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Study of the Safety and Effectiveness of NXN-188 for the Treatment of Migraine Headache Without Aura

NCT00959751 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 195

Last updated 2014-07-23

Study results available
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Summary

This is a a multi-center, randomized, double-blind, parallel group, and placebo controlled, two-arm study of a single oral dose of NXN-188 for the treatment of acute migraine headache without aura. Up to 120 migraineurs will be enrolled. Approximately 60 subjects having a headache history of migraine without aura will complete each of the two treatment arms to evaluate NXN-188 600 mg or placebo.

Conditions

  • Migraine Without Aura

Interventions

DRUG

NXN-188

200 mg capsules, 600 mg, PRN

DRUG

Placebo

200 mg capsules with no active ingredient designed to match the NXN-188 capsules

Sponsors & Collaborators

  • NeurAxon Inc.

    lead INDUSTRY

Principal Investigators

  • Guy Boudreau, MD · Hopital Notre-Dame Du Chum, Montreal

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-02-28
Completion
2010-03-31

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT00959751 on ClinicalTrials.gov