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A Study of a Melatonin Receptor Agonist to Prevent Migraine

NCT00739024 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2012-08-23

Study results available
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Summary

The purpose of this study is to see if ramelteon will reduce the number of migraine headaches over a 12 week period. The safety and tolerability of ramelteon will also be evaluated. Ramelteon has been approved by the U.S. Food and Drug Administration (FDA) for insomnia (trouble sleeping); however; ramelteon has not been approved for the prevention of migraines.

Conditions

  • Migraine
  • Migraine With Aura
  • Migraine Without Aura

Interventions

DRUG

Ramelteon

8 mg tablet, oral, once daily

DRUG

Placebo

Placebo tablet, oral, once daily

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • Swedish Medical Center

    lead OTHER

Principal Investigators

  • Sheena K Aurora, MD · Swedish Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-04-30
Completion
2010-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT00739024 on ClinicalTrials.gov