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.

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	7

Condition MeSH

Condition MeSH for Rotigotine
Intervention	Trials
Parkinson Disease	46
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	29
Italy	16
Spain	9
Canada	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
Phase 4	11
Phase 3	29
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Rotigotine
Clinical Trial Phase	Trials
Completed	66
Terminated	5
Unknown status	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	72
Other	21
NIH	2

Rotigotine: Clinical Trials, Market Analysis, and Projections

Introduction to Rotigotine

Rotigotine is a non-ergoline dopamine agonist approved for the treatment of Parkinson’s disease (PD) and restless legs syndrome (RLS) in Europe and the United States. It is formulated as a once-daily transdermal patch to enhance bioavailability and provide a steady supply of the drug over 24 hours[3].

Clinical Trials and Efficacy

Meta-Analysis and Clinical Outcomes

A meta-analysis of six randomized controlled trials involving 1789 patients showed that rotigotine significantly improved symptoms of Parkinson’s disease. The Unified Parkinson’s Disease Rating Scale (UPDRS) scores indicated greater improvements in activities of daily living, motor scores, and the combined activities of daily living and motor subtotal scores compared to placebo. However, rotigotine was associated with a higher incidence of adverse events and withdrawals due to these events[1].

Ongoing and Planned Clinical Trials

BioNxt Solutions Inc. is preparing for a human clinical pilot study in Q2 2023 to assess the relative bioavailability, skin adhesion, and skin tolerance of their new optimized transdermal formulation of rotigotine compared to the existing name brand product. This study will be conducted in Europe, following Good Clinical Practice (GCP) and European Medical Agency (EMA) guidelines[2].

Another clinical trial aims to investigate the patch adhesion properties of a newly developed rotigotine patch and the marketed Neupro® 8 mg/24 h patch. This multi-centre, open, randomized trial will evaluate patch adhesion after multiple applications in patients with idiopathic Parkinson’s disease[5].

Market Analysis

Global Market Size and Growth

The global market for rotigotine patches is substantial and growing. In 2021, total global sales for rotigotine patches were approximately $518 million, with the market expected to surpass $766 million by 2030[3].

Transdermal Skin Patch Market

The broader transdermal skin patch market had a value of nearly $6.5 billion in 2020 and is projected to reach approximately $20 billion by 2028. This growth indicates a strong demand for transdermal delivery systems, which rotigotine patches are a part of[3].

Therapeutic Market for Parkinson’s Disease

The therapeutic market for Parkinson’s disease is significant, with over 10 million people worldwide affected and the number growing. This demographic trend supports the continued demand for effective treatments like rotigotine[3].

Commercialization and Market Projections

BioNxt Solutions Inc.

BioNxt Solutions Inc. has reported excellent in-vitro/ex-vivo results for their new optimized transdermal formulation of rotigotine. The company is leveraging its TDS platform technology to enhance drug absorption and skin adhesion. With positive results, BioNxt is moving forward with clinical trials and commercialization plans, which could further expand the market share of rotigotine patches[2].

XPhyto Therapeutics

XPhyto Therapeutics has also reported excellent in-vitro/ex-vivo results for their rotigotine transdermal product. Their platform technology represents a scalable opportunity for additional TDS drug development and manufacturing programs, potentially increasing the market presence of rotigotine patches[3].

Safety and Adverse Events

Adverse Events in Clinical Trials

Clinical trials have shown that rotigotine is associated with a higher rate of withdrawals due to adverse events compared to placebo. Common adverse events include those related to the gastrointestinal system, nervous system, and skin reactions. Despite these side effects, the overall efficacy of rotigotine in managing Parkinson’s disease symptoms is well-documented[1][4].

Future Outlook

Market Growth Potential

The market for rotigotine patches is expected to continue growing, driven by the increasing prevalence of Parkinson’s disease and the preference for transdermal delivery systems. The projected growth to over $766 million by 2030 underscores the potential for rotigotine to remain a significant player in the treatment of PD and RLS[3].

Technological Advancements

Advancements in transdermal patch technology, such as those being developed by BioNxt and XPhyto, are likely to improve the bioavailability, skin adhesion, and overall patient compliance with rotigotine treatment. These improvements could further enhance the market position of rotigotine patches[2][3].

Key Takeaways

• Efficacy: Rotigotine significantly improves Parkinson’s disease symptoms, as evidenced by clinical trials and meta-analyses.
• Market Size: The global market for rotigotine patches was approximately $518 million in 2021 and is projected to surpass $766 million by 2030.
• Transdermal Market: The broader transdermal skin patch market is growing, expected to reach $20 billion by 2028.
• Commercialization: Companies like BioNxt and XPhyto are advancing the technology and commercialization of rotigotine patches.
• Safety: While effective, rotigotine is associated with a higher rate of adverse events and withdrawals compared to placebo.

FAQs

Q: What is rotigotine used for?

A: Rotigotine is used for the treatment of Parkinson’s disease and restless legs syndrome (RLS).

Q: How is rotigotine administered?

A: Rotigotine is administered via a once-daily transdermal patch to enhance bioavailability and provide a steady supply of the drug over 24 hours.

Q: What are the common adverse events associated with rotigotine?

A: Common adverse events include gastrointestinal issues, nervous system reactions, and skin reactions.

Q: What is the current market size for rotigotine patches?

A: The global sales for rotigotine patches were approximately $518 million in 2021.

Q: What are the projected market growth and future outlook for rotigotine patches?

A: The market is expected to surpass $766 million by 2030, driven by the increasing prevalence of Parkinson’s disease and advancements in transdermal patch technology.

Sources

1. PLOS ONE: "Rotigotine Transdermal Patch in Parkinson's Disease"
2. BioSpace: "BioNxt Reports Update on Commercialization of Rotigotine Patch for Treatment of Parkinson’s Disease"
3. BioSpace: "XPhyto Reports Excellent Rotigotine In-Vitro/Ex-Vivo Results for Parkinson’s Disease Treatment"
4. FDA: "Neupro (Rotigotine) patch transdermal system"
5. Veeva: "Clinical Trial to Investigate Patch Adhesion of Rotigotine Containing Patches in Patients with Parkinson’s Disease"