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Yohimbine HCl for Parkinson's Disease (NAinPD Trial)

Phase < 1

Waitlist Available

Led By Nathaniel M Robbins, MD

Research Sponsored by Nathaniel M. Robbins

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (supine position), after 5 minutes of head-up tilt, 60 minutes after yohimbine administration (supine position), and 5 minutes after that with repeat head-up tilt.

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to understand how a drug called Yohimbine affects non-motor symptoms in Parkinson's disease patients, especially those with blood pressure drops when standing. By comparing patients with and without this issue, researchers hope to learn more about symptoms like depression and fatigue. Yohimbine has been shown to reduce certain movement issues in Parkinson's disease models.

Eligible Conditions

Parkinson's Disease
Overactive Bladder

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (supine position), after 5 minutes of head-up tilt, 60 minutes after yohimbine administration (supine position), and 5 minutes after that with repeat head-up tilt.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (supine position), after 5 minutes of head-up tilt, 60 minutes after yohimbine administration (supine position), and 5 minutes after that with repeat head-up tilt.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (supine position), after 5 minutes of head-up tilt, 60 minutes after yohimbine administration (supine position), and 5 minutes after that with repeat head-up tilt. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Difference in fatigue (measured with the self-reported Fatigue Severity Scale) in patients with Parkinson's disease with and without orthostatic hypotension (PD+OH v PD-OH)

Secondary study objectives

Change in serum catecholamine levels (supine and orthostatic) before and after yohimbine administration

Body Weight Changes

Hypotension, Orthostatic

+6 more

Other study objectives

Between group (PD+OH v PD-OH) change in diastolic blood pressure before and after yohimbine

Between group (PD+OH v PD-OH) change in time until pupillary redilation before and after yohimbine

Bronchial Provocation Tests

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: YohimbineExperimental Treatment1 Intervention

The first visit in the study has no interventional drug. Yohimbine (5mg) is administered orally during visit two, during a head up tilt test, to manipulate the noradrenergic system to determine the association between OH and NP symptoms in those with PD. Yohimbine is not administered as a treatment in this study, but as a pharmacologic tool to study the adrenergic system.

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