Clinical trial NCT00690716: The Effect of Nasal Carbon Dioxide (CO2) in the Treatment of Mild Headache in People Who Experience Migraines
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Nasal Carbon Dioxide in the Treatment of Mild Headache in Migraineurs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Migraine
Keywords: Nasal CO2
Phase II
Adaptive
Randomized
Double-Blind
Placebo-Controlled
Multiple-Dose
Multi-center
Safety
Efficacy
Mild Headache
Migraineur
Lead sponsor: Capnia, Inc.
Sponsor class: INDUSTRY
First posted: 2008-06-05
Enrollment: 292
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The proportion of patients who are pain-free
timeFrame: 2 hours post study drug administration
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Capnia Investigative Site
state: Alabama
city: Stanford
country: United States
facility: Capnia Investigative Site
state: California
city: East Hartford
country: United States
facility: Capnia Investigative Site
state: Connecticut
city: West Palm Beach
country: United States
facility: Capnia Investigative Site
state: Florida
city: Chicago
country: United States
facility: Capnia Investigative Site
state: Illinois
city: North Dartmouth
country: United States
facility: Capnia Investigative Site
state: Massachusetts
city: Wellesley Hills
country: United States
facility: Capnia Investigative Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Capnia Investigative Site
state: Michigan
city: Kalamazoo
country: United States
facility: Capnia Investigative Site
state: Michigan
city: Springfield
country: United States
facility: Capnia Investigative Site
state: Missouri
city: St. Louis
country: United States
facility: Capnia Investigative Site
state: Missouri
city: Philadelphia
country: United States
facility: Capnia Investigative Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Capnia Investigative Site
state: Pennsylvania
city: Nashville
country: United States
facility: Capnia Investigative Site
state: Tennessee
city: Seattle
country: United States
facility: Capnia Investigative Site
state: Washington
Study officials:
affiliation: Clinvest
name: Roger K. Cady, MD
role: STUDY_CHAIR
References: