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

Migraine Without Aura Clinical Trial

Official title:

Amylin and CGRP Migraine Provocation in Migraine Without Aura Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03598075
• Other study ID #: H-17035931
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: June 2020
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 31, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine Disorders
• Migraine without Aura

Intervention

Other:
• Amylin (Pramlintide)
Pramlintide is a amylin analog. It will be given intravenously at the rate of 120 micrograms over 20 minutes .
• CGRP
CGRP It will be given intravenously at the rate of 30 microgram over 20 minutes.

Locations

Country	Name	City	State
Denmark	Danish Headache Center	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Dilatation of Arteria radialis and arteria temporalis superficialis	Dermascan will be used to measure the above mentioned Radial and temporal arteries diameter.	2 hours
Secondary	Facial flushing	Flushing will measured by laser contrast imaging	2 hours
Secondary	Plasma blood samples	Measumrent of amylin and CGRP peptides in the plasma in picomol/L	2 hours
Secondary	Headache intensity	Measured by visual analog score (VAS) ( 0 to 10). Change in area under curve (AUC)	12 hours