A Phase 2/3 interventional study of BOTULINUM NEUROTOXIN TYPE-A in Sialorrhea and Cerebral Palsy, sponsored by Hospital Vall d'Hebron. Status unknown at 1 site in Spain. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-10-30.
Sponsored by Hospital Vall d'Hebron · Phase 2/3, Interventional, and Treatment
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.
60 studies on the registry are indexed under Sialorrhea; 5 are open to participants now.
This study's planned enrollment of 60 is above the median of 31 across 44 interventional studies indexed under Sialorrhea.
Browse Sialorrhea studies →Hospital Vall d'Hebron is the lead sponsor of 18 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Botulinum Toxin type-A
Biological: BOTULINUM NEUROTOXIN TYPE-A
No intervention
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
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.
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
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.
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.
Time frame: every 4 weeks ( after each infiltration)
The record gives a start of Nov 2011, a primary completion of Nov 2011 and a completion of Nov 2012. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Botulinum toxin type A
Hospital Vall d'Hebron