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Last Updated: June 3, 2020

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CLINICAL TRIALS PROFILE FOR SELEGILINE HYDROCHLORIDE

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505(b)(2) Clinical Trials for Selegiline Hydrochloride

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 Selegiline Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000188 Selegiline in Treatment of Cocaine Dependence - 2 Completed National Institute on Drug Abuse (NIDA) Phase 2 1994-09-01 The purpose of this study is to assess selegiline as a pharmacotherapy for cocaine dependence.
NCT00000188 Selegiline in Treatment of Cocaine Dependence - 2 Completed University of Pennsylvania Phase 2 1994-09-01 The purpose of this study is to assess selegiline as a pharmacotherapy for cocaine dependence.
NCT00000201 Pharmacological Modulation of Cocaine Effects - 1 Completed Johns Hopkins University Phase 2 1969-12-31 The purpose of this study is to conduct human laboratory studies of possible cocaine interactions with various potential treatment medications.
NCT00000201 Pharmacological Modulation of Cocaine Effects - 1 Completed National Institute on Drug Abuse (NIDA) Phase 2 1969-12-31 The purpose of this study is to conduct human laboratory studies of possible cocaine interactions with various potential treatment medications.
NCT00000336 Selegiline in Outpatient Treatment for Cocaine Dependence - 1 Completed National Institute on Drug Abuse (NIDA) Phase 2 1995-01-01 The purpose of this study is to evaluate the efficacy and clinical safety of selegiline in the treatment of cocaine dependence and to assess neurotoxicity (Magnetic Resonance Imaging, MRI) post-hoc as a possible variable for future stratification in clinical trials.
NCT00000337 Infusion Laboratory: Protocol 1 - Selegeline - 2 Completed National Institute on Drug Abuse (NIDA) Phase 1 1994-11-01 The purpose of this study is to determine the effects of selegiline on the subjective and physiological effects of cocaine challenge in chronic crack abusers, and to evaluate clinical safety issues pertaining to selegeline, to cocaine and their interaction in a chronic crack dependent population.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Selegiline Hydrochloride

Condition Name

Condition Name for Selegiline Hydrochloride
Intervention Trials
Parkinson's Disease 6
Cocaine-Related Disorders 5
HIV Infections 3
Parkinson Disease 3
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Condition MeSH

Condition MeSH for Selegiline Hydrochloride
Intervention Trials
Parkinson Disease 10
Cocaine-Related Disorders 5
HIV Infections 4
Cognition Disorders 4
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Clinical Trial Locations for Selegiline Hydrochloride

Trials by Country

Trials by Country for Selegiline Hydrochloride
Location Trials
United States 114
Spain 1
Iran, Islamic Republic of 1
United Kingdom 1
Canada 1
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Trials by US State

Trials by US State for Selegiline Hydrochloride
Location Trials
California 14
Maryland 12
Florida 7
Texas 6
New York 5
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Clinical Trial Progress for Selegiline Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Selegiline Hydrochloride
Clinical Trial Phase Trials
Phase 4 10
Phase 3 3
Phase 2 15
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Clinical Trial Status

Clinical Trial Status for Selegiline Hydrochloride
Clinical Trial Phase Trials
Completed 28
Unknown status 2
Recruiting 2
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Clinical Trial Sponsors for Selegiline Hydrochloride

Sponsor Name

Sponsor Name for Selegiline Hydrochloride
Sponsor Trials
National Institute on Drug Abuse (NIDA) 11
National Institute of Neurological Disorders and Stroke (NINDS) 6
Somerset Pharmaceuticals 5
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Sponsor Type

Sponsor Type for Selegiline Hydrochloride
Sponsor Trials
Other 21
NIH 19
Industry 8
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