The Effect of Sumatriptan and Placebo Injection on Cilostazol Induced Headache
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2017
CompletedStudy Start
First participant enrolled
November 1, 2017
CompletedFirst Posted
Study publicly available on registry
February 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedJanuary 29, 2020
January 1, 2020
10 months
October 20, 2017
January 27, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Difference in median headache score after sumatriptan/placebo
The investigators will assess the outcome measures 1 year after the beginning of the study
2hours
difference in AUC 0-4h post treatment
The difference in area under the curve 0-4h after treatment with sumatriptan and placebo
4hours
Study Arms (2)
Sumatriptan
ACTIVE COMPARATORheadache is induced with Cilostazol. This headache is treated double-blinded with 6mg/ml sumatriptan
Placebo
PLACEBO COMPARATORheadache is induced with Cilostazol. This headache is treated double-blinded with 1 tablet of placeb
Interventions
Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
Eligibility Criteria
You may qualify if:
- Migraine patients who meet IHS criteria for migraine with or without aura of both sexes
- years
- kg.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rigshospitalet Glostrup
Glostrup Municipality, 2600, Denmark
Related Publications (1)
Falkenberg K, Bjerg HR, Olesen J. Subcutaneous sumatriptan reduces cilostazol induced headache in migraine patients. Cephalalgia. 2020 Jul;40(8):842-850. doi: 10.1177/0333102420915166. Epub 2020 Mar 26.
PMID: 32216457DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical doctor
Study Record Dates
First Submitted
October 20, 2017
First Posted
February 6, 2018
Study Start
November 1, 2017
Primary Completion
September 1, 2018
Study Completion
September 1, 2018
Last Updated
January 29, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share