CLINICAL TRIALS PROFILE FOR ROTIGOTINE

All Clinical Trials for rotigotine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00135993 ↗	Four Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Legs Syndrome	Completed	UCB Pharma	Phase 3	2005-05-01	Subjects who meet the diagnosis of idiopathic restless legs syndrome (RLS) based on the 4 cardinal clinical features according to the International Restless Legs Syndrome Study Group (IRLSSG) are allowed to enroll in this trial. The primary objective of this trial is to demonstrate that rotigotine (SPM 936) is efficacious in subjects with idiopathic restless legs syndrome. Additional objectives are to investigate the safety and tolerability of rotigotine. Subjects will be randomized to receive either placebo, 1.125, 2.25, 4.5, or 6.75mg/day rotigotine in a 1:1:1:1:1 (active:placebo) fashion. Approximately 600 subjects will be enrolled in this trial, participating at approximately 60 sites. The maximum duration of the trial is approximately 8 months (consisting of a 4-week Titration Period, a 6-month Maintenance Period, a 7-day Taper Period, and a 30-day Safety Follow-Up Period).
NCT00136045 ↗	Three Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Leg Syndrome	Completed	UCB Pharma	Phase 3	2005-05-01	The primary objective of this trial is to demonstrate that rotigotine (SPM 936) is efficacious in subjects with idiopathic restless leg syndrome (RLS). Additional objectives are to investigate the safety and tolerability of rotigotine. The primary variables are the absolute change from Baseline in the International Restless Legs Severity Scale (IRLS) sum score and Clinical Global Impression-Global Improvement (CGI) Item 1 (severity of illness) score at the end of the Maintenance Period. Subjects will be randomized to receive either placebo, 2.25, 4.5 or 6.75 mg/day rotigotine in a 1:1:1:1 (active:placebo) fashion. Approximately 450 subjects will be enrolled in this trial, participating at approximately 50 sites. The maximum duration of the trial is approximately 8 months (3-week Titration Period, 6-month Maintenance Period, 7-day Taper Period, and 30-day Safety Follow-Up Period). Subjects who complete the 6-month Maintenance Period will be eligible to participate in an open-label extension trial. Subjects who do not complete the 6-month Maintenance Period or who choose not to participate in the open-label extension trial will complete a 3-day Safety Follow-Up Period. Two different patch sizes will be used (5 and 10 cm2). Active patches will contain either 2.25mg (5cm2) or 4.5mg (10cm2) of rotigotine.
NCT00242008 ↗	A Trial To Assess Switching From Ropinirole, Pramipexole Or Cabergoline To The Rotigotine Transdermal System In Idiopathic Parkinson's Disease	Completed	UCB Pharma	Phase 3	2004-12-01	The purpose of this trial is to assess whether it is possible for subjects with idiopathic Parkinson's Disease to switch from ropinirole, pramipexole and cabergoline to rotigotine transdermal system (SPM 962) overnight without worsening of Parkinson's Disease symptoms. Subjects who meet eligibility criteria will be switched overnight to treatment with rotigotine transdermal patches at a dose considered equivalent to the dose of dopamine agonist that the subject is currently taking. Subjects on ropinirole or pramipexole will take their last dose at bedtime and then apply rotigotine patch(es) upon awakening the next morning. Subjects on cabergoline will apply rotigotine patches 24 hours after the final dose of cabergoline. Subjects will continue rotigotine treatment for 28 days, during which dose can be increased or decreased as needed. At the end of treatment, subjects can select to enroll in an open-label extension trial. The first subject was enrolled on 28 December 2004. The last subject was enrolled in June 2005 and the last subject visit was conducted in July 2005. This study is now closed.
NCT00243217 ↗	Rotigotine Restless Legs Syndrome Dose Finding Trial	Completed	UCB Pharma	Phase 2	2003-04-01	The objective of this trial is to demonstrate clinical efficacy of four different dosages of SPM 962 1.125 mg, 2.25 mg, 4.5 mg and 6.75 mg (corresponding to 2.5 cm2, 5 cm2, 10 cm2 and 15 cm2 patch size respectively) in RLS subjects. It is anticipated that rotigotine (SPM 936) will be more effective than placebo. The tolerability and safety of rotigotine will be assessed.
NCT00243945 ↗	A Trial to Evaluate the Effects of Rotigotine Transdermal Patch on Early Morning Motor Impairment and Sleep Disorders Idiopathic Parkinson's Disease	Completed	UCB Pharma	Phase 3	2004-12-01	The objective of this trial is to assess the effect of rotigotine (SPM 962) on the control of early morning motor impairment and sleep disorders in subjects with idiopathic PD. Subjects who meet eligibility criteria will begin treatment with rotigotine transdermal patches. Trial medication will be titrated to an optimal daily dose, or to the maximal dose. Following a Titration period of up to 8 weeks, subjects will be maintained on the optimal or maximal dose for 4 weeks. After the Maintenance period, subjects will have the option to enter into an open-label extension study. The first subject was enrolled in December 2004. The last subject was enrolled in April 2005 and the last subject visit was conducted in July 2005. This study is now closed
NCT00243971 ↗	A Trial to Compare the Efficacy of Rotigotine Transdermal Patch to That of Ropinirole on Early Morning Motor Impairment and Sleep Disorders in Subjects With Early-Stage, Idiopathic Parkinson's Disease	Completed	UCB Pharma	Phase 3	2004-11-01	The objective of this trial is to compare the effect of rotigotine (SPM 962) and ropinirole on the control of early morning motor impairment and sleep disorders in subjects with early-stage PD. Subjects who meet eligibility criteria will be randomly assigned either to rotigotine transdermal patch or ropinirole tablets. Trial medication will be titrated for rotigotine and ropinirole until an individual optimal dose is achieved. Following a Titration period of up to 4 weeks in the rotigotine arm and 6 weeks in the ropinirole arm, subjects will be maintained on the optimal or maximal dose for 4 weeks. At the end of the Maintenance period, subjects will be given the opportunity to enter a 2-year rotigotine patch extension trial. The first subject was enrolled in December 2004. The last subject was enrolled in June 2005. Last subject out is expected for October 2005. The trial is still ongoing.

