The Effect of Sumatriptan and Placebo Injection on Cilostazol Induced Headache

Migraine Clinical Trial

Official title:

The Effect of Sumatriptan and Placebo Injection on Cilostazol Induced Headache

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03422796
• Other study ID #: H-17026731
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: September 1, 2018

Study information

• Verified date: January 2020
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 1, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Migraine patients who meet IHS criteria for migraine with or without aura of both sexes

• 18-70 years

• 45-95 kg.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Headache
• Migraine

Intervention

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
• 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
• Placebo
Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan

Locations

Country	Name	City	State
Denmark	Rigshospitalet Glostrup	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in median headache score after sumatriptan/placebo	The investigators will assess the outcome measures 1 year after the beginning of the study	2hours
Primary	difference in AUC 0-4h post treatment	The difference in area under the curve 0-4h after treatment with sumatriptan and placebo	4hours