CLINICAL TRIALS PROFILE FOR ROPINIROLE HYDROCHLORIDE

505(b)(2) Clinical Trials for Ropinirole Hydrochloride

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.
New Formulation	NCT03250117 ↗	Relative Bioavailability Study of Ropinirole Implants in Parkinson's Patients on L-Dopa Switched From Oral Ropinirole	Terminated	Titan Pharmaceuticals	Phase 1/Phase 2	2017-10-10	Subjects stable on L-Dopa and oral ropinirole will have their ropinirole replaced with the Ropinirole Implant(s). The Ropinirole Implant was designed using the ProNeura™ implant technology where the implant is inserted under the skin. This study will measure how much ropinirole is released in the blood during 3 months of treatment, and evaluate the side effects of this new formulation.

All Clinical Trials for Ropinirole Hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00036218 ↗	Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's Disease.	Completed	Pfizer	Phase 3	2001-12-01	The primary purpose of this study is to determine whether sumanirole is effective and safe in the treatment of the signs and symptoms of early Parkinson's disease.
NCT00086294 ↗	ACP-103 to Treat Parkinson's Disease	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2	2004-06-25	This study will evaluate the effects of an experimental drug called ACP-103 on Parkinson's disease symptoms and on dyskinesias (involuntary movements) that develop as a result of long-term levodopa treatment. ACP-103 changes the spread of certain brain signals that are affected in patients with Parkinson's disease. Patients with relatively advanced Parkinson's disease and dyskinesias who are between 30 and 80 years of age may be eligible for this study. Candidates are screened with a complete medical history and physical examination, neurological evaluation, blood and urine tests, and electrocardiogram (ECG). A brain magnetic resonance imaging (MRI) scan, CT scan, and chest x-ray may be done if medically indicated. Patients enrolled in the study will, if possible, stop taking all antiparkinsonian medications for one month (2 months for Selegiline) before the study begins and throughout its duration. Exceptions are Sinemet (levodopa/carbidopa), Mirapex (pramipexole) and Requip (ropinirole). Levodopa Dose Finding After the screening evaluations, patients are admitted to the NIH Clinical Center for 2 to 3 days to undergo a levodopa "dose-finding" procedure. For this test, patients stop taking Sinemet and instead have levodopa infused through a vein. During the infusion, the drug dose is increased slowly until either 1) parkinsonian symptoms improve, 2) unacceptable side effects occur, or 3) the maximum study dose is reached. Side effects are monitored closely during the infusions, and parkinsonian symptoms are evaluated frequently during and after the infusions. The infusions usually begin early in the morning and continue until evening. Once the infusion is finished, patients resume taking their regular oral Sinemet dose. The infusions are repeated once a week during 1-day inpatient evaluations. Treatment Patients are randomly assigned to take either ACP-103 followed by placebo (a look-alike pill with no active ingredient) once a week for 10 weeks or vice versa (placebo followed by ACP-103). Patients are admitted to the Clinical Center for each dose. During this admission they have a brief medical examination, blood and urine tests, ECG, and review of symptoms or changes in their condition. They also have an infusion of levodopa (see above) at the previously determined optimal rate. Parkinsonism symptoms and dyskinesias are evaluated every 30 minutes for about 6 hours. At the end of the infusions and ratings, patients are discharged home with their regular Parkinson's medications until the following visit. Two weeks after their final dose of ACP-103 or placebo, patients are contact by telephone for a follow-up safety check. At that time, the investigator may ask the patient to return to the clinic for closer evaluation.
NCT00140712 ↗	Ropinirole Tablets In Young Patients With Restless Legs Syndrome	Completed	GlaxoSmithKline	Phase 1	2005-06-10	This is a two-period dose rising study of Ropinirole Immediate Release in adolescent patients with restless legs syndrome (RLS) in order to determine the starting dose for the ropinirole titration regimen for this age group. Patients will receive two single doses unless poor tolerability is observed following the first dose.
NCT00144300 ↗	Ophthalmologic Safety Study of Pramipexole Immediate Release (IR) Versus Ropinirole in Early Parkinson's Disease (PD) Patients	Completed	Boehringer Ingelheim	Phase 4	2005-01-01	To determine if there is any difference in the presence of retinal deterioration in PD patients treated with pramipexole IR versus ropinirole as monitored by comprehensive ophthalmologic assessments from baseline to the end of study at two years.
NCT00197080 ↗	Ropinirole XR (Extended Release) In Patients With Restless Legs Syndrome	Completed	GlaxoSmithKline	Phase 3	2005-06-01	The purpose of this study is to assess the efficacy and safety of ropinirole XR in the treatment of adults with Restless Legs Syndrome (RLS).
NCT00200941 ↗	Efficacy and Safety Study of Topiramate to Treat Restless Legs Syndrome	Completed	Ortho-McNeil Pharmaceutical	Phase 4	2001-08-01	This study is intended to determine whether topiramate is an efficacious and safe treatment for restless legs syndrome.
NCT00200941 ↗	Efficacy and Safety Study of Topiramate to Treat Restless Legs Syndrome	Completed	Neurocare	Phase 4	2001-08-01	This study is intended to determine whether topiramate is an efficacious and safe treatment for restless legs syndrome.

