Patients with ALS, Parkinson´s disease, brain-damage cerebral paralysis or other neurological conditions often have an impaired swallowing, resulting in drooling. This adds a social handicap and often also causes facial dermatitis, especially around the mouth.
Conditions
Interventions
Trade Name: Botox
Product Name: Botox
Product Code: M03AX01
Pharmaceutical Form: Powder for solution for injection
Trade Name: Atropin Chauvin
Product Name: Atropin Chauvin
Product Code: S01FA01
Phar
Sponsors
Käkkliniken, Universitetssjukhuset i Linköping
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adults and juvenile patients with a severe drooling secondary to a neurologic medical condition, as e.g. cerebral palsy, ALS, Mb Parkinson Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Poor dental status. ASA 3 or more. Children who can´t undergo general anaesthesia. Hypersensitivity to Botox and/or Atropine w. ingredients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: We want to compare the effect of these two methods and evaluate the effect and see if there is a level of discomfort connected to the use of Atropine and/or Botulinum toxin;Primary end point(s): Less subjective and/or objective drooling.;Main Objective: Patients with ALS, Parkinson´s disease, brain-damage cerebral paralysis or other neurological conditions often have an impaired swallowing, resulting in drooling. This adds a social handicap and often also dermatitis in the face, especially around the mouth. Several different attempts to treat this condition have been tried, e.g. surgery, medication, radiation therapy, but no method has been proven effective, without severe side effects. Atropine has lately been tried by patients, and has, by many, been found to be effective. However, no thorough studies exist. Botulinum toxin has been tried in a few studies, with mainly positive results. Are these drugs suitable for treating patients with severe drooling? | — |
Countries
Sweden
Outcome results
None listed