This trial is active, not recruiting.

Conditions sialorrhea, cerebral palsy
Treatment botulinum neurotoxin type-a
Phase phase 2/phase 3
Sponsor Hospital Vall d'Hebron
Collaborator Allergan
Start date November 2011
End date November 2011
Trial size 60 participants
Trial identifier NCT01489904, 2010-021691-28


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 effects and tolerance . To assess whether patients with cerebral palsy have hypersalivation comparing with patients without treatment and healthy volunteers and if botulinum toxin may reduce the volume of drooling without altering the swallowing function.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Botulinum Toxin type-A
botulinum neurotoxin type-a Botulinum Neurotoxin type -A
Botulinum toxin type A / First infiltration: 25U in each salivary gland=100 U in Parotid and submandibular glands. 24 weeks after first infiltration is a Second infiltration with 50U Botulinum toxin type -A 25 U in each salivary gland only in parotid glands.
(No Intervention)
No intervention

Primary Outcomes

Asses drool quantification pre and post-infiltration in submandibular and parotid glands with BoNT-A
time frame: Change from baseline in drooling0,4,8,12,16,20,24 weeks post infiltration/baseline, and again second infiltration only in parotid glands

Secondary Outcomes

Asses at what period of time after infiltration occurs the maximum response in decreased drooling, and whether Botulinum toxin-A reduce the volume of drooling without altering the swallowing function.
time frame: every 4 weeks ( after each infiltration)

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

Inclusion Criteria: - 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 Criteria: - 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

Additional Information

Official title Phase 2/3 Application of Botulinum Neurotoxin Type A in Salivary Glands as a Treatment of Chronic Drooling in Patients With Cerebral Palsy: A Controlled Clinical Trial.
Principal investigator Maria D González Luis/ Inma Bori, MS/MD
Description Patients with cerebral palsy (CP) and other neurological diseases ( Parkinson´s disease (PD), bulbar amyotrophic lateral sclerosis, neurodegenerative diseases, idiopathic hypersalivation, head and neck carcinomas, etc) frequently have lifelong issues with oral motor control that may present as eating, drinking difficulties, drooling and/or speech problems. Inadequate saliva control occurs in approximately 30% of patients with CP. Drooling usually caused by swallowing dysfunction and can lead to choking, salivary aspiration, pneumonia, chest infections,chronic irritation of the facial skin, and /or dehydration, in some cases the person loss of self esteem and impede community inclusion. Numerous therapies, anticholinergic medication, surgery, etc, have all been used to reduce drooling with varying side effects and degrees of success, but none with optimal results. Systemic anticholinergics may reduce salivary secretion but are frequently not tolerated by the patients because they have multiple side effects. Recently Botulinum toxin type A has been used in the treatment of sialorrhea, in clinical studies have found that botulinum toxin type-A may have a good response with fewer side effects.
Trial information was received from ClinicalTrials.gov and was last updated in October 2012.
Information provided to ClinicalTrials.gov by Hospital Vall d'Hebron.