Back to resultsThe Effect of Histamine H1 Receptor Antagonist, Clemastin, on PACAP38 Induced Headache in Migraine Patients
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 prevention trial for Migraine Without Aura
Eligibility Criteria
Inclusion Criteria:
- migraine patients fulfilling IHS criteria for migraine without aura, ages 18-50, 50-100 kg, fertile women must be using safe prevention
Exclusion Criteria:
- other types of primary headache than migraine
- headache on trial day or later than 48 hours before trial day
- migraine up to three days before trial day
- any type of cardiovascular disease
- clinical signs or patient history of any type of illness that the medical doctor in charge of trials deems relevant for participation
Sites / Locations
- Danish Headache Center & Department of Neurology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Placebo to PACAP38
Clemastin 1 mg/ml to PACAP38 8pmol/kg/min
Arm Description
Pre-treatment with placebo. PACAP38 8pmol/kg/min
Pre-treatment with Clemastin 1 mg/ml PACAP38 8 pmol/kg/min
Outcomes
Primary Outcome Measures
Development of migraine in migraine patients
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02364453
Brief Title
The Effect of Histamine H1 Receptor Antagonist, Clemastin, on PACAP38 Induced Headache in Migraine Patients
Official Title
The Effect of Histamine H1 Receptor Antagonist, Clemastin, on PACAP38 Induced Headache in Migraine Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Song Guo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine the effects of antihistamine (Clemastin) on migraines triggered by pituitary adenylate cyclase activating peptide-38 (PACAP38) as well as on biochemical markers for mast cell degranulation in migraine patients. Also, to investigate the occurrence of migraine in migraine patients after infusion of PACAP38 in lower dosages than previously investigated. As this has never been done before it is unknown how a lower dose of PACAP38 will affect 1) the incidence of migraine attacks, 2) the accompanying symptoms, 3) head pain characteristics, and 4) debut and duration of migraine attacks.
Our three hypotheses are:
Pre-treatment with Clemastin reduces PACAP38 sensitivity and inhibits development of migraine in migraine patients.
Clemastin inhibits the increase in plasma concentration of TNF-alpha, histamine and tryptase after PACAP38-infusion.
PACAP38 in lower dosages (4, 6 and 8 pmol/kg/min) induces migraine in migraine patients.
Detailed Description
The purpose of this study is to determine the effects of antihistamine (Clemastin) on migraines triggered by pituitary adenylate cyclase activating peptide-38 (PACAP38) as well as on biochemical markers for mast cell degranulation in migraine patients. Also, to investigate the occurrence of migraine in migraine patients after infusion of PACAP38 in lower dosages than previously investigated. As this has never been done before it is unknown how a lower dose of PACAP38 will affect 1) the incidence of migraine attacks, 2) the accompanying symptoms, 3) head pain characteristics, and 4) debut and duration of migraine attacks.
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
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo to PACAP38
Arm Type
Experimental
Arm Description
Pre-treatment with placebo. PACAP38 8pmol/kg/min
Arm Title
Clemastin 1 mg/ml to PACAP38 8pmol/kg/min
Arm Type
Experimental
Arm Description
Pre-treatment with Clemastin 1 mg/ml PACAP38 8 pmol/kg/min
Intervention Type
Drug
Intervention Name(s)
PACAP38
Other Intervention Name(s)
Pituitary Adenylate Cyclase Activating Peptide 38
Intervention Description
Giving doses of 4, 6 or 8 pg/kg/min on three separate trial days.
Primary Outcome Measure Information:
Title
Development of migraine in migraine patients
Time Frame
Up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
migraine patients fulfilling IHS criteria for migraine without aura, ages 18-50, 50-100 kg, fertile women must be using safe prevention
Exclusion Criteria:
other types of primary headache than migraine
headache on trial day or later than 48 hours before trial day
migraine up to three days before trial day
any type of cardiovascular disease
clinical signs or patient history of any type of illness that the medical doctor in charge of trials deems relevant for participation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Messoud Ashina, Professor
Organizational Affiliation
Danish Headache Center
Official's Role
Study Director
Facility Information:
Facility Name
Danish Headache Center & Department of Neurology
City
Copenhagen
State/Province
Glostrup
ZIP/Postal Code
2600
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
The Effect of Histamine H1 Receptor Antagonist, Clemastin, on PACAP38 Induced Headache in Migraine Patients
We'll reach out to this number within 24 hrs