Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00515437 | A Multi-Center Study of MYOBLOC for the Treatment of Sialorrhea in Parkinson's Disease Patients | PHASE2 | COMPLETED | 54 | — | — | Jul 1, 2007 | Sep 1, 2008 | Apr 21, 2026 | 18 | United States |
9 point scale, 0 = no drooling, 9 = severe drooling
| Arm | Type | Description |
|---|---|---|
| Treatment 1 | EXPERIMENTAL | 1,500 Units (0.3 mL) MYOBLOC (0.3mL) with 500 Units (0.1 mL) injected into each parotid gland and 250 Units (0.05 mL) inject into each submandibular gland and will be compared to pooled placebo |
| Treatment 2 | EXPERIMENTAL | 2,500 Units of (0.5mL) MYOBLOC with 1,000 Units (0.2 mL) injected into each parotid gland and 250 Units (0.05mL) inject into each submandibular gland and will be compared to pooled placebo |
| Treatment 3 | EXPERIMENTAL | 3,500 Units of (0.7mL) MYOBLOC with 1,500 Units (0.3 mL) injected into each parotid gland and 250 Units (0.05mL) inject into each submandibular gland and will be compared to pooled placebo |
| Treatment 4 | PLACEBO_COMPARATOR | volume-matched placebo injected into each parotid gland and each submandibular gland |
| Name | Type | Description |
|---|---|---|
| Botulinum Toxin Type B (Myobloc) | BIOLOGICAL | - |
| Matched placebo to Myobloc | BIOLOGICAL | - |
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/...