At a glance
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Effect of Levodopa on Cardiovascular Autonomic Function in Parkinson's Disease With and Without Orthostatic Hypotension: a Cross-over Study
In Brief
A Phase 3 clinical trial evaluating Autonomic testing on and off levodopa for Parkinson Disease and Orthostatic Hypotension. Completed, enrolled 40 participants across 1 site.
Detailed Summary
Levodopa is a precursor of dopamine and is the treatment of choice to treat the motor symptoms of Parkinson's disease (PD); however, the effect of levodopa on cardiovascular autonomic function in PD is poorly understood. Orthostatic hypotension has been documented as a potential side effect of levodopa. As a result, clinicians may be reluctant to prescribe levodopa in patients with PD with neurogenic orthostatic hypotension (PD+OH), which leads to suboptimal management of motor symptoms. On the other hand, other studies failed to show any clear relationship between levodopa and orthostatic hypotension in patients with PD. Important limitations of prior studies include the lack of detailed investigation of baroreflex cardiovagal and sympathetic noradrenergic functions and the fact that the same patients were not tested on and off levodopa. The investigators propose to investigate the effects of levodopa on cardiovascular autonomic function in patients with PD+OH and PD without neurogenic orthostatic hypotension (PD-OH) by performing standardized autonomic testing in the same patients on and off levodopa.
Study Details
Timeline
Interventions
Participants with Parkinson's disease with and without orthostatic hypotension will undergo standardized autonomic testing on two separate days "on levodopa" and "off levodopa".