CLINICAL TRIALS PROFILE FOR STALEVO 100

505(b)(2) Clinical Trials for STALEVO 100

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 100

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 100

Condition Name

Condition Name for STALEVO 100
Intervention	Trials
Parkinson's Disease	11
Parkinson Disease	4
Idiopathic Parkinson's Disease	1
Multi-system Atrophy - Parkinsonian Type	1

Condition MeSH

Condition MeSH for STALEVO 100
Intervention	Trials
Parkinson Disease	17
Shy-Drager Syndrome	1
Sleep Wake Disorders	1
Parasomnias	1

Clinical Trial Locations for STALEVO 100

Trials by Country

Trials by Country for STALEVO 100
Location	Trials
United States	37
Italy	11
Canada	11
Finland	8
United Kingdom	7

Trials by US State

Trials by US State for STALEVO 100
Location	Trials
Michigan	3
Florida	3
California	3
Virginia	2
Ohio	2

Clinical Trial Progress for STALEVO 100

Clinical Trial Phase

Clinical Trial Phase for STALEVO 100
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	4
Phase 3	3

Clinical Trial Status

Clinical Trial Status for STALEVO 100
Clinical Trial Phase	Trials
Completed	13
Terminated	1
Unknown status	1

Clinical Trial Sponsors for STALEVO 100

Sponsor Name

Sponsor Name for STALEVO 100
Sponsor	Trials
Orion Corporation, Orion Pharma	10
Novartis Pharmaceuticals	2
Novartis	1

Sponsor Type

Sponsor Type for STALEVO 100
Sponsor	Trials
Industry	16
Other	5

Clinical Trials Update, Market Analysis, and Projection for Stalevo 100

Last updated: October 31, 2025

Introduction

Stalevo 100, a pharmaceutical formulation combining levodopa, carbidopa, and entacapone, serves as a cornerstone therapy for Parkinson’s disease management. As a fixed-dose combination, its clinical efficacy and market positioning hinge on ongoing research, regulatory status, and competitive landscape. This article provides a detailed update on clinical trials, examines current market dynamics, and offers future projections, equipping stakeholders with insights to inform strategic decisions.

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Clinical Trials Landscape for Stalevo 100

Current Status of Clinical Research

Stalevo 100 has been a staple in Parkinson’s management since its approval, designed to optimize dopaminergic therapy. The core active ingredients—levodopa, carbidopa, and entacapone—are well-established. However, ongoing clinical trials aim to refine its usage parameters, assess long-term safety, and explore novel therapeutic combinations.

As of late 2022, clinicaltrials.gov lists no active studies explicitly targeting Stalevo 100. Existing trials predominantly focus on generics or expanded indications such as treatment of motor fluctuations and non-motor symptoms. For instance, some recent studies examine the efficacy of extended-release formulations and nanotechnology-based delivery systems aiming to improve bioavailability and reduce dyskinesia.

Key Clinical Trials and Initiatives

• Long-term Safety and Efficacy: Multiple observational studies continue evaluating the sustained neuroprotective potential of levodopa-based therapies. While not specific to Stalevo 100, these impact prescribing patterns.

• Combination Therapy Trials: Novel combinations with other dopaminergic agents or adjuvants are under early-stage investigation. These could influence future formulations incorporating elements of Stalevo 100.

• Genetic and Biomarker Studies: Research into patient-specific responses may lead to more personalized therapeutic options, potentially affecting the demand for fixed-dose combinations versus monotherapies.

Regulatory and Reformulation Considerations

The absence of active pivotal trials points to a mature product profile, with regulatory bodies generally undertaking post-market surveillance rather than new approvals. Pending patent expirations and the emergence of generics have shifted focus toward bioequivalence and manufacturing efficiency rather than new clinical trials.

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Market Analysis of Stalevo 100

Market Size and Segmentation

The global Parkinson’s disease treatment market was valued at approximately USD 4.3 billion in 2021 and is projected to grow at a CAGR of 6-8% through 2030 [1]. Stalevo 100, as a branded formulation, holds a significant share within combination therapies, especially in markets where clinical familiarity and physician preference sustain its usage.

Geographical distribution:

• North America: Largest market, driven by high disease prevalence, advanced healthcare infrastructure, and strong regulatory frameworks.
• Europe: Second-largest, with expanding access and reimbursement policies.
• Asia-Pacific: Rapid growth owing to increasing awareness, local manufacturing, and rising prevalence.

