Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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15 November 2021 |
Main ID: |
NCT01723228 |
Date of registration:
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05/11/2012 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Parallel-Group Study to Assess the Effect of Rasagiline on Cognition in Patients With Parkinson's Disease
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Scientific title:
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A 24-Week, Multicenter, Randomized, Double-blind, Placebo-Controlled, Add-on, Parallel-Group Study to Assess the Effect of Rasagiline on Cognition in Patients With Parkinson's Disease |
Date of first enrolment:
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November 2012 |
Target sample size:
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170 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT01723228 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Teva Medical Expert |
Address:
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Telephone:
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Email:
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Affiliation:
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Teva Branded Pharmaceutical Products R&D, Inc. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Nondemented man or woman 45 through 80 years of age with idiopathic Parkinson's
disease (PD) based on the United Kingdom (UK) Parkinson's Disease Society Brain Bank
Clinical Diagnostic Criteria
2. Hoehn and Yahr stage = 1 (symptoms on only 1 side of the body) with treatment and = 3
(mild-to-moderate bilateral disease; some postural instability; physically
independent)
3. Mild cognitive impairment in Parkinson's disease based on the Movement Disorder
Society (MDS) Task Force Diagnostic Criteria and the Montreal Cognitive Assessment
(MoCA) rating scale (range, 20-25, inclusive)
4. Medically stable outpatient, based on the investigator's judgment
5. The patient is on a stable dopaminergic medication regimen for = 30 days before
entering the study (Screening/Baseline Visit)
6. Other inclusion criteria apply; please contact the site for more information
Exclusion Criteria:
1. Clinically relevant history of vascular disease (eg, stroke)
2. History of melanoma
3. History of deep brain stimulation (DBS)
4. Impaired hepatic function, based on the investigator's judgment
5. Psychosis or is receiving antipsychotic treatment
6. Clinically significant or unstable medical or surgical condition that may preclude
safe and complete study participation, based on the investigator's judgment
7. Other exclusion criteria apply; please contact the site for more information
Age minimum:
45 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease
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Intervention(s)
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Drug: Placebo
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Drug: Rasagiline
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Primary Outcome(s)
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Mean Change From Baseline to Week 24 in the Scales for Outcomes in Parkinson's Disease-Cognition (SCOPA-COG) Summary Score
[Time Frame: Baseline to Week 24 (or early discontinuation)]
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Secondary Outcome(s)
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Change From Baseline to Week 24 in UPDRS, Activities of Daily Living (ADL) Subscale (Part 2), Version 3, Score
[Time Frame: Baseline to week 24 (or early discontinuation)]
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Change From Baseline to Week 24 in the Unified Parkinson's Disease Rating Scale (UPDRS), Motor Subscale (Part 3), Version 3, Score
[Time Frame: Baseline to Week 24 (or early discontinuation)]
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Alzheimer's Disease Cooperative Study's Clinical Global Impression of Change Modified for Mild Cognitive Impairment (ADCS MCI-CGIC) Score at Week 24
[Time Frame: Week 24 (or early discontinuation)]
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Change From Baseline to Week 24 in the Penn Daily Activities Questionnaire (PDAQ) Score
[Time Frame: Baseline to Week 24 (or early discontinuation)]
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Change From Baseline to Week 24 in the Montreal Cognitive Assessment (MoCA) Score
[Time Frame: Baseline to Week 24 (or early discontinuation)]
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Secondary ID(s)
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TVP-1012/PM106
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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