Back to resultsPACAP38 Induced Headache, Migraine and Flushing in Patients With Migraine
Primary Purpose
Migraine Without Aura
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Imigran
Isotonic Saline
Pituitary adenylate cyclase-activating peptide-38
Sponsored by
About this trial
This is an interventional treatment trial for Migraine Without Aura
Eligibility Criteria
Inclusion Criteria:
- diagnosis of migraine, according to IHS criteria
- weight between 50 - 100 kilograms
- women in fertile age must not be pregnant and must use adequate contraception
Exclusion Criteria:
- migraine more than 5 days per month in average over the past year
- any primary headache other than migraine, apart from tension-type headache which must be less than 5 days per month
- headache < 48 hours before experimental day
- migraine < 72 hours before each experimental day
- daily / frequent use of any medication apart from contraceptive medication
- use of any drug less than 5 times the half-life of the drug at the time of the experiment
- women who are pregnant or breast-feeding at the time of the experiment
- anamnestic or clinical signs of hypertension (systolic blood pressure > 150 mmHg and/or
- diastolic blood pressure > 100 mmHg) or hypotension (systolic blood pressure < 90 mmHg and/or diastolic blood pressure < 50 mmHg)
- anamnestic or clinical signs of mental illness, or abuse of alcohol / drugs
- patients with glaucoma or prostate hyperplasia
- anamnestic or clinical symptoms of any sort that the investigating doctor deemed unfit for participating in the study
Sites / Locations
- DanishHC
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
PACAP38 + Imigran
PACAP38 + Isotonic Saline
Arm Description
Pituitary adenylate cyclase-activating peptide-38 infusion (10 picomol/kg/min) for 20 mins AND Imigran infusion (0.4 mg/min) for 10 mins
Pituitary adenylate cyclase-activating peptide-38 infusion (10 picomol/kg/min) for 20 mins AND Isotonic saline for 10 mins (placebo)
Outcomes
Primary Outcome Measures
Incidence of migraine
Incidence of migraine after PACAP38-infusion will be estimated through a standardized interview based on the international headache classification for migraine
Effect of Sumatriptan
Severity of PACAP38-induced headache and migraine after pretreatment with sumatriptan in migraine patients measured by numerical rating scale for pain from 0 ("no pain") to 10 ("worst pain imaginable")
Secondary Outcome Measures
Severity of flushing
Facial skin blood flow (flushing) will be measured by laser doppler flowmetry to evaluate the severity of PACAP38-induced flushing with and without sumatriptan-treatment
Facial temperature
PACAP38-induced temperature changes with and without sumatriptan-treatment measured by infrared thermography
Superficial temporal artery diameter
Superficial temporal artery diameter after PACAP38 with and without sumatriptan-treatment measured by ultrasound
Severity of headache
Severity of PACAP38-induced headache will be rated on a numerical rating scale for pain from 0 ("no pain") to 10 ("worst pain imaginable")
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03881644
Brief Title
PACAP38 Induced Headache, Migraine and Flushing in Patients With Migraine
Official Title
Investigation of PACAP38 Induced Headache, Migraine and Flushing in Patients With Migraine
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
July 17, 2018 (Actual)
Primary Completion Date
December 7, 2019 (Actual)
Study Completion Date
December 7, 2019 (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
Yes
5. Study Description
Brief Summary
The aim is to investigate the incidence of headache, migraine attacks and flushing after pituitary adenylate cyclase-activating peptide-38 (PACAP38) with and without treatment with sumatriptan in patients with migraine
Detailed Description
Pituitary adenylate cyclase-activating peptide-38 (PACAP38) plays a role in migraine pathophysiology. Infusions of PACAP38 can trigger migraine-like attacks in some migraine patients and will induce flushing in all patients. We are investigating whether treatment with sumatriptan has an effect on the PACAP38-induced flushing and on whether headache and migraine is induced.
The purpose of this study is to investigate PACAP38-induced headache and migraine in patients with migraine who have been treated with either sumatriptan or placebo using purpose-developed standardized interview. The study will be conducted with a double-blind, placebo-controlled crossover study design.
