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Last Updated: February 16, 2025

CLINICAL TRIALS PROFILE FOR STALEVO 75


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505(b)(2) Clinical Trials for Stalevo 75

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 Combination NCT01766258 ↗ Efficacy and Safety Proof of Concept Study in Patients With Parkinson's Disease and End-of-dose Motor Fluctuations Completed Orion Corporation, Orion Pharma Phase 2 2011-05-01 The primary objective of the study is to assess the efficacy, carbidopa dose response and safety of ODM-101, a new combination of levodopa, carbidopa and entacapone in the treatment of Parkinson's disease (PD) patients with end-of-dose motor fluctuations.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Stalevo 75

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00099268 ↗ Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy Completed Orion Corporation, Orion Pharma Phase 3 2004-09-01 The CELC200A2401 study has been designed in order to evaluate the hypothesis that administering the combination carbidopa/levodopa/entacapone at the time that levodopa therapy is initiated results in a decrease in the risk of the development of motor complications for patients with Parkinson's disease.
NCT00099268 ↗ Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy Completed Novartis Pharmaceuticals Phase 3 2004-09-01 The CELC200A2401 study has been designed in order to evaluate the hypothesis that administering the combination carbidopa/levodopa/entacapone at the time that levodopa therapy is initiated results in a decrease in the risk of the development of motor complications for patients with Parkinson's disease.
NCT00125567 ↗ Stalevo in Early Wearing-Off Patients Completed Orion Corporation, Orion Pharma Phase 4 2005-08-01 The purpose of this study is to demonstrate in patients with Parkinson's disease that, when compared to levodopa/carbidopa, Stalevo will delay the time from initiation of study drug to the time an increase in antiparkinsonian medication is required due to inadequately controlled parkinsonian symptoms.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Stalevo 75

Condition Name

Condition Name for Stalevo 75
Intervention Trials
Parkinson's Disease 11
Parkinson Disease 3
Sleep Disorders 1
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Condition MeSH

Condition MeSH for Stalevo 75
Intervention Trials
Parkinson Disease 16
Parasomnias 1
Narcolepsy 1
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Clinical Trial Locations for Stalevo 75

Trials by Country

Trials by Country for Stalevo 75
Location Trials
United States 37
Canada 11
Italy 11
Finland 8
United Kingdom 7
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Trials by US State

Trials by US State for Stalevo 75
Location Trials
Michigan 3
Florida 3
California 3
Rhode Island 2
Pennsylvania 2
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Clinical Trial Progress for Stalevo 75

Clinical Trial Phase

Clinical Trial Phase for Stalevo 75
Clinical Trial Phase Trials
Phase 4 4
Phase 3 3
Phase 2 6
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Clinical Trial Status

Clinical Trial Status for Stalevo 75
Clinical Trial Phase Trials
Completed 13
Terminated 1
Unknown status 1
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Clinical Trial Sponsors for Stalevo 75

Sponsor Name

Sponsor Name for Stalevo 75
Sponsor Trials
Orion Corporation, Orion Pharma 10
Novartis Pharmaceuticals 2
Asan Medical Center 1
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Sponsor Type

Sponsor Type for Stalevo 75
Sponsor Trials
Industry 16
Other 4
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Stalevo 75: Clinical Trials, Market Analysis, and Projections

Introduction to Stalevo 75

Stalevo 75 is a medication used in the treatment of Parkinson's disease, combining carbidopa, levodopa, and entacapone. This combination aims to enhance the efficacy of levodopa by inhibiting the enzyme catechol-O-methyltransferase (COMT), which breaks down levodopa, thereby increasing its availability in the brain.

Clinical Trials Update

Completed Trials

A clinical trial with the EudraCT Number 2015-004507-23, sponsored by Orion Corporation, was completed and registered in the EU Clinical Trials Register. This trial, which began in 2016, was focused on various aspects of Stalevo and other related medications, but specific details on Stalevo 75 are not explicitly mentioned in the available summary[1].

General Clinical Profile

Stalevo, including the 75 mg formulation, has been studied extensively in clinical settings. The medication is known for its ability to stabilize patients on equivalent doses of carbidopa/levodopa and to add entacapone for enhanced therapeutic effect. Clinical experience has shown that Stalevo must be carefully titrated to determine the optimum daily dosage for each patient[4].

Safety and Efficacy Profile

Safety Considerations

Stalevo 75, like other formulations of Stalevo, comes with several safety considerations. It is contraindicated in patients with concomitant use of nonselective monoamine oxidase (MAO) inhibitors and narrow-angle glaucoma. Common side effects include falling asleep during activities, daytime drowsiness, syncope, hypotension, dyskinesia, and depression[4].

Efficacy

The efficacy of Stalevo 75 is well-documented. By inhibiting COMT, entacapone increases the plasma levels of levodopa, thereby enhancing its therapeutic effect. Clinical studies have shown that Stalevo can improve motor function and reduce the symptoms of Parkinson's disease in patients who have been stabilized on carbidopa/levodopa[4].

Market Analysis

Sales Performance

Historically, Stalevo, including the 75 mg formulation, has shown steady sales growth. In the first quarter of 2009, Orion Group reported that global in-market sales of Stalevo and related drugs continued to grow, albeit at a slower rate than before. The sales were part of a broader pharmaceutical portfolio that contributed significantly to Orion's net sales[2].

Market Forecast

A detailed market analysis by Research and Markets forecasted the sales of Stalevo for the top eight countries from 2012 to 2022. The report included a SWOT analysis and sales forecasts, indicating a stable market presence for Stalevo. While specific projections for Stalevo 75 are not isolated, the overall trend suggests a consistent demand for Parkinson's disease treatments, with Stalevo being a key player[5].

Competitive Landscape

The market for Parkinson's disease treatments is competitive, with several drugs available. Stalevo, however, holds a significant position due to its combination therapy, which offers a unique advantage over single-agent treatments. The competitive landscape includes other COMT inhibitors and dopamine agonists, but Stalevo's established brand and clinical efficacy maintain its market share[5].

Projections and Future Outlook

Sales Projections

Given the stable demand for Parkinson's disease treatments and the established market presence of Stalevo, sales projections for Stalevo 75 are likely to remain positive. The forecast from 2012 to 2022 indicated steady growth, and this trend is expected to continue as the global population ages and the incidence of Parkinson's disease increases[5].

Market Expansion

Orion Corporation's continued investment in research and development, as well as its global marketing efforts, are expected to support the growth of Stalevo 75. The company's ability to navigate patent litigations and maintain a strong product portfolio will be crucial in sustaining market share[2].

Key Takeaways

  • Clinical Trials: While specific trials on Stalevo 75 may not be extensively detailed, the medication is part of broader clinical studies on Parkinson's disease treatments.
  • Safety and Efficacy: Stalevo 75 is known for its safety profile and efficacy in managing Parkinson's disease symptoms.
  • Market Analysis: The drug has a stable market presence with consistent sales growth and a strong competitive position.
  • Projections: Sales projections indicate continued growth driven by increasing demand for Parkinson's disease treatments.

FAQs

What is Stalevo 75 used for?

Stalevo 75 is used in the treatment of Parkinson's disease, combining carbidopa, levodopa, and entacapone to enhance the efficacy of levodopa.

What are the common side effects of Stalevo 75?

Common side effects include falling asleep during activities, daytime drowsiness, syncope, hypotension, dyskinesia, and depression.

How does Stalevo 75 work?

Stalevo 75 works by inhibiting the enzyme catechol-O-methyltransferase (COMT), which breaks down levodopa, thereby increasing its availability in the brain.

What is the market outlook for Stalevo 75?

The market outlook is positive, with steady sales growth expected due to the increasing demand for Parkinson's disease treatments and the drug's established market presence.

Are there any contraindications for Stalevo 75?

Yes, Stalevo 75 is contraindicated in patients with concomitant use of nonselective monoamine oxidase (MAO) inhibitors and narrow-angle glaucoma.

How is Stalevo 75 dosed?

The optimum daily dosage of Stalevo 75 must be determined by careful titration in each patient, with the maximum recommended daily dose depending on the strength used.

Sources

  1. EU Clinical Trials Register: Clinical trials register entry for EudraCT Number 2015-004507-23.
  2. Orion Group Interim Report 1-3/2009: Financial and operational report for the first quarter of 2009.
  3. Newron Valuation Report 3JAN23: Valuation report for Newron Pharmaceuticals, including details on clinical trials.
  4. FDA Prescribing Information: Prescribing information for Stalevo tablets.
  5. Research and Markets: Market analysis and forecast for Stalevo/Comtan.

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