Clinical Trial Conditions for Ropinirole Hydrochloride

Condition Name

Condition Name for Ropinirole Hydrochloride
Intervention	Trials
Parkinson Disease	22
Restless Legs Syndrome	21
Parkinson's Disease	14
Restless Legs Syndrome (RLS)	5

Condition MeSH

Condition MeSH for Ropinirole Hydrochloride
Intervention	Trials
Parkinson Disease	35
Restless Legs Syndrome	23
Psychomotor Agitation	20
Syndrome	18

Clinical Trial Locations for Ropinirole Hydrochloride

Trials by Country

Trials by Country for Ropinirole Hydrochloride
Location	Trials
United States	324
Germany	47
Italy	26
United Kingdom	20
Canada	17

Trials by US State

Trials by US State for Ropinirole Hydrochloride
Location	Trials
Florida	18
California	18
Georgia	17
New York	16
Texas	15

Clinical Trial Progress for Ropinirole Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Ropinirole Hydrochloride
Clinical Trial Phase	Trials
Phase 4	15
Phase 3	28
Phase 2	11

Clinical Trial Status

Clinical Trial Status for Ropinirole Hydrochloride
Clinical Trial Phase	Trials
Completed	62
Terminated	4
Unknown status	4

Clinical Trial Sponsors for Ropinirole Hydrochloride

Sponsor Name

Sponsor Name for Ropinirole Hydrochloride
Sponsor	Trials
GlaxoSmithKline	38
UCB Pharma	4
Otsuka Pharmaceutical Co., Ltd.	3

Sponsor Type

Sponsor Type for Ropinirole Hydrochloride
Sponsor	Trials
Industry	64
Other	25
NIH	2

Ropinirole Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Ropinirole Hydrochloride

Ropinirole hydrochloride is a dopamine agonist primarily used in the treatment of Parkinson's disease and Restless Legs Syndrome (RLS). It works by stimulating dopamine receptors in the brain, helping to manage motor symptoms associated with these conditions.

Clinical Trials Update

Parkinson's Disease

Ropinirole hydrochloride has been extensively studied for its efficacy in treating Parkinson's disease. A notable study published in the Journal of the American Medical Association (JAMA) Neurology highlighted its effectiveness as monotherapy for early Parkinson's disease. The study showed that patients treated with ropinirole demonstrated significant improvement in motor function compared to those receiving a placebo. Specifically, fewer patients in the ropinirole group required additional levodopa therapy, and more patients completed the 12-month study without needing supplemental levodopa[4].

Amyotrophic Lateral Sclerosis (ALS)

Recently, there has been interest in exploring the potential of ropinirole hydrochloride for treating ALS. A feasibility trial published in Cell Stem Cell investigated the use of ropinirole hydrochloride for ALS, although the results were preliminary and inconclusive. Experts noted that the study was too small to determine efficacy or safety definitively, and larger studies are necessary to draw meaningful conclusions. The trial showed some positive effects in the Open Label Extension, but these were likely influenced by prognostic factors and biases[1].

Market Analysis

Current Market Status

The global ropinirole hydrochloride market has been growing steadily, driven by the increasing prevalence of Parkinson's disease and RLS. In 2022, the market reached a significant value, and it is projected to continue growing at a Compound Annual Growth Rate (CAGR) of around 5-14.4% during the forecast period from 2023 to 2030[2][5].

Market Segmentation

The market is segmented by product type, downstream industry, and region. North America and Europe currently lead in market share, accounting for approximately 30% and 25%, respectively. The Asia-Pacific region is rapidly emerging, driven by increasing healthcare investments and rising awareness of Parkinson's disease. Key players in the market include USV Private Limited, Ind-Swift, Glenmark, Neuland, and others, each contributing to the competitive landscape[5].

