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
  Purpose

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 Intervention Phase
Sialorrhea
Cerebral Palsy
Biological: BOTULINUM NEUROTOXIN TYPE-A
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Hospital Vall d'Hebron:

Primary Outcome Measures:
  • 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.



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. [ 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.


Estimated Enrollment: 60
Study Start Date: November 2011
Estimated Study Completion Date: November 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01489904

Locations
Spain
CEIC Hospital Vall d Hebron
Barcelona, Spain, 08035
Sponsors and Collaborators
Hospital Vall d'Hebron
Allergan
Investigators
Principal Investigator: Maria D González Luis/ Inma Bori, MS/MD Hospital Vall d Hebron. Barcelona Spain
  More Information

No publications provided

Responsible Party: Inma Bori i Fortuny, MD, Neurology- Rehabilitation, Hospital Vall d'Hebron
ClinicalTrials.gov Identifier: NCT01489904     History of Changes
Other Study ID Numbers: 2010-021691-28
Study First Received: November 29, 2011
Last Updated: October 28, 2012
Health Authority: Spain: Ministry of Health
Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Hospital Vall d'Hebron:
drooling
cerebral palsy

Additional relevant MeSH terms:
Cerebral Palsy
Sialorrhea
Paralysis
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Neurologic Manifestations
Signs and Symptoms
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 20, 2014