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Last Updated: April 25, 2025

CLINICAL TRIALS PROFILE FOR SINEMET CR


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505(b)(2) Clinical Trials for Sinemet Cr

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 Formulation NCT00363727 ↗ Onset Motor Complications Using REQUIP CR (Ropinirole Controlled-release) As Add-on Therapy To L-dopa In Parkinson's Completed GlaxoSmithKline Phase 3 2003-12-01 This study evaluates how effective a new formulation of a marketed drug is in increasing the time to onset of dyskinesia (abnormal twisting, writhing movements) in patients with Parkinson's Disease who have been taking levodopa for less than 2 years.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Sinemet Cr

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00004576 ↗ Study of LY300164 for the Treatment of Parkinson's Disease Completed National Institute of Neurological Disorders and Stroke (NINDS) Phase 2 2000-02-01 This study will test the effectiveness of an experimental drug called LY300164 on improving Parkinson's disease symptoms, such as movement impairments and tremor, as well as involuntary movements produced by long-term treatment with levodopa. Patients with relatively advanced (Stage II to IV) Parkinson's disease between 30 and 75 years of age may be eligible for this 8-week study. Participants will have a complete medical history and physical examination, including blood tests and an electrocardiogram, and possibly brain magnetic resonance imaging (MRI), CT scan, and chest X-ray. Patients will stop taking all anti-parkinsonism medications except levodopa (Sinemet) and the experimental drug during the study. For the first 1 to 3 days, patients will be in the hospital for a levodopa "dose-finding" procedure. For this study, levodopa is infused through a vein for up to 8 hours, with symptoms monitored frequently to determine the doses that will produce two results: 1) the dose that is less than what is needed to relieve symptoms, and 2) the dose that relieves symptoms, but may produce dyskinesias. When these dose rates are determined, patients will begin treatment in one of two groups. One will take LY300164 3 times a day, along with levodopa, for 3 weeks. The second group will take placebo tablets (a look-alike tablet with no active ingredient) and levodopa on the same schedule as the LY300164 group. A brief medical examination and routine blood and urine tests will be done weekly. The drug dose will be increased every 3 to 4 days until significant side effects occur or the maximal dose is reached. Patients will be closely monitored for 4 hours after every increase. At the end of the 3 weeks, or when the maximal dose is reached, patients will be readmitted to the hospital for 2 to 3 days for a second levodopa dose-finding study, while continuing on LY300164 or placebo. After this test, patients will resume taking levodopa and the experimental drug or placebo as before for another 2 weeks. At the end of the 2-weeks, the entire procedure will be repeated in both groups, but the treatments will be switched-that is, the patients who were taking LY300164 will now take placebo, and the patients who took placebo will now take the drug. At the end of the second 3 weeks, the levodopa infusion procedure will be repeated once more. Throughout the study, parkinsonism symptoms and dyskinesias will be evaluated and blood samples will be drawn periodically to measure drug levels.
NCT00004733 ↗ Timing of Levodopa Treatment in Parkinson's Disease Completed National Institute of Neurological Disorders and Stroke (NINDS) Phase 3 1998-01-01 The ELLDOPA study is a controlled clinical trial in patients with newly diagnosed PD to determine the optimal timing and dosing with levodopa (Sinemet or its generic equivalents).
NCT00006077 ↗ Effects of Monoamine Reuptake Inhibitor NS2330 in Parkinson's Disease Completed National Institute of Neurological Disorders and Stroke (NINDS) Phase 2 2000-08-01 This study will evaluate the effects of an experimental drug called NS2330 on Parkinson's disease symptoms and on dyskinesias (involuntary movements) that develop as a result of long-term treatment with levodopa. This drug prevents the neurotransmitter dopamine from entering nerve cells. Patients between 18 and 75 years old who have moderately advanced Parkinson's disease and motor problems resulting from levodopa therapy may be eligible for this 5-week study. Candidates will have a complete medical history and physical examination with a detailed neurological evaluation. If needed, some patients will undergo a magnetic resonance imaging (MRI) or computerized tomography (CT) scan of the brain and a chest X-ray. All patients will have blood and urine tests and an electrocardiogram (EKG) and will take a written test for evaluation of depression. Patients enrolled in the study will, if possible, stop taking all antiparkinson medications except levodopa (Sinemet) for one month before the study begins and through its duration. For the first 1 to 3 days, patients will undergo a levodopa "dose-finding" procedure. For this study, patients will stop taking their usual oral levodopa medicine and instead will have levodopa infused through a vein for up to 12 hours. During the infusions, the drug dose will be increased slowly until either 1) parkinsonism symptoms improve, 2) dyskinesias appear, 3) unacceptable side effects occur, or 4) the maximum study dose is reached. When the patient's optimal dose is determined, treatment will begin. Patients will take three pills containing NS2330 or placebo (a look-alike pill with no active ingredient) 3 days a week for up to 5 weeks, in addition to their regular levodopa medication. All participants will receive placebo at some point in the study; some patients will receive only placebo throughout the entire 5 weeks. On treatment days, patients will have a brief medical examination before receiving the drug and will then be monitored for side effects for about 6 to 8 hours after taking the drug. At the beginning of weeks 2 and 5, the levodopa infusions will be repeated at the previously determined optimum rate. Throughout the study, parkinsonism symptoms, dyskinesias and depression will be evaluated. Blood and urine samples will be collected each week for standard safety tests, and blood will also be drawn periodically to measure NS2330 levels.
