Clinical Trials

Numerous clinical trials evaluate the therapeutic application, transdermal patch pharmacokinetics, long-term safety, and non-motor symptom outcomes of rotigotine across Phase 1 through Phase 4 studies. Sponsored by pharmaceutical developers and academic institutions, these investigations encompass completed, recruiting, terminated, and unknown recruitment statuses. The research primarily focuses on healthy volunteers, restless legs syndrome, and Parkinson's disease, including idiopathic, advanced-stage, and apathy-associated presentations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06291116 RECRUITING
Kidney Diseases
University Hospital, Rouen
 2026-05-12 PHASE2
NCT05886582 COMPLETED
Substance-Related Disorders
Virginia Commonwealth University
 2023-09-11 PHASE2
NCT07769359 COMPLETED
Bioequivalence; Adhesion; Adverse Effects
Amarin Technologies S.A.U.
 2025-12-04 PHASE1
NCT06702124 RECRUITING
Alzheimer Disease
I.R.C.C.S. Fondazione Santa Lucia
 2023-12-01 PHASE3
NCT04937452 COMPLETED
Frontotemporal Dementia; Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Neurodegenerative Diseases; Frontotemporal Lobar Degeneration; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Disease; Aphasia; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations
I.R.C.C.S. Fondazione Santa Lucia
 2021-06-03 PHASE2
NCT03992196 TERMINATED
Restless Legs Syndrome
UCB Biopharma SRL
 2019-12-03 PHASE3
NCT03728933 TERMINATED
Restless Legs Syndrome
UCB Biopharma SRL
 2018-12-20 PHASE3
NCT04571164 COMPLETED
Parkinson Disease
Luye Pharma Group Ltd.
 2020-05-11 PHASE3
NCT06247410 COMPLETED
Parkinson Disease
SocraTec R&D GmbH
 2021-08-23 PHASE2
NCT04384666 COMPLETED
Parkinson Disease
Luye Pharma Group Ltd.
 2020-06-02 PHASE1
NCT04183634 TERMINATED
Parkinson Disease
Sandoz
 2019-12-03 PHASE1
NCT02365870 TERMINATED
Anxiety Disorders; Parkinson Disease
Johns Hopkins University
 2016-08 PHASE4
NCT04045678 COMPLETED
Parkinson Disease
Luye Pharma Group Ltd.
 2017-10-10 PHASE1
NCT04455555 COMPLETED
Parkinson's Disease
Peking University Third Hospital
 2018-08-01 PHASE3
NCT03733561 COMPLETED
Parkinson Disease
Luye Pharma Group Ltd.
 2018-11-09 PHASE1
NCT03250741 COMPLETED
Alzheimer Disease
I.R.C.C.S. Fondazione Santa Lucia
 2016-06 PHASE2
NCT03103919 COMPLETED
Parkinson´s Disease
UCB Biopharma S.P.R.L.
 2017-03-16 PHASE4
NCT03098368 UNKNOWN
Nocturnal Hypokinesia
Chulalongkorn University
 2016-09 PHASE4
NCT02786667 UNKNOWN
Parkinson Disease; Apathy
University Hospital, Grenoble
 2012-06 PHASE3
NCT02123979 UNKNOWN
Post-op Pain
East Carolina University
 2015-11 PHASE2
NCT02728947 COMPLETED
Parkinson's Disease
Luye Pharma Group Ltd.
 2016-05 PHASE1
NCT01823770 COMPLETED
Restless Legs Syndrome (RLS)
University Hospital, Montpellier
 2012-11-26 PHASE4
NCT02728947 Completed
Parkinson''s Disease
Luye Pharma Group Ltd.
 2016-05 Phase 1
NCT01498120 COMPLETED
Restless Legs Syndrome
UCB BIOSCIENCES, Inc.
