Back to resultsThe Effect of Sumatriptan and Placebo on CGRP Induced Headache
Primary Purpose
Migraine
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Calcitonin Gene Related Peptide
Sumatriptan 50 mg
Placebo Oral Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Migraine
Eligibility Criteria
Inclusion criteria:
Healthy:
Healthy subjects of both sexes Age 18-60 years Weight 45-95 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 18-60 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
Sites / Locations
- Rigshospitalet Glostrup
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Sumatriptan
Placebo
Arm Description
headache is induced with CGRP. This headache is treated double-blinded with 1 tablet of sumatriptan 50 mg as a pre-treatment
headache is induced with CGRP. This headache is treated double-blinded with 1 tablet of placebo as a pre-treatment
Outcomes
Primary Outcome Measures
AUC after infusion
The investigators will assess the outcome measures 1 year after the beginning of the study
Secondary Outcome Measures
Full Information
NCT ID
NCT03542357
First Posted
October 20, 2017
Last Updated
September 11, 2019
Sponsor
Danish Headache Center
1. Study Identification
Unique Protocol Identification Number
NCT03542357
Brief Title
The Effect of Sumatriptan and Placebo on CGRP Induced Headache
Official Title
The Effect of Sumatriptan and Placebo on CGRP Induced Headache
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
February 15, 2018 (Actual)
Primary Completion Date
September 1, 2018 (Actual)
Study Completion Date
September 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Headache Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sumatriptan
Arm Type
Active Comparator
Arm Description
headache is induced with CGRP. This headache is treated double-blinded with 1 tablet of sumatriptan 50 mg as a pre-treatment
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
headache is induced with CGRP. This headache is treated double-blinded with 1 tablet of placebo as a pre-treatment
Intervention Type
Drug
Intervention Name(s)
Calcitonin Gene Related Peptide
Other Intervention Name(s)
CGRP
Intervention Description
CGRP is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
Intervention Type
Drug
Intervention Name(s)
Sumatriptan 50 mg
Other Intervention Name(s)
Imigran
Intervention Description
CGRP is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
CGRPis given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
Primary Outcome Measure Information:
Title
AUC after infusion
Description
The investigators will assess the outcome measures 1 year after the beginning of the study
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
Healthy:
Healthy subjects of both sexes Age 18-60 years Weight 45-95 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 18-60 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
Facility Information:
Facility Name
Rigshospitalet Glostrup
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Sumatriptan and Placebo on CGRP Induced Headache
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