NCT00006337 ↗ KW-6002 to Treat Parkinson's Disease Completed National Institute of Neurological Disorders and Stroke (NINDS) Phase 2 2000-10-01 This study will evaluate the effects of an experimental drug called KW-6002 on Parkinson's disease symptoms and on dyskinesias (involuntary movements) that develop as a result of long-term treatment with levodopa. This drug blocks the action of the neurotransmitter adenosine, thought to be involved in producing Parkinson's symptoms. Patients with relatively advanced (Stage II to IV) Parkinson's disease between 30 and 80 years of age may be eligible for this 7-week study. Participants will have a complete medical history and physical examination, including blood tests and an electrocardiogram, and possibly brain magnetic resonance imaging (MRI), CT scan, and chest X-ray. Patients enrolled in the study will, if possible, stop taking all antiparkinsonian medications except levodopa (Sinemet) for one month before the study begins and throughout its duration. For the first 1 to 3 days, patients will be admitted to the NIH Clinical center to undergo a levodopa "dose-finding" procedure. For this study, patients will stop taking Sinemet and instead will have levodopa infused through a vein for up to 8 hours/day. During the infusions, the drug dose will be increased slowly until either 1) parkinsonian symptoms improve, 2) unacceptable side effects occur, or 3) the maximum study dose is reached. Symptoms will be monitored frequently to find two infusion rates: 1) one that is less than what is needed to relieve symptoms, and 2) one that relieves symptoms but may produce dyskinesias. This procedure will be repeated at the end of weeks 2, 4 and 6 of the study. When the patient's optimal dose is determined treatment will begin. Patients will take tablets or capsules containing KW-6002 or placebo (a look-alike pill with no active ingredient) once a day for 2 weeks, in addition to their regular Sinemet. All participants will receive placebo at least 2 weeks during the study; some patients will receive only placebo throughout the entire 7 weeks. At the end of weeks 1, 3 and 5, patients will be evaluated with a brief physical examination, routine blood and urine tests, and assessment of any adverse effects. Throughout the study, parkinsonian symptoms and dyskinesias will be evaluated and blood samples will be drawn periodically to measure drug levels.
NCT00009048 ↗ EMD 128130 for the Treatment of Parkinson's Disease Completed National Institute of Neurological Disorders and Stroke (NINDS) Phase 2 2001-01-01 This study will evaluate the effects of an experimental drug called EMD 128130 on Parkinson's disease symptoms and on dyskinesias (involuntary movements) that develop as a result of long-term treatment with levodopa. EMD 128130 inhibits the function of serotonin, a chemical messenger thought to regulate dopamine release, and thus affect Parkinson's disease symptoms. Patients with relatively advanced Parkinson's disease between 30 and 80 years of age may be eligible for this 3-phase study. - Phase 1 - Baseline Evaluation Participants will have a medical history, physical examination, detailed neurologic evaluation, routine blood tests, urinalysis and an electrocardiogram. A chest X-ray and MRI or CT scan of the brain will be done if needed. In addition, an ACTH stimulation test will be done before and at the end of the study. For this test, a hormone called ACTH is injected into a vein. A small amount of blood is drawn before the injection and 30 and 60 minutes afterwards to measure levels of another hormone called cortisol. After these tests are completed, patients will, if possible, stop taking all antiparkinsonian medications except levodopa (Sinemet) for one month before the study begins and throughout its duration. - Phase 2 - Levodopa and Apomorphine Dose Finding For 1 to 3 days, patients will be admitted to the NIH Clinical center to undergo a levodopa and apomorphine (a dopamine agonist) "dose-finding" procedure. For this procedure, patients will stop taking Sinemet and instead will have levodopa, and subsequently apomorphine, infused through a vein. During the infusions, the drug dose will be increased slowly until either 1) parkinsonian symptoms improve, 2) unacceptable side effects occur, or 3) the maximum study dose is reached. Symptoms will be monitored frequently to find two infusion rates: 1) one that is less than what is needed to relieve symptoms, and 2) one that relieves symptoms but may produce dyskinesias. - Phase 3 - Active Study Patients will begin the treatment phase within 3 months of the dose-finding phase. After a brief physical examination, routine blood tests, and evaluation of parkinsonism symptoms, patients will begin taking either EMD 128130 tablets or capsules or a placebo (a look-alike pill with no active ingredient) twice a day, along with Sinemet, for 3 weeks. All participants will receive placebo at least 1 week during the study, and about four patients, selected at random, will receive only placebo the entire 3 weeks. Levodopa and apomorphine infusions will be repeated at the end of weeks 1, 2 and 3 of Phase 3. The procedure for the infusions will be the same as in the dose-finding phase. Throughout the study, parkinsonian symptoms and dyskinesias will be assessed and blood samples will be drawn periodically to measure drug levels. Patients will return for a follow-up evaluation 2 weeks after the end of the study.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Sinemet Cr

