Amylin and CGRP Head to Head Provocation in Migraine Without Aura Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03598075|
Recruitment Status : Active, not recruiting
First Posted : July 25, 2018
Last Update Posted : September 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Migraine Without Aura||Other: Amylin (Pramlintide) Other: CGRP||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Crossover Assignment|
|Intervention 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:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Amylin and CGRP Migraine Provocation in Migraine Without Aura Patients|
|Actual Study Start Date :||July 1, 2018|
|Estimated Primary Completion Date :||September 30, 2019|
|Estimated Study Completion Date :||September 30, 2019|
Pramlintide intravenous infusion 30 micrograms/mL over 20 minutes
Other: Amylin (Pramlintide)
Pramlintide is a amylin analog. It will be given intravenously at the rate of 1.5 microgram /ml over 20 minutes .
CGRP intravenous infusion 30 micrograms/mL over 20 minutes
CGRP It will be given intravenously at the rate of 1.5 microgram /ml over 20 minutes.
- Headache intensity [ Time Frame: 24 hours ]Measured by visual analog score (VAS) ( 0 to 10).
- Headache characteristics [ Time Frame: 24 hours ]Headache questionnaire will be used to record following symptoms (localization, duration, nausea, photophobia and phonophobia.)
- Dilatation of Arteria radialis and arteria temporalis superficialis [ Time Frame: 2 hours ]Dermascan will be used to measure the above mentioned Radial and temporal arteries diameter.
- Arteria cerebri Media (MCA) [ Time Frame: 2 hours ]MCA blood flow will be measured by transcranial Doppler
- Facial flushing [ Time Frame: 2 hours ]Flushing will measured by laser contrast imaging
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03598075
|Danish Headache Center|
|Glostrup, Denmark, 2600|