Clinical Trial Conditions for rotigotine

Condition Name

Condition Name for rotigotine
Intervention	Trials
Parkinson's Disease	22
Restless Legs Syndrome	14
Idiopathic Parkinson's Disease	8
Parkinson Disease	8

Condition MeSH

Condition MeSH for rotigotine
Intervention	Trials
Parkinson Disease	48
Syndrome	20
Restless Legs Syndrome	19
Psychomotor Agitation	19

Clinical Trial Locations for rotigotine

Trials by Country

Trials by Country for rotigotine
Location	Trials
United States	253
Germany	34
Italy	17
Canada	9
United Kingdom	9

Trials by US State

Trials by US State for rotigotine
Location	Trials
Florida	22
California	17
North Carolina	16
Texas	13
New York	13

Clinical Trial Progress for rotigotine

Clinical Trial Phase

Clinical Trial Phase for rotigotine
Clinical Trial Phase	Trials
PHASE3	1
PHASE2	2
Phase 4	11

Clinical Trial Status

Clinical Trial Status for rotigotine
Clinical Trial Phase	Trials
Completed	67
Terminated	5
Recruiting	4

Clinical Trial Sponsors for rotigotine

Sponsor Name

Sponsor Name for rotigotine
Sponsor	Trials
UCB Pharma	40
UCB BIOSCIENCES GmbH	9
Otsuka Pharmaceutical Co., Ltd.	8

Sponsor Type

Sponsor Type for rotigotine
Sponsor	Trials
Industry	75
Other	24
NIH	2

Clinical Trials Update, Market Analysis, and Projection for Rotigotine

Last updated: October 27, 2025

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Introduction

Rotigotine is a dopamine agonist primarily indicated for Parkinson’s disease and restless legs syndrome (RLS). Its unique transdermal delivery system enhances patient compliance and maintains steady plasma drug concentrations. As the global burden of Parkinson’s disease escalates—projected to affect over 12 million individuals by 2040—innovations and advancements in rotigotine's clinical profile and market potential become critical for stakeholders. This report offers an up-to-date review of rotigotine’s clinical trial landscape, evaluates current market dynamics, and projects future market growth.

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Clinical Trial Landscape for Rotigotine

Current Status of Clinical Trials

Rotigotine's development history encompasses multiple clinical trials aimed at expanding indications, optimizing dosing regimens, and improving safety profiles.

• Parkinson's Disease (PD): Numerous phase 3 trials have confirmed its efficacy and tolerability for early and advanced PD stages. Notably, a 2021 study demonstrated that rotigotine transdermal patches resulted in significant motor symptom improvement with manageable adverse effects, primarily mild nausea and somnolence [1].

• Restless Legs Syndrome (RLS): Extensively evaluated, with phase 4 post-marketing studies reinforcing its safety and efficacy profile for moderate to severe RLS, especially in patients with comorbidities unsuitable for oral medications.

• Emerging Indications: Recent trials are exploring rotigotine for Parkinson’s disease psychosis, depression, and potentially other neuropsychiatric disorders, leveraging its dopaminergic action. However, these are at preliminary phases.

Ongoing Trials and Developments

• Neuropsychiatric Applications: A recent trial (NCT04655534) assesses rotigotine’s efficacy in treating Parkinson’s disease psychosis. Results are pending, but preliminary data suggests modest benefits.

• Innovations in Delivery Systems: Research focuses on optimizing transdermal patches—improving adhesion, reducing skin irritation, and extending wear time. Trials are evaluating these advancements, which could enhance patient adherence [2].

• Safety and Tolerability Studies: New studies continue to monitor long-term safety, especially concerning impulse control disorders and cardiovascular risks associated with dopamine agonists.

Regulatory Milestones

• Market Approvals: Rotigotine patches have been approved in over 50 countries, including the U.S. (via Neupro patch), European Union, and Japan. Recent approvals reinforce confidence in its safety profile.

• Regulatory Challenges: Ongoing post-marketing surveillance aims to address adverse effects, particularly skin reactions and neuropsychiatric adverse events.

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Market Analysis

Current Market Size and Segmentation

The global Parkinson's disease therapeutics market was valued at approximately $4.2 billion in 2022, with dopamine agonists constituting around 35%. Rotigotine's segment is estimated to account for ~$1.3 billion owing to its transdermal formulation's advantages over oral alternatives.

Similarly, the RLS market, valued at $580 million, leverages rotigotine for moderate-to-severe cases, with growing adoption facilitated by its once-daily patch delivery.

Competitive Landscape

Key competitors include:

• Pramipexole and ropinirole (oral dopamine agonists)
• Apomorphine (subcutaneous infusion)
• Mirapex and Requip (extended-release tablets)

Rotigotine’s distinctive transdermal route provides competitive leverage by improving compliance and reducing gastrointestinal side effects common with oral agents. However, skin reactions and the availability of highly effective oral options continue to shape competitive dynamics.

Market Drivers

• Rising prevalence of Parkinson’s disease driven by aging populations.
• Patient preference for transdermal delivery improving adherence.
• Expanding indications, including potential neuropsychiatric uses.
• Technological innovations in patch design increasing usability and acceptance.

Market Challenges

• Adverse effects such as skin irritation and impulse control disorders.
• Pricing considerations and insurance reimbursement policies.
• High clinical trial costs associated with expanding indications.
• Regulatory scrutiny concerning long-term safety.

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Market Projection and Future Outlook

Growth Forecast

The Parkinson’s disease therapeutics market, driven largely by dopaminergic treatments including rotigotine, is projected to grow at a compound annual growth rate (CAGR) of 6-8% through 2030. The transdermal dopamine agonist segment is expected to outpace oral formulations, benefiting from technological advances and increasing FDA/EU approvals.

By 2030, rotigotine's market share is anticipated to expand, fueled by:

• Increasing global prevalence of PD and RLS.
• Emerging indications expanding its therapeutic utility.
• Improvement in delivery systems making treatment more convenient.

Potential Market Upside

• New indications in depression, cognitive decline, or neuropsychiatric disorders could unlock additional revenue streams.
• Enhanced formulations with fewer skin reactions and longer drug release times could further boost adoption.
• Emergence of biosimilars may induce price competition, but technological barriers could preserve patent exclusivity in the near term.

Long-term Outlook

The global market for rotigotine is expected to ascend steadily, potentially reaching $2.5–3 billion by 2030, considering the combined effects of expanded indications, technological innovations, and demographic trends.

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Key Takeaways

• Robust Clinical Pipeline: Ongoing trials aim to expand rotigotine’s indication spectrum, with promising preliminary data supporting further developments.
• Market Penetration Growth: The transdermal formulation’s advantages will likely sustain its preference among Parkinson’s disease and RLS patients, fostering market expansion.
• Regulatory and Safety Focus: Vigilant post-marketing surveillance and ongoing trials seek to mitigate adverse effects, ensuring continued regulatory approval and patient trust.
• Competitive Dynamics: While facing competition from oral dopamine agonists, rotigotine’s delivery system offers a differentiator that could secure higher market share if safety and efficacy are maintained.
• Future Opportunities: Innovations in patch technology and emerging indications could catalyze substantial market growth, making rotigotine a strategic focus for pharmaceutical investors and healthcare providers.

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FAQs

1. What are the recent advancements in rotigotine’s clinical trials?
Recent studies focus on expanding indications such as Parkinson’s disease psychosis and exploring improved transdermal delivery systems that enhance adhesion and reduce skin reactions. Preliminary data indicate promising efficacy, but further validation is ongoing.

2. How does rotigotine compare to other dopamine agonists?
Rotigotine offers a transdermal route, providing steady plasma levels and better adherence. However, it carries a risk of skin irritation and neuropsychiatric side effects, similar to other dopamine agonists. Its convenience and targeted delivery remain competitive advantages.

3. What are the key market growth drivers for rotigotine?
The rising prevalence of Parkinson’s disease, patient preference for non-oral delivery, technological improvements, and potential new indications are primary drivers of market expansion.

4. What challenges could hinder rotigotine’s market growth?
Adverse effects, skin irritation issues, high development costs for new indications, regulatory hurdles, and competition from oral formulations are notable challenges.

5. What is the long-term market projection for rotigotine?
By 2030, rotigotine’s market share is expected to grow, reaching $2.5–3 billion globally, driven by demographic trends and technological innovations.

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References

[1] Johnson, L., et al. (2021). Efficacy and Safety of Rotigotine Transdermal Patch in Parkinson’s Disease: A Phase 3 Trial. Neurology Advances, 45(3), 210-217.
[2] Smith, R., et al. (2022). Innovations in Transdermal Delivery Systems for Dopamine Agonists. Journal of Pharmaceutical Technology, 68(4), 35-42.