Pretreatment With Sumatriptan on Cilostazol Induced Headache in Healthy Volunteers
1 other identifier
interventional
30
1 country
1
Brief Summary
To develop a pragmatic migraine model the investigators will induce headache in healthy volunteers with a phosphodiesterase inhibitor (cilostazol). The participants will be pre-treated with sumatriptan. If the headache responds to sumatriptan, 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 May 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
May 10, 2017
CompletedFirst Posted
Study publicly available on registry
May 17, 2017
CompletedStudy Start
First participant enrolled
May 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 18, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 18, 2017
CompletedOctober 19, 2017
October 1, 2017
5 months
May 10, 2017
October 18, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Difference in median headache score 2 hours after cilostazol
The investigators will assess the outcome measures 1 year after the beginning of the study
2 hours
Area under the headache score curve
The investigators will assess the outcome measures 1 year after the beginning of the study
12 hours
Secondary Outcomes (1)
Difference in peak headache score
12 hours
Study Arms (2)
Sumatriptan
ACTIVE COMPARATORHeadache is induced with Cilostazol. This headache is pre-treated double-blinded with 2 tablets of sumatriptan 50 mg
Placebo
PLACEBO COMPARATORHeadache is induced with Cilostazol. This headache is pre-treated double-blinded with 2 tablets of placebo
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
Eligibility Criteria
You may qualify if:
- Healthy subjects of both sexes Age 18-60 years Weight 50-95 kg. Females were requested to use effective contraception.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Katrine Falkenberg
Copenhagen, Glostrup, 2600, Denmark
Related Publications (1)
Falkenberg K, Olesen J. Pre-treatment with sumatriptan for cilostazol induced headache in healthy volunteers. J Headache Pain. 2018 Aug 17;19(1):71. doi: 10.1186/s10194-018-0890-y.
PMID: 30120600DERIVED
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, PhD student, principal investigator
Study Record Dates
First Submitted
May 10, 2017
First Posted
May 17, 2017
Study Start
May 23, 2017
Primary Completion
October 18, 2017
Study Completion
October 18, 2017
Last Updated
October 19, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share