The Effect of Sumatriptan and Placebo on Cilostazol Induced Headache

D

Danish Headache Center

Status

Completed

Conditions

Migraine

Treatments

Drug: Placebo
Drug: Cilostazol
Drug: Sumatriptan

Study type

Interventional

Funder types

Other

Identifiers

NCT02486276
H-8-2014-009

Details and patient eligibility

About

To develop a pragmatic migraine model the investigators will induce headache in healthy volunteers and in patients with migraine without aura with a phosphodiesterase inhibitor (cilostazol). If the headache responds to sumatriptan, the model can be used to test new drug candidates.

Full 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 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.

Enrollment

30 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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 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
  • Intake of daily medication (except oral contraceptives)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

30 participants in 2 patient groups, including a placebo group

Sumatriptan
Active Comparator group
Description:
headache is induced with Cilostazol. This headache is treated double-blinded with 1 tablet of sumatriptan 50 mg
Treatment:
Drug: Sumatriptan
Drug: Cilostazol
Placebo
Placebo Comparator group
Description:
headache is induced with Cilostazol. This headache is treated double-blinded with 1 tablet of placebo
Treatment:
Drug: Cilostazol
Drug: Placebo

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems