CLINICAL TRIALS PROFILE FOR STALEVO 125

505(b)(2) Clinical Trials for Stalevo 125

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.

All Clinical Trials for Stalevo 125

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.
NCT00134966 ↗	A Study to Evaluate Fixed Dose Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa	Completed	Novartis	Phase 3	2005-08-01	The purpose of this study is to achieve approval for the use of carbidopa/levodopa/entacapone in early Parkinson's disease (PD) by demonstrating that when used as initial levodopa therapy in early PD, carbidopa/levodopa/entacapone provides significantly greater symptomatic benefit than immediate release carbidopa/levodopa administered at the same levodopa dosage level of 100 mg three times a day (t.i.d.).
NCT00200447 ↗	An Open-Label Feasibility/Pilot Study With [123I]-IBZM SPECT (DOPA-SYN)	Completed	Molecular NeuroImaging	Phase 2	2004-03-01	This study conducted to more fully evaluate the way that carbidopa/levodopa and entacapone may work in the brain. This research study uses [123I]-IBZM and dynamic SPECT imaging to determine the amount and the duration of dopamine release from specific regions in the brain after treatment with either the combination of carbidopa/levodopa or the combination of carbidopa/levodopa/entacapone.
NCT00462007 ↗	Study to Evaluate Initiation of Stalevo in Early Wearing-off	Completed	Orion Corporation, Orion Pharma	Phase 4	2006-09-01	An open, non-randomised, multinational, multicentre direct switch study in levodopa-treated Parkinson's disease patients suffering from early wearing-off in Parkinson's disease. The study will consist of 2 consecutive periods: screening period and study treatment period. Duration of the study will be up to 8 weeks for each subject. The study treatment dosage will be determined by the subject's current, separately administered standard levodopa/DDCI treatment (3-4 doses per day, maximum of total daily dose of 600 mg levodopa) which will be switched to an equivalent dose of Stalevo® without changing the number of doses per day. The levodopa daily dose during Stalevo® treatment may be adjusted according to the study subject's clinical response.
NCT00562198 ↗	PET-Study: Effects of Single Doses of Stalevo and Levodopa/Carbidopa on Striatal 11C-Raclopride Binding	Terminated	Orion Corporation, Orion Pharma	Phase 2	2008-01-01	This is an open, randomised, active-controlled, 2-period crossover study comparing the effect of single doses of Stalevo 200 and Sinemet on striatal (putamenal and caudate) 11C-raclopride BP in PD patients with wearing-off symptoms. The study consists of 4 visits: a screening visit (visit 1), 2 treatment periods (period 1=visit 2, period 2=visit 3) separated by a minimum wash-out period of at least 3 days, and an end-of-study visit (visit 4). Subjects will be randomly allocated to start the period 1 with a single dose of Stalevo 200 or Sinemet. After the wash-out the study drug on period 2 will be administered according to a crossover design.

Clinical Trial Conditions for Stalevo 125

Condition Name

Condition Name for Stalevo 125
Intervention	Trials
Parkinson's Disease	11
Parkinson Disease	3
Idiopathic Parkinson's Disease	1
Parkinson´s Disease	1

Condition MeSH

Condition MeSH for Stalevo 125
Intervention	Trials
Parkinson Disease	16
Disease	1
Sleep Wake Disorders	1
Parasomnias	1

Clinical Trial Locations for Stalevo 125

Trials by Country

Trials by Country for Stalevo 125
Location	Trials
United States	37
Canada	11
Italy	11
Finland	8
United Kingdom	7

Trials by US State

Trials by US State for Stalevo 125
Location	Trials
Florida	3
California	3
Michigan	3
Arizona	2
Virginia	2

Clinical Trial Progress for Stalevo 125

Clinical Trial Phase

Clinical Trial Phase for Stalevo 125
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	3
Phase 2	6

Clinical Trial Status

Clinical Trial Status for Stalevo 125
Clinical Trial Phase	Trials
Completed	13
Terminated	1
Unknown status	1

Clinical Trial Sponsors for Stalevo 125

Sponsor Name

Sponsor Name for Stalevo 125
Sponsor	Trials
Orion Corporation, Orion Pharma	10
Novartis Pharmaceuticals	2
Second Affiliated Hospital, School of Medicine, Zhejiang University	1

Sponsor Type

Sponsor Type for Stalevo 125
Sponsor	Trials
Industry	16
Other	4

Stalevo 125: Clinical Trials, Market Analysis, and Projections

Introduction

Stalevo 125, a combination drug consisting of carbidopa, levodopa, and entacapone, is widely used in the management of idiopathic Parkinson's disease. This article will delve into the clinical trials, market analysis, and projections for Stalevo 125, providing a comprehensive overview of its role in Parkinson's disease treatment.

Clinical Trials and Efficacy

Background and Mechanism

Stalevo 125 works by combining a dopa-decarboxylase inhibitor (carbidopa), a dopamine precursor (levodopa), and a catechol-O-methyltransferase (COMT) inhibitor (entacapone). This combination enhances the bioavailability of levodopa, thereby improving the management of Parkinson's disease symptoms[4].

Clinical Studies

Clinical trials for Stalevo have primarily focused on its efficacy and safety in patients with Parkinson's disease. These studies have shown that Stalevo can effectively substitute for equivalent doses of carbidopa/levodopa and entacapone, and it is particularly beneficial for patients experiencing end-of-dose "wearing-off" symptoms[1][4].

Safety Profile

The safety profile of Stalevo 125 includes potential side effects such as falling asleep during activities, daytime drowsiness, somnolence, syncope, hypotension, dyskinesia, and depression. It is contraindicated in patients taking nonselective monoamine oxidase inhibitors (MAOIs) and those with narrow-angle glaucoma[1][4].

Market Analysis

Market Overview

The market for Parkinson's disease treatments is significant and growing, driven by the increasing prevalence of the disease. Stalevo, including the 125mg formulation, is a key player in this market.

Sales Forecast

Historical sales forecasts for Stalevo have been positive, with the drug performing well in major markets such as the US, France, Germany, Italy, Spain, the UK, Japan, and Brazil. From 2012 to 2022, Stalevo showed steady sales growth, reflecting its established position in the treatment of Parkinson's disease[2].

Competitive Landscape

The Parkinson's disease treatment market is competitive, with several drugs available. However, Stalevo's unique combination of carbidopa, levodopa, and entacapone gives it a distinct advantage. The drug's ability to manage end-of-dose "wearing-off" symptoms makes it a preferred choice for many patients and healthcare providers[2].

Market Projections

Future Outlook

Given the ongoing need for effective Parkinson's disease treatments, Stalevo 125 is expected to continue playing a significant role in the market. As the population ages and the incidence of Parkinson's disease increases, the demand for drugs like Stalevo is likely to rise.

Generic Availability

The availability of generic versions of Stalevo 125 is expected to impact the market dynamics. Generic formulations, priced lower than the brand name, can increase accessibility but may also affect the sales of the branded version. For example, the generic version of Stalevo 125 is available at a significantly lower price point, around $169.45 for 100 tablets, compared to the branded version which can cost around $815 for the same quantity[5].

Pricing and Accessibility

Cost Considerations

The cost of Stalevo 125 can be a significant factor for patients. The branded version is expensive, with a 100-tablet supply costing around $815. However, the generic version offers a more affordable option, making the treatment more accessible to a wider range of patients[5].

Patient Assistance Programs

To improve accessibility, various patient assistance programs and discount cards are available. For instance, the Drugs.com Discount Card can save patients up to 80% on prescription medicines, including Stalevo 125[5].

Regulatory Considerations

Approval and Labeling

Stalevo 125 has been approved for use in patients with idiopathic Parkinson's disease, specifically to substitute for equivalent doses of carbidopa/levodopa and entacapone, and to replace immediate-release carbidopa and levodopa in patients experiencing end-of-dose "wearing-off" symptoms[1][4].

Dosage and Administration

The dosage of Stalevo 125 must be carefully individualized and adjusted according to the desired therapeutic response. The maximum recommended daily dose varies by the strength of the tablet, with a maximum of 8 tablets per day for Stalevo 125 and other lower strengths, and a maximum of 6 tablets per day for the highest strength, Stalevo 200[1][4].

Conclusion

Stalevo 125 remains a crucial treatment option for patients with idiopathic Parkinson's disease. Its efficacy in managing symptoms, particularly end-of-dose "wearing-off," and its safety profile, albeit with some cautionary notes, make it a preferred choice. The market for Stalevo 125 is expected to continue growing, driven by the increasing prevalence of Parkinson's disease and the availability of generic formulations.

Key Takeaways

• Efficacy: Stalevo 125 is effective in managing Parkinson's disease symptoms, especially end-of-dose "wearing-off" symptoms.
• Safety Profile: The drug has a notable safety profile, including potential side effects like somnolence and dyskinesia.
• Market Performance: Stalevo has shown steady sales growth in major markets.
• Generic Availability: Generic versions are available, making the treatment more accessible.
• Regulatory Status: Approved for use in idiopathic Parkinson's disease with specific dosing guidelines.

FAQs

Q: What is the primary use of Stalevo 125?

A: Stalevo 125 is used to substitute for equivalent doses of carbidopa/levodopa and entacapone in patients with idiopathic Parkinson's disease, particularly those experiencing end-of-dose "wearing-off" symptoms.

Q: What are the potential side effects of Stalevo 125?

A: Potential side effects include falling asleep during activities, daytime drowsiness, somnolence, syncope, hypotension, dyskinesia, and depression.

Q: Can Stalevo 125 be used in patients taking nonselective MAOIs?

A: No, Stalevo 125 is contraindicated in patients taking nonselective monoamine oxidase inhibitors (MAOIs) and those with narrow-angle glaucoma.

Q: How does the generic version of Stalevo 125 compare in price to the branded version?

A: The generic version of Stalevo 125 is significantly cheaper, costing around $169.45 for 100 tablets, compared to the branded version which costs around $815 for the same quantity.

Q: Are there any patient assistance programs available for Stalevo 125?

A: Yes, various patient assistance programs and discount cards, such as the Drugs.com Discount Card, can help reduce the cost of Stalevo 125.

Sources

1. FDA Prescribing Information: Stalevo tablets prescribing information. Accessed January 2025.
2. Research and Markets: Orion's Stalevo/Comtan (Parkinson's Disease) - Forecast and Market Analysis to 2022. Accessed January 2025.
3. Newron Valuation Report: vL Newron Valuation Report 3JAN23. Accessed January 2025.
4. eMPR: Stalevo 125 Prescription & Dosage Information. Accessed January 2025.
5. Drugs.com: Stalevo 125 Prices, Coupons, Copay Cards & Patient Assistance. Accessed January 2025.