CLINICAL TRIALS PROFILE FOR SELEGILINE HYDROCHLORIDE
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505(b)(2) Clinical Trials for Selegiline Hydrochloride
| 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 | >Sponsor | >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. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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