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The Effect of Sumatriptan and Placebo on CGRP Induced Headache

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ClinicalTrials.gov Identifier: NCT03542357
Recruitment Status : Recruiting
First Posted : May 31, 2018
Last Update Posted : May 31, 2018
Sponsor:
Information provided by (Responsible Party):
Katrine Falkenberg, Danish Headache Center

Brief Summary:
To develop a pragmatic migraine model the investigators will induce headache in healthy volunteers and in patients with migraine without aura with aCalcitonine Gene Related Peptide (CGRP). If the headache responds to sumatriptan, the model can be used to test new drug candidates.

Condition or disease Intervention/treatment Phase
Migraine Drug: Calcitonin Gene Related Peptide Drug: Sumatriptan 50 mg Drug: Placebo Oral Tablet Not Applicable

Detailed Description:

There remains a great need for more effective anti-migraine drugs with fewer side effects. Human experimental models are valuable in early phase development of new anti-migraine drugs but useful models have not yet been developed. The investigators' group has shown that Calcitonine Gene Related Peptide (CGRP) induce headache/migraine in both healthy volunteers and in patients with migraine without aura (MO). To validate this model, the headache must respond to specific migraine treatment with sumatriptan.

Hypothesis: CGRP induces a migraine-like headache in both healthy subjects and in MO-patients and induced headache responds to a specific anti migraine drug; sumatriptan.

Aim: Developing a pragmatic and valid model for the testing of new anti-migraine drugs.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Sumatriptan and Placebo on CGRP Induced Headache
Actual Study Start Date : February 15, 2018
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache
Drug Information available for: Sumatriptan

Arm Intervention/treatment
Active Comparator: Sumatriptan
headache is induced with CGRP. This headache is treated double-blinded with 1 tablet of sumatriptan 50 mg as a pre-treatment
Drug: Calcitonin Gene Related Peptide
CGRP is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
Other Name: CGRP

Drug: Sumatriptan 50 mg
CGRP is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
Other Name: Imigran

Placebo Comparator: Placebo
headache is induced with CGRP. This headache is treated double-blinded with 1 tablet of placebo as a pre-treatment
Drug: Calcitonin Gene Related Peptide
CGRP is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
Other Name: CGRP

Drug: Placebo Oral Tablet
CGRPis given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan




Primary Outcome Measures :
  1. AUC 2h after infusion [ Time Frame: 1 year ]
    The investigators will assess the outcome measures 1 year after the beginning of the study



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

Healthy:

Healthy subjects of both sexes Age 18-70 years Weight 50-90 kg. Females were requested to use effective contraception.

Migraine patients:

Migraine patients who meet IHS criteria for migraine with or without aura of both sexes 18-70 years 45-95 kg.

Exclusion Criteria:

Healthy:

Any type of headache (except episodic tension-type headache < 1 day per week) Serious somatic or psychiatric disease Pregnancy Intake of daily medication (except oral contraceptives).

Migraine patients:

Any other type of headache then migraine without aura (except episodic tension-type headache < 1 day per week) Serious somatic or psychiatric disease Pregnancy Intake of daily medication (except oral contraceptives) Triptan non-responders


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): NCT03542357


Contacts
Contact: Katrine Falkenberg, Doctor 21158408 katrine.falkenberg@regionh.dk

Locations
Denmark
Rigshospitalet Glostrup Recruiting
Glostrup, Denmark, 2600
Contact: Jes Olesen, Professor    38633036    jes.olesen@regionh.dk   
Sponsors and Collaborators
Danish Headache Center

Responsible Party: Katrine Falkenberg, Medical doctor, Danish Headache Center
ClinicalTrials.gov Identifier: NCT03542357     History of Changes
Other Study ID Numbers: H-16000065
First Posted: May 31, 2018    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 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:
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sumatriptan
Calcitonin
Calcitonin Gene-Related Peptide
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Bone Density Conservation Agents
Vasodilator Agents