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

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ClinicalTrials.gov Identifier: NCT03598075
Recruitment Status : Recruiting
First Posted : July 25, 2018
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
Hashmat Ghanizada, Danish Headache Center

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.

Condition or disease Intervention/treatment Phase
Migraine Without Aura Other: Amylin (Pramlintide) Other: CGRP Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
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)
Primary Purpose: Other
Official Title: Amylin and CGRP Migraine Provocation in Migraine Without Aura Patients
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
Amylin (Pramlintide)
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
CGRP intravenous infusion 30 micrograms/mL over 20 minutes
Other: CGRP
CGRP It will be given intravenously at the rate of 1.5 microgram /ml over 20 minutes.




Primary Outcome Measures :
  1. Headache intensity [ Time Frame: 24 hours ]
    Measured by visual analog score (VAS) ( 0 to 10).

  2. Headache characteristics [ Time Frame: 24 hours ]
    Headache questionnaire will be used to record following symptoms (localization, duration, nausea, photophobia and phonophobia.)


Secondary Outcome Measures :
  1. 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.

  2. Arteria cerebri Media (MCA) [ Time Frame: 2 hours ]
    MCA blood flow will be measured by transcranial Doppler

  3. Facial flushing [ Time Frame: 2 hours ]
    Flushing will measured by laser contrast imaging



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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


Contacts
Contact: Hashmat Ghanizada, MD 0045-51447278 hashmat.ghanizada@regionh.dk

Locations
Denmark
Danish Headache Center Recruiting
Glostrup, Denmark, 2600
Contact: Hashmat Ghanizada, MD    0045-51447278    hashmat.ghanizada@regionh.dk   
Sponsors and Collaborators
Danish Headache Center

Responsible Party: Hashmat Ghanizada, Principal investigator, Danish Headache Center
ClinicalTrials.gov Identifier: NCT03598075     History of Changes
Other Study ID Numbers: H-17035931
First Posted: July 25, 2018    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Migraine Disorders
Migraine without Aura
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pramlintide
Islet Amyloid Polypeptide
Hypoglycemic Agents
Physiological Effects of Drugs
Appetite Depressants
Anti-Obesity Agents
Amylin Receptor Agonists
Molecular Mechanisms of Pharmacological Action