Condition Name

Condition Name for Sinemet Cr
Intervention Trials
Parkinson's Disease 31
Parkinson Disease 17
Dyskinesias 5
Stroke 5
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Condition MeSH

Condition MeSH for Sinemet Cr
Intervention Trials
Parkinson Disease 53
Dyskinesias 6
Depressive Disorder 4
Stroke 4
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Clinical Trial Locations for Sinemet Cr

Trials by Country

Trials by Country for Sinemet Cr
Location Trials
United States 154
Canada 8
Italy 6
Finland 6
Spain 6
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Trials by US State

Trials by US State for Sinemet Cr
Location Trials
Maryland 12
California 11
Georgia 10
Texas 10
Illinois 10
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Clinical Trial Progress for Sinemet Cr

Clinical Trial Phase

Clinical Trial Phase for Sinemet Cr
Clinical Trial Phase Trials
Phase 4 12
Phase 3 5
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Sinemet Cr
Clinical Trial Phase Trials
Completed 61
Recruiting 10
Terminated 4
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Clinical Trial Sponsors for Sinemet Cr

Sponsor Name

Sponsor Name for Sinemet Cr
Sponsor Trials
National Institute of Neurological Disorders and Stroke (NINDS) 13
Bial - Portela C S.A. 7
Orion Corporation, Orion Pharma 7
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Sponsor Type

Sponsor Type for Sinemet Cr
Sponsor Trials
Other 63
Industry 45
NIH 28
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Clinical Trials, Market Analysis, and Projections for Sinemet CR

Introduction to Sinemet CR

Sinemet CR, a controlled-release formulation of carbidopa/levodopa, is a pivotal medication in the management of Parkinson's disease, particularly for patients experiencing motor fluctuations. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Long-Term Efficacy

In a long-term open-label study, Sinemet CR was administered to 8 patients with Parkinson's disease for 36 or 39 months. The results showed that 5 patients experienced an increase in daily "on" time compared to baseline values on standard Sinemet. All patients required fewer daily doses after 3 months on Sinemet CR, although only 3 maintained this reduction after 36 or 39 months. Patients preferred Sinemet CR due to improved predictability of response and fewer severe "off" episodes[1].

Controlled Studies

A multicenter double-blind trial involving 202 patients with advanced Parkinson's disease compared Sinemet CR with standard Sinemet. The study found that Sinemet CR significantly reduced daily "off" time and improved patient and physician global ratings. Patients preferred Sinemet CR by a ratio of approximately 2 to 1, and the daily dosing frequency was 33% less with Sinemet CR, although the daily intake of levodopa was increased by 25%[4].

