CLINICAL TRIALS PROFILE FOR SELEGILINE HYDROCHLORIDE

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.

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.

Clinical Trial Conditions for Selegiline Hydrochloride

Condition Name

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

Condition MeSH

Condition MeSH for Selegiline Hydrochloride
Intervention	Trials
Parkinson Disease	13
Cocaine-Related Disorders	5
Cognition Disorders	4

Clinical Trial Locations for Selegiline Hydrochloride

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for Selegiline Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Selegiline Hydrochloride
Clinical Trial Phase	Trials
Phase 4	11
Phase 3	3
Phase 2	16

Clinical Trial Status

Clinical Trial Status for Selegiline Hydrochloride
Clinical Trial Phase	Trials
Completed	29
Unknown status	4
Recruiting	2

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

Sponsor Type

Sponsor Type for Selegiline Hydrochloride
Sponsor	Trials
Other	27
NIH	19
Industry	10

Selegiline Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Selegiline Hydrochloride

Selegiline hydrochloride is a potent, selective, and irreversible inhibitor of monoamine oxidase B (MAO-B), widely used in the treatment of Parkinson's disease and, in some cases, major depressive disorder and attention deficit hyperactivity disorder (ADHD)[1][3].

Clinical Uses and Indications

Parkinson's Disease

Selegiline hydrochloride is primarily prescribed for the treatment of Parkinson's disease. It works by inhibiting the breakdown of dopamine in the brain, thereby increasing its availability and helping to alleviate symptoms such as tremors, rigidity, and bradykinesia[3].

Major Depressive Disorder and ADHD

In addition to its use in Parkinson's disease, selegiline hydrochloride is also used off-label for major depressive disorder and ADHD. Its mechanism of action involves the inhibition of MAO-B, which can increase the levels of neurotransmitters like dopamine, norepinephrine, and serotonin in the brain[1].

Clinical Trials and Research

Current Status

While selegiline hydrochloride has been well-established in clinical practice, ongoing and recent clinical trials continue to explore its efficacy and safety in various patient populations. For instance, there have been no head-to-head clinical trials comparing selegiline directly with another MAO-B inhibitor, rasagiline, in patients with early Parkinson's disease[3].

Future Directions

Future clinical trials may focus on optimizing dosing regimens, exploring new indications, and comparing selegiline with other treatments for Parkinson's disease and other conditions. Additionally, studies on the long-term effects and potential interactions with other medications are crucial for enhancing patient care.

Market Analysis

Market Size and Growth

The global selegiline hydrochloride market has experienced significant growth in recent years and is anticipated to continue this trend. According to market research, the selegiline hydrochloride market is projected to reach substantial values by 2031, driven by increasing demand and advancements in healthcare infrastructure[2][5].

Segmentation

The market is segmented based on type (capsules, tablets, others), application (hospitals, clinics, retail pharmacies, online pharmacies), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa). This segmentation helps in understanding the diverse market dynamics and identifying key growth areas[2].

Drivers and Restraints

Key drivers of the market include the rising prevalence of Parkinson's disease and other neurological disorders, increasing awareness about the benefits of selegiline hydrochloride, and advancements in pharmaceutical technology. However, restraints such as side effects, drug interactions, and regulatory challenges may impact market growth[2][5].

Market Projections

Forecast Period

From 2023 to 2031, the selegiline hydrochloride market is expected to exhibit robust growth rates. This projection is based on a comprehensive analysis of market dynamics, including drivers, restraints, opportunities, and challenges[2].

Regional Outlook

The Asia-Pacific region is anticipated to be a significant contributor to the market growth due to the large patient population and increasing healthcare expenditure. North America and Europe are also expected to remain key markets due to their well-established healthcare systems and high demand for neurological treatments[2][5].

Pricing and Availability

Dosage Forms and Brand Names

Selegiline hydrochloride is available in various dosage forms, including oral capsules and tablets, under brand names such as Atapryl, Eldepryl, Emsam, and Zelapar. The availability of generic versions has also made the drug more accessible and cost-effective for patients[1].

Pricing

The pricing of selegiline hydrochloride varies based on the dosage form, brand, and geographical location. Generic versions are generally lower in cost compared to branded products, making the drug more affordable for a wider range of patients[1].

Side Effects and Drug Interactions

Common Side Effects

Common side effects of selegiline hydrochloride include nausea, dizziness, headache, and insomnia. Less common but more serious side effects can include orthostatic hypotension, hallucinations, and increased risk of melanoma[1].

Drug Interactions

Selegiline hydrochloride interacts with a significant number of drugs, including other antidepressants, antipsychotics, and certain over-the-counter medications. It is crucial for patients to inform their healthcare providers about all medications they are taking to avoid potential interactions[1].

Key Takeaways

• Clinical Use: Selegiline hydrochloride is primarily used for Parkinson's disease but also has applications in major depressive disorder and ADHD.
• Market Growth: The global market for selegiline hydrochloride is projected to grow significantly from 2023 to 2031.
• Segmentation: The market is segmented by type, application, and geographical region.
• Drivers and Restraints: Key drivers include increasing prevalence of neurological disorders and advancements in pharmaceutical technology, while restraints include side effects and drug interactions.
• Pricing and Availability: Available in various dosage forms and under different brand names, with generic versions making it more affordable.

FAQs

What is the primary use of selegiline hydrochloride?

Selegiline hydrochloride is primarily used for the treatment of Parkinson's disease.

What are the common side effects of selegiline hydrochloride?

Common side effects include nausea, dizziness, headache, and insomnia.

Is selegiline hydrochloride available in generic form?

Yes, selegiline hydrochloride is available in generic form, which is generally lower in cost compared to branded products.

What are the potential drug interactions with selegiline hydrochloride?

Selegiline hydrochloride interacts with a significant number of drugs, including other antidepressants, antipsychotics, and certain over-the-counter medications.

What is the projected market growth for selegiline hydrochloride from 2023 to 2031?

The market is expected to exhibit robust growth rates, driven by increasing demand and advancements in healthcare infrastructure.

Sources

1. Drugs.com: Selegiline Alternatives Compared - Drugs.com
2. Market Research Intellect: Selegiline Hydrochloride Sales Market Size, Scope And Forecast ...
3. Science.gov: anti-parkinsonian drug selegiline: Topics by Science.gov
4. Mayo Clinic: Trazodone (oral route) - Mayo Clinic
5. Biospace: Selegiline Hydrochloride Market Size, Share, Trends, and Forecast ...