Clinical Trials

Numerous clinical trials evaluate the therapeutic efficacy of ropinirole across various neurological and endocrine conditions, primarily Parkinson's disease and restless legs syndrome, alongside secondary indications including major depressive disorder, hyperprolactinemia, and cerebrovascular accident. Spanning Phase 1 through Phase 4 clinical development with recruitment statuses ranging from completed to terminated, these studies assess various formulations and combination regimens. The research is sponsored by major pharmaceutical corporations and academic research centers, highlighting the broad scope of ropinirole's clinical evaluation.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06468371 COMPLETED
Hemodialysis; Restless Legs Syndrome; ESRD (End Stage Renal Disease); Diabetes Complications
Lahore General Hospital
 2022-01-02
NCT03806530 COMPLETED
End Stage Renal Disease; Restless Legs Syndrome
Population Health Research Institute
 2019-05-01 PHASE3
NCT03176966 COMPLETED
Muscle Cramp; Cirrhosis
Vanderbilt University Medical Center
 2016-09-02 PHASE4
NCT03038308 COMPLETED
Hyperprolactinemia; Prolactinoma
Columbia University
 2016-09-16 PHASE1; PHASE2
NCT03708237 TERMINATED
Restless Legs Syndrome; End Stage Renal Disease
University of Alberta
 2019-02-19 PHASE2
NCT03708237 Terminated
Restless Legs Syndrome|End Stage Renal Disease
University of Alberta
 2019-02-19 Phase 2
NCT03250117 TERMINATED
Parkinson Disease
Titan Pharmaceuticals
 2017-10-10 PHASE1; PHASE2
NCT03250117 Terminated
Parkinson Disease
Titan Pharmaceuticals
 2017-10-10 Phase 1|Phase 2
NCT01393457 COMPLETED
Cocaine Dependence
The University of Texas Health Science Center, Houston
 2011-06 PHASE2
NCT01494532 COMPLETED
Parkinson Disease
GlaxoSmithKline
 2012-04-02 PHASE4
NCT01929317 TERMINATED
Parkinson Disease
GlaxoSmithKline
 2013-08-28 PHASE3
NCT01485172 COMPLETED
Parkinson Disease
GlaxoSmithKline
 2012-01-31 PHASE4
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
NCT01007864 COMPLETED
Idiopathic Parkinson's Disease
Desitin Arzneimittel GmbH
 2010-01 PHASE3
NCT01154166 COMPLETED
Parkinson Disease
GlaxoSmithKline
 2010-02-15 PHASE3
NCT01628926 COMPLETED
Parkinson's Disease
Otsuka Pharmaceutical Co., Ltd.
 2009-06 PHASE3
NCT00986245 COMPLETED
Parkinson Disease
Seoul National University Hospital
 2009-09 PHASE4
NCT00823836 COMPLETED
Parkinson Disease
GlaxoSmithKline
 2009-03 PHASE3
NCT00144300 COMPLETED
Parkinson Disease
Boehringer Ingelheim
 2005-01 PHASE4
NCT01435915 COMPLETED
Parkinson Disease
GlaxoSmithKline
 2010-06-28 PHASE1
NCT00996944 TERMINATED
Restless Legs Syndrome
GlaxoSmithKline
 2009-11-30 PHASE2
NCT00632736 COMPLETED
Parkinson Disease; Parkinson's Disease
GlaxoSmithKline
 2004-02 PHASE3
NCT01371682 COMPLETED
Parkinson Disease
GlaxoSmithKline
 2009-09-18 PHASE1
NCT00485069 COMPLETED
Parkinson Disease; Parkinson's Disease
GlaxoSmithKline
 2007-06 PHASE4
NCT01627834 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
 2009-10 PHASE1
NCT01627847 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
 2009-10 PHASE1
NCT00434304 COMPLETED
Parkinson Disease
GlaxoSmithKline
 2007-04-09 PHASE2
NCT00823836 Completed
Parkinson Disease
GlaxoSmithKline
 2009-03 Phase 3
NCT00650104 COMPLETED
Parkinson Disease
GlaxoSmithKline
 2002-05 PHASE3
NCT01714856 COMPLETED
Pharmacokinetic Study
Lupin Ltd.
 2008-09 PHASE1
NCT01717235 COMPLETED
Pharmacokinetic Study
Lupin Ltd.
 2008-09 PHASE1
NCT00329602 COMPLETED
Restless Legs Syndrome
GlaxoSmithKline
 2006-03 PHASE4
NCT01712568 COMPLETED
Pharmacokinetic Study
Lupin Ltd.
