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Last Updated: April 28, 2025

CLINICAL TRIALS PROFILE FOR AMANTADINE HYDROCHLORIDE


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

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000301 ↗ Rapid Evaluation of Amantadine for Treatment of Cocaine Abuse/Dependence - 4 Completed National Institute on Drug Abuse (NIDA) Phase 2 1996-03-01 The purpose of this study is to empirically test a series of medications to: 1) determine each medication's efficacy in treatment of cocaine abuse/dependence; 2) find most effective dose range for each medication. In this study, amantadine is tested."
NCT00000301 ↗ Rapid Evaluation of Amantadine for Treatment of Cocaine Abuse/Dependence - 4 Completed University of California, Los Angeles Phase 2 1996-03-01 The purpose of this study is to empirically test a series of medications to: 1) determine each medication's efficacy in treatment of cocaine abuse/dependence; 2) find most effective dose range for each medication. In this study, amantadine is tested."
NCT00001930 ↗ Treatment of Huntington's Chorea With Amantadine Completed National Institute of Neurological Disorders and Stroke (NINDS) Phase 2 1999-04-01 Huntington's disease is a chronic disorder passed on through genetic autosomal dominant inheritance. The condition usually begins between the ages of 30 and 50 years and it is characterized by involuntary movements in the face and extremities, (chorea), accompanied by changes in behavior and gradual loss of the mental function. The disease typically ends in a state of disorientation, impaired memory, judgement, and intellect (dementia). The objective of this study is to test the effectiveness of the drug amantadine for the treatment of chorea associated with Huntington's disease. Amantadine is an antiviral drug that has been used to treat a variety of illnesses including Parkinson's disease. Amantadine works by attaching to special sites called NMDA (N-methyl-D-aspartate) receptors and blocking the normal activity of glutamate there. Glutamate is an amino acid released by brain cells and has been associated with the symptoms of Parkinson's disease.
NCT00015249 ↗ Prepulse Inhibition of Startle in Cocaine Dependence - 7 Completed New York MDRU Phase 1 1997-02-01 The purpose of this study is to assess the effects of chronic cocaine use on the acoustic startle response and on gating of this response in humans.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Amantadine Hydrochloride

Condition Name

Condition Name for Amantadine Hydrochloride
Intervention Trials
Parkinson's Disease 15
Parkinson Disease 10
Traumatic Brain Injury 9
Multiple Sclerosis 7
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Condition MeSH

Condition MeSH for Amantadine Hydrochloride
Intervention Trials
Parkinson Disease 30
Dyskinesias 14
Brain Injuries, Traumatic 13
Brain Injuries 13
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Clinical Trial Locations for Amantadine Hydrochloride

Trials by Country

Trials by Country for Amantadine Hydrochloride
Location Trials
United States 345
Germany 40
Canada 28
France 19
Spain 11
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Trials by US State

Trials by US State for Amantadine Hydrochloride
Location Trials
California 18
Texas 17
Florida 17
New York 17
North Carolina 17
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Clinical Trial Progress for Amantadine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Amantadine Hydrochloride
Clinical Trial Phase Trials
Phase 4 22
Phase 3 26
Phase 2/Phase 3 6
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Clinical Trial Status

Clinical Trial Status for Amantadine Hydrochloride
Clinical Trial Phase Trials
Completed 58
Unknown status 17
Terminated 15
[disabled in preview] 14
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Clinical Trial Sponsors for Amantadine Hydrochloride

Sponsor Name

Sponsor Name for Amantadine Hydrochloride
Sponsor Trials
Adamas Pharmaceuticals, Inc. 9
Hoffmann-La Roche 5
Oregon Health and Science University 5
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Sponsor Type

Sponsor Type for Amantadine Hydrochloride
Sponsor Trials
Other 145
Industry 39
NIH 9
[disabled in preview] 7
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Amantadine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Amantadine Hydrochloride

Amantadine hydrochloride is a versatile drug with a wide range of applications, including the treatment of Parkinson's disease, influenza, and more recently, its potential in motor neurone disease (MND). Here, we will delve into the latest clinical trials, market analysis, and projections for this drug.

Clinical Trials Update

Parkinson's Disease and Dyskinesia

One of the significant clinical trials involving amantadine hydrochloride is its use in treating levodopa-induced dyskinesia (LID) in patients with Parkinson's disease. The FDA approved amantadine (under the brand name Gocovri) in 2017 specifically for this indication. Two phase 3 clinical trials, Study 1 and Study 2, demonstrated a significant reduction in dyskinesia and an improvement in "on" time without troublesome dyskinesia, as well as a decrease in "off" time[4].

Another trial, although terminated early due to slow enrollment, aimed to compare the efficacy and safety of different dose levels of amantadine extended-release tablets to placebo for treating LID. This multi-center, randomized, double-blind study enrolled 87 out of 162 planned subjects before its termination[1].

Motor Neurone Disease (MND)

The MND-SMART platform trial, which started recruiting in February 2020, includes amantadine as one of the drugs being evaluated. Recent updates indicate that amantadine will continue to be part of the trial, with no safety concerns identified at the interim analysis. The drug is being investigated for its potential to reduce abnormal clumping of proteins in cells, a factor in the onset and progression of MND[3].

