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A Double-Blind Placebo-Controlled Trial of Rozerem in Migraine Headaches

NCT00391755 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2012-02-10

No results posted yet for this study

Summary

To study the effect of Rozerem, a high affinity MT1 and MT2, low affinity 5-HT2B receptor agonist used for insomnia, as a migraine prophylactic agent.

Conditions

  • Migraine Headache

Interventions

DRUG

ramelteon

1. ramelteon 8mg po qhs with sleep and headache diary 2. placebo 1 po qhs with sleep and headache diary

Sponsors & Collaborators

  • Takeda Pharmaceuticals North America, Inc.

    collaborator INDUSTRY

  • Charlottesville Neuroscience

    lead OTHER

Principal Investigators

  • Patricia J Shipley, MD · Charlottesville Neuroscience

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • United States

Study Locations

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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 NCT00391755 on ClinicalTrials.gov