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
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PACAP38 + Imigran
Arm Type
Active Comparator
Arm Description
Pituitary adenylate cyclase-activating peptide-38 infusion (10 picomol/kg/min) for 20 mins
AND
Imigran infusion (0.4 mg/min) for 10 mins
Arm Title
PACAP38 + Isotonic Saline
Arm Type
Placebo Comparator
Arm Description
Pituitary adenylate cyclase-activating peptide-38 infusion (10 picomol/kg/min) for 20 mins
AND
Isotonic saline for 10 mins (placebo)
Intervention Type
Drug
Intervention Name(s)
Imigran
Other Intervention Name(s)
Sumatriptan
Intervention Description
All patients will undergo this intervention on one of two study days
Intervention Type
Other
Intervention Name(s)
Isotonic Saline
Intervention Description
All patients will undergo this intervention on one of two study days
Intervention Type
Other
Intervention Name(s)
Pituitary adenylate cyclase-activating peptide-38
Other Intervention Name(s)
PACAP38
Intervention Description
All patients will undergo this intervention on both study days
Primary Outcome Measure Information:
Title
Incidence of migraine
Description
Incidence of migraine after PACAP38-infusion will be estimated through a standardized interview based on the international headache classification for migraine
Time Frame
From 0 to 12 hours after infusion
Title
Effect of Sumatriptan
Description
Severity of PACAP38-induced headache and migraine after pretreatment with sumatriptan in migraine patients measured by numerical rating scale for pain from 0 ("no pain") to 10 ("worst pain imaginable")
Time Frame
From 0 to 12 hours after infusion
Secondary Outcome Measure Information:
Title
Severity of flushing
Description
Facial skin blood flow (flushing) will be measured by laser doppler flowmetry to evaluate the severity of PACAP38-induced flushing with and without sumatriptan-treatment
Time Frame
From 0 to 4 hours after infusion
Title
Facial temperature
Description
PACAP38-induced temperature changes with and without sumatriptan-treatment measured by infrared thermography
Time Frame
From 0 to 4 hours after infusion
Title
Superficial temporal artery diameter
Description
Superficial temporal artery diameter after PACAP38 with and without sumatriptan-treatment measured by ultrasound
Time Frame
From 0 to 4 hours after infusion
Title
Severity of headache
Description
Severity of PACAP38-induced headache will be rated on a numerical rating scale for pain from 0 ("no pain") to 10 ("worst pain imaginable")
Time Frame
From 0 to 12 hours after infusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosis of migraine, according to IHS criteria
weight between 50 - 100 kilograms
women in fertile age must not be pregnant and must use adequate contraception
Exclusion Criteria:
migraine more than 5 days per month in average over the past year
any primary headache other than migraine, apart from tension-type headache which must be less than 5 days per month
headache < 48 hours before experimental day
migraine < 72 hours before each experimental day
daily / frequent use of any medication apart from contraceptive medication
use of any drug less than 5 times the half-life of the drug at the time of the experiment
women who are pregnant or breast-feeding at the time of the experiment
anamnestic or clinical signs of hypertension (systolic blood pressure > 150 mmHg and/or
diastolic blood pressure > 100 mmHg) or hypotension (systolic blood pressure < 90 mmHg and/or diastolic blood pressure < 50 mmHg)
anamnestic or clinical signs of mental illness, or abuse of alcohol / drugs
patients with glaucoma or prostate hyperplasia
anamnestic or clinical symptoms of any sort that the investigating doctor deemed unfit for participating in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Messoud Ashina, MD,PhD,DMSc
Organizational Affiliation
Danish Headache Center
Official's Role
Study Director
Facility Information:
Facility Name
DanishHC
City
Glostrup
ZIP/Postal Code
DK-2600
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33567890
Citation
Wienholtz NKF, Christensen CE, Zhang DG, Coskun H, Ghanizada H, Al-Karagholi MA, Hannibal J, Egeberg A, Thyssen JP, Ashina M. Early treatment with sumatriptan prevents PACAP38-induced migraine: A randomised clinical trial. Cephalalgia. 2021 May;41(6):731-748. doi: 10.1177/0333102420975395. Epub 2021 Feb 10.
Results Reference
derived
Learn more about this trial
PACAP38 Induced Headache, Migraine and Flushing in Patients With Migraine
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