Status:
UNKNOWN
Application of Botulinum Toxin Type A in Salivary Glands in the Treatment of Drooling in Patients With Cerebral Palsy
Lead Sponsor:
Hospital Vall d'Hebron
Collaborating Sponsors:
Allergan
Conditions:
Sialorrhea
Cerebral Palsy
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of botulinum toxin-A in salivary glands as a treatment for decrease drooling in patients with cerebral palsy and evaluate the long-term...
Detailed Description
Patients with cerebral palsy (CP) and other neurological diseases ( Parkinson´s disease (PD), bulbar amyotrophic lateral sclerosis, neurodegenerative diseases, idiopathic hypersalivation, head and nec...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of cerebral palsy ( medical history, neurological examination,magnetic resonance
- Patients with disorders for eating, drinking, pneumonia, irritation of the skin face, social exclusion
- Score of \>3 on drooling severity and frequency scale
Exclusion
- Patients under 18 years
- Swallowing disorders
- Diagnosis of Myasthenia, Eaton Lambert Syndrome, Amyotrophic lateral Sclerosis or diseases that interfere with the function neuroglandular
- Pregnant or lactating period
- Patients without informed consent
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01489904
Start Date
November 1 2011
End Date
November 1 2012
Last Update
October 30 2012
Active Locations (1)
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1
CEIC Hospital Vall d Hebron
Barcelona, Barcelona, Spain, 08035