drugset / Trial / NCT02619617
Safety and Efficacy Study of SOM230 s.c. in Cluster Headache
Non-randomizedSequentialDouble-blindTreatment
Summary
The purpose of this study was to determine if SOM230 is safe and effective for the treament of cluster headache.
Timeline
- Start
- 2016-10-31
- Primary completion
- 2018-09-25
- Completion
- 2018-09-25
Outcome
Missed primary endpoint
Stopped: “Novartis decision based on Cohort 1 results”
registry analysis (other test); Placebo s.c. vs SOM230 1.5 mg; p = 0.698; Odds Ratio (OR) 1.308 (90% CI 0.419 to 4.082); Regression, Logistic NCT02619617 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pasireotide | Other / unclassified | 0.9 mg | Subcutaneous |
| Subject | Pasireotide | Other / unclassified | 1.5 mg | Subcutaneous |