Clinical Trials

Numerous clinical trials evaluate benserazide across multiple indications, primarily Parkinson's disease, healthy volunteers, and schizotypal personality disorder, alongside conditions such as beta thalassemia intermedia, sickle cell disease, periodontitis, and aphasia. Spanning early phase 1 through phase 4, these studies are sponsored by diverse academic and industry organizations, including Bial - Portela C S.A. and the University of Zurich. Recruitment statuses range from active and enrolling by invitation to completed trials evaluating levodopa/benserazide bioequivalence and pharmacokinetic interactions.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04432623 ENROLLING_BY_INVITATION
Beta Thalassemia Intermedia; Sickle Cell Disease
Phoenicia BioScience
 2020-10-05 PHASE1; PHASE2
NCT06115538 UNKNOWN
Parkinson Disease; Treatment Adherence
Ankara Ataturk Sanatorium Training and Research Hospital
 2023-10-01 PHASE4
NCT02769793 COMPLETED
Parkinson Disease
Seoul National University Hospital
 2015-06 PHASE4
NCT02741947 COMPLETED
Parkinson Disease
IRCCS San Raffaele Roma
 2014-04 PHASE4
NCT03333369 COMPLETED
Healthy; Schizotypal Personality
University of Zurich
 2014-05-15 EARLY_PHASE1
NCT01568073 COMPLETED
Parkinson's Disease
Bial - Portela C S.A.
 2011-03 PHASE3
NCT01227655 COMPLETED
Parkinson's Disease
Bial - Portela C S.A.
 2011-03 PHASE3
NCT02169414 COMPLETED
Parkinson's Disease (PD)
Bial - Portela C S.A.
 2010-02 PHASE1
NCT01568047 COMPLETED
Parkinson's Disease
Bial - Portela C S.A.
 2010-02 PHASE2
NCT01327261 COMPLETED
Healthy Volunteers
University of Buenos Aires
 2009-08 PHASE4
NCT00941265 COMPLETED
Aphasia
University Hospital, Geneva
 2007-02
NCT01533116 COMPLETED
Parkinson Disease
Bial - Portela C S.A.
 2009-03 PHASE1
NCT01327261 Completed
Healthy Volunteers
University of Buenos Aires|Laboratorios Phoenix S.A.I.C.y F.
 2009-08 Phase 4
NCT02169466 COMPLETED
Parkinson's Disease (PD)
Bial - Portela C S.A.
 2009-01 PHASE1
NCT02169895 COMPLETED
Parkinson's Disease (PD)
Bial - Portela C S.A.
 2008-09 PHASE1
NCT03103399 COMPLETED
Parkinson Disease
Bial - Portela C S.A.
 2006-09-26 PHASE2
NCT03097211 COMPLETED
Parkinson Disease
Bial - Portela C S.A.
 2006-07-17 PHASE1
NCT03094156 COMPLETED
Parkinson Disease
Bial - Portela C S.A.
 2006-04-26 PHASE1
NCT02778594 COMPLETED
Parkinson's Disease (PD)
Bial - Portela C S.A.
 2005-09 PHASE1
NCT00144209 COMPLETED
Restless Legs Syndrome
Boehringer Ingelheim
 2003-02 PHASE3
NCT03091543 COMPLETED
Parkinson Disease
Bial - Portela C S.A.
 2004-05-04 PHASE1
NCT00203164 Completed
Parkinson''s Disease
Teva Branded Pharmaceutical Products R&D Inc.
 2002-05 Phase 3
NCT02763852 COMPLETED
Parkinson's Disease
Bial - Portela C S.A.
 2001-04 PHASE1

(data from https://clinicaltrials.gov, updated on 2025-08-15)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Benserazide selectively binds to and inhibits peripheral aromatic L-amino acid decarboxylase, thereby blocking the enzymatic conversion of levodopa into dopamine in peripheral tissues. This inhibition prevents peripheral dopamine accumulation while facilitating central nervous system levodopa uptake, effectively mitigating peripheral side effects such as nausea and arrhythmia in the clinical management of Parkinson's disease.

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>).

Jump to

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