Clinical Trial: Application of Botulinum Toxin Type A in Salivary Glands in the Treatment of Drooling in Patients With Cerebral Palsy
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
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.
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 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.
Detailed Summary:
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.
Sponsor: Hospital Vall d'Hebron
Current Primary Outcome: 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 ]
Drool quantification using a pre-and post injection "drool rating scale" dental roll weights, drool quotient.
Safety evaluate. The proportion of patients with a good response according to the criteria, defined response during treatment or follow-up.
Original Primary Outcome: Same as current
Current Secondary Outcome: 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) ]
Original Secondary Outcome: Same as current
Information By: Hospital Vall d'Hebron
Dates:
Date Received: November 29, 2011
Date Started: November 2011
Date Completion: November 2012
Last Updated: October 28, 2012
Last Verified: October 2012
