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The Effect of Sumatriptan and Placebo Injection on Cilostazol Induced Headache

Sponsor
Danish Headache Center (Other)
Overall Status
Completed
CT.gov ID
NCT03422796
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
10
Actual Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Drug: Cilostazol 200mg
  • Drug: SUMAtriptan 6 MG/ML
  • Drug: Placebo
 N/A

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 Design

Study Type:
Interventional
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 Injection on Cilostazol Induced Headache
Actual Study Start Date :
Nov 1, 2017
Actual Primary Completion Date :
Sep 1, 2018
Actual Study Completion Date :
Sep 1, 2018

Arms and Interventions

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 Names:
  • 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 Names:
  • 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 Names:
  • 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

    Outcome Measures

    Primary Outcome Measures

    1. Difference in median headache score after sumatriptan/placebo [2hours]

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

    2. difference in AUC 0-4h post treatment [4hours]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rigshospitalet Glostrup Glostrup Denmark 2600

    Sponsors and Collaborators

    • Danish Headache Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Katrine Falkenberg, Medical doctor, Danish Headache Center
    ClinicalTrials.gov Identifier:
    NCT03422796
    Other Study ID Numbers:
    • H-17026731
    First Posted:
    Feb 6, 2018
    Last Update Posted:
    Jan 29, 2020
    Last Verified:
    Jan 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    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
    Cilostazol
    Sumatriptan

    Study Results

    No Results Posted as of Jan 29, 2020