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Pretreatment With Sumatriptan on Cilostazol Induced Headache in Healthy Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03156920
First Posted: May 17, 2017
Last Update Posted: October 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Katrine Falkenberg, Danish Headache Center
  Purpose
To develop a pragmatic migraine model the investigators will induce headache in healthy volunteers with a phosphodiesterase inhibitor (cilostazol). The participants will be pre-treated with sumatriptan. If the headache responds to sumatriptan, the model can be used to test new drug candidates.

Condition Intervention
Migraine Drug: Placebo Drug: Sumatriptan

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Pretreatment With Sumatriptan on Cilostazol Induced Headache in Healthy Volunteers. Development of a Pragmatic Migraine Model

Resource links provided by NLM:


Further study details as provided by Katrine Falkenberg, Danish Headache Center:

Primary Outcome Measures:
  • Difference in median headache score 2 hours after cilostazol [ Time Frame: 2 hours ]
    The investigators will assess the outcome measures 1 year after the beginning of the study

  • Area under the headache score curve [ Time Frame: 12 hours ]
    The investigators will assess the outcome measures 1 year after the beginning of the study


Secondary Outcome Measures:
  • Difference in peak headache score [ Time Frame: 12 hours ]

Enrollment: 30
Actual Study Start Date: May 23, 2017
Study Completion Date: October 18, 2017
Primary Completion Date: October 18, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sumatriptan
Headache is induced with Cilostazol. This headache is pre-treated double-blinded with 2 tablets 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
Placebo Comparator: Placebo
Headache is induced with Cilostazol. This headache is pre-treated double-blinded with 2 tablets 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

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 cilostazol as a model, the headache must respond to specific migraine treatment with sumatriptan.

Hypothesis: Cilostazol induces a migraine-like headache in healthy subjects. The induced headache can be pre-treated with a specific anti-migraine drug; sumatriptan.

Aim: Developing a pragmatic and valid model for the testing of new anti-migraine drugs.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Healthy subjects of both sexes Age 18-60 years Weight 50-95 kg. Females were requested to use effective contraception.

Exclusion Criteria:

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).

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03156920


Locations
Denmark
Katrine Falkenberg
Copenhagen, Glostrup, Denmark, 2600
Sponsors and Collaborators
Danish Headache Center
  More Information

Responsible Party: Katrine Falkenberg, Medical doctor, PhD student, principal investigator, Danish Headache Center
ClinicalTrials.gov Identifier: NCT03156920     History of Changes
Other Study ID Numbers: H-15011960
First Submitted: May 10, 2017
First Posted: May 17, 2017
Last Update Posted: October 19, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Cilostazol
Sumatriptan
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists