- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00380263
PACAP38´s (Pituitary Adenylate Cyclase-Activating Polypeptide) Headache Inducing Characteristics and Effects on the Cerebral Blood Flow
May 29, 2008 updated by: Danish Headache Center
Basic Scientific Research Investigating PACAP38 Headache Inducing Effects in Migraine Patients
To investigate headache score and accompanying symptoms during and after infusion of PACAP38 i migraine patients
Study Overview
Detailed Description
To investigate headache score and accompanying symptoms during and after infusion of PACAP38
Changes in regional cerebral blood flow (rCBF) in the area supplied by middle cerebral artery (MCA), blood flow in MCA, diameter of the superficial temporal artery (STA) and radial artery (RA)
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Glostrup, Denmark, 2600
- Dansih Headache Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy migraine patient without aura
- Aged 18-50
- 50-100 kg
- Fertile women must use safe contraceptives (IUD, oral contraceptives, surgical sterilisation and long lasting gestagen.
Exclusion Criteria:
- Tension type headache more than five times/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 48 hours before start of trial
- Hypertension
- Hypotension
- Respiratory or cardiac disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Henrik Schytz, MD, Danish Headache Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2006
Primary Completion (Actual)
November 1, 2007
Study Completion (Actual)
November 1, 2007
Study Registration Dates
First Submitted
September 21, 2006
First Submitted That Met QC Criteria
September 21, 2006
First Posted (Estimate)
September 25, 2006
Study Record Updates
Last Update Posted (Estimate)
May 30, 2008
Last Update Submitted That Met QC Criteria
May 29, 2008
Last Verified
May 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Headache Disorders, Primary
- Headache Disorders
- Migraine Disorders
- Headache
- Migraine without Aura
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Growth Substances
- Pituitary Adenylate Cyclase-Activating Polypeptide
Other Study ID Numbers
- KA-20060087
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Brigham and Women's HospitalNot yet recruitingMigraine Disorders | Migraine Without Aura | Migraine With Aura | Episodic MigraineUnited States
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Clinical Trials on PACAP38
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