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The Effect of Sumatriptan and Placebo Injection on Cilostazol Induced Headache

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ClinicalTrials.gov Identifier: NCT03422796
Recruitment Status : Recruiting
First Posted : February 6, 2018
Last Update Posted : February 6, 2018
Sponsor:
Information provided by (Responsible Party):
Katrine Falkenberg, Danish Headache Center

Brief 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.

Condition or disease Intervention/treatment
Migraine Drug: Cilostazol 200mg Drug: SUMAtriptan 6 MG/ML Drug: Placebo

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 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Sumatriptan and Placebo Injection on Cilostazol Induced Headache
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Sumatriptan
headache is induced with Cilostazol. This headache is treated double-blinded with 6mg/ml sumatriptan
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
Other Name: Pletal
Drug: 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
Other Name: Imigran
Placebo Comparator: Placebo
headache is induced with Cilostazol. This headache is treated double-blinded with 1 tablet of placeb
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
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: 2hours ]
    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 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03422796


Contacts
Contact: Katrine Falkenberg, Doctor 21158408 katrine.falkenberg@regionh.dk

Locations
Denmark
Rigshospitalet Glostrup Recruiting
Glostrup, Denmark, 2600
Contact: Katrine Falkenberg    21158408    katrine.falkenberg@regionh.dk   
Sponsors and Collaborators
Danish Headache Center

Responsible Party: Katrine Falkenberg, Medical doctor, Danish Headache Center
ClinicalTrials.gov Identifier: NCT03422796     History of Changes
Other Study ID Numbers: H-17026731
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: January 2018
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:
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
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
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents