NCT00690716

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
292

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 5, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

August 15, 2012

Status Verified

August 1, 2012

Enrollment Period

10 months

First QC Date

June 3, 2008

Last Update Submit

August 6, 2012

Conditions

Migraine

Keywords

Nasal CO2Phase IIAdaptiveRandomizedDouble-BlindPlacebo-ControlledMultiple-DoseMulti-centerSafetyEfficacyMild HeadacheMigraineur

Outcome Measures

Primary Outcomes (1)

  • The proportion of patients who are pain-free

    2 hours post study drug administration

Study Arms (2)

1

EXPERIMENTAL

Nasal CO2

Drug: Nasal CO2

2

PLACEBO COMPARATOR

Inactive Placebo

Drug: Inactive Placebo

Interventions

Nasal CO2DRUG

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

1
Inactive PlaceboDRUG

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

2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Capnia Investigative Site

Birmingham, Alabama, 35233, United States

Location

Capnia Investigative Site

Stanford, California, 94305, United States

Location

Capnia Investigative Site

East Hartford, Connecticut, 06118, United States

Location

Capnia Investigative Site

West Palm Beach, Florida, 33407, United States

Location

Capnia Investigative Site

Chicago, Illinois, 60647, United States

Location

Capnia Investigative Site

North Dartmouth, Massachusetts, 02747, United States

Location

Capnia Investigative Site

Wellesley Hills, Massachusetts, 02481, United States

Location

Capnia Investigative Site

Ann Arbor, Michigan, 48104, United States

Location

Capnia Investigative Site

Kalamazoo, Michigan, 49009, United States

Location

Capnia Investigative Site

Springfield, Missouri, 65807, United States

Location

Capnia Investigative Site

St Louis, Missouri, 63141, United States

Location

Capnia Investigative Site

Philadelphia, Pennsylvania, 19107, United States

Location

Capnia Investigative Site

Pittsburgh, Pennsylvania, 15213, United States

Location

Capnia Investigative Site

Nashville, Tennessee, 37203, United States

Location

Capnia Investigative Site

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Roger K. Cady, MD

    Clinvest

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2008

First Posted

June 5, 2008

Study Start

August 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

August 15, 2012

Record last verified: 2012-08

Locations

US(15)