Safety and efficacy study of SOM230 s.c. in Cluster Headaches
Research type
Research Study
Full title
A Two Part Multicentre, Placebo-Controlled, Active-Comparator Controlled, Single Dose Study in Acute Episodic and Chronic Cluster Headache to Evaluate the Safety and Efficacy of SOM230 subcutaneous (s.c.)
IRAS ID
209044
Contact name
Peter Goadsby
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2015-004436-34
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 10 months, 31 days
Research summary
The purpose of this study is to determine if SOM230 (Pasireotide) subcutaneous (injection under the skin)is an effective and safe drug to warrant further clinical development in cluster headache (CH).
The causes underlying CH attacks are not fully known. The hormone somatostatin is believed to reduce pain by preventing pain transmitters however somatostatin in CH has a very short lasting physiological effect. A significant number of patients do not respond to the current approved treatment or are unable to be prescribed this medication. SOM230 is similar to somatostatin and hopes to relieve the CH and delay the time to the next attack.
This study is a non-randomised, subject blinded study; therefore all participants will receive the same course of treatment and the identity of study treatment will not be known to the subject. The study will have two cohorts (parts). Cohort 1 will be a comparison of 1.5mg SOM230 versus placebo (dummy drug with no active medicine inside). Two consecutive attacks will be treated; the first attack with placebo and the next attack with SOM230. Following a review of the effectiveness and safety of SOM230 in cohort 1, cohort 2 comparing 0.9mg SOM230 versus placebo may be considered for investigation. Subject participation on the study will be a maximum of 30 days.
The study is sponsored by Novartis and will be run in 3 countries; Germany, UK and USA. There will be one centre in the UK which will aim to enrol approximately 6 subjects.REC name
London - Central Research Ethics Committee
REC reference
16/LO/1861
Date of REC Opinion
20 Dec 2016
REC opinion
Further Information Favourable Opinion