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Dose Ranging Study of the Efficacy and Tolerability of Tonabersat in the Prophylaxis of Migraine Headache

NCT00534560 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 542

Last updated 2009-03-31

No results posted yet for this study

Summary

Primary objective:

To investigate the efficacy and tolerability of two doses of tonabersat compared to placebo in the prophylaxis of migraine headache and to evaluate the longer term tolerability of tonabersat in an open label extension.

Secondary objective(s):

To obtain further data on the efficacy and dose response of tonabersat; To extend the safety and tolerability database of tonabersat; To obtain data on the pharmacokinetics of tonabersat.

Conditions

  • Migraine Without Aura
  • Migraine With Aura

Interventions

DRUG

Tonabersat

Tablets, 4 week dose titration and 16 weeks treatment at target dose of 40 mg per day

DRUG

Tonabersat

Tablets: 4 week titration and 16 weeks at target dose of 80 mg per day

DRUG

Placebo

Tablets; 4 week dose titration with 16 weeks at target dose

Sponsors & Collaborators

  • Minster Research Ltd

    lead INDUSTRY

Principal Investigators

  • Richard Lipton, MD · Montefiore Medical Center Headache Unit

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-11-30
Completion
2009-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00534560 on ClinicalTrials.gov