Unlock all Features See Plans and Pricing

Serving leading biopharmaceutical companies globally:

McKinsey
AstraZeneca
Baxter
Medtronic
Merck
Boehringer Ingelheim

Last Updated: January 27, 2023

CLINICAL TRIALS PROFILE FOR RASAGILINE


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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 Branded Pharmaceutical Products R&D, 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 Branded Pharmaceutical Products R&D, Inc. Phase 3 2000-05-01 Study for patients currently using Levodopa/Carbidopa who will be assigned to receive either Rasagiline or Placebo
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 Branded Pharmaceutical Products R&D, Inc. 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 7
Alzheimer's Disease 2
Amyotrophic Lateral Sclerosis (ALS) 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Rasagiline
Intervention Trials
Parkinson Disease 44
Sclerosis 3
Motor Neuron Disease 3
Amyotrophic Lateral Sclerosis 3
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Rasagiline

Trials by Country

Trials by Country for Rasagiline
Location Trials
United States 234
Germany 27
Canada 15
Spain 8
France 5
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Rasagiline
Location Trials
California 16
New York 13
Florida 12
Texas 12
Illinois 11
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Rasagiline

Clinical Trial Phase

Clinical Trial Phase for Rasagiline
Clinical Trial Phase Trials
Phase 4 19
Phase 3 14
Phase 2/Phase 3 3
[disabled in preview] 15
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Rasagiline
Clinical Trial Phase Trials
Completed 40
Terminated 6
Unknown status 5
[disabled in preview] 5
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Rasagiline

Sponsor Name

Sponsor Name for Rasagiline
Sponsor Trials
Teva Branded Pharmaceutical Products R&D, Inc. 17
Teva Pharmaceutical Industries 16
H. Lundbeck A/S 10
[disabled in preview] 12
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Rasagiline
Sponsor Trials
Other 66
Industry 63
NIH 2
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Merck
Colorcon
Mallinckrodt
Harvard Business School
Johnson and Johnson
Boehringer Ingelheim

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.