A Randomized Placebo Controlled Study to Show That Rasagiline May Slow Disease Progression for Parkinson's Disease

Phase 3

Completed

Conditions: Parkinson's Disease

Interventions: Drug: Rasagiline Mesylate
Other: Placebo

Registration Number: NCT00256204

Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Brief Summary: A 2 phase study to evaluate disease progression in Parkinson's disease patients taking rasagiline

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1174

Inclusion Criteria

Men and women with idiopathic PD whose diagnosis is confirmed at screening, with at least two cardinal signs without any other known or suspected cause of parkinsonism. If tremor is not present, subjects must have unilateral onset and persistent asymmetry.
Subjects with a diagnosis of early idiopathic PD of less than 1½ years duration from time of documented diagnosis.
Subjects whose clinical condition at the time of enrollment does not require anti-PD treatment and will not require for the next 9 months.
Willing and able to give informed consent.

Exclusion Criteria

Subjects younger than 30 or older than 80 years.
Subjects with loss of postural reflexes.
Subjects with UPDRS Tremor score of 3 or greater in any limb.
Subjects with Hoehn &Yahr Stage III or greater at screening.
Subjects with freezing while walking.
Subjects with any of the following features that tend to exclude PD as the cause of Parkinsonism:
History of repeated strokes with stepwise progression of Parkinsonian features
History of repeated head injury or history of definite encephalitis
Sustained remission
Supranuclear gaze palsy
Cerebellar signs
Early severe autonomic involvement
Babinski's sign
Presence of a cerebral tumour or communicating hydrocephalus
MPTP exposure
Oculogyric crises
Subjects who have had previous use of rasagiline or selegiline
Subjects having used other anti-PD medication basis at any time prior to baseline
Subjects having used other anti-PD medication (including anticholinergics) for less than 3 weeks during the 3 month period prior to baseline. (not including a single L-Dopa dose as part of L-Dopa test)
Subjects having used any other anti-PD medication (including anticholinergics) for less than 3 weeks prior to the 3 month period preceding baseline whose anti-PD medication is intentionally ceased in order for the subject to enter the study.
Subjects who have a clinically significant or unstable medical or surgical condition that may preclude safe and complete participation
Hypertensive subjects whose BP is not well controlled according to the medical record or as observed during the week of home BP recording prior to baseline
Subjects diagnosed with melanoma based on the screening dermatologic examination, or with a history of melanoma. Subjects with suspicious lesions at baseline who do not undergo biopsy
Subjects with significant cognitive impairment as defined by MMSE score < 26
Subjects with clinically significant psychiatric illness, including major depression [Beck Depression Inventory (short form) ≥15
Subjects with a history of alcohol or substance abuse within the past 2 years
Subjects who have taken any experimental medications within 60 days prior to baseline
Subjects who have used coenzyme Q10 (in daily doses > 300 mg) within 120 days prior to baseline
Subjects who have used sympathomimetics (including over-the-counter remedies - nasal or oral), dextromethorphan, pethidine or St. John's Wort within the 7 days prior to baseline
Subjects who have used antidepressants within 42 days prior to baseline
Subjects who have used ciprofloxacin, a potent CYP 1A2 inhibitor within 7 days prior to baseline
Subjects who have used MAO inhibitors including reserpine or methyldopa within the three months prior to baseline, or treatment with an anti-emetic or antipsychotic medication with central dopamine antagonist activity within the six months prior to baseline
Women who are not postmenopausal, surgically sterilized, or using adequate birth control [oral birth control pills, IUD, or a long acting injectable form of contraception; barrier methods alone (i.e., condom) are not sufficient]. Women of childbearing potential without a negative pregnancy test at screening. Nursing women

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1mg rasagiline	Rasagiline Mesylate	1mg early start active treatment arm (72 weeks active)followed by 1mg 36 week delayed start active treatment arm (36 weeks placebo followed by 36 weeks active)
2mg rasagiline	Rasagiline Mesylate	2mg early start active treatment arm (72 weeks active)followed by 2mg 36 week delayed start active treatment arm (36 weeks placebo followed by 36 weeks active)
Placebo	Placebo	Each arm is followed by 36 weeks of placebo

Primary Outcome Measures

Name	Time	Method
Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline	12w, 24w, 36w, 42w, 48w, 54w, 60w, 66w, 72w	The primary efficacy endpoint was defined as the change in Total UPDRS from Baseline. Subjects were assessed according to the United Parkinson's Disease Rating Scale (UPDRS,(version 3;) Parts I and II are historical data and are designed to rate mentation, behavior and mood; Part III is done as a motor examination at the time of a visit. The UPDRS measures patient status on a scale 0, which is normal or none, to 4, which is severe or the worst scenario.

Secondary Outcome Measures

Name	Time	Method
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline to Last Observed Value in the Placebo Phase	36 weeks	Subjects were assessed according to the United Parkinson's Disease Rating Scale UPDRS,(version 3;) Parts I and II are historical data and are designed to rate mentation, behavior and mood; Part III is done as a motor examination at the time of a visit. The UPDRS measures patient status on a scale 0, which is normal or none, to 4, which is severe or the worst scenario.