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Eldepryl (Selegiline Hydrochloride) - Summary



ELDEPRYL (selegiline hydrochloride) is a levorotatory acetylenic derivative of phenethylamine. It is commonly referred to in the clinical and pharmacological literature as l-deprenyl.

ELDEPRYL is indicated as an adjunct in the management of Parkinsonian patients being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy. There is no evidence from controlled studies that selegiline has any beneficial effect in the absence of concurrent levodopa therapy.

Evidence supporting this claim was obtained in randomized controlled clinical investigations that compared the effects of added selegiline or placebo in patients receiving levodopa/carbidopa. Selegiline was significantly superior to placebo on all three principal outcome measures employed: change from baseline in daily levodopa/carbidopa dose, the amount of 'off' time, and patient self-rating of treatment success. Beneficial effects were also observed on other measures of treatment success (e.g., measures of reduced end of dose akinesia, decreased tremor and sialorrhea, improved speech and dressing ability and improved overall disability as assessed by walking and comparison to previous state).

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Media Articles Related to Eldepryl (Selegiline)

Diabetes Drug May Slow Parkinson's Disease
Source: Medscape NeurologyHeadlines [2017.08.14]
Exenatide improved off-medication motor scores in patients with Parkinson's disease in a placebo-controlled trial, and the benefits persisted for several weeks after the drug was discontinued.
Medscape Medical News

Researchers identify visual system changes that may signal Parkinson's disease
Source: Eye Health / Blindness News From Medical News Today [2017.07.14]
Changes in the visual systems of newly diagnosed Parkinson's disease patients may provide important biomarkers for the early detection and monitoring of the disease, according to a new study...

Parkinson's Disease and Melanoma May Occur Together, Study Finds
Source: MedicineNet Melanoma Specialty [2017.07.10]
Title: Parkinson's Disease and Melanoma May Occur Together, Study Finds
Category: Health News
Created: 7/7/2017 12:00:00 AM
Last Editorial Review: 7/10/2017 12:00:00 AM

Transcranial stimulation and/or physical therapy improves walking speed in Parkinson's disease
Source: Rehabilitation / Physical Therapy News From Medical News Today [2017.06.29]
Noninvasive brain stimulation and physical therapy - alone or in combination - improve some measures of walking ability in patients with Parkinson's disease (PD), concludes a clinical trial in the...

Statins may raise the risk of Parkinson's disease
Source: Statins News From Medical News Today [2017.06.15]
New research suggests that rather than protecting against Parkinson's disease, it is possible that the use of statins may increase its risk.

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Published Studies Related to Eldepryl (Selegiline)

The relationship between depression and regional cerebral blood flow in Parkinson's disease and the effect of selegiline treatment. [2011.07]
OBJECTIVES: We examined the relationship between severity of depression in Parkinson's disease (PD) and regional cerebral blood flow (rCBF) using single photon emission computed tomography (SPECT) and the reaction to levodopa-selegiline combination therapy... CONCLUSIONS: These results indicate that selegiline controlled not only worsening of motor function and cognitive function in PD but also aggravation of minor depression, and restrained a fall in whole brain rCBF. (c) 2010 John Wiley & Sons A/S.

A double-blind, placebo-controlled, randomized clinical trial of oral selegiline hydrochloride for smoking cessation in nicotine-dependent cigarette smokers. [2010.03.01]
AIM: The primary aim of this study was to determine the safety and efficacy of the monoamine oxidase-B (MAO-B) inhibitor selegiline hydrochloride (SEL, l-Deprenyl; Eldepryl) as an aid for smoking cessation in cigarette smokers... CONCLUSIONS: Our results suggest that SEL was safe and well-tolerated by adult cigarette smokers, but did not improve smoking abstinence rates compared to PLO. Copyright 2009 Elsevier Ireland Ltd. All rights reserved.

A double-blind, placebo-controlled, randomized clinical trial of oral selegiline hydrochloride for smoking cessation in nicotine-dependent cigarette smokers. [2010]
l-Deprenyl; Eldepryl) as an aid for smoking cessation in cigarette smokers... CONCLUSIONS: Our results suggest that SEL was safe and well-tolerated by adult

Selegiline and oxidative stress in HIV-associated cognitive impairment. [2009.12.08]
OBJECTIVE: To assess the effectiveness of the selegiline transdermal system (STS) in reversing HIV-induced metabolic brain injury (as measured by proton magnetic resonance spectroscopy [MRS]) and in decreasing oxidative stress, measured by CSF protein carbonyl concentration... CONCLUSION: In this 24-week study, the selegiline transdermal system (STS) had no effect on either magnetic resonance spectroscopy (MRS) metabolites or oxidative stress, as measured by CSF protein carbonyl concentration. The lack of effect on these biomarkers is also reflected in the lack of cognitive improvement in the STS groups compared to placebo. Level of evidence: This study provides Class II evidence that STS had no effect on either MRS metabolites or oxidative stress, as measured by CSF protein carbonyl concentration over a period of 24 weeks.

Efficacy of selegiline add on therapy to risperidone in the treatment of the negative symptoms of schizophrenia: a double-blind randomized placebo-controlled study. [2008.03]
OBJECTIVE: It has been reported that selegiline, a Selective Monoamine Oxidase Inhibitor B (MAOI-B), at low doses would be helpful for treating negative symptoms in schizophrenia. Nevertheless, the results are contradictory so far. This study was designed to investigate the effect of selegiline added to risperidone as augmentation therapy in patients with chronic schizophrenia and prominent negative symptoms in an 8 week, double blind and randomized clinical trial... CONCLUSION: The present study indicates selegiline as a potential adjunctive treatment strategy for the negative symptoms of schizophrenia. Nevertheless, results of larger controlled trials are needed before recommendation for a broad clinical application can be made. (c) 2007 John Wiley & Sons, Ltd.

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Clinical Trials Related to Eldepryl (Selegiline)

Evaluation of Adhesion and Dermal Tolerability of EMSAM [Completed]

PK Comparison of 6mg and 12mg EMSAM in Elderly vs. Non-Elderly [Completed]
Evaluate the effect of age on the PK of two different doses of EMSAM.

Tolerability and Efficacy of Switch From Oral Selegiline to Orally Disintegrating Selegiline (Zelapar) in Patients With Parkinson's Disease [Completed]
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.

A Pilot Study Assessing EmSam in Bipolar Depression [Terminated]
This pilot study will evaluate the efficacy of the monoamine oxidase inhibitor (MAOI)EmSam, a selegiline transdermal system (STS), in bipolar depression.

A Study of Thioctic Acid and Deprenyl in HIV-Infected Patients With Dementia [Completed]
The purpose of this study is to see if it is safe and effective to give thioctic acid and deprenyl (selegiline hydrochloride), alone or in combination, to HIV-infected patients who have mild to moderate dementia (a decline in their mental abilities).

more trials >>

Page last updated: 2017-08-14

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