxis when used in low doses. Considering the differences in proposed mechanisms of action of these agents, it is likely that a novel anticonvulsant such as zonisamide may also be an effective prophylactic treatment for migraine. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00055484
Study type Interventional
Source Elan Pharmaceuticals
Contact
Status Completed
Phase Phase 2
Start date March 2002
Completion date May 2003
View Details
See also
  Status Clinical Trial Phase
Completed NCT04084314 - Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study Phase 4
Not yet recruiting NCT05943457 - Vitamin K2 Supplementation in Adult Episodic Migraine N/A
Completed NCT01211145 - Zomig - Treatment of Acute Migraine Headache in Adolescents Phase 4
Completed NCT00530517 - A Study on the Usability of the Needle-free Intraject® System in Adult Patients During Acute Migraine Attack Phase 2
Completed NCT00898677 - Rizatriptan 5 mg and 10 mg, Sumatriptan 100 mg, and Placebo Comparison Study (0462-030) Phase 3
Recruiting NCT06459635 - Migraine Attack Pain Phase Prediction Study
Completed NCT03971071 - A Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Medication Overuse Headache Phase 4
Withdrawn NCT02706015 - Cefaliv® Compared to Neosaldina® in the Treatment of Migraine Attacks Phase 3
Completed NCT02518464 - Ticagrelor Therapy for RefrACTORy Migraine Study Phase 4
Terminated NCT02375789 - Intranasal Cooling for Symptomatic Relief of Migraine N/A
Terminated NCT00391755 - A Double-Blind Placebo-Controlled Trial of Rozerem in Migraine Headaches Phase 4
Completed NCT03401346 - Bioavailability of DHE Administered by I123 POD Device, IV Injection, and Migranal Nasal Spray in Healthy Adults Phase 1
Completed NCT05085483 - Ketone for Migraine Prevention N/A
Completed NCT01604785 - Low-dose Propofol for Pediatric Migraine Phase 2/Phase 3
Terminated NCT00804973 - Study in Participants With Acute Migraines Headaches Phase 2
Completed NCT03341689 - Psilocybin for the Treatment of Migraine Headache Phase 1
Completed NCT01630044 - Neurostimulation Device for Treatment of Migraine Headache N/A
Active, not recruiting NCT00285402 - Efficacy and Safety Clinical Trial of Intranasal AST-726 for the Prevention of Migraine Phase 2
Completed NCT00203255 - Clinical Study Examining Use of an Over-the-Counter Supplement for the Prevention of Menstrually-Associated Migraine Headache N/A
Recruiting NCT06046508 - Migraine With Aura and Patent Foramen Ovale: Identification of Biomarkers to Select Patients In Whom Intervention Would Be Beneficial (MANET)