Hypersalivation (chronic sialorrhea)in patients with cerebral palsy MedDRA version: 14.0 Level: PT Classification code 10039424 Term: Salivary hypersecretion System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: BOTOX
Product Name: NEUROTOXINA BOTULINICA TIPO-A (Botox)
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: Toxina botulínica A
CAS Number: 93384-43-1
Current Spons
Sponsors
Hospital Vall d'Hebron
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: EVALUATE THE SAFETY AND EFFICAY OF BOTULINUM TOXIN TYPE -A AS A TREATMENT FOR DECREASE DROOLING IN PATIENTS WITH CEREBRAL PASY AND DETERMINATE THE SALIVARY FLOW ML/MIN.;Secondary Objective: ASSESS AT WHAT PERIOD OF TIME AFTER INFILTRATION OCCURS THE MAXIMUM RESPONSE OF BOTULINUM NEUROTOXIN TYPE-A IN DECREASED DROOLING. EVALUATE THE LONG-TERM EFFECTS OF BOTULINUM NEUROTOXIN TYPE-A IN SALIVARY GLANDS. ASSESS WHETER THE BOTULINUM TOXIN TYPE-A MAY REDUCE THE VOLUME OF DROOLING WITHOUT ALTERING THE SWALLOWING FUNCTION.;Primary end point(s): Efficacy Evaluate: Decrease of salivary flow expressed in ml/min before and after infiltration,will be considered the proportion of patients showing a decrease of 25% of salivary secretion. Safety Evaluate: The proportion of patients with a good response according to the criteria defined response during treatment or follow-up. Good response: If the patients register a proportion of adeverse events not more than usual due to underlying pathology. - Low/ non response. Register a high proportion of adverse events more than usual.;Timepoint(s) of evaluation of this end point: Average time of evaluation every 4 weeks after first infiltration, allowed a washout period. The second infiltration evaluation every 4 weeks untill complete one year of follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Average time of evaluation every 4 weeks after first infiltration, allowed a washout period. The second infiltration evaluation every 4 weeks untill complete one year of follow-up.;Secondary end point(s): Salivary flow expressed in ml/min evaluated in different subtypes of cerebral palsy compared with healthy volunteers salivary flow. To assess wheter patients with cerebral palsy have hypersalivation or oral motor dysfunction. Assess wheter the Botulinum Toxin Type A reduce the volume of drooling without altering the swallowing function | — |
Countries
Spain
Contacts
Public ContactMaira González
Hospital Vall d'Hebron
Outcome results
None listed