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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

Tracking Information
First Submitted Date  ICMJE October 20, 2017
First Posted Date  ICMJE February 6, 2018
Last Update Posted Date February 6, 2018
Actual Study Start Date  ICMJE November 1, 2017
Estimated Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Sumatriptan and Placebo Injection on Cilostazol Induced Headache
Official Title  ICMJE The Effect of Sumatriptan and Placebo Injection on Cilostazol Induced Headache
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Migraine
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: Sumatriptan
    headache is induced with Cilostazol. This headache is treated double-blinded with 6mg/ml sumatriptan
    Interventions:
    • Drug: Cilostazol 200mg
    • Drug: SUMAtriptan 6 MG/ML
  • Placebo Comparator: Placebo
    headache is induced with Cilostazol. This headache is treated double-blinded with 1 tablet of placeb
    Interventions:
    • Drug: Cilostazol 200mg
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 30, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2018
Estimated Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Katrine Falkenberg, Doctor 21158408 katrine.falkenberg@regionh.dk
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03422796
Other Study ID Numbers  ICMJE H-17026731
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Katrine Falkenberg, Danish Headache Center
Study Sponsor  ICMJE Danish Headache Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Danish Headache Center
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP