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

Sponsor

Hospital Vall d'Hebron (Other)

Overall Status

Unknown status

CT.gov ID

NCT01489904

Collaborator

Allergan (Industry)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sialorrhea Cerebral Palsy	Biological: BOTULINUM NEUROTOXIN TYPE-A	Phase 2/Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Nov 1, 2011

Actual Primary Completion Date :

Nov 1, 2011

Anticipated Study Completion Date :

Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Botulinum Toxin Botulinum Toxin type-A	Biological: 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. Other Names: Botulinum Neurotoxin type -A BOTOX
No Intervention: Control Treatment No intervention

Arm

Intervention/Treatment

Experimental: Botulinum Toxin

Botulinum Toxin type-A

Biological: 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.

Other Names:

Botulinum Neurotoxin type -A

BOTOX

No Intervention: Control Treatment

No intervention

Outcome Measures

Primary Outcome Measures

Asses drool quantification pre and post-infiltration in submandibular and parotid glands with BoNT-A [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.

Secondary Outcome Measures

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. [every 4 weeks ( after each infiltration)]
Salivary flow expressed in ml/ min evaluated in diferent subtypes of cerebral palsy compared before and after infiltration and compared with control group without infiltration and control group of healthy volunteers.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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