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Last Updated: November 24, 2020

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CLINICAL TRIALS PROFILE FOR RASAGILINE

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505(b)(2) Clinical Trials for Rasagiline

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT00640159 Tolerability and Efficacy of Switch From Oral Selegiline to Orally Disintegrating Selegiline (Zelapar) in Patients With Parkinson's Disease Completed Baylor College of Medicine Phase 4 2007-01-01 Parkinson's disease (PD) is a progressive neurodegenerative disease. Symptomatic therapy is primarily aimed at restoring dopamine function in the brain. Oral selegiline in conjunction with L-dopa has been a mainstay of therapy for PD patients experiencing motor fluctuations for many years. The mechanisms accounting for selegiline's beneficial adjunctive action in the treatment of PD are not fully understood. Inhibition of monoamine oxidase (MAO) type B (MAO-B) activity is generally considered to be of primary importance. Oral selegiline has low bio-availability and is typically dosed BID, for a total of 5-10 mg daily. Recently, the FDA approved a new orally disintegration tablet (ODT) formulation of selegiline, called ZelaparTM. This new formulation utilizes Zydis technology to dissolve in the mouth, with absorption through the oral mucosa, thereby largely bypassing the gut and avoiding first pass hepatic metabolism. This allows more active drug to be delivered at a lower dose. Consequently, Zelapar is dosed once-daily, up to 2.5 mg per day. There are no empirical data indicating whether the use of the new approved formulation of selegiline ODT (Zelapar) is superior or preferred by patients compared to traditional oral selegiline. It is believed that clinical efficacy will be preserved or enhanced, by delivering more active drug, with improved patient preference for the ODT formulation due to the once-daily dosing . The effectiveness of orally disintegrating selegiline as an adjunct to carbidopa/levodopa in the treatment of PD was established in a multicenter randomized placebo-controlled trial (n=140; 94 received orally disintegrating selegiline, 46 received placebo) of three months' duration. Patients randomized to orally disintegrating selegiline received a daily dose of 1.25 mg for the first 6 weeks and a daily dose of 2.5 mg for the last 6 weeks. Patients were all treated with levodopa and could additionally have been on dopamine agonists, anticholinergics, amantadine, or any combination of these during the trial. At 12 weeks, orally disintegrating selegiline-treated patients had an average of 2.2 hours per day less "OFF" time compared to baseline. Placebo treated patients had 0.6 hours per day less "OFF" time compared to baseline. These differences were significant (p < 0.001). Adverse events were very similar between drug and placebo.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Rasagiline

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00104273 Rasagiline 1 mg and 2 mg Added to Aricept 10 mg Daily in Patients With Mild to Moderate Alzheimer's Disease (AD) Completed Eisai Inc. Phase 2 2004-08-01 The purpose of this study is to evaluate the safety, tolerability, and efficacy of two dose levels of rasagiline mesylate versus placebo in patients with mild-to-moderate Alzheimer's Disease who are taking Aricept.
NCT00104273 Rasagiline 1 mg and 2 mg Added to Aricept 10 mg Daily in Patients With Mild to Moderate Alzheimer's Disease (AD) Completed Teva Pharmaceutical Industries Phase 2 2004-08-01 The purpose of this study is to evaluate the safety, tolerability, and efficacy of two dose levels of rasagiline mesylate versus placebo in patients with mild-to-moderate Alzheimer's Disease who are taking Aricept.
NCT00203034 Multicenter Study of Rasagiline in Parkinson's Disease Patients Using Levodopa and Experiencing Motor Fluctuations Completed Teva Pharmaceutical Industries Phase 3 2000-05-01 Study for patients currently using Levodopa/Carbidopa who will be assigned to receive either Rasagiline or Placebo
NCT00203060 Effectiveness, Tolerability and Safety of Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa Completed Teva Neuroscience, Inc. Phase 3 1997-07-01 Study to look at the effectiveness, tolerability and safety of two doses of Study Medication in Early Parkinson's Disease (PD) Patients who have not been treated with Levodopa.
NCT00203125 A Study to Evaluate the Effects of Tyramine in Patients Who Completed the PRESTO Study. Completed Teva Pharmaceutical Industries Phase 3 2000-10-01 This study is to determine if Tyramine has any side effects on patients receiving 0.5mg, 1mg of Rasagiline or Placebo
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Rasagiline

Condition Name

Condition Name for Rasagiline
Intervention Trials
Parkinson's Disease 31
Parkinson Disease 6
Amyotrophic Lateral Sclerosis (ALS) 2
Alzheimer's Disease 2
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Condition MeSH

Condition MeSH for Rasagiline
Intervention Trials
Parkinson Disease 43
Motor Neuron Disease 3
Amyotrophic Lateral Sclerosis 3
Sclerosis 3
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Clinical Trial Locations for Rasagiline

Trials by Country

Trials by Country for Rasagiline
Location Trials
United States 208
Germany 18
Canada 14
France 5
Israel 5
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Trials by US State

Trials by US State for Rasagiline
Location Trials
California 14
New York 12
Florida 12
Texas 11
Illinois 10
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Clinical Trial Progress for Rasagiline

Clinical Trial Phase

Clinical Trial Phase for Rasagiline
Clinical Trial Phase Trials
Phase 4 20
Phase 3 14
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Rasagiline
Clinical Trial Phase Trials
Completed 34
Recruiting 6
Terminated 5
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Clinical Trial Sponsors for Rasagiline

Sponsor Name

Sponsor Name for Rasagiline
Sponsor Trials
Teva Pharmaceutical Industries 16
H. Lundbeck A/S 9
Teva Neuroscience, Inc. 6
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Sponsor Type

Sponsor Type for Rasagiline
Sponsor Trials
Other 50
Industry 44
NIH 2
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