Evaluation d'une solution hydro-alcoolique de sumatriptan administrée par voie sublinguale dans le traitement d'une crise d'algie vasculaire de la face, à la dose de 2mg, 4mg ou 6mg déterminée par une première partie d'étude en dose-ranging.
- Conditions
- Cluster headaches
- Registration Number
- EUCTR2007-002435-93-FR
- Lead Sponsor
- ITHER PHARMACEUTICALS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Adults (18-65 years) of both sexes
Acute cluster headache
Previous episodes of cluster headaches
Previous successful treatment with subcutaneous sumatriptan
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
History of cardiovascular diseases, CVA, ITA, severe hypertension
Severe hepatic disease
Known hypersensibility to sulfamides
Recent treatment with ergot (less than 24 hr) or MAOI (less than 2 weeks)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the delay of efficacy of a sublingual solution of sumatriptan in acute cluster headache and compare the results to published data obtained with subcutaneous administration.;Secondary Objective: To evaluate the systemic and local safety of this new formulation of sumatriptan in cluster headaches.;Primary end point(s): Decrease in pain intensity from severe to moderate
- Secondary Outcome Measures
Name Time Method