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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 8 January 2018
Main ID:  NCT03075020
Date of registration: 06/03/2017
Prospective Registration: No
Primary sponsor: Danish Headache Center
Public title: Carbon Monoxide Migraine-inducing Effects in Patients With Migraine Without Aura.
Scientific title: Basic Research on Carbon Monoxide's Headache Inducing Characteristics in a Humane Experimental Headache Model
Date of first enrolment: October 2016
Target sample size: 12
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03075020
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Double (Participant, Investigator).  
Phase:  N/A
Countries of recruitment
Denmark
Contacts
Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy volunteers

- Aged 18-50

- 50-100 kg

Exclusion Criteria:

- Tension type headache more than once/month

- Other primary headaches

- Daily medication except contraceptives

- Drug taken within 4 times the halflife for the specific drug except contraceptives

- Pregnant or lactating women

- Exposure to radiation within the last year

- Headache within the last 24 hours before start of trial

- Hypertension

- Hypotension

- Respiratory or cardiac disease

- Smoking

- Primary relatives with current or previous migraine



Age minimum: 18 Years
Age maximum: 50 Years
Gender: All
Health Condition(s) or Problem(s) studied
Headache, Migraine
Intervention(s)
Other: Carbon monoxide
Other: AIR
Primary Outcome(s)
Headache scores, 12 hours [Time Frame: 12 hours]
Secondary Outcome(s)
Facial blood flow [Time Frame: [ Time Frame: 0-180 min ]]
Secondary ID(s)
H-16021497
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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