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Funding for the study could not be obtained.
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rasagiline monotherapy | Active Comparator | Participants will be taking rasagiline 1 mg oral tablet daily |
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| placebo monotherapy | Placebo Comparator | Participants will be taking placebo 1 mg orally daily. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Fekete, MD | New York Medical College | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17078067 | Background | 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. |
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Institutional Review Board approval explicitly marked clinical study data as protected patient data and stated that data will be stored locally.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Sep 15, 2014 | Jul 21, 2025 | Prot_SAP_ICF_001.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C031967 | rasagiline |
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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. 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.
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| Rasagiline 1 mg capsule | Drug | Rasagiline 1 mg oral tablet daily will be administered to study participants. |
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| Placebo | Drug | Placebo 1 mg oral tablet daily will be administered to study participants. |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |