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

What Was Tested

In this not phased trial, researchers set out to test Amylin (Islet Amyloid Polypeptide) for migraine.

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.

It had two arms (groups): Amylin (Pramlintide) (other) and CGRP (other).

The registry classes the interventions as other.

More on the Plan

Amylin has many similarities with CGRP.

Amylin and CGRP share 16 out 37 amino acids.

The aim of the study is pin point the role of amylin and amylin receptor compare to CGRP in migraine pathophysiology.

Who Took Part

36 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers could join, not only people with the condition.

The full record lists 2 inclusion and 15 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, crossover and triple-blind study.

Because people in this Amylin (Islet Amyloid Polypeptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between Amylin (Islet Amyloid Polypeptide) and the comparison at some point, usually with a gap in between.

Blinding on both sides kept the migraine participants and researchers unaware of who received Amylin (Islet Amyloid Polypeptide).

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2018-07-01 with completion listed for 2019-09-30.

It ran at 1 site in Denmark.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Migraine incidence (time frame: 12 hours).

It also tracked 4 secondary outcomes, for example Dilatation of Arteria radialis and arteria temporalis superficialis, Facial flushing and Plasma blood samples.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Amylin (Islet Amyloid Polypeptide) in 36 people with migraine.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Amylin (Islet Amyloid Polypeptide) compound page, Migraine research.