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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Inma Bori i Fortuny, MD, Hospital Vall d'Hebron
ClinicalTrials.gov Identifier:
NCT01489904
First received: November 29, 2011
Last updated: October 28, 2012
Last verified: October 2012
History of Changes

November 29, 2011
October 28, 2012
November 2011
November 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]

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.
Same as current
Complete list of historical versions of study NCT01489904 on ClinicalTrials.gov Archive Site
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) ] [ Designated as safety issue: Yes ]
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.
Same as current
Not Provided
Not Provided
 
Application of Botulinum Toxin Type A in Salivary Glands in the Treatment of Drooling in Patients With Cerebral Palsy
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.

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.

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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Sialorrhea
  • Cerebral Palsy
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
  • Experimental: Botulinum Toxin
    Botulinum Toxin type-A
    Intervention: Biological: BOTULINUM NEUROTOXIN TYPE-A
  • No Intervention: Control Treatment
    No intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
November 2012
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01489904
2010-021691-28
Yes
Inma Bori i Fortuny, MD, Hospital Vall d'Hebron
Hospital Vall d'Hebron
Allergan
Principal Investigator: Maria D González Luis/ Inma Bori, MS/MD Hospital Vall d Hebron. Barcelona Spain
Hospital Vall d'Hebron
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP