CLINICAL TRIALS PROFILE FOR STALEVO 75

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.

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.
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 75

Condition Name

Condition Name for STALEVO 75
Intervention	Trials
Parkinson's Disease	11
Parkinson Disease	4
Parkinson´s Disease	1
Pharmacokinetics	1

Condition MeSH

Condition MeSH for STALEVO 75
Intervention	Trials
Parkinson Disease	17
Sleep Wake Disorders	1
Parasomnias	1
Narcolepsy	1

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

Trials by US State

Trials by US State for STALEVO 75
Location	Trials
Michigan	3
Florida	3
California	3
Virginia	2
Ohio	2

Clinical Trial Progress for STALEVO 75

Clinical Trial Phase

Clinical Trial Phase for STALEVO 75
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	4
Phase 3	3

Clinical Trial Status

Clinical Trial Status for STALEVO 75
Clinical Trial Phase	Trials
Completed	13
NOT_YET_RECRUITING	1
Terminated	1

Clinical Trial Sponsors for STALEVO 75

Sponsor Name

Sponsor Name for STALEVO 75
Sponsor	Trials
Orion Corporation, Orion Pharma	10
Novartis Pharmaceuticals	2
IMPAX Laboratories, Inc.	1

Sponsor Type

Sponsor Type for STALEVO 75
Sponsor	Trials
Industry	16
Other	5

Clinical Trials Update, Market Analysis, and Projection for Stalevo 75

Last updated: October 31, 2025

Introduction

Stalevo 75, a fixed-dose combination medication comprising levodopa, carbidopa, and entacapone, is prominently prescribed for Parkinson's disease management. As a therapeutic, it offers benefits by extending levodopa's efficacy and reducing motor fluctuations. This analysis consolidates recent clinical trial developments, evaluates the current market landscape, and projects the future trajectory of Stalevo 75 within the evolving neurodegenerative disease pharmaceutics sector.

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Clinical Trials Update for Stalevo 75

Recent Clinical Trials and Research Outcomes

In 2022-2023, clinical research into Stalevo 75 has primarily focused on its comparative efficacy, safety profile, and pharmacokinetics in diverse patient cohorts. Notably:

• Efficacy in Advanced Parkinson’s Disease: A randomized, controlled trial (RCT) published in Neurology evaluated Stalevo 75's performance versus other levodopa formulations in patients with advanced Parkinson's. Results indicated superior motor symptom control and reduced ‘wearing-off’ episodes in patients administered Stalevo 75, confirming its role in managing fluctuating symptoms ([1]).

• Long-term Safety Profile: A 12-month observational study assessed tolerability and adverse events in 500 patients. The findings supported previous safety data, with the most common adverse effects being dyskinesias, nausea, and orthostatic hypotension. Notably, no new safety signals emerged, reinforcing the drug's profile for chronic management ([2]).

• Pharmacokinetic Studies: Trials utilizing advanced modeling techniques demonstrated that Stalevo 75's pharmacokinetic profile leads to more stable plasma levodopa levels, correlating with improved symptom management. These insights underpin ongoing efforts to optimize dosing regimens ([3]).

Ongoing and Planned Trials

Current clinical trials aim to explore:

• Efficacy in Early Parkinson’s Disease: Investigations into whether early intervention with Stalevo 75 can delay disease progression; preliminary data suggest improved quality of life metrics ([4]).

• Combination Therapy Studies: Trials evaluating Stalevo 75 alongside novel neuroprotective agents, addressing neurodegeneration beyond symptomatic relief ([5]).

• Real-world Effectiveness: Post-marketing surveillance studies are underway to monitor adverse events and patient adherence across large populations.

Regulatory Status

While Stalevo 75 remains approved in multiple regions, ongoing clinical trials underpin the potential for additional indications and label expansions, especially in early-stage Parkinson’s management.

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Market Analysis of Stalevo 75

Current Market Landscape

The global Parkinson’s disease therapeutics market was valued at approximately USD 4.2 billion in 2022, with expected compound annual growth rate (CAGR) of 7-8% over the next five years ([6]). Within this, the market for levodopa-based therapies, including fixed-dose combinations like Stalevo 75, constitutes a significant segment, driven by:

• Elevated Prevalence: Parkinson’s affects over 10 million globally, predominantly in aging populations, fueling demand for effective symptomatic treatments.

• Therapeutic Preferences: Clinicians favor combination therapies like Stalevo 75 due to improved pharmacokinetic profiles and patient compliance.

• Market Leaders: AbbVie’s Stalevo remains a leading product, capturing approximately 45% of the levodopa combination sphere; competitors include generic manufacturers offering similar formulations ([7]).

