Effect of Rasagiline on Balance in Parkinson's Disease as Measured by Computerized Posturography

Not Applicable

Withdrawn

• Conditions: PARKINSON DISEASE (Disorder)
• Interventions: Diagnostic Test: computerized dynamic posturography; Drug: Rasagiline 1 mg capsule; Drug: Placebo

• Registration Number: NCT07077187
• Lead Sponsor: New York Medical College

Brief Summary

This study evaluates the effect of rasagiline on balance in Parkinson's disease. Participants taking study medication which is rasagiline or sugar pill will undergo a computerized balance test on and off medication. Participants will stand on a platform which which moves slightly and a computer will measure their body sway and provide a balance score.

Detailed Description

The study will test the hypothesis that therapy with rasagiline improves balance in PD patients as measured by computerized dynamic posturography. 5 subjects will be randomized to rasagiline or placebo and 5 further subjects will be randomized to rasagiline as adjuvant therapy versus placebo. Subjects will be analyzed by computerized dynamic posturography testing. The device measures body sway under varying visual and vestibular cues and is used for assessment of balance

Study Timeline

• Study Start: 2014-09-15
• Primary Completion: 2017-07-10
• Study Completion: 2017-07-10
• Status Verified: 2025-07
• Study First Submitted: 2025-07-11
• Study First Submitted QC: 2025-07-11
• Last Update Submitted: 2025-07-21
• Study First Posted: 2025-07-22
• Last Update Posted: 2025-07-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. 18 years old or above
2. Clinical diagnosis of Parkinson disease by verified by movement disorders expert at the initial study visit with at least two cardinal signs of the disease (rest tremor, bradykinesia, rigidity, and postural instability).
3. For the monotherapy arm, patients must not be on amantadine, dopamine agonists, or levodopa. For the adjuvant therapy arm: Patients must be on a stable dose of their current medication for treatment of Parkinson disease which may include any combination of the following: amantadine, trihexiphenydil, dopamine agonist, and/or levodopa.
4. Patients may continue their stable dose of tricyclic, selective serotonin reuptake inhibitor, or serotonin norepinephrine reuptake inhibitor if they are on these medications at randomization.

Exclusion Criteria

1. Catechol-O-Methyltransferase (COMT) inhibitor therapy use 30 days prior to start of study (both study arms).
2. Dopamine receptor blocker use (such as quetiapine) one week prior to taking study drug
3. For both monotherapy and adjuvant therapy arms: use of MAO inhibitor therapy including selegiline or rasagiline within 30 days prior to taking study drug and first posturography evaluation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rasagiline monotherapy	computerized dynamic posturography	Participants will be taking rasagiline 1 mg oral tablet daily
placebo monotherapy	computerized dynamic posturography	Participants will be taking placebo 1 mg orally daily.
Rasagiline monotherapy	Rasagiline 1 mg capsule	Participants will be taking rasagiline 1 mg oral tablet daily
placebo monotherapy	Placebo	Participants will be taking placebo 1 mg orally daily.
placebo adjuvant therapy	computerized dynamic posturography	Participants will be taking placebo 1 mg orally daily as adjuvant therapy in addition to their stable existing Parkinson disease medication.
rasagiline adjuvant therapy	computerized dynamic posturography	Participants will be taking rasagiline 1 mg orally daily as adjuvant therapy in addition to their stable existing Parkinson disease medication.
rasagiline adjuvant therapy	Rasagiline 1 mg capsule	Participants will be taking rasagiline 1 mg orally daily as adjuvant therapy in addition to their stable existing Parkinson disease medication.
placebo adjuvant therapy	Placebo	Participants will be taking placebo 1 mg orally daily as adjuvant therapy in addition to their stable existing Parkinson disease medication.

Primary Outcome Measures

Name	Time	Method
Computerized Dynamic Posturography Strategy Composite Score	8 weeks	Change from baseline to week 8 measurement of Computerized Dynamic Posturography Strategy Composite Score will be compared among the 4 arms of the study.