CLINICAL TRIALS PROFILE FOR PARCOPA

All Clinical Trials for Parcopa

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00139867 ↗	A Multicenter, Open-label Trial to Assess Subject Preference of PARCOPA, Carbidopa/Levodopa Orally Disintegrating Tablets, Compared to Conventional Carbidopa/Levodopa Tablets in Subjects With Stable Parkinson's Disease	Completed	UCB Pharma	Phase 3	2004-01-01	The objective of this trial was to assess subject preference for PARCOPA, carbidopa/levodopa Orally Disintegrating Tablets (ODT), compared with conventional carbidopa/levodopa tablets, in subjects with stable Parkinson's disease.
NCT00139880 ↗	A Single Center, Randomized, Double-blind, Crossover Pilot Trial Comparing the Onset of Action of Parcopa™ With Sinemet® in Subjects With Stable Parkinson's Disease	Completed	UCB Pharma	Phase 3	2005-06-01	To test whether Parcopa, a new Orally Disintegrating Tablet of Carbidopa-Levodopa, has a faster onset of action, changes in the UPDRS Motor Exam score at intervals after a single dose of Parcopa or Sinemet are being compared in 10 subjects with Parkinson's disease. Subjects 40 years or older having idiopathic PD with Hoehn and Yahr state II or III are eligible if taking a stable dose of < 200 mg carbidopa and < 2000 mg levodopa daily. At both treatment visits, either Parcopa or Sinemet, plus a placebo of the opposite tablet (ODT or conventional) are administered. The dose is the same as the subject's prestudy regimen. The primary efficacy variable, time to onset of action, is the first postdose time when a 30% decrease (30% improvement) in the total score is achieved. All UPDRS evaluations are done by a rater blinded to the active treatment received by the subject.
NCT00590122 ↗	Parcopa Versus Carbidopa-Levodopa in a Single Dose Cross-Over Comparison Study	Completed	UCB Pharma	Phase 4	2006-10-01	To find out if a single dose of Parcopa®, a form of levodopa that dissolves in your mouth, works faster than regular oral levodopa which is swallowed, in fluctuating PD patients.
NCT00590122 ↗	Parcopa Versus Carbidopa-Levodopa in a Single Dose Cross-Over Comparison Study	Completed	Baylor College of Medicine	Phase 4	2006-10-01	To find out if a single dose of Parcopa®, a form of levodopa that dissolves in your mouth, works faster than regular oral levodopa which is swallowed, in fluctuating PD patients.

Clinical Trial Conditions for Parcopa

Condition Name

Condition Name for Parcopa
Intervention	Trials
Parkinson's Disease	3
Acute Pain	1
Albinism	1
Bunionectomy	1

Condition MeSH

Condition MeSH for Parcopa
Intervention	Trials
Parkinson Disease	3
Albinism	1
Pain, Postoperative	1
Acute Pain	1

Clinical Trial Locations for Parcopa

Trials by Country

Trials by Country for Parcopa
Location	Trials
United States	6

Trials by US State

Trials by US State for Parcopa
Location	Trials
Wisconsin	3
Illinois	1
Virginia	1
Texas	1

Clinical Trial Progress for Parcopa

Clinical Trial Phase

Clinical Trial Phase for Parcopa
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	2
Phase 2	3

Clinical Trial Status

Clinical Trial Status for Parcopa
Clinical Trial Phase	Trials
Completed	4
Not yet recruiting	1
Terminated	1

Clinical Trial Sponsors for Parcopa

Sponsor Name

Sponsor Name for Parcopa
Sponsor	Trials
UCB Pharma	3
Baylor College of Medicine	1
University of Wisconsin, Madison	1

Sponsor Type

Sponsor Type for Parcopa
Sponsor	Trials
Other	5
Industry	3
NIH	2

Transforming Parkinson’s Disease Management: Updates on Parcopa and Market Projections

Introduction to Parkinson’s Disease and Parcopa

Parkinson’s disease is a neurodegenerative disorder characterized by the loss of dopamine-producing neurons in the brain, leading to motor symptoms such as tremors, rigidity, and bradykinesia. One of the cornerstone treatments for Parkinson’s disease is the combination of carbidopa and levodopa, often formulated in various delivery systems to optimize symptom control. Parcopa, a formulation of carbidopa and levodopa, is one such treatment that has undergone significant advancements.

Clinical Trials Update: IPX203 and Parcopa

IPX203: The Extended-Release Formulation

IPX203, an extended-release formulation of carbidopa-levodopa, has been a focal point in recent clinical trials. The RISE-PD study, a 20-week, randomized, double-blind, double-dummy, active-controlled phase 3 clinical trial, compared IPX203 with immediate-release carbidopa-levodopa in patients with Parkinson’s disease experiencing motor fluctuations[1][4].

