Phase 2
Completed N=54
A Multi-Center Study of MYOBLOC for the Treatment of Sialorrhea in Parkinson's Disease Patients
Drooling
Source: ClinicalTrials.gov NCT00515437 ↗
Enrolled (actual)
54
Serious AEs
—
Results posted
Aug 2009
Primary outcomePrimary: Change in Drooling Frequency & Severity Scale (DFSS)at Wk 4 Post-injection — -2.1; -3.3; -3.5; -1.3 points on a scale
Summary
To determine safety, tolerability and preliminary efficacy of intraglandular injections of MYOBLOC for the treatment of sialorrhea in Parkinsons' Disease patients
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Drooling Frequency & Severity Scale (DFSS)at Wk 4 Post-injection |
-2.1; -3.3; -3.5; -1.3 | — |
| SECONDARY Change in Drooling Frequency and Severity Scale (DFSS) at Wk 12 Post-injection |
-1.9; -2.2; -2.2; -1.2 | — |
| SECONDARY Change in Unstimulated Salivary Flow Rate at Wk 4 Post-injection |
-0.497; -.381; -0.146; -0.052 | — |
| SECONDARY Change in Unstimulated Salivary Flow Rate at Wk 12 Post-injection |
-0.414; -0.166; -0.028; 0.108 | — |
Eligibility Criteria
Inclusion Criteria
- Parkinsons' Disease patients with Sialorrhea for at least 3 months
Exclusion Criteria
- Patients with non-idiopathic PD parkinsonism
- Patients previously exposed to botulinum toxins
- Patients with a history of aspiration pneumonia, moderate/severe choking and/or moderate/severe dysphagia
- Patients with prior salivary gland surgery
Data sourced from ClinicalTrials.gov (NCT00515437). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.