Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00256204 | A Randomized Placebo Controlled Study to Show That Rasagiline May Slow Disease Progression for Parkinson's Disease | PHASE3 | COMPLETED | 1,174 | — | — | Nov 1, 2005 | Jun 1, 2009 | Jan 12, 2012 | - | — |
| NCT00203138 | Safety, Tolerability, and Effectiveness of Rasagiline Mesylate in Patients With Parkinson's Disease | PHASE3 | COMPLETED | 306 | — | — | Jun 1, 2004 | Dec 1, 2006 | Apr 12, 2011 | - | — |
| NCT00203164 | Study to Evaluate the Safety and Tolerability of Rasagiline in Advanced Parkinson's Disease Patients | PHASE3 | COMPLETED | 254 | — | — | May 1, 2002 | Sep 1, 2006 | Mar 9, 2010 | 6 | United States |
| NCT00203177 | Rasagiline in Advanced Parkinson's Disease Patients With Motor Fluctuations Treated With Levodopa/Carbidopa Therapy. | PHASE3 | COMPLETED | 254 | — | — | Oct 1, 2001 | - | Mar 9, 2010 | 8 | United States, Canada |
| NCT00203125 | A Study to Evaluate the Effects of Tyramine in Patients Who Completed the PRESTO Study. | PHASE3 | COMPLETED | 55 | — | — | Oct 1, 2000 | Jan 1, 2003 | Apr 12, 2011 | - | — |
| NCT00203034 | Multicenter Study of Rasagiline in Parkinson's Disease Patients Using Levodopa and Experiencing Motor Fluctuations | PHASE3 | COMPLETED | 472 | — | — | May 1, 2000 | Jan 1, 2003 | Mar 9, 2010 | 4 | United States |
| NCT00203060 | Effectiveness, Tolerability and Safety of Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa | PHASE3 | COMPLETED | 404 | — | — | Jul 1, 1997 | Jul 1, 2000 | Apr 12, 2011 | - | — |
| NCT01879748 | A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Single and Multiple Doses of Rasagiline | PHASE1 | COMPLETED | 64 | — | — | Jun 1, 2013 | Nov 1, 2013 | Dec 20, 2013 | 1 | United States |
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.
To evaluate the long-term safety and tolerability of rasagiline in PD patients with motor fluctuations treated with chronic levodopa/carbidopa (LD/CD) or levodopa/benserazide (LD/BZD) therapy
To evaluate the long-term safety and tolerability of rasagiline in PD patients with motor fluctuations treated with chronic levodopa/carbidopa (LD/CD) or levodopa/benserazide (LD/BZD) therapy.
AUC 0-t will be calculated after administration of a single dose of rasagiline.
AUC∞ will be calculated after administration of a single dose of rasagiline.
%AUCext will be calculated after administration of a single dose of rasagiline.
minimum measured plasma concentration at steady state by inspection (Cmin,ss) (multiple dose \[predose concentrations on days 8 and 9\]))
The average plasma concentration at steady state (Cav,ss) is obtained by the calculation: AUCτ/τ, where tau is the dosing interval
Fluctuation at steady state, calculated as (Cmax,ss-Cmin,ss)/Cav,ss
Steady-state accumulation ratio (Rss) calculated as (AUCτ/AUC∞)
| Arm | Type | Description |
|---|---|---|
| 1mg rasagiline | EXPERIMENTAL | 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 | EXPERIMENTAL | 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_COMPARATOR | Each arm is followed by 36 weeks of placebo |
| rasagiline mesylate | EXPERIMENTAL | rasagiline mesylate 1 mg oral once daily |
| Experimental 1 | EXPERIMENTAL | 0.5 mg rasagiline mesylate oral once daily |
| Expermental 2 | EXPERIMENTAL | 1.0 mg rasagiline mesylate oral once daily |
| Experimental 2 | EXPERIMENTAL | 1.0 mg rasagiline mesylate oral once daily |
| A | EXPERIMENTAL | Rasagiline treatment |
| B | PLACEBO_COMPARATOR | placebo arm |
| Rasagiline | EXPERIMENTAL | Rasagiline mesylate oral tablets (AZILECT®) are provided at dose strengths of 0.5 and 1 mg (based on rasagiline base). Rasagiline oral tablets will be dispensed for 10 consecutive days of treatment. The oral dose will be administered each day with 240 mL water at room temperature after an overnight fast of at least 10 hours. |
| Name | Type | Description |
|---|---|---|
| Rasagiline Mesylate | DRUG | tablet, 1mg once daily |
| Placebo | OTHER | Placebo |
| rasagiline mesylate 1.0 mg | DRUG | 1.0 mg rasagiline mesylate |
| tyramine | OTHER | 50 mg once daily |
| 1.0 mg rasagiline mesylate | DRUG | 1.0 mg rasagiline mesylate oral once daily |
| Rasagiline | DRUG | Each subject will be enrolled into 1 of 4 cohorts: * cohort 1 (16 Japanese subjects): 4 subjects each for 0.5, 1, and 2 mg of rasagiline and placebo * cohort 2 (16 Caucasian subjects): 4 subjects each for 0.5, 1, and 2 mg of rasagiline and placebo * cohort 3 (16 Japanese subjects): 4 subjects each for 0.5, 1, and 2 mg of rasagiline and placebo * cohort 4 (16 Caucasian subjects): 4 subjects each for 0.5, 1, and 2 mg of rasagiline and placebo Each subject will then be randomly assigned to 1 of the following groups: * rasagiline at 0.5 mg (8 Japanese and 8 Caucasian subjects) * rasagiline at 1 mg (8 Japanese and 8 Caucasian subjects) * rasagiline at 2 mg (8 Japanese and 8 Caucasian subjects) * placebo (8 Japanese and 8 Caucasian subjects) |
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 di...