• Key Findings: IPX203 demonstrated a statistically significant improvement in daily "good on-time" (time without troublesome dyskinesia) compared to immediate-release carbidopa-levodopa. Patients on IPX203 experienced an increase of 0.53 hours in good on-time per day, despite being dosed less frequently (mean 3 times per day vs 5 times per day for immediate-release)[1][4].

• Adverse Events: The most common adverse events in the IPX203 group were nausea and anxiety, which were generally well-tolerated[1].

Implications for Parcopa

While Parcopa itself is not the subject of these specific trials, the advancements in extended-release formulations like IPX203 indicate a trend towards developing more efficient and less frequently dosed treatments. This could potentially influence future formulations of Parcopa or similar carbidopa-levodopa combinations.

Market Analysis and Projections

Current Market Landscape

The Parkinson’s disease treatment market has been growing steadily due to several factors:

• Increasing Prevalence: The ageing population is a significant driver, as Parkinson’s disease is more common among older adults[5].
• Advancements in Diagnostics: Improved diagnostic techniques have led to more accurate and earlier diagnoses, contributing to market growth[2].
• Government Funding: Increased funding for research has accelerated the development of new treatments[5].

Market Size and Growth

As of 2023, the Parkinson’s disease market size in the 7 major markets (7MM) was valued at USD 3.2 billion. The market is expected to grow at a Compound Annual Growth Rate (CAGR) of 5.8% from 2020 to 2034[2].

Drug Class and Distribution Channels

The carbidopa/levodopa drug class, which includes formulations like Parcopa, is projected to register the highest CAGR during the forecast period. Distribution channels such as hospitals, online pharmacies, and retail pharmacies play crucial roles in the market dynamics[5].

Emerging Pipeline

The current pipeline for Parkinson’s disease treatments is robust, with several late-stage drugs expected to enter the market. These include Supernus Pharmaceuticals/Britannia Pharmaceuticals' SPN-830, AbbVie's tavapadon, and Pharma Two B's P2B001. The approval of these therapies could significantly impact the market dynamics and provide more treatment options for patients[2].

New Therapies and Devices

Continuous Infusions and Reformulated Pills

In addition to extended-release formulations like IPX203, other innovative treatments are on the horizon:

• Continuous Infusions: Under-the-skin continuous infusions of apomorphine and levodopa/carbidopa, delivered through pump-like devices or patch systems, aim to provide consistent medication levels and smooth out symptom fluctuations[3].
• Reformulated Pills: The FDA-approved reformulated, longer-acting levodopa/carbidopa pill, Crexont, is another example of advancements in oral treatments. This pill aims to provide better symptom control with fewer daily doses[3].

Key Takeaways

• Clinical Trials: IPX203 has shown significant improvements in good on-time for patients with Parkinson’s disease, indicating potential benefits for similar extended-release formulations.
• Market Growth: The Parkinson’s disease treatment market is expected to grow at a CAGR of 5.8% from 2020 to 2034, driven by increasing prevalence, advancements in diagnostics, and government funding.
• Emerging Therapies: The pipeline includes several promising treatments, such as continuous infusions and reformulated pills, which could further transform the management of Parkinson’s disease.

FAQs

What is IPX203 and how does it differ from immediate-release carbidopa-levodopa?

IPX203 is an extended-release formulation of carbidopa-levodopa designed to provide more consistent and longer-lasting symptom control. It differs from immediate-release carbidopa-levodopa by requiring fewer daily doses while increasing the hours of good on-time per day[1][4].

What are the common adverse events associated with IPX203?

The most common adverse events reported in the IPX203 group were nausea and anxiety, which were generally well-tolerated[1].

How is the Parkinson’s disease treatment market expected to grow?

The Parkinson’s disease treatment market is expected to grow at a CAGR of 5.8% from 2020 to 2034, driven by factors such as increasing prevalence, advancements in diagnostics, and government funding for research[2].

What new therapies are being developed for Parkinson’s disease?

New therapies include continuous infusions of apomorphine and levodopa/carbidopa, as well as reformulated, longer-acting levodopa/carbidopa pills like Crexont. These aim to provide better symptom control and reduce the frequency of dosing[3].

What impact do emerging pipeline treatments have on the market?

Emerging pipeline treatments, such as SPN-830, tavapadon, and P2B001, could significantly impact market dynamics by providing more treatment options and potentially altering the competitive landscape[2].

Sources

1. IPX203 vs Immediate-Release Carbidopa-Levodopa for ... - PubMed
2. Parkinson's Disease Market is Expected to Showcase a ... - GlobeNewswire
3. FDA Reviewing Four New Parkinson's Medications in 2024 - Michael J. Fox Foundation
4. IPX203 vs Immediate-Release Carbidopa-Levodopa for the ... - JAMA Network
5. Parkinson's Disease Treatment Market Revenue Forecast - MarketsandMarkets

Last updated: 2025-01-07