Table 2 Trial registration data
Data category | Information |
|---|---|
Primary registry | ClinicalTrials.gov NCT02546999 |
EudraCT Number 2014-002539-32 | |
Secondary identifying numbers | REC North 2013/1195 |
The Norwegian Medicines Agency 14/15799-9 | |
Sponsor | St. Olav’s University Hospital, Trondheim, Norway |
Contact | Siri.merete.brendvik@stolav.no |
Short title | The WE-Study (Walking Easier with cerebral palsy) |
Scientific title | Does botulinum toxin A make walking easier in children with cerebral palsy? |
Country of recruitment | Norway |
Population | Children with cerebral palsy (4 − 17.5 years) |
Intervention | Active comparator: botulinum toxin A (Botox®) |
Placebo comparator: saline | |
Study type | Interventional parallel-group, randomized, double-blinded |
Phase IV | |
Primary purpose: treatment effect | |
First enrollment | September 2015 |
Target sample size | 96 |
Primary outcome | Energy cost during walking |
Secondary outcome | Activity, pain, walking capacity, perceived benefit |