Skip to main content

Table 2 Trial registration data

From: The WE-Study: does botulinum toxin A make walking easier in children with cerebral palsy?: Study protocol for a randomized controlled trial

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