APPLICATION OF BOTULINUM TOXIN TYPE -A IN SALIVARY GLANDS AS A TREATMENT OF CHRONIC DROOLING IN PATIENTS WITH CEREBRAL PALSY. CLINICAL TRIAL.

• Conditions: Hypersalivation (chronic sialorrhea)in patients with cerebral palsy; MedDRA version: 14.0Level: PTClassification code 10039424Term: Salivary hypersecretionSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2010-021691-28-ES
• Lead Sponsor: Hospital Vall d'Hebron

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-Chronic sialorrhea,score of > on drooling severity and frecuency scale.
- Patients aged > 18 years.
- Confirmed diagnosis of cerebral palsy.
- Patients with disorders for eating, drinking, chronic irritation of the skin, pneumonia, social exclusion.
- Informed consent from parents, caregivers or self patient.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients < 18 years.
Swallowing disorders,dysphagia.
-Diagnoses of Eaton-Lambert Syndrome. Amyothropic lateral Sclerosis or diseases that interfere with the function neuroglandular.
-Presence of significant lung problems.
- Pregnant or lactating period
-Enrolment in another medical study or participation 30 days before.
-Use of drugs that interfere with salival secretion.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified