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

NCT ID: NCT03598075

Last Updated: 2020-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2019-12-31

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.

Conditions

Migraine Without Aura

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Amylin (Pramlintide)

Pramlintide intravenous infusion 120 micrograms over 20 minutes

Group Type: OTHER

Amylin (Pramlintide)

Intervention Type: OTHER

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

CGRP

CGRP intravenous infusion 30 micrograms over 20 minutes

Group Type: OTHER

CGRP

Intervention Type: OTHER

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

Interventions

Amylin (Pramlintide)

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

Intervention Type: OTHER

CGRP

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Danish Headache Center

OTHER

Sponsor Role: lead

Responsible Party

Hashmat Ghanizada, MD

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Danish Headache Center

Glostrup Municipality, , Denmark

Countries

Denmark

Other Identifiers

H-17035931

Identifier Type: -

Identifier Source: org_study_id