Pretreatment With Sumatriptan on Cilostazol Induced Headache in Healthy Volunteers
Mots clés
Abstrait
La 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 cilostazol as a model, the headache must respond to specific migraine treatment with sumatriptan.
Hypothesis: Cilostazol induces a migraine-like headache in healthy subjects. The induced headache can be pre-treated with a specific anti-migraine drug; sumatriptan.
Aim: Developing a pragmatic and valid model for the testing of new anti-migraine drugs.
Rendez-vous
| Dernière vérification: | 09/30/2017 |
| Première soumission: | 05/09/2017 |
| Inscription estimée soumise: | 05/15/2017 |
| Première publication: | 05/16/2017 |
| Dernière mise à jour soumise: | 10/17/2017 |
| Dernière mise à jour publiée: | 10/18/2017 |
| Date de début réelle de l'étude: | 05/22/2017 |
| Date d'achèvement primaire estimée: | 10/17/2017 |
| Date estimée d'achèvement de l'étude: | 10/17/2017 |
Condition ou maladie
Intervention / traitement
Drug: Placebo
Drug: Sumatriptan
Phase
Groupes d'armes
| Bras | Intervention / traitement |
|---|---|
| Active Comparator: Sumatriptan Headache is induced with Cilostazol. This headache is pre-treated double-blinded with 2 tablets of sumatriptan 50 mg | Drug: Sumatriptan Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan |
| Placebo Comparator: Placebo Headache is induced with Cilostazol. This headache is pre-treated double-blinded with 2 tablets of placebo | Drug: Placebo Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan |
Critère d'éligibilité
| Âges éligibles aux études | 18 Years À 18 Years |
| Sexes éligibles à l'étude | All |
| Accepte les bénévoles en santé | Oui |
| Critères | Inclusion Criteria: Healthy subjects of both sexes Age 18-60 years Weight 50-95 kg. Females were requested to use effective contraception. Exclusion Criteria: 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). |
Résultat
Mesures des résultats primaires
1. Difference in median headache score 2 hours after cilostazol [2 hours]
2. Area under the headache score curve [12 hours]
Mesures des résultats secondaires
1. Difference in peak headache score [12 hours]
