Amylin and CGRP Head to Head Provocation in Migraine Without Aura Patients

NCT03598075 | Completed DMC

• 1 other identifier: H-17035931
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine Without Aura

Outcome Measures

Primary Outcomes (1)

• 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

  12 hours

Secondary Outcomes (4)

• Dilatation of Arteria radialis and arteria temporalis superficialis

  2 hours

• Facial flushing

  2 hours

• Plasma blood samples

  2 hours

• Headache intensity

  12 hours

Study Arms (2)

Amylin (Pramlintide)

OTHER

Pramlintide intravenous infusion 120 micrograms over 20 minutes

Other: Amylin (Pramlintide)

CGRP

OTHER

CGRP intravenous infusion 30 micrograms over 20 minutes

Other: CGRP

Interventions

Amylin (Pramlintide) OTHER

Pramlintide is a amylin analog. It will be given intravenously at the rate of 120 micrograms over 20 minutes .

Amylin (Pramlintide)

CGRP OTHER

CGRP It will be given intravenously at the rate of 30 microgram over 20 minutes.

CGRP

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Danish Headache Center: lead

Study Sites (1)

Danish Headache Center

Glostrup Municipality, 2600, Denmark

Location

MeSH Terms

Conditions

Migraine without Aura

Interventions

Islet Amyloid Polypeptide; pramlintide

Condition Hierarchy (Ancestors)

Migraine Disorders; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Amyloidogenic Proteins; Amyloid; Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: July 26, 2018
• Study Start: July 1, 2018
• Primary Completion: September 30, 2019
• Study Completion: December 31, 2019
• Last Updated: June 25, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)