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The Effect of Nasal Carbon Dioxide in the Treatment of Moderate to Severe Migraine

NCT01253915 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2013-10-31

No results posted yet for this study

Summary

This multi-center, double-blind, placebo-controlled, parallel group trial carbon dioxide in the treatment of moderate to severe migraine. At approximately 8 US sites, approximately 450 patients who meet the eligibility criteria will be randomized to active or placebo in a 1:1 ratio to ensure that 400 patients will treat at least one moderate to severe migraine with the study drug.

Patients will be randomized to one of two treatment groups and be provided with either an active or placebo dispenser.

All patients will administer study drug for 10 seconds to each nostril when experiencing a qualifying headache. Patients will assess their pain and other migraine-related symptoms in a patient diary. If a patient still has pain and/or any other symptoms after the initial dose then the patient may opt to take 3 more doses to treat the headache.

Each patient's participation in the study may last up to 56 days or once the patient treats 4 headaches with the study drug, whichever occurs first.

There will be a total of 2 scheduled clinic visits:

* Visit 1 Screening/Randomization
* Visit 2 End of Study (within 7 days after the patients treats his/her fourth headache or after the end of the 56-day treatment period, whichever occurs first)

Conditions

Interventions

DRUG

Nasal Carbon Dioxide

10 sec/nostril up to 4 times to treat one migraine

DRUG

Placebo

10 sec/nostril up to 4 times to treat a migraine

Sponsors & Collaborators

  • Walter Reed National Military Medical Center

    collaborator FED

  • United States Naval Medical Center, San Diego

    collaborator FED

  • United States Naval Medical Center, Portsmouth

    collaborator FED

  • Madigan Army Medical Center

    collaborator FED

  • Capnia, Inc.

    lead INDUSTRY

Principal Investigators

  • Peter M Bertrand, DDS · National Naval Medical Center, Bethesda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-04-30
Completion
2013-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT01253915 on ClinicalTrials.gov