 2008-09 PHASE1
NCT00639119 UNKNOWN
Unverricht-Lundborg Syndrome
University of Turku
 2007-08 PHASE2
NCT00275275 COMPLETED
Parkinson Disease
Rajesh Pahwa, MD
 2006-01 PHASE3
NCT00140712 COMPLETED
Restless Legs Syndrome
GlaxoSmithKline
 2005-06-10 PHASE1
NCT00530790 COMPLETED
Restless Legs Syndrome
GlaxoSmithKline
 2007-08-23 PHASE2
NCT00357097 COMPLETED
Restless Legs Syndrome; Moderate to Severe Idiopathic Restless Legs Syndrome (RLS)
GlaxoSmithKline
 2006-06 PHASE3
NCT00593606 COMPLETED
Parkinson's Disease
UCB Pharma
 2007-07 PHASE3
NCT00355641 COMPLETED
Restless Legs Syndrome
GlaxoSmithKline
 2005-10 PHASE3
NCT00334048 COMPLETED
Sexual Dysfunction
St. Luke's-Roosevelt Hospital Center
 2006-06 PHASE4
NCT00344994 COMPLETED
Restless Legs Syndrome
Augusta University
 2006-05 PHASE4
NCT00331149 COMPLETED
Parkinson Disease
GlaxoSmithKline
 2006-06-20 PHASE3
NCT00530790 Completed
Restless Legs Syndrome
GlaxoSmithKline
 2007-08-23 Phase 2
NCT00314821 COMPLETED
Bipolar Disorder
Cambridge Health Alliance
 2005-09 PHASE4
NCT00373542 COMPLETED
Restless Legs Syndrome (RLS); Restless Legs Syndrome
GlaxoSmithKline
 2006-10 PHASE4
NCT00460148 Completed
Parkinson Disease
GlaxoSmithKline
 2007-04 Phase 2
NCT00221390 COMPLETED
Cerebrovascular Accident; Hemiparesis
University of California, Irvine
 2003-10 PHASE2
NCT00419692 COMPLETED
Restless Legs Syndrome
GlaxoSmithKline
 2006-08-24 PHASE1
NCT00314860 COMPLETED
Restless Legs Syndrome; Restless Legs Syndrome (RLS)
GlaxoSmithKline
 2006-02 PHASE3
NCT00422994 COMPLETED
Restless Legs Syndrome
GlaxoSmithKline
 2006-04 PHASE1
NCT00256854 COMPLETED
Restless Legs Syndrome; Restless Legs Syndrome (RLS)
GlaxoSmithKline
 2005-11-14 PHASE3
NCT00363727 COMPLETED
Parkinson's Disease; Parkinson Disease; Dyskinesias
GlaxoSmithKline
 2003-12 PHASE3
NCT00243971 COMPLETED
Parkinson's Disease
UCB Pharma
 2004-11 PHASE3
NCT00242008 COMPLETED
Parkinson's Disease
UCB Pharma
 2004-12 PHASE3
NCT00830219 COMPLETED
Healthy
Teva Pharmaceuticals USA
 2004-11 PHASE1
NCT00829504 COMPLETED
Healthy
Teva Pharmaceuticals USA
 2004-10 PHASE1
NCT00363857 COMPLETED
Restless Legs Syndrome (RLS); Restless Legs Syndrome
GlaxoSmithKline
 2003-08 PHASE3
NCT00673088 COMPLETED
Parkinson's Disease; Restless Leg Syndrome
Roxane Laboratories
 2004-02
NCT00674310 COMPLETED
Parkinson's Disease; Restless Leg Syndrome
Roxane Laboratories
 2004-02
NCT00036218 COMPLETED
Parkinson Disease
Pfizer
 2001-12 PHASE3
NCT00285727 COMPLETED
Depressive Disorder, Major
Stanford University
 2006-01
NCT00381472 COMPLETED
Parkinson Disease
GlaxoSmithKline
 2003-06 PHASE3
NCT00367822 COMPLETED
Restless Legs Syndrome
Axxonis Pharma AG
 PHASE3
NCT00197080 COMPLETED
Restless Legs Syndrome
GlaxoSmithKline
 2005-06 PHASE3
NCT00260793 UNKNOWN
Parkinson's Disease
Agarwal, Pinky, M.D.
 2005-11 PHASE3
NCT00256893 COMPLETED
Fibromyalgia Syndrome, Primary
GlaxoSmithKline
 2004-11 PHASE2
NCT00335205 UNKNOWN
Bipolar Disorder; Major Depressive Disorder
Sheba Medical Center
 2003-04 PHASE4
NCT00460148 COMPLETED
Parkinson Disease
GlaxoSmithKline
 2007-04 PHASE2
NCT00225862 COMPLETED
Restless Legs Syndrome
GlaxoSmithKline
 2005-01 PHASE3

(data from https://clinicaltrials.gov, updated on 2024-06-21)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ropinirole acts as a selective dopamine D2 receptor agonist with a Ki of 29 nM, binding to postsynaptic D2 receptors to stimulate downstream intracellular signaling pathways that mimic endogenous dopamine action. By restoring dopaminergic neurotransmission within the striatum, this compound alleviates motor deficits in patients with Parkinson's disease and suppresses abnormal sensorimotor urge symptoms associated with 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.