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The Effect of Sumatriptan and Placebo on Cilostazol Induced Headache

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ClinicalTrials.gov Identifier: NCT02486276
Recruitment Status : Completed
First Posted : July 1, 2015
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Emma Katrine Hansen, Danish Headache Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Migraine Drug: Cilostazol Drug: Sumatriptan Drug: Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Sumatriptan and Placebo on Cilostazol Induced Headache. Development of a Pragmatic Migraine Model
Study Start Date : June 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

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: 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 Name: Pletal

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 Name: Imigran

Placebo Comparator: Placebo
headache is induced with Cilostazol. This headache is treated double-blinded with 1 tablet of placebo
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 Name: Pletal

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




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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

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): NCT02486276


Locations
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Denmark
Emma Katrine Hansen
Copenhagen, Glostrup, Denmark, 2600
Sponsors and Collaborators
Danish Headache Center
Investigators
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Principal Investigator: Emma Katrine Hansen, Doctor Danish Headache Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Emma Katrine Hansen, Medical doctor, Danish Headache Center
ClinicalTrials.gov Identifier: NCT02486276     History of Changes
Other Study ID Numbers: H-8-2014-009
First Posted: July 1, 2015    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
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Sumatriptan
Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Cilostazol
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