Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-29 @ 2:56 PM
Study NCT ID:
NCT03542357
Status:
COMPLETED
Last Update Posted:
2019-09-12
First Post:
2017-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Sumatriptan and Placebo on CGRP Induced Headache
Sponsor:
Danish Headache Center
Organization:
Study Overview
Official Title:
The Effect of Sumatriptan and Placebo on CGRP Induced Headache
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: