PACAP38´s (Pituitary Adenylate Cyclase-Activating Polypeptide) Headache Inducing Characteristics and Effects on the Cerebral Blood Flow

This study has been completed.
Sponsor:
Information provided by:
Danish Headache Center
ClinicalTrials.gov Identifier:
NCT00380263
First received: September 21, 2006
Last updated: May 29, 2008
Last verified: May 2008
  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:
    Drug: PACAP38
    10 pmol/kg/min given one time
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)

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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

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

No publications provided

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
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Headache
Migraine Disorders
Migraine without Aura
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Pituitary Adenylate Cyclase-Activating Polypeptide
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014