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Application of Botulinum Toxin Type A in Salivary Glands in the Treatment of Drooling in Patients With Cerebral Palsy

NCT ID: NCT01489904

Last Updated: 2012-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-11-30

Brief Summary

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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

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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.

Conditions

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Sialorrhea Cerebral Palsy

Keywords

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drooling cerebral palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Botulinum Toxin

Botulinum Toxin type-A

Group Type EXPERIMENTAL

BOTULINUM NEUROTOXIN TYPE-A

Intervention Type BIOLOGICAL

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.

Control Treatment

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BIOLOGICAL

Other Intervention Names

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Botulinum Neurotoxin type -A BOTOX

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Allergan

INDUSTRY

Sponsor Role collaborator

Hospital Vall d'Hebron

OTHER

Sponsor Role lead

Responsible Party

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Inma Bori i Fortuny, MD

Neurology- Rehabilitation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria D González Luis/ Inma Bori, MS/MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Vall d Hebron. Barcelona Spain

Locations

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CEIC Hospital Vall d Hebron

Barcelona, Barcelona, Spain

Site Status

Countries

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Spain

Other Identifiers

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2010-021691-28

Identifier Type: -

Identifier Source: org_study_id