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

NCT07077187 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: L-10,768
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

PARKINSON DISEASE (Disorder)

Keywords

balance; posturography; computerized dynamic posturography; rasagiline; Parkinson disease

Outcome Measures

Primary Outcomes (1)

• Computerized Dynamic Posturography Strategy Composite Score

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

  8 weeks

Study Arms (4)

Rasagiline monotherapy

ACTIVE COMPARATOR

Participants will be taking rasagiline 1 mg oral tablet daily

Diagnostic Test: computerized dynamic posturography; Drug: Rasagiline 1 mg capsule

placebo monotherapy

PLACEBO COMPARATOR

Participants will be taking placebo 1 mg orally daily.

Diagnostic Test: computerized dynamic posturography; Drug: Placebo

rasagiline adjuvant therapy

ACTIVE COMPARATOR

Participants will be taking rasagiline 1 mg orally daily as adjuvant therapy in addition to their stable existing Parkinson disease medication.

Diagnostic Test: computerized dynamic posturography; Drug: Rasagiline 1 mg capsule

placebo adjuvant therapy

PLACEBO COMPARATOR

Participants will be taking placebo 1 mg orally daily as adjuvant therapy in addition to their stable existing Parkinson disease medication.

Diagnostic Test: computerized dynamic posturography; Drug: Placebo

Interventions

computerized dynamic posturography DIAGNOSTIC_TEST

Patients in each arm will have computerized dynamic posturography performed at baseline prior to taking first tablet as well as at 4 weeks and 8 weeks. In the adjuvant therapy arm, subjects will be evaluated on rasagiline but in a functional OFF state for their other Parkinson disease medications.

Rasagiline monotherapy; placebo adjuvant therapy; placebo monotherapy; rasagiline adjuvant therapy

Rasagiline 1 mg capsule DRUG

Rasagiline 1 mg oral tablet daily will be administered to study participants.

Rasagiline monotherapy; rasagiline adjuvant therapy

Placebo DRUG

Placebo 1 mg oral tablet daily will be administered to study participants.

placebo adjuvant therapy; placebo monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or above
• 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).
• 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.
• 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.

You may not qualify if:

• Catechol-O-Methyltransferase (COMT) inhibitor therapy use 30 days prior to start of study (both study arms).
• Dopamine receptor blocker use (such as quetiapine) one week prior to taking study drug
• 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.

Sponsors & Collaborators

• New York Medical College: lead

Related Publications (1)

• Ondo WG, Almaguer M, Cohen H. Computerized posturography balance assessment of patients with bilateral ventralis intermedius nuclei deep brain stimulation. Mov Disord. 2006 Dec;21(12):2243-7. doi: 10.1002/mds.21165.

  PMID: 17078067 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

rasagiline

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Robert Fekete, MD

  New York Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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. Subjects will be evaluated at baseline prior to taking first tablet as well as at 4 weeks and 8 weeks. In the adjuvant therapy arm, subjects will be evaluated on rasagiline but in a functional OFF state for their other PD medications.

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 22, 2025
• Study Start: September 15, 2014
• Primary Completion: July 10, 2017
• Study Completion: July 10, 2017
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share