Trials / Completed
CompletedNCT00515437
A Multi-Center Study of MYOBLOC for the Treatment of Sialorrhea in Parkinson's Disease Patients
A Multi-Center, Randomized, Double-blind, Placebo-Controlled,Sequential Dose Escalation, Safety, Tolerability, and Preliminary Efficacy Study of MYOBLOC for the Treatment of Sialorrhea in Parkinson's Disease Patients
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 54 (actual)
- Sponsor
- Solstice Neurosciences · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
To determine safety, tolerability and preliminary efficacy of intraglandular injections of MYOBLOC for the treatment of sialorrhea in Parkinsons' Disease patients
Detailed description
This is a multi-center, outpatient, double-blind, placebo-controlled, single treatment, sequential dose escalation study designed to evaluate the safety, tolerability and preliminary efficacy of single doses of MYOBLOC versus placebo for the treatment of sialorrhea in Parkinson's disease patients, lasting approximately 20 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Botulinum Toxin Type B (Myobloc) | |
| BIOLOGICAL | Matched placebo to Myobloc |
Timeline
- Start date
- 2007-07-01
- Primary completion
- 2008-06-01
- Completion
- 2008-09-01
- First posted
- 2007-08-13
- Last updated
- 2019-05-07
- Results posted
- 2009-08-13
Locations
18 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00515437. Inclusion in this directory is not an endorsement.