Pharmacoeconomic Analysis

Cost-Effectiveness

A pharmacoeconomic analysis compared the costs of pharmacotherapy in patients with Parkinson's disease before and after converting from standard Sinemet to Sinemet CR. Although Sinemet CR is more costly, it was found to be more cost-effective in patients with motor fluctuations. Patients experienced an increase in "on" time by 2.2 hours and a decrease in total cost per hour "on" without chorea. Additionally, patients taking selegiline were able to reduce their selegiline expenses by 20% after switching to Sinemet CR[2].

Market Analysis

Market Share and Growth

In 2023, the Sinemet-CR segment accounted for a noticeable share of the global Parkinson Disease Drugs Market and is projected to experience significant growth in the near future. The market is driven by the increasing prevalence of Parkinson's disease and the preference for controlled-release formulations that offer better symptom management and patient compliance[5].

Key Players and Strategies

Major pharmaceutical companies such as Merck and GSK are focusing on strengthening their product portfolios and expanding their business in the global Parkinson's disease drugs market. These companies are investing in research and development to improve existing treatments and develop new therapies, which is expected to further boost the market growth[5].

Market Projections

Future Growth

The global Parkinson Disease Drugs Market, including the Sinemet-CR segment, is expected to witness significant growth in the coming years. The Under 40 Years Old segment is anticipated to expand at a significant Compound Annual Growth Rate (CAGR) throughout the forecast period. This growth is driven by increasing awareness, better diagnostic tools, and the development of more effective treatments[5].

Regional Dominance

The market is expected to be dominated by regions with high healthcare spending and advanced medical infrastructure. North America and Europe are likely to remain key markets due to their strong healthcare systems and high demand for advanced Parkinson's disease treatments[5].

Patient Preferences and Compliance

Patient Acceptance

Patients have shown a high acceptance rate for Sinemet CR due to its improved predictability of response and reduced severity of "off" episodes. This preference is reflected in the higher patient and physician global ratings compared to standard Sinemet[1][4].

Compliance

The reduced dosing frequency with Sinemet CR, despite the need for occasional adjustments, enhances patient compliance. This is crucial for managing a chronic condition like Parkinson's disease, where consistent medication adherence is vital for maintaining quality of life[1][4].

Conclusion

Sinemet CR has established itself as a valuable treatment option for patients with Parkinson's disease, particularly those experiencing motor fluctuations. The clinical trials have demonstrated its efficacy in increasing "on" time, reducing "off" episodes, and improving patient compliance. From a market perspective, Sinemet CR is expected to continue its significant growth, driven by patient preference, cost-effectiveness, and the overall expansion of the Parkinson's disease drugs market.

Key Takeaways

  • Efficacy: Sinemet CR has been shown to increase "on" time and reduce "off" episodes in patients with Parkinson's disease.
  • Cost-Effectiveness: Despite higher costs, Sinemet CR can be more cost-effective due to reduced need for adjunctive medications and improved disease control.
  • Market Growth: The Sinemet-CR segment is projected to experience significant growth in the global Parkinson Disease Drugs Market.
  • Patient Preference: Patients prefer Sinemet CR due to its improved predictability and reduced severity of "off" episodes.
  • Compliance: Reduced dosing frequency enhances patient compliance.

FAQs

What is Sinemet CR?

Sinemet CR is a controlled-release formulation of carbidopa/levodopa used to manage Parkinson's disease, especially in patients with motor fluctuations.

How does Sinemet CR compare to standard Sinemet?

Sinemet CR reduces daily "off" time, improves patient and physician global ratings, and requires fewer daily doses compared to standard Sinemet[1][4].

Is Sinemet CR cost-effective?

Although more costly, Sinemet CR can be more cost-effective by reducing the need for adjunctive medications and improving disease control[2].

What is the market outlook for Sinemet CR?

The Sinemet-CR segment is expected to experience significant growth in the global Parkinson Disease Drugs Market, driven by patient preference and market expansion[5].

Which regions are expected to dominate the market for Sinemet CR?

North America and Europe are likely to remain key markets due to their strong healthcare systems and high demand for advanced Parkinson's disease treatments[5].

Sources

  1. PubMed: Long-term clinical efficacy of Sinemet CR in patients with Parkinson's disease.
  2. PubMed: Pharmacoeconomic analysis of using Sinemet CR over standard Sinemet.
  3. BioSpace: 7 Most Promising Drugs in Parkinson's Disease Treatment Pipeline.
  4. PubMed: Multicenter controlled study of Sinemet CR vs Sinemet (25/100).
  5. Cognitive Market Research: Parkinson Disease Drugs Market Report 2024 (Global Edition).

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