Trials / Completed
CompletedNCT03422796
The Effect of Sumatriptan and Placebo Injection on Cilostazol Induced Headache
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Danish Headache Center · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
To develop a pragmatic migraine model the investigators will induce headache in patients with migraine without aura with a phosphodiesterase inhibitor (cilostazol). If the headache responds to sumatriptan injection, 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 Cilostazol, a phosphodiesterase inhibitor 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: Cilostazol induces a migraine-like headache in MO-patients and the induced headache responds to sumatriptan injection Aim: Developing a pragmatic and valid model for the testing of new anti-migraine drugs.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cilostazol 200mg | Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan |
| DRUG | SUMAtriptan 6 MG/ML | Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan |
| DRUG | Placebo | Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan |
Timeline
- Start date
- 2017-11-01
- Primary completion
- 2018-09-01
- Completion
- 2018-09-01
- First posted
- 2018-02-06
- Last updated
- 2020-01-29
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT03422796. Inclusion in this directory is not an endorsement.