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

New York Medical College

Status and phase: Withdrawn; Phase 4

Conditions: PARKINSON DISEASE (Disorder)

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07077187

L-10,768

Details and patient eligibility

About

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.

Full 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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 4 patient groups, including a placebo group

Rasagiline monotherapy

Active Comparator group

Description:

Participants will be taking rasagiline 1 mg oral tablet daily

Treatment:

Drug: Rasagiline 1 mg capsule

Diagnostic Test: computerized dynamic posturography

placebo monotherapy

Placebo Comparator group

Description:

Participants will be taking placebo 1 mg orally daily.

Treatment:

Diagnostic Test: computerized dynamic posturography

Drug: Placebo

rasagiline adjuvant therapy

Active Comparator group

Description:

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

Treatment:

Drug: Rasagiline 1 mg capsule

Diagnostic Test: computerized dynamic posturography

placebo adjuvant therapy

Placebo Comparator group

Description:

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

Treatment:

Diagnostic Test: computerized dynamic posturography

Drug: Placebo