The Effect of Sumatriptan and Placebo on Cilostazol Induced Headache

The Effect of Sumatriptan and Placebo on Cilostazol Induced Headache. Development of a Pragmatic Migraine Model

To develop a pragmatic migraine model the investigators will induce headache in healthy volunteers and in patients with migraine without aura with a phosphodiesterase inhibitor (cilostazol). If the headache responds to sumatriptan, the model can be used to test new drug candidates.

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Drug: Sumatriptan; Drug: Placebo; Drug: Cilostazol

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 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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Glostrup
    • Copenhagen, Glostrup, Denmark, 2600
      • Emma Katrine Hansen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion criteria:

Healthy:

• Healthy subjects of both sexes
• Age 18-70 years
• Weight 50-90 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
• 18-70 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sumatriptan; headache is induced with Cilostazol. This headache is treated double-blinded with 1 tablet of sumatriptan 50 mg	Drug: Sumatriptan; 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; Drug: Cilostazol; 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
Placebo Comparator: Placebo; headache is induced with Cilostazol. This headache is treated double-blinded with 1 tablet of placebo	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; Drug: Cilostazol; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in median headache score 2 hours after sumatriptan/placebo	The investigators will assess the outcome measures 1 year after the beginning of the study	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the headache score curve	The investigators will assess the outcome measures 1 year after the beginning of the study	12 hours

Collaborators and Investigators

• Sponsor: Danish Headache Center

Publications and helpful links

General Publications

• Falkenberg K, Dunga BOA, Guo S, Ashina M, Olesen J. Cilostazol induced migraine does not respond to sumatriptan in a double blind trial. J Headache Pain. 2018 Feb 2;19(1):11. doi: 10.1186/s10194-018-0841-7.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: June 4, 2015
• First Submitted That Met QC Criteria: June 26, 2015
• First Posted (Estimate): July 1, 2015

Study Record Updates

• Last Update Posted (Actual): May 9, 2017
• Last Update Submitted That Met QC Criteria: May 8, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Neuroprotective Agents; Protective Agents; Serotonin Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Phosphodiesterase Inhibitors; Vasoconstrictor Agents; Phosphodiesterase 3 Inhibitors; Cilostazol; Sumatriptan
• Other Study ID Numbers: H-8-2014-009