MedDataX Logo

The Effect of Nasal Carbon Dioxide (CO2) in the Treatment of Mild Headache in People Who Experience Migraines

NCT ID: NCT00690716

Last Updated: 2012-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

292 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the safety and effect of nasal carbon dioxide in the treatment of mild headaches in people who have migraines.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This multi-center, adaptively randomized, double-blind, placebo-controlled trial will evaluate the efficacy and safety of a nasal, non-inhaled administration of carbon dioxide (CO2) in the treatment of mild headaches. An estimated 250 patients who meet the eligibility criteria will be enrolled into this study at approximately 15 sites to ensure that about 220 patients are randomized and complete the study.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Migraine

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Nasal CO2 Phase II Adaptive Randomized Double-Blind Placebo-Controlled Multiple-Dose Multi-center Safety Efficacy Mild Headache Migraineur

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Nasal CO2

Group Type EXPERIMENTAL

Nasal CO2

Intervention Type DRUG

Adaptive Randomization to a Dosing Regimen for Treatment of a Qualifying Headache

2

Inactive Placebo

Group Type PLACEBO_COMPARATOR

Inactive Placebo

Intervention Type DRUG

Adaptive Randomization to a Dosing Regimen for Treatment of a Qualifying Headache

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nasal CO2

Adaptive Randomization to a Dosing Regimen for Treatment of a Qualifying Headache

Intervention Type DRUG

Inactive Placebo

Adaptive Randomization to a Dosing Regimen for Treatment of a Qualifying Headache

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Able to read and understand informed consent form and voluntarily consent to participate in this study by signing the IRB-approved informed consent form
* Established diagnosis of migraine with or without aura per ICHD-II (patients with a diagnosis of only menstrual migraine are not eligible)
* History of 2-8 migraine attacks per month during the 3 months prior to randomization
* Have a typical migraine which progresses from a distinct mild headache to a moderate or severe migraine
* Able to recognize a mild headache that could develop into a moderate or severe migraine

Exclusion Criteria

* Have less than 48 hours of freedom from headache between attacks of migraine
* Have 15 or more headache days per month
* Are females who are pregnant or lactating
* Use antipsychotic or antidepressant medications (unless only for migraine prophylaxis) within 12 weeks prior to randomization and for the duration of the study
* Have a concurrent diagnosis of TMD or trigeminal neuralgia requiring treatment
* Clinically significant deviated septum, nasal polyps or other nasal condition that prevents unrestricted breathing through each nostril
* Have participated in another study with nasal CO2
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Capnia, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Roger K. Cady, MD

Role: STUDY_CHAIR

Clinvest

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Capnia Investigative Site

Birmingham, Alabama, United States

Site Status

Capnia Investigative Site

Stanford, California, United States

Site Status

Capnia Investigative Site

East Hartford, Connecticut, United States

Site Status

Capnia Investigative Site

West Palm Beach, Florida, United States

Site Status

Capnia Investigative Site

Chicago, Illinois, United States

Site Status

Capnia Investigative Site

North Dartmouth, Massachusetts, United States

Site Status

Capnia Investigative Site

Wellesley Hills, Massachusetts, United States

Site Status

Capnia Investigative Site

Ann Arbor, Michigan, United States

Site Status

Capnia Investigative Site

Kalamazoo, Michigan, United States

Site Status

Capnia Investigative Site

Springfield, Missouri, United States

Site Status

Capnia Investigative Site

St Louis, Missouri, United States

Site Status

Capnia Investigative Site

Philadelphia, Pennsylvania, United States

Site Status

Capnia Investigative Site

Pittsburgh, Pennsylvania, United States

Site Status

Capnia Investigative Site

Nashville, Tennessee, United States

Site Status

Capnia Investigative Site

Seattle, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

C112

Identifier Type: -

Identifier Source: org_study_id