Regional Market

The USA remains a pivotal player in the ropinirole hydrochloride market, contributing around 15% of the global share. China, with its expanding pharmaceutical sector, is expected to capture around 10% of the market. The market in emerging economies is also growing due to improved access to therapies and increased healthcare expenditure[5].

Market Projections

Growth Drivers

The market for ropinirole hydrochloride is expected to grow due to several key drivers:

• Increasing Prevalence of Neurodegenerative Disorders: The rising incidence of Parkinson's disease and RLS is a significant factor driving market growth.
• Advancements in Formulations and Drug Delivery Systems: Innovations in drug delivery are enhancing patient compliance and the effectiveness of therapy.
• Heightened Awareness and Healthcare Investments: Increased awareness of treatment options and rising healthcare expenditure, particularly in emerging economies, are contributing to market expansion[5].

Future Trends

• Personalized Medicine: The shift towards personalized medicine and ongoing clinical trials may provide new growth opportunities for ropinirole hydrochloride.
• Regulatory Approvals and Generics: Regulatory approvals and the entry of generics into the market will influence pricing dynamics and accessibility, shaping the industry's future landscape.
• Emerging Markets: The Asia-Pacific region, particularly China, is expected to play a significant role in the market's growth due to its expanding pharmaceutical sector[5].

Key Opportunities for Manufacturers

Manufacturers of ropinirole hydrochloride have several key opportunities to capitalize on:

• Product Development: Focusing on product development and innovation in formulations can enhance market reach and patient compliance.
• Strategic Collaborations: Engaging in strategic collaborations can help companies expand their market presence and access new technologies.
• Clinical Trials: Ongoing and future clinical trials exploring the efficacy of ropinirole hydrochloride in other neurological conditions could open new avenues for growth[5].

Challenges and Limitations

Despite the positive outlook, there are challenges and limitations to consider:

• Clinical Trial Size and Design: As seen in the ALS feasibility trial, small study sizes and biases can limit the ability to draw definitive conclusions about the drug's efficacy and safety[1].
• Market Competition: The market is competitive, with several key players, which can make it challenging for new entrants to gain significant market share[5].

Key Takeaways

• Ropinirole hydrochloride is effective in treating Parkinson's disease and RLS, with significant improvements in motor function and patient outcomes.
• The global market is growing, driven by increasing prevalence of neurodegenerative disorders and advancements in drug delivery systems.
• Future growth is expected, particularly in emerging markets like the Asia-Pacific region.
• Larger clinical trials are needed to explore the drug's potential in other conditions like ALS.
• Manufacturers should focus on product development and strategic collaborations to enhance market reach and patient compliance.

FAQs

What is the primary use of ropinirole hydrochloride?

Ropinirole hydrochloride is primarily used to treat Parkinson's disease and Restless Legs Syndrome (RLS) by stimulating dopamine receptors in the brain.

How effective is ropinirole hydrochloride in treating Parkinson's disease?

Studies have shown that ropinirole hydrochloride is effective in improving motor function and reducing the need for additional levodopa therapy in patients with early Parkinson's disease[4].

Is ropinirole hydrochloride being explored for other neurological conditions?

Yes, there have been preliminary studies exploring the use of ropinirole hydrochloride for conditions like ALS, although larger studies are needed to draw meaningful conclusions[1].

What are the key drivers of the ropinirole hydrochloride market growth?

The market growth is driven by the increasing prevalence of neurodegenerative disorders, advancements in formulations and drug delivery systems, and heightened awareness and healthcare investments[5].

Which regions are leading in the ropinirole hydrochloride market?

North America and Europe currently lead in market share, with the Asia-Pacific region rapidly emerging as a significant market[5].

What are the future trends in the ropinirole hydrochloride market?

Future trends include the shift towards personalized medicine, ongoing clinical trials, and the impact of regulatory approvals and generics on market dynamics[5].

Sources

1. Science Media Centre: Expert reaction to a feasibility trial of Parkinson's drug ropinirole for ALS[1].
2. Maia Research: Global Ropinirole Hydrochloride Industry Market Report[2].
3. GlobeNewswire: Parkinson's Disease Market is Expected to Showcase a Significant Growth at a CAGR of 5.8% During the Study Period (2020–2034)[3].
4. JAMA Neurology: Ropinirole for the Treatment of Early Parkinson Disease: A 12-Month Randomized, Double-Blind, Placebo-Controlled Study[4].
5. Reliable Research Reports: Ropinirole HCL Market Research Report[5].