Clinical trial NCT01489904: Application of Botulinum Toxin Type A in Salivary Glands in the Treatment of Drooling in Patients With Cerebral Palsy
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Sialorrhea
Cerebral Palsy
Keywords: drooling
cerebral palsy
Lead sponsor: Hospital Vall d'Hebron
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2011-12-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Asses drool quantification pre and post-infiltration in submandibular and parotid glands with BoNT-A
timeFrame: 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:
measure: 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.
timeFrame: every 4 weeks ( after each infiltration)
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: CEIC Hospital Vall d Hebron
Study officials:
affiliation: Hospital Vall d Hebron. Barcelona Spain
name: Maria D González Luis/ Inma Bori, MS/MD
role: PRINCIPAL_INVESTIGATOR
References: