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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00380263
Recruitment Status : Completed
First Posted : September 25, 2006
Last Update Posted : May 30, 2008
Information provided by:
Danish Headache Center

Brief Summary:
To investigate headache score and accompanying symptoms during and after infusion of PACAP38 i migraine patients

Condition or disease Intervention/treatment
Migraine Without Aura Drug: PACAP38

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  (Clinical Trial)
Actual Enrollment : 12 participants
Official Title: Basic Scientific Research Investigating PACAP38 Headache Inducing Effects in Migraine Patients
Study Start Date : November 2006
Primary Completion Date : November 2007
Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine
U.S. FDA Resources

Intervention Details:
    Drug: PACAP38
    10 pmol/kg/min given one time

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00380263

Dansih Headache Center
Glostrup, Denmark, 2600
Sponsors and Collaborators
Danish Headache Center
Principal Investigator: Henrik Schytz, MD Danish Headache Center

Responsible Party: Henrik Schytz/MD, Danish Headache Center Identifier: NCT00380263     History of Changes
Other Study ID Numbers: KA-20060087
First Posted: September 25, 2006    Key Record Dates
Last Update Posted: May 30, 2008
Last Verified: May 2008

Additional relevant MeSH terms:
Migraine Disorders
Migraine without Aura
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
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