Cluster headaches
Conditions
Interventions
Product Name: SL07
Product Code: SL07
Pharmaceutical Form: Sublingual spray
INN or Proposed INN: SUMATRIPTAN
CAS Number: 103628462
Concentration unit: mg milligram(s)
Concentration type: equal
Concent
Sponsors
UNITHER PHARMACEUTICALS
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
France
Outcome results
None listed