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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01370811 | A Relative Efficacy and Safety Study of OC Oral Solution for Sialorrhoea in Patients With Parkinson's Disease | PHASE2 | COMPLETED | 24 | — | — | Aug 1, 2011 | Sep 1, 2012 | Apr 10, 2023 | 1 | United States |
Change from baseline, negative mean reduce secret rate from baseline, positive mean not reduce secretion.
| Arm | Type | Description |
|---|---|---|
| oxybutynin and clonidine oral solution treatment D | PLACEBO_COMPARATOR | Placebo |
| oxybutynin and clonidine oral solution treatment C | EXPERIMENTAL | High dose oxybutynin and clonidine |
| oxybutynin and clonidine oral solution treatment A | EXPERIMENTAL | Low dose oxybutynin and clonidine |
| oxybutynin and clonidine oral solution treatment B | EXPERIMENTAL | Intermediate dose oxybutynin and clonidine |
| Name | Type | Description |
|---|---|---|
| oxybutynin and clonidine oral solution treatment A | DRUG | - |
| oxybutynin and clonidine oral solution treatment B | DRUG | - |
| oxybutynin and clonidine oral solution treatment C | DRUG | - |
| oxybutynin and clonidine oral solution treatment D | DRUG | Placebo |
Inclusion Criteria: * Diagnosis of Parkinson's Disease for at least 2 years * Patients with a score of ≥2 on the salivation section of UPDRS, item 6 * Patients Hoehn and Yahr stage must be ≤4 * under stable anti-Parkinson therapy throughout the study * Able and willing to comply with the study proc...