NCT02549573

Outpatient Physical Therapy Intervention in Subjects With Parkinson's Disease Currently Using APOKYN®

Outpatient Physical Therapy Intervention in Subjects With Parkinson's DiseaseCurrently Using APOKYN®: A Phase IV Study of Outcome Assessments of Physical Therapy in Subjects in an "On" Versus "End-of-Dose-Off" Motor State

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: MDD US Operations, LLC a subsidiary of Supernus Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 78 Years
• Healthy volunteers: Not accepted

Summary

To determine if PT intervention will be improved while in the "on" motor state vs. the "end-of-dose-off" motor state during the PT Intervention Visit in subjects with PD.

Detailed description

Multicenter, outpatient trial to evaluate PT outcomes in subjects diagnosed with PD and currently using APOKYN. Those subjects who satisfy all eligibility criteria will be randomized to 2 treatment groups: 1. "APO+" (APOKYN treatment before the PT Intervention Visit) and; 2. "APO-" (APOKYN treatment withheld before the PT Intervention Visit). The study will have: * Baseline Assessment Visit(s) - 1 day at Investigator's clinic and PT clinic * APOKYN Response Verification Visit - 1 day * PT Intervention Visits - for 6 weeks * End-of-study Assessment Visit(s) - 1 day at Investigator's clinic and PT clinic All subjects will participate in a standardized PT intervention. In both treatment groups, ALL subjects will arrive for the PT Intervention Visit in an "end-of-dose-off" motor state. The "end-of-dose-off" motor state will be achieved by the subject withholding his/her carbidopa/levodopa dose and APOKYN dose for at least 3 hours before the PT Intervention Visit. It is hypothesized that the outcome of PT will be improved when subjects are in the "on" motor state during PT Intervention visits compared with being in the "end-of-dose-off" motor state during PT Intervention visits.

Conditions

• Parkinson's Disease
• Motor Symptoms

Interventions

Type	Name	Description
DRUG	APOKYN	Subjects in the APOKYN+ group will administer his/her usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.
BEHAVIORAL	Physical Therapy	All subjects will participate in a standardized PT intervention

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2015-09-15
• Last updated: 2023-09-01
• Results posted: 2018-01-12

Locations

12 sites across 1 country: United States