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

NCT01489904 | Unknown Phase 2 DMC

• 1 other identifier: 2010-021691-28
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sialorrhea; Cerebral Palsy

Keywords

drooling; cerebral palsy

Outcome Measures

Primary Outcomes (1)

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

  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.

  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 (1)

• 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)

Study Arms (2)

Botulinum Toxin

EXPERIMENTAL

Botulinum Toxin type-A

Biological: BOTULINUM NEUROTOXIN TYPE-A

Control Treatment

NO INTERVENTION

No intervention

Interventions

BOTULINUM NEUROTOXIN TYPE-A 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.

Also known as: Botulinum Neurotoxin type -A, BOTOX

Botulinum Toxin

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Confirmed diagnosis of cerebral palsy ( medical history, neurological examination,magnetic resonance
• Score of \>3 on drooling severity and frequency scale

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Vall d'Hebron: lead
• Allergan: collaborator

Study Sites (1)

CEIC Hospital Vall d Hebron

Barcelona, Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Sialorrhea; Cerebral Palsy

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Maria D González Luis/ Inma Bori, MS/MD

  Hospital Vall d Hebron. Barcelona Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurology- Rehabilitation

Study Record Dates

• First Submitted: November 29, 2011
• First Posted: December 12, 2011
• Study Start: November 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2012
• Last Updated: October 30, 2012

Record last verified: 2012-10

Locations

ES (1)