 2011-12 PHASE2
NCT02103465 TERMINATED
Parkinson's Disease
Azienda Ospedaliera Cardinale G. Panico
 2013-12 PHASE2
NCT01976871 COMPLETED
Restless Legs Syndrome; Ekbom Syndrome; Willis-Ekbom Disease
John Winkelman, MD, PhD
 2014-08 PHASE4
NCT02230904 COMPLETED
Parkinson's Disease
UCB BIOSCIENCES GmbH
 2014-09 PHASE1
NCT01646255 COMPLETED
Idiopathic Parkinson's Disease
UCB Pharma
 2012-07 PHASE3
NCT01523301 COMPLETED
Idiopathic Parkinson's Disease
UCB Korea Co., Ltd.
 2012-04 PHASE4
NCT02070796 COMPLETED
Healthy
UCB Pharma SA
 2014-02 PHASE1
NCT01646268 COMPLETED
IDIOPATHIC PARKINSON'S DISEASE
UCB Pharma
 2012-07 PHASE3
NCT01495793 COMPLETED
Restless Legs Syndrome
UCB BIOSCIENCES, Inc.
 2011-12 PHASE2
NCT04044547 COMPLETED
Parkinson Disease
Luye Pharma Group Ltd.
 2013-11-22 PHASE1
NCT02070796 Completed
Healthy
UCB Pharma SA|UCB Pharma
 2014-02 Phase 1
NCT01782222 COMPLETED
Idiopathic Parkinson's Disease
UCB BIOSCIENCES GmbH
 2013-02 PHASE4
NCT01744496 COMPLETED
Advanced Idiopathic Parkinson's Disease
UCB BIOSCIENCES GmbH
 2012-11 PHASE4
NCT01537042 COMPLETED
Restless Legs Syndrome; End-Stage Renal Disease
UCB BIOSCIENCES GmbH
 2012-04 PHASE3
NCT02727205 COMPLETED
Bioequivalence - Irritation and Sensitization Potential of Transdermal Patch
Inflamax Research Incorporated
 2013-08 PHASE1
NCT01536015 TERMINATED
Advanced Parkinson's Disease
UCB Pharma
 2012-01 PHASE3
NCT01569464 COMPLETED
Restless Legs Syndrome
UCB Pharma
 2012-03 PHASE3
NCT01723904 COMPLETED
Advanced Parkinson's Disease
UCB BIOSCIENCES GmbH
 2012-10 PHASE3
NCT01711866 COMPLETED
Advanced Idiopathic Parkinson's Disease
UCB BIOSCIENCES GmbH
 2012-09 PHASE4
NCT01519882 TERMINATED
Advanced Idiopathic Parkinson's Disease
UCB Pharma SA
 2012-03 PHASE4
NCT01300819 COMPLETED
Idiopathic Parkinson's Disease
UCB Pharma
 2011-02 PHASE4
NCT01675024 COMPLETED
Healthy
UCB Pharma
 2012-08 PHASE1
NCT01675024 Completed
Healthy
UCB Pharma
 2012-08 Phase 1
NCT01565018 COMPLETED
Healthy Volunteers
UCB Pharma
 2012-03 PHASE1
NCT02786667 Unknown status
Parkinson Disease|Apathy
University Hospital Grenoble
 2012-06 Phase 3
NCT01455012 COMPLETED
Restless Legs Syndrome
UCB BIOSCIENCES GmbH
 2011-09 PHASE4
NCT01565018 Completed
Healthy Volunteers
UCB Pharma|Otsuka Pharmaceutical Co. Ltd.
