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BOTOX for Chronic Drooling in Cerebral Palsy
NCT01489904Phase 3
Key facts
- Status
- Unknown
- Start
- Nov 2011
- Primary completion
- Nov 2011
- Countries
- 1
- Sponsor
- Vall d'Hebron University Hospital
- Modality
- Recombinant Proteins and Enzymes
- Conditions
- sialorrhea
01
Overview
Phase 3, randomised, open-label trial of botulinum toxin type A in sialorrhea, sponsored by Vall d'Hebron University Hospital. Primary endpoint: Drool quantification at 24 weeks. Status: unknown.
02
Design
- Study design
- RandomizedOpen-label
03
Who it enrols
Adults with cerebral palsy and a drooling severity and frequency scale score > 3, excluding those with swallowing disorders or certain neuromuscular diseases like Myasthenia or ALS.
04
Endpoints
Primary
Drool quantification
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