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Completed

NCT Number: NCT03422796

The Effect of Sumatriptan and Placebo Injection on Cilostazol Induced Headache

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet Glostrup

Glostrup Municipality, 2600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cilostazol 200mg

Drug

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

Other names: Pletal

SUMAtriptan 6 MG/ML

Drug

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

Other names: Imigran

Placebo

Drug

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

Primary outcomes

  1. Difference in median headache score after sumatriptan/placebo

    Time frame: 2hours

    The investigators will assess the outcome measures 1 year after the beginning of the study

  2. difference in AUC 0-4h post treatment

    Time frame: 4hours

    The difference in area under the curve 0-4h after treatment with sumatriptan and placebo

Sponsors and collaborators

Lead sponsor

Danish Headache Center

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 6, 2018
Registry last updated
Jan 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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