Mechanism of Action and Side Effects

Amantadine hydrochloride acts as an N-methyl-D-aspartate (NMDA) receptor antagonist and exhibits anticholinergic and dopaminergic-like activities. Its exact mechanism in treating dyskinesia is not fully understood, but it is known to improve "on" time and reduce "off" time in patients with Parkinson's disease[4].

Common side effects include hallucinations, dizziness, dry mouth, peripheral edema, constipation, falls, and orthostatic hypotension. The drug is contraindicated in patients with end-stage renal disease and should not be discontinued abruptly to avoid worsening Parkinson's symptoms or inducing delirium and other adverse effects[4].

Market Analysis

Global Market Size and Growth

The global amantadine hydrochloride market is anticipated to grow significantly over the next few years. As of 2023, the market was valued at several million USD and is expected to reach a higher value by 2030, with a notable compound annual growth rate (CAGR)[5].

Key Players and Market Segmentation

The market is dominated by several key players, including Sine Pharma, Hengshan Pharma, Taiyi Pharma, NE Pharma, and others. The market is segmented by type (tablets, oral solution) and application (hospital pharmacies, retail pharmacies, online pharmacies)[5].

Regional Analysis

The global market is analyzed regionally, with different regions expected to contribute varying shares to the overall market. The report provides detailed insights into the market trends, drivers, opportunities, and restraints in each region[2].

Competitive Landscape

The competitive landscape of the amantadine hydrochloride market is highly competitive, with multiple pharmaceutical companies vying for market share. The report includes competitor analysis, SWOT analysis, and PESTEL analysis to provide a comprehensive view of the market dynamics[2].

Market Projections

Forecast Period

The market forecast extends from 2025 to 2031, with the base year being 2023. The report includes historical data from 2019 to 2023 and estimated data for 2024, providing a robust framework for understanding the market's future trajectory[2].

Growth Factors and Trends

The growth of the amantadine hydrochloride market is driven by several factors, including the increasing prevalence of Parkinson's disease and MND, advancements in drug delivery technologies, and the expanding use of amantadine in various therapeutic areas. The report highlights these trends and their impact on the market[2].

Regulatory and Safety Updates

FDA Approval and Orphan Drug Status

Amantadine received FDA approval in 2017 for the treatment of dyskinesia in patients with Parkinson's disease. It was also granted orphan drug status for levodopa-induced dyskinesia in 2015[4].

Safety and Interim Analysis

Recent interim analysis from the MND-SMART trial has confirmed no safety concerns with amantadine, allowing it to continue in the trial. This is a positive indicator for its potential use in MND treatment[3].

Conclusion

Amantadine hydrochloride is a drug with significant therapeutic potential, particularly in the treatment of Parkinson's disease and potentially in MND. The clinical trials have shown promising results, and the market analysis indicates a strong growth trajectory. As the drug continues to be evaluated and used in various therapeutic areas, it is likely to remain a key player in the pharmaceutical market.

Key Takeaways

  • Clinical Trials: Amantadine hydrochloride has shown efficacy in treating levodopa-induced dyskinesia in Parkinson's disease and is being evaluated for its potential in MND.
  • Market Growth: The global amantadine hydrochloride market is expected to grow significantly, driven by increasing disease prevalence and advancements in drug delivery.
  • Regulatory Approval: FDA-approved for dyskinesia in Parkinson's disease and granted orphan drug status.
  • Safety Profile: Generally safe, but with notable side effects and contraindications.
  • Market Segmentation: Dominated by key players and segmented by type and application.

FAQs

What is the primary use of amantadine hydrochloride in clinical settings?

Amantadine hydrochloride is primarily used to treat levodopa-induced dyskinesia in patients with Parkinson's disease.

Which regulatory body approved amantadine hydrochloride for dyskinesia in Parkinson's disease?

The US Food and Drug Administration (FDA) approved amantadine hydrochloride for this indication in 2017[4].

What are the common side effects of amantadine hydrochloride?

Common side effects include hallucinations, dizziness, dry mouth, peripheral edema, constipation, falls, and orthostatic hypotension[4].

Is amantadine hydrochloride being evaluated for any other conditions besides Parkinson's disease?

Yes, it is being evaluated as part of the MND-SMART trial for its potential in treating motor neurone disease (MND)[3].

What is the expected growth rate of the global amantadine hydrochloride market?

The market is expected to grow at a notable CAGR from 2025 to 2031, driven by various growth factors[2].

Sources

  1. Lake Clinical Trial Efficacy and Safety of Amantadine Hydrochloride (HCl) ER Tablets to Treat Parkinson's Disease Patients With LID. Mental Health Network of Care.
  2. Global Amantadine Hydrochloride Market Report 2024 Edition. Cognitive Market Research.
  3. MND-SMART team releases update about trial drug amantadine. Motor Neurone Disease Association.
  4. Gocovri (Amantadine) First Drug Approved for Dyskinesia in Patients with Parkinson’s Disease. AHDB Online.
  5. Global Amantadine Hydrochloride Market Research Report 2024. Valuates Reports.

More… ↓

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