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PACAP38´s (Pituitary Adenylate Cyclase-Activating Polypeptide) Headache Inducing Characteristics and Effects on the Cerebral Blood Flow
This study has been completed.
Sponsor:
Danish Headache Center
Information provided by:
Danish Headache Center
ClinicalTrials.gov Identifier:
NCT00380263
First received: September 21, 2006
Last updated: May 29, 2008
Last verified: May 2008
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Purpose
To investigate headache score and accompanying symptoms during and after infusion of PACAP38 i migraine patients
| Condition | Intervention |
|---|---|
| Migraine Without Aura | Drug: PACAP38 |
| Study Type: | Interventional |
| Official Title: | Basic Scientific Research Investigating PACAP38 Headache Inducing Effects in Migraine Patients |
Resource links provided by NLM:
Further study details as provided by Danish Headache Center:
| Enrollment: | 12 |
| Study Start Date: | November 2006 |
| Study Completion Date: | November 2007 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: PACAP38
10 pmol/kg/min given one time
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)
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00380263
Please refer to this study by its ClinicalTrials.gov identifier: NCT00380263
Locations
| Denmark | |
| Dansih Headache Center | |
| Glostrup, Denmark, 2600 | |
Sponsors and Collaborators
Danish Headache Center
Investigators
| Principal Investigator: | Henrik Schytz, MD | Danish Headache Center |
More Information
| Responsible Party: | Henrik Schytz/MD, Danish Headache Center |
| ClinicalTrials.gov Identifier: | NCT00380263 History of Changes |
| Other Study ID Numbers: |
KA-20060087 |
| Study First Received: | September 21, 2006 |
| Last Updated: | May 29, 2008 |
Additional relevant MeSH terms:
|
Migraine Disorders Headache Migraine without Aura Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Pain |
Neurologic Manifestations Signs and Symptoms Pituitary Adenylate Cyclase-Activating Polypeptide Growth Substances Physiological Effects of Drugs Vasodilator Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on July 18, 2017