Back to resultsAmylin and CGRP Head to Head Provocation in Migraine Without Aura Patients
Primary Purpose
Migraine Without Aura
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Amylin (Pramlintide)
CGRP
Sponsored by
About this trial
This is an interventional other 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
Other
Other
Arm Label
Amylin (Pramlintide)
CGRP
Arm Description
Pramlintide intravenous infusion 120 micrograms over 20 minutes
CGRP intravenous infusion 30 micrograms over 20 minutes
Outcomes
Primary Outcome Measures
Migraine incidence
Before (-10 min) and after infusion (+12 hours) of amlyin compared with before and after infusion of CGRP based on questionnaire reported headache and associated symptoms
Secondary Outcome Measures
Dilatation of Arteria radialis and arteria temporalis superficialis
Dermascan will be used to measure the above mentioned Radial and temporal arteries diameter.
Facial flushing
Flushing will measured by laser contrast imaging
Plasma blood samples
Measumrent of amylin and CGRP peptides in the plasma in picomol/L
Headache intensity
Measured by visual analog score (VAS) ( 0 to 10). Change in area under curve (AUC)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03598075
Brief Title
Amylin and CGRP Head to Head Provocation in Migraine Without Aura Patients
Official Title
Amylin and CGRP Migraine Provocation in Migraine Without Aura Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
December 31, 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
Amylin and calcitonin gene related peptide (CGRP) are related to the same peptide family. Both share 16 out of 37 amino acids and can activate each others receptor. CGRP is implicated in migraine pathophysiology but the role of Amylin and its receptor in migraine is not fully clarified.
Detailed Description
Amylin is a peptide hormone that binds to a G-protein coupled receptor (GPCR). amylin was originally found in the pancreas (Beta Cell of Islets of Langerhans) but also shown to be present in the trigeminal ganglion, hind horn ganglia and perivascular nerve fibers.
Amylin has many similarities with CGRP. Amylin and CGRP share 16 out 37 amino acids. Both peptides can activate the amylin 1 subtype (AMY1)receptor with high affinity and reported to have more similar physiological and pharmacological effects.
In addition, both peptides increase the intracellular concentration of cyclic AMP (cAMP) which has a central role in migraine pathophysiology.
The aim of the study is pin point the role of amylin and amylin receptor compare to CGRP in migraine pathophysiology.
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
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
In a Randomized, double blind, cross over experiment. Migraine without aura patients will received amylin or CGRP in two separate days apart by a week.
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Amylin (Pramlintide)
Arm Type
Other
Arm Description
Pramlintide intravenous infusion 120 micrograms over 20 minutes
Arm Title
CGRP
Arm Type
Other
Arm Description
CGRP intravenous infusion 30 micrograms over 20 minutes
Intervention Type
Other
Intervention Name(s)
Amylin (Pramlintide)
Intervention Description
Pramlintide is a amylin analog. It will be given intravenously at the rate of 120 micrograms over 20 minutes .
Intervention Type
Other
Intervention Name(s)
CGRP
Intervention Description
CGRP It will be given intravenously at the rate of 30 microgram over 20 minutes.
Primary Outcome Measure Information:
Title
Migraine incidence
Description
Before (-10 min) and after infusion (+12 hours) of amlyin compared with before and after infusion of CGRP based on questionnaire reported headache and associated symptoms
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
Dilatation of Arteria radialis and arteria temporalis superficialis
Description
Dermascan will be used to measure the above mentioned Radial and temporal arteries diameter.
Time Frame
2 hours
Title
Facial flushing
Description
Flushing will measured by laser contrast imaging
Time Frame
2 hours
Title
Plasma blood samples
Description
Measumrent of amylin and CGRP peptides in the plasma in picomol/L
Time Frame
2 hours
Title
Headache intensity
Description
Measured by visual analog score (VAS) ( 0 to 10). Change in area under curve (AUC)
Time Frame
12 hours
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
Plan to Share IPD
No
Learn more about this trial
Amylin and CGRP Head to Head Provocation in Migraine Without Aura Patients
We'll reach out to this number within 24 hrs