 2012-03 Phase 1
NCT00522379 COMPLETED
Parkinson's Disease
UCB Pharma
 2007-07 PHASE3
NCT01338896 COMPLETED
Parkinson's Disease
UCB Pharma
 2011-04 PHASE1
NCT00663338 COMPLETED
Right Hemisphere Stroke; Hemispatial Neglect; Motor Deficit
University College, London
 2010-01 PHASE2
NCT01059903 COMPLETED
Healthy Volunteers
UCB Pharma
 2010-01 PHASE1
NCT00957944 COMPLETED
Healthy Volunteers
UCB Pharma
 2009-07 PHASE1
NCT00519532 TERMINATED
Parkinson's Disease
UCB Pharma
 2007-07 PHASE3
NCT00498186 COMPLETED
Restless Legs Syndrome
UCB Pharma
 2003-07 PHASE2
NCT00474058 COMPLETED
Parkinson's Disease
UCB Pharma
 2007-05 PHASE3
NCT00501969 COMPLETED
Advanced Stage Parkinson's Disease
UCB Pharma
 2004-08 PHASE3
NCT00505687 COMPLETED
Idiopathic Parkinson's Disease
UCB Pharma
 2005-02 PHASE3
NCT00594386 COMPLETED
Parkinson's Disease
UCB Pharma
 2002-08 PHASE3
NCT00599196 COMPLETED
Early Stage Parkinson's Disease
UCB Pharma
 2002-08 PHASE3
NCT00881894 COMPLETED
Healthy
UCB Pharma
 2008-10 PHASE1
NCT00594165 COMPLETED
Early-Stage Parkinson's Disease
UCB Pharma
 2002-06 PHASE3
NCT00464737 COMPLETED
Fibromyalgia Syndrome
UCB Pharma
 2007-03 PHASE2
NCT00594464 COMPLETED
Parkinson's Disease
UCB Pharma
 2007-09 PHASE4
NCT00593606 COMPLETED
Parkinson's Disease
UCB Pharma
 2007-07 PHASE3
NCT00263068 COMPLETED
Restless Legs Syndrome
UCB Pharma
 2005-12 PHASE3
NCT00498108 COMPLETED
Idiopathic Restless Legs Syndrome
UCB Pharma
 2006-01 PHASE3
NCT01964573 COMPLETED
Parkinson's Disease
UCB Pharma
 2006-12 PHASE1
NCT00389831 COMPLETED
Restless Legs Syndrome
UCB Pharma
 2006-08 PHASE2
NCT00135993 COMPLETED
Restless Legs Syndrome
UCB Pharma
 2005-05 PHASE3
NCT00292227 COMPLETED
Parkinson's Disease
UCB Pharma
 2006-01 PHASE1
NCT00136045 COMPLETED
Restless Legs Syndrome
UCB Pharma
 2005-05 PHASE3
NCT00275236 COMPLETED
Restless Legs Syndrome
UCB Pharma
 2005-11 PHASE3
NCT00296192 COMPLETED
Parkinson's Disease
UCB Pharma
 2006-02 PHASE2
NCT00243971 COMPLETED
Parkinson's Disease
UCB Pharma
 2004-11 PHASE3
NCT00244387 COMPLETED
Parkinson Disease, Idiopathic
UCB Pharma
 2004-03 PHASE3
NCT00243945 COMPLETED
IDIOPATHIC PARKINSON'S DISEASE
UCB Pharma
 2004-12 PHASE3
NCT00242008 COMPLETED
Parkinson's Disease
UCB Pharma
 2004-12 PHASE3
NCT00243217 COMPLETED
Idiopathic Restless Leg Syndrome
UCB Pharma
 2003-04 PHASE2
NCT01854216 COMPLETED
Healthy
UCB BIOSCIENCES GmbH
 2002-12 PHASE1
NCT01761526 COMPLETED
Healthy
UCB BIOSCIENCES GmbH
 2002-10 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-06-09)

Check the Rotigotine product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Rotigotine functions as a potent dopamine receptor agonist that directly binds to and activates central dopamine receptors, thereby stimulating downstream intracellular G-protein signaling cascades within striatal neurons. This activation compensates for nigrostriatal dopamine depletion and normalizes sensorimotor basal ganglia circuits, effectively restoring motor control and reducing symptoms in patients evaluated for Parkinson's disease and restless legs syndrome.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.