PHASE 0 STUDY TO VALIDATE PD ENDPOINTS IN HEALTHY SUBJECTS
Research type
Research Study
Full title
A RANDOMISED, PLACEBO-CONTROLLED, PHASE 0 STUDY TO VALIDATE SEVERAL PHARMACODYNAMIC ENDPOINTS IN HEALTHY MALE SUBJECTS USING BOTULINUM TOXIN A AS A CHALLENGE
IRAS ID
157361
Contact name
Aliya Asher
Contact email
Sponsor organisation
Ipsen Innovation
Research summary
This is a study to test a number of different techniques as appropriate markers of botulinum toxin activity. Eligible subjects are healthy males aged between 18 and 55. Dysport®, a marketed botulinum toxin A licensed in the UK for removing facial lines and also for treatment of muscle spasms and spasticity or tightness, will be used. The information collected in this study is expected to find out how effective and sensitive each technique is in detecting effects of different doses of Dysport®. It will allow us to determine which are the most appropriate to be assessed in future studies.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
14/NW/1038
Date of REC Opinion
15 Jul 2014
REC opinion
Further Information Favourable Opinion