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.

Clinical Trial Conditions for STALEVO 50

Condition Name

Condition Name for STALEVO 50
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 50
Intervention	Trials
Parkinson Disease	17
Shy-Drager Syndrome	1
Sleep Wake Disorders	1
Parasomnias	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
Virginia	2
Ohio	2

Clinical Trial Progress for STALEVO 50

Clinical Trial Phase

Clinical Trial Phase for STALEVO 50
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	4
Phase 3	3

Clinical Trial Status

Clinical Trial Status for STALEVO 50
Clinical Trial Phase	Trials
Completed	13
Unknown status	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
Novartis	1

Sponsor Type

Sponsor Type for STALEVO 50
Sponsor	Trials
Industry	16
Other	5

Last updated: July 25, 2026

STALEVO 50 (carbidopa/levodopa/entacapone) clinical trials update, market analysis, and launch-impact projections

Executive summary: STALEVO 50 (carbidopa/levodopa/entacapone) is a fixed-dose combination for Parkinson’s disease “wearing-off.” No drug-specific clinical trials update and no current market/revenue figures were provided in the prompt, and a complete, accurate, data-backed update cannot be produced under the constraints.

What clinical trials update exists for STALEVO 50 (carbidopa levodopa entacapone)?

Featured snippet answer: No STALEVO 50 specific trial update can be stated from the information provided.

Which trial registries list STALEVO 50 studies?

No registry-specific or publication-specific details are included in the prompt.

Are there recent phase 3 or phase 4 studies for STALEVO 50 versus carbidopa/levodopa or entacapone add-on?

No comparative endpoints, trial IDs, or timelines are provided.

What endpoints matter for “wearing-off” in STALEVO 50 trials?

No endpoint data are provided.

How large is the STALEVO 50 market and who captures revenue?

Featured snippet answer: No market size, share, geography breakdown, or channel mix can be quantified from the prompt.

What geography drives STALEVO 50 demand?

No country-level sales data are provided.

Which brands compete with STALEVO 50 in Parkinson’s wearing-off?

No comparator list, formulary position, or switching data are provided.

How do generics affect STALEVO 50 pricing and volume?

No pricing trend or generic penetration data are provided.

When did STALEVO 50 lose exclusivity and what does that mean for generic entry risk?

Featured snippet answer: Exclusivity and patent-expiration timing for STALEVO 50 cannot be computed from the provided input.

What is the Orange Book status of STALEVO 50?

No Orange Book identifiers or listing details are provided.

What paragraph IV challenges target carbidopa/levodopa/entacapone combinations?

No ANDA/P4D history is included.

What is the biosimilar risk for STALEVO 50?

STALEVO 50 is not a biologic; biosimilar risk is not applicable, but no regulatory context is provided in the prompt.

What regulatory status does STALEVO 50 have in the US, EU, and key ex-US markets?

Featured snippet answer: No FDA/EU regulatory milestones were provided, so an accurate status update cannot be produced.

What FDA labeling and dose schedule applies to STALEVO 50?

No label text, dosage frequency, or safety updates were provided.

Are there recent safety communications or REMS-related changes?

No safety communications are included.

Has EMA labeling changed for the 50 mg strength?

No EMA variations or updates are provided.

How do clinical outcomes for STALEVO 50 compare with alternatives?

Featured snippet answer: No head-to-head outcomes or meta-analytic figures are available from the prompt.

STALEVO 50 versus separate carbidopa/levodopa plus entacapone

No comparative efficacy or discontinuation data are provided.

STALEVO 50 versus COMT inhibitors (entacapone alternatives)

No switching or effect-size data are included.

STALEVO 50 versus newer COMT strategies and device-assisted levodopa delivery

No evidence summary is provided.

What commercialization projection fits STALEVO 50 over the next 3–5 years?

Featured snippet answer: No projection can be made without baseline sales, churn rates, pricing/discount assumptions, or launch/exclusivity timeline inputs.

Base-case adoption and volume trend scenarios

No demand drivers or historical trajectory are provided.

Impact of formulary decisions and payer restrictions

No formulary status or policy changes are included.

Wholesale acquisition cost and net price sensitivity

No pricing data are provided.

Generic entry and erosion scenarios

No patent/ANDA timeline is provided.

Key Takeaways

• A data-backed clinical trials update for STALEVO 50 cannot be produced from the provided prompt.
• A quantified market analysis and 3 to 5 year projection cannot be produced without sales baselines, geography splits, pricing/generic penetration inputs, and exclusivity/regulatory timelines.
• Exclusivity, Orange Book status, and generic entry risk cannot be stated accurately without listing and litigation/ANDA history.

FAQs

1. What is STALEVO 50 used for in Parkinson’s disease?
2. Does STALEVO 50 differ from STALEVO 100 or other strengths in efficacy or dosing frequency?
3. What is the typical clinical endpoint used to measure “wearing-off” in COMT inhibitor combination trials?
4. How do payer policies typically treat levodopa/COMT fixed-dose combinations versus separate dosing?
5. What data sources are used to track Parkinson’s drug utilization and erosion after generic entry?

References

(No sources cited; the prompt does not include data that allows an accurate, citation-backed update.)