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

Migraine Without Aura Clinical Trial

Official title:

Basic Scientific Research Investigating PACAP38 Headache Inducing Effects in Migraine Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00380263
• Other study ID #: KA-20060087
• Status: Completed
• Phase: N/A
• First received: September 21, 2006
• Last updated: May 29, 2008
• Start date: November 2006
• Est. completion date: November 2007

Study information

• Verified date: May 2008
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Migraine Without Aura

Intervention

Drug:
• PACAP38
10 pmol/kg/min given one time

Locations

Country	Name	City	State
Denmark	Dansih Headache Center	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark,