CLINICAL TRIALS PROFILE FOR STALEVO 50

505(b)(2) Clinical Trials for Stalevo 50

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 50

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 50

Condition Name

Condition Name for Stalevo 50
Intervention	Trials
Parkinson's Disease	11
Parkinson Disease	3
Idiopathic Parkinson's Disease	1
Parkinson´s Disease	1

Condition MeSH

Condition MeSH for Stalevo 50
Intervention	Trials
Parkinson Disease	16
Parasomnias	1
Narcolepsy	1
Disease	1

Clinical Trial Locations for Stalevo 50

Trials by Country

Trials by Country for Stalevo 50
Location	Trials
United States	37
Canada	11
Italy	11
Finland	8
United Kingdom	7

Trials by US State

Trials by US State for Stalevo 50
Location	Trials
Michigan	3
Florida	3
California	3
Ohio	2
Texas	2

Clinical Trial Progress for Stalevo 50

Clinical Trial Phase

Clinical Trial Phase for Stalevo 50
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	3
Phase 2	6

Clinical Trial Status

Clinical Trial Status for Stalevo 50
Clinical Trial Phase	Trials
Completed	13
Withdrawn	1
Not yet recruiting	1

Clinical Trial Sponsors for Stalevo 50

Sponsor Name

Sponsor Name for Stalevo 50
Sponsor	Trials
Orion Corporation, Orion Pharma	10
Novartis Pharmaceuticals	2
Impax Laboratories, LLC	1

Sponsor Type

Sponsor Type for Stalevo 50
Sponsor	Trials
Industry	16
Other	4

Stalevo 50: Clinical Trials, Market Analysis, and Projections

Introduction to Stalevo 50

Stalevo 50 is a medication used in the treatment of Parkinson's disease, particularly for patients experiencing end-of-dose wearing off. It is a combination of carbidopa, levodopa, and entacapone, which works to extend the period of action of levodopa, a key component in managing Parkinson's symptoms.

Clinical Trials Update

Current Studies

A prospective, multi-center, randomized open-label study with blinded raters is currently recruiting participants to evaluate the effects of immediate versus delayed switch to Stalevo® on motor function and quality of life in patients with Parkinson's disease who experience end-of-dose wearing off. This study, conducted by Novartis Pharmaceuticals Corporation, aims to assess the impact of Stalevo on motor symptoms and quality of life in these patients[1][3].

Inclusion and Exclusion Criteria

• Inclusion Criteria: Patients must be between 30-80 years old, clinically diagnosed with idiopathic Parkinson's disease, and experiencing end-of-dose wearing off. They must also be taking a stable dose of immediate release carbidopa/levodopa 25/100 mg for at least one month prior to the study.
• Exclusion Criteria: Patients with previous or current use of Comtan or Tasmar, a diagnosis of secondary or atypical parkinsonism, or unstable Parkinson's disease requiring booster doses or treatment with "when needed" dose regimens of levodopa are excluded. Specific carbidopa/levodopa doses and strengths are also not permitted[1][3].

Study Objectives

The primary objective of this study is to compare the effects of an immediate switch to Stalevo® versus a delayed switch on motor function and quality of life. This will help determine whether switching to Stalevo earlier can provide better symptom management and improve the overall quality of life for patients with Parkinson's disease.

Pharmacological Profile of Stalevo 50

Composition

Stalevo 50 contains 12.5 mg of carbidopa, 50 mg of levodopa, and 200 mg of entacapone. Carbidopa inhibits the enzyme dopa-decarboxylase, levodopa is a precursor to dopamine, and entacapone inhibits the enzyme catechol-O-methyltransferase (COMT), which helps extend the plasma half-life of levodopa[2][4].

Dosage Forms and Strengths

Stalevo is available in six different strengths, each with a fixed ratio of carbidopa to levodopa and a constant dose of entacapone. The strengths include Stalevo 50, 75, 100, 125, 150, and 200, each with corresponding doses of carbidopa, levodopa, and entacapone[2].

