Back to resultsPACAP27 Headache Properties in Migraine Without Aura Patients
Primary Purpose
Migraine Without Aura
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
PACAP27
Saline
Sponsored by
About this trial
This is an interventional health services research trial for Migraine Without Aura
Eligibility Criteria
Inclusion Criteria:
Migraine patients meeting International Headache Society (IHS) criteria for migraine without aura of both sexes, 18-60 year, 50-100 kg.
- Fertile women should use safe contraception. Fertile women do not include hysterectomized women or women who are postmenopausal for at least 2 years. Safe contraception includes either Intra Uterine Device (IUD), birth control pills, surgical sterilization of the woman or depot progestogen.
Exclusion Criteria:
Tension Type headache for more than 5 days the month on average in the last year.
- All other primary headaches .
- Headache later than 48 hours before trial start.
- Daily intake of any medicine other than oral contraception.
- Ingestion of any form of medicinal product later than 4 times the plasma half-life substance (on trial day), except for oral contraception.
- Pregnant or breastfeeding women.
- Headache on the test day or later than 48 hours prior to administration of trial medicine / placebo
- Migraine within 5 days before the trial date.
- Ancestral information or clinical signs of (on the day of inclusion):
- Hypertension (systolic blood pressure> 150 mmHg and / or diastolic blood pressure> 100 mmHg)
Hypotension (systolic blood pressure <90 mm Hg and / or diastolic blood pressure <50 mmHg)
- Cardiovascular disease of all kinds, including cerebrovascular disease.
- Anamnestic or clinical signs of mental illness or abuse.
- Patients with glaucoma or prostatic hyperplasia
- Anamnestic or clinical signs of diseases of any kind such as the investigating physician is considered relevant for participation in the trial.
Sites / Locations
- Danish Headache Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Active
Placebo
Arm Description
PACAP-27
Saline
Outcomes
Primary Outcome Measures
Headache Scores
Comparison between PACAP27 and Placebo
Secondary Outcome Measures
Facial blood flow (flushing)
PACAP27 induces facial flushing compare to placebo measured by laser speckle contrast imaging
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03471039
Brief Title
PACAP27 Headache Properties in Migraine Without Aura Patients
Official Title
Pituitary Adenylate Cyclase-activating Polypeptide (PACAP27) Headache Properties in Migraine Without Aura Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
August 30, 2017 (Actual)
Primary Completion Date
August 30, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Headache Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Pituitary adenylate cyclase-activating polypeptide (PACAP) is a signaling molecule, localized in sensory and parasympathetic perivascular nerves fibres. PACAP exists i to functional iso-forms Pituitary adenylate cyclase-activating polypeptide-38 (PACAP38) and PACAP27.
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
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Active Comparator
Arm Description
PACAP-27
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline
Intervention Type
Drug
Intervention Name(s)
PACAP27
Intervention Description
Infusion of PACAP27 over 20 minutes.
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Infusion of Saline over 20 minutes.
Primary Outcome Measure Information:
Title
Headache Scores
Description
Comparison between PACAP27 and Placebo
Time Frame
0-12 hours
Secondary Outcome Measure Information:
Title
Facial blood flow (flushing)
Description
PACAP27 induces facial flushing compare to placebo measured by laser speckle contrast imaging
Time Frame
0-120 mins
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Migraine patients meeting International Headache Society (IHS) criteria for migraine without aura of both sexes, 18-60 year, 50-100 kg.
Fertile women should use safe contraception. Fertile women do not include hysterectomized women or women who are postmenopausal for at least 2 years. Safe contraception includes either Intra Uterine Device (IUD), birth control pills, surgical sterilization of the woman or depot progestogen.
Exclusion Criteria:
Tension Type headache for more than 5 days the month on average in the last year.
All other primary headaches .
Headache later than 48 hours before trial start.
Daily intake of any medicine other than oral contraception.
Ingestion of any form of medicinal product later than 4 times the plasma half-life substance (on trial day), except for oral contraception.
Pregnant or breastfeeding women.
Headache on the test day or later than 48 hours prior to administration of trial medicine / placebo
Migraine within 5 days before the trial date.
Ancestral information or clinical signs of (on the day of inclusion):
Hypertension (systolic blood pressure> 150 mmHg and / or diastolic blood pressure> 100 mmHg)
Hypotension (systolic blood pressure <90 mm Hg and / or diastolic blood pressure <50 mmHg)
Cardiovascular disease of all kinds, including cerebrovascular disease.
Anamnestic or clinical signs of mental illness or abuse.
Patients with glaucoma or prostatic hyperplasia
Anamnestic or clinical signs of diseases of any kind such as the investigating physician is considered relevant for participation in the trial.
Facility Information:
Facility Name
Danish Headache Center
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
12. IPD Sharing Statement
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PACAP27 Headache Properties in Migraine Without Aura Patients
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