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The Effect of Sumatriptan and Placebo on Isosorbide-5-mononitrate Induced Headache

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ClinicalTrials.gov Identifier: NCT02485340
Recruitment Status : Completed
First Posted : June 30, 2015
Last Update Posted : January 22, 2016
Sponsor:
Information provided by (Responsible Party):
Emma Katrine Hansen, Danish Headache Center

Tracking Information
First Submitted Date  ICMJE June 4, 2015
First Posted Date  ICMJE June 30, 2015
Last Update Posted Date January 22, 2016
Study Start Date  ICMJE April 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2015)
  • Median headache score 0 hours after sumatriptan/placebo [ Time Frame: 0 hours ]
  • Median headache score 2 hours after sumatriptan/placebo [ Time Frame: 2 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02485340 on ClinicalTrials.gov Archive Site
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 on Isosorbide-5-mononitrate Induced Headache
Official Title  ICMJE The Effect of Sumatriptan and Placebo on Isosorbide-5-mononitrate Induced Headache. Development of a Pragmatic Migraine Model
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 long lasting Nitrogen Oxide (NO) donor. If the headache responds to sumatriptan, 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 Isosorbide-5-mononitrate (5-ISMN), a long lasting NO-donor, 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: 5-ISMN 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

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: 5-ISMN (isosorbide-5-mononitrate)
    5-ISMN is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
    Other Name: Imdur
  • Drug: Sumatriptan
    5-ISMN 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
    5-ISMN 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 5-ISMN. This headache is treated double-blinded with 1 tablet of sumatriptan 50 mg
    Interventions:
    • Drug: 5-ISMN (isosorbide-5-mononitrate)
    • Drug: Sumatriptan
  • Placebo Comparator: Placebo
    headache is induced with 5-ISMN. This headache is treated double-blinded with 1 tablet of placebo (the tablet is similar to the active tablet)
    Interventions:
    • Drug: 5-ISMN (isosorbide-5-mononitrate)
    • 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 Completed
Actual Enrollment  ICMJE
 (submitted: June 26, 2015)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 International headache society (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, and intake of daily medication (except oral contraceptives).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02485340
Other Study ID Numbers  ICMJE H-6-2014-071
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Emma Katrine Hansen, Danish Headache Center
Study Sponsor  ICMJE Danish Headache Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Emma Katrine Hansen, Doctor Danish Headache Center
PRS Account Danish Headache Center
Verification Date January 2016

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