Market Analysis

Current Market Trends

The Parkinson's disease drug market has seen a slight decline in overall sales from $2.7 billion in 2010 to $2.6 billion in 2020, according to Decision Resources. This decline is partly due to the introduction of generic versions of key drugs[5].

Market Position of Stalevo 50

Despite the overall decline in the market, Stalevo 50 remains a significant player due to its efficacy in managing end-of-dose wearing off symptoms. Its unique combination of carbidopa, levodopa, and entacapone makes it a preferred option for many patients and healthcare providers.

Generic Availability

Stalevo 50 is available in generic form, which can impact its market share. However, the brand name version still maintains a strong presence due to its established reputation and clinical evidence supporting its effectiveness[4].

Projections for the Future

Market Growth

While the overall Parkinson's disease drug market is expected to remain relatively stable, there is potential for growth driven by increasing awareness and diagnosis of Parkinson's disease. New clinical trials and studies, such as the one currently recruiting, can further solidify Stalevo 50's position in the market.

Competitive Landscape

The introduction of new treatments and the expansion of existing ones will continue to shape the competitive landscape. Stalevo 50's ability to adapt to these changes and maintain its clinical superiority will be crucial for its continued market presence.

Patient Needs and Preferences

As patient needs and preferences evolve, there will be a greater emphasis on treatments that not only manage symptoms but also improve quality of life. Stalevo 50's impact on motor symptoms and quality of life, as demonstrated in clinical trials, positions it well to meet these evolving needs.

Key Takeaways

• Clinical Trials: Ongoing studies are evaluating the immediate versus delayed switch to Stalevo 50 in patients with Parkinson's disease experiencing end-of-dose wearing off.
• Pharmacological Profile: Stalevo 50 combines carbidopa, levodopa, and entacapone to extend the period of action of levodopa.
• Market Analysis: The Parkinson's disease drug market is stable but slightly declining, with Stalevo 50 maintaining a strong position due to its efficacy.
• Projections: Future growth is anticipated based on increasing diagnosis and awareness of Parkinson's disease, as well as the drug's ability to meet evolving patient needs.

FAQs

What is Stalevo 50 used for?

Stalevo 50 is used to treat Parkinson's disease, particularly for patients experiencing end-of-dose wearing off symptoms. It substitutes for equivalent doses of previously administered carbidopa/levodopa and entacapone[2][4].

What are the components of Stalevo 50?

Stalevo 50 contains 12.5 mg of carbidopa, 50 mg of levodopa, and 200 mg of entacapone[2][4].

Is Stalevo 50 available in generic form?

Yes, Stalevo 50 is available in generic form[4].

What is the current status of the clinical trial on Stalevo 50?

The clinical trial is currently recruiting participants to evaluate the effects of immediate versus delayed switch to Stalevo 50 on motor function and quality of life in patients with Parkinson's disease[1][3].

How does Stalevo 50 impact the quality of life for Parkinson's patients?

Stalevo 50 helps extend the period of action of levodopa, thereby reducing end-of-dose wearing off symptoms and improving motor function and overall quality of life for patients with Parkinson's disease[1][3].

What are the exclusion criteria for the Stalevo 50 clinical trial?

Patients with previous or current use of Comtan or Tasmar, a diagnosis of secondary or atypical parkinsonism, or unstable Parkinson's disease requiring booster doses or specific carbidopa/levodopa regimens are excluded[1][3].

Sources

1. Clinical Trials at Stanford Health Care: "A prospective, multi-center study to evaluate the effects of immediate versus delayed switch to Stalevo® on motor function and quality of life in patients with Parkinson's disease."
2. Guideline Central: "Stalevo - Drug Information from Guideline Central."
3. Stanford Health Care: "A prospective, multi-center study to evaluate the effects of immediate versus delayed switch to Stalevo® in patients with Parkinson's disease."
4. eMPR: "STALEVO 50 Prescription & Dosage Information - MPR - eMPR.com."
5. FiercePharma: "Through 2020, Growth in the Parkinson's Disease Drug Market Will Be Constrained by Generic Competition."