Competitive Landscape

Stalevo 100 faces competition from:

• Generic formulations of levodopa/carbidopa/entacapone, providing cost-effective options.
• Alternative delivery systems: Extended-release and novel drug delivery platforms aim to optimize symptom control.
• Other combination drugs: Duodopa (levodopa-carbidopa intestinal gel) and novel agents like opicapone.

Major pharmaceutical players include Meiji Seika Pharma, Boehringer Ingelheim, and Sun Pharmaceutical, which produce generic equivalents or similar combination therapies.

Pricing and Reimbursement Trends

Pricing strategies for Stalevo 100 vary globally. In developed markets, reimbursement policies favor branded drugs owing to perceived quality and safety profiles, sustaining higher margins. Conversely, in emerging markets, price sensitivity prompts shift toward generics.

Reimbursement dynamics are influenced by:

• Cost-effectiveness evaluations.
• Physician prescribing habits.
• Patient access programs facilitating broader utilization.

Market Challenges and Opportunities

Challenges:

• Patent expirations threaten revenue streams.
• Growing preference for affordable generics.
• Competitive innovations in drug delivery mechanisms.

Opportunities:

• Expansion into emerging markets.
• Developing extended-release formulations.
• Potential for combination with disease-modifying agents as research evolves.

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Market Projection and Future Outlook

Short- to Mid-term Forecast (Next 5 Years)

In light of patent expirations and generic proliferation, revenue for Stalevo 100 is expected to decline modestly, with a forecasted compound annual decline rate of 3-5% in mature markets. However, continued demand persists, driven by prescriber familiarity and efficacy.

Moreover, increased adoption in countries with expanding healthcare infrastructure maintains steady growth, especially in Asia-Pacific, where Parkinson’s prevalence is increasing at approximately 5.2% annually [2].

Long-term Outlook (Beyond 5 Years)

The future of Stalevo 100 hinges on:

• Innovative formulations: Extended-release versions could enhance compliance, potentially revitalizing market interest.
• Personalized medicine: Biomarker-driven strategies may redefine treatment algorithms, possibly reducing reliance on fixed-dose combinations.
• New therapeutic paradigms: As disease-modifying therapies emerge, the role of symptomatic treatments like Stalevo 100 may evolve.

Given these factors, the overall market share is projected to decline gradually; however, the drug's entrenched clinical role assures continued relevance, especially in resource-limited settings.

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Key Takeaways

• Clinical Trials: No current pivotal trials specifically target Stalevo 100; ongoing research focuses on broader dopamine therapies and delivery innovations that could influence its future form.

• Market Dynamics: The global Parkinson’s market remains robust with steady growth, though Stalevo 100 faces intensified competition from generics and alternative formulations.

• Revenue Outlook: Patent expirations and market maturation predict a gradual decline in sales, mitigated by emerging markets and potential reformulations.

• Strategic Positioning: To maintain relevance, stakeholders should explore product extensions, such as extended-release versions, and consider positioning in emerging markets where demand continues to grow.

• Regulatory Environment: Favorable policies and reimbursement frameworks in developed economies support continued usage, though cost pressures necessitate innovation and diversification.

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FAQs

1. What is the current regulatory status of Stalevo 100?
Stalevo 100 is approved in multiple markets for Parkinson’s disease treatment and is classified as a prescription drug. Its patent protections have largely expired, resulting in generic availability, with ongoing post-market monitoring.

2. Are there any recent clinical indications that could expand Stalevo 100’s use?
Currently, no new indications are approved. Research continues into adjunct therapies and delivery systems, but these are not yet incorporated into standard treatment guidelines.

3. How does the competition impact Stalevo 100’s market share?
The rise of generic formulations and alternative delivery mechanisms suppress branded sales. Physicians often prefer cost-effective generics, especially in price-sensitive markets, although brand loyalty persists in certain regions.

4. What future innovations could influence Stalevo 100’s market?
Extended-release formulations, novel delivery systems, and personalized treatment strategies have the potential to sustain or expand its market share. Research into neuroprotective agents may also impact its role as a symptomatic therapy.

5. Is there potential for Stalevo 100 to be included in combination regimens for disease-modifying therapies?
While currently focused on symptomatic control, future research into disease-modifying agents may influence combination strategies, but such developments are speculative at this stage.

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References

1. Research and Markets. "Global Parkinson's Disease Market Analysis." 2021.
2. World Health Organization. "Neurological Disorders: Public Health Challenges." 2022.