Back to resultsPACAP38´s (Pituitary Adenylate Cyclase-Activating Polypeptide) Headache Inducing Characteristics and Effects on the Cerebral Blood Flow
Primary Purpose
Migraine Without Aura
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
PACAP38
Sponsored by
About this trial
This is an interventional trial for Migraine Without Aura
Eligibility 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
Sites / Locations
- Dansih Headache Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00380263
First Posted
September 21, 2006
Last Updated
May 29, 2008
Sponsor
Danish Headache Center
1. Study Identification
Unique Protocol Identification Number
NCT00380263
Brief Title
PACAP38´s (Pituitary Adenylate Cyclase-Activating Polypeptide) Headache Inducing Characteristics and Effects on the Cerebral Blood Flow
Official Title
Basic Scientific Research Investigating PACAP38 Headache Inducing Effects in Migraine Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Danish Headache Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To investigate headache score and accompanying symptoms during and after infusion of PACAP38 i migraine patients
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Without Aura
7. Study Design
Study Phase
Not Applicable
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
PACAP38
Intervention Description
10 pmol/kg/min given one time
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henrik Schytz, MD
Organizational Affiliation
Danish Headache Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dansih Headache Center
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
PACAP38´s (Pituitary Adenylate Cyclase-Activating Polypeptide) Headache Inducing Characteristics and Effects on the Cerebral Blood Flow
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