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The Effect of Sumatriptan and Placebo Injection on Cilostazol Induced Headache

Primary Purpose

Migraine

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Cilostazol 200mg
SUMAtriptan 6 MG/ML
Placebo
Sponsored by
Danish Headache Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rigshospitalet Glostrup

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Sumatriptan

Placebo

Arm Description

headache is induced with Cilostazol. This headache is treated double-blinded with 6mg/ml sumatriptan

headache is induced with Cilostazol. This headache is treated double-blinded with 1 tablet of placeb

Outcomes

Primary Outcome Measures

Difference in median headache score after sumatriptan/placebo
The investigators will assess the outcome measures 1 year after the beginning of the study
difference in AUC 0-4h post treatment
The difference in area under the curve 0-4h after treatment with sumatriptan and placebo

Secondary Outcome Measures

Full Information

First Posted
October 20, 2017
Last Updated
January 27, 2020
Sponsor
Danish Headache Center
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1. Study Identification

Unique Protocol Identification Number
NCT03422796
Brief Title
The Effect of Sumatriptan and Placebo Injection on Cilostazol Induced Headache
Official Title
The Effect of Sumatriptan and Placebo Injection on Cilostazol Induced Headache
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
September 1, 2018 (Actual)
Study Completion Date
September 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Headache Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sumatriptan
Arm Type
Active Comparator
Arm Description
headache is induced with Cilostazol. This headache is treated double-blinded with 6mg/ml sumatriptan
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
headache is induced with Cilostazol. This headache is treated double-blinded with 1 tablet of placeb
Intervention Type
Drug
Intervention Name(s)
Cilostazol 200mg
Other Intervention Name(s)
Pletal
Intervention Description
Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
Intervention Type
Drug
Intervention Name(s)
SUMAtriptan 6 MG/ML
Other Intervention Name(s)
Imigran
Intervention Description
Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
Primary Outcome Measure Information:
Title
Difference in median headache score after sumatriptan/placebo
Description
The investigators will assess the outcome measures 1 year after the beginning of the study
Time Frame
2hours
Title
difference in AUC 0-4h post treatment
Description
The difference in area under the curve 0-4h after treatment with sumatriptan and placebo
Time Frame
4hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Rigshospitalet Glostrup
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32216457
Citation
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.
Results Reference
derived

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The Effect of Sumatriptan and Placebo Injection on Cilostazol Induced Headache

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