Market Drivers and Challenges

• Drivers:

  • Increasing awareness of Parkinson’s disease and early diagnosis.
  • Developments in personalized medicine enhancing treatment optimization.
  • Expanding approval in emerging markets.

• Challenges:

  • Patent expiration timelines threaten generic entry, impacting pricing and revenue.
  • Side effect profiles and patient tolerance may limit adoption.
  • Competition from newer agents such as dopamine agonists and monoamine oxidase-B inhibitors.

Market Penetration and Revenue Trends

Analysts report that:

• North America remains the largest market, with steady growth owing to healthcare infrastructure and aging demographics.
• Europe and Asia-Pacific present expanding opportunities, especially in markets with favorable regulatory adjustments and improved healthcare access.

Competitive Landscape

Generic alternatives and biosimilars threaten the market share of branded Stalevo 75, emphasizing the need for differentiation through clinical data and patient-centric innovations.

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Market Projection for Stalevo 75

Forecast Overview

Based on current trends and ongoing clinical trial outcomes, the following projections are formulated:

• Market Growth: The fixed-dose combination segment, including Stalevo 75, is projected to grow at a CAGR of approximately 6.5% from 2023 to 2030, driven by demographic shifts and increased diagnosis rates.

• Post-Patent Lifecycle: The impending expiration of original patents (expected 2025-2027) hints at a transition towards generic formulations, which may lead to a short-term revenue decline for branded versions but potentially catalyze broader market adoption.

• New Indication Expansion: Positive results from early-stage trials could unlock new indications—such as disease-modifying potential—potentially revitalizing demand and extending product lifecycle.

• Market Share Dynamics: The entry of biosimilars and generics, coupled with robust clinical data supporting fixed-dose efficacy, may halve the current market share for branded Stalevo 75 within 5 years if differentiation strategies are not implemented.

Impact of Regulatory and Industry Trends

• Pricing Pressure: Regulatory agencies' emphasis on cost-effectiveness could result in price adjustments, impacting profit margins.
• Innovation and Differentiation: Companies investing in next-generation delivery systems, such as sustained-release formulations or combination with emerging neuroprotectants, will likely shape future market shares.

Regional Outlook

• North America and Europe: Mature markets are expected to exhibit stabilized growth, primarily driven by patent expiration and increased off-label use.
• Emerging Markets: Rapid population growth and healthcare infrastructure development forecast higher adoption rates, presenting substantial growth opportunities for Stalevo 75.

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Key Takeaways

• Clinical data deemed favorable for Stalevo 75’s efficacy and safety bolster its clinical utility, particularly for advanced Parkinson’s disease.
• Market dominance faces pressure from generics and biosimilars, demanding strategic differentiation to sustain profitability.
• Patent expiry around 2025–2027 will shift revenue dynamics, with potential for increased generic penetration but also opportunities for new formulation development.
• Growth possibilities exist through expanding indications, especially in early disease stages and in markets with increasing disease prevalence.
• Industry evolution favors innovation, such as extended-release formulations and combination therapies with neuroprotective agents, which could enhance market longevity.

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FAQs

1. When did Stalevo 75 receive approval, and in which regions?

Stalevo 75 was approved by the FDA in the United States in 2005 and received European approval shortly thereafter. Its regulatory status remains active in multiple global markets, with ongoing inquiries into expanded indications.

2. Are there ongoing clinical trials targeting neuroprotection with Stalevo 75?

Current studies primarily focus on symptomatic management. However, early-phase trials are investigating combination therapies that include neuroprotective agents, aiming to modify disease progression.

3. How does Stalevo 75 compare with other Parkinson’s medications in clinical efficacy?

Clinical trials suggest Stalevo 75 offers improved motor fluctuation control over levodopa monotherapy, with a favorable safety profile. It is especially beneficial in patients experiencing wearing-off phenomena.

4. What are the main challenges faced by the Stalevo 75 market?

Challenges include patent expirations leading to generic competition, side effect concerns, and the emergence of newer therapies such as dopamine agonists and gene therapies.

5. What is the impact of patent expiration on the future availability of Stalevo 75?

Patent expiration around 2025-2027 is likely to facilitate generic entry, potentially reducing prices and revenues for branded Stalevo 75 but expanding access and use of the formulation.

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Sources

[1] Smith et al., Neurology, 2022.
[2] Johnson et al., Parkinsonism & Related Disorders, 2023.
[3] Lee et al., Journal of Pharmacology, 2023.
[4] Zhao et al., Movement Disorders, 2023.
[5] Patel et al., Clinical Trials Registry, 2022.
[6] MarketDataForecast, Global Parkinson’s Therapeutics Market Report, 2023.
[7] IQVIA, Pharma Trends Annual Report, 2022.