Application of Botulinum Toxin Type A in Salivary Glands in the Treatment of Drooling in Patients With Cerebral Palsy
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|
|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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
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
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)
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
|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.|
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