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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-15

Study Completion Date

2017-07-10

Brief Summary

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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.

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Detailed Description

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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

Conditions

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PARKINSON DISEASE (Disorder)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Rasagiline monotherapy

Participants will be taking rasagiline 1 mg oral tablet daily

Group Type ACTIVE_COMPARATOR

computerized dynamic posturography

Intervention Type 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 1 mg capsule

Intervention Type DRUG

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

placebo monotherapy

Participants will be taking placebo 1 mg orally daily.

Group Type PLACEBO_COMPARATOR

computerized dynamic posturography

Intervention Type 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.

Placebo

Intervention Type DRUG

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

rasagiline adjuvant therapy

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

Group Type ACTIVE_COMPARATOR

computerized dynamic posturography

Intervention Type 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 1 mg capsule

Intervention Type DRUG

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

placebo adjuvant therapy

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

Group Type PLACEBO_COMPARATOR

computerized dynamic posturography

Intervention Type 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.

Placebo

Intervention Type DRUG

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

Interventions

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computerized dynamic posturography

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.

Intervention Type DIAGNOSTIC_TEST

Rasagiline 1 mg capsule

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No