Drugs / Tolcapone

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) TASMAR 1998-01-29 fda.gov
Approved EU (EMA) Tasmar 1997-08-27 europa.eu

Trials 19 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 03 trials
Phase 0 NCT04205994 Dec 2019 → Dec 2023 University of California, Berkeley Completed No outcome recorded
Phase 0 NCT03591757 Oct 2018 → Apr 2019 hereditary amyloidosis Boston University Completed No outcome recorded
Phase 0 NCT02260570 Aug 2015 → Jun 2021 traumatic brain injury VA Office of Research and Development Completed No outcome recorded
Phase 15 trials
Phase 1 NCT05065671 Feb 2022 → Sep 2025 Rutgers, The State University of New Jersey Completed No outcome recorded
Phase 1 NCT03633591 Jun → Oct 2018 Corino Therapeutics, Inc. Completed No outcome recorded
Phase 1 NCT02630043 Dec 2015 → Jul 2019 neuroblastoma Giselle Sholler Terminated No outcome recorded
Phase 1 NCT02080715 Jun 2013 → Apr 2014 University of Zurich Completed No outcome recorded
Phase 1 NCT00033059 Jul 2001 → Mar 2002 substance-related disorder National Institute on Drug Abuse (NIDA) Unknown No outcome recorded
Phase 27 trials
Phase 2 NCT05624528 Jun 2023 → Jun 2026 overdue obsessive-compulsive disorder University of Chicago Active not recruiting No outcome recorded
Phase 2 NCT03904498 Aug 2021 → Mar 2026 alcohol-related disorders, attention deficit-hyperactivity disorder University of Colorado, Denver Completed No outcome recorded
Phase 2 NCT02740582 Oct 2016 → Sep 2019 alcohol abuse, impulse control disorder Jennifer Mitchell Completed No outcome recorded
Phase 2 NCT02652598 Nov 2015 → Jan 2020 cognitive disorder, traumatic brain injury Sheppard Pratt Health System Unknown No outcome recorded
Phase 2 NCT06387771 Sep 2014 → Aug 2025 schizophrenia Clinica Universidad de Navarra, Universidad de Navarra Unknown No outcome recorded
Phase 2 NCT00927563 Jun 2009 → May 2012 pathological gambling University of Chicago Completed No outcome recorded
Phase 2 NCT00604591 Jan 2008 → Jun 2016 frontotemporal dementia Columbia University Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT03348930 Mar 2018 → Dec 2020 obsessive-compulsive disorder University of Chicago Completed No outcome recorded
Phase 42 trials
Phase 4 NCT02929485 Jul 2013 → Jan 2018 substance dependence University of California, Berkeley Withdrawn No outcome recorded
Phase 4 NCT00906828 Oct 2008 → Nov 2009 Parkinson disease Uppsala University Completed No outcome recorded
Phase not applicable1 trial
NCT01158950 Mar 2010 → Dec 2018 impulse control disorder University of California, San Francisco Completed No outcome recorded
Also used as a comparator or background therapy in 7 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 25 trials
Phase 2 NCT03273062 Comparator Jul 2017 → Jul 2018 traumatic brain injury Sheppard Pratt Health System Unknown No outcome recorded
Phase 2 NCT02949934 Comparator May 2016 → Apr 2021 alcohol-related disorders Medical University of South Carolina Completed No outcome recorded
Phase 2 NCT01001520 Comparator Jan 2010 → Oct 2012 nicotine dependence University of Pennsylvania Completed No outcome recorded
Phase 2 NCT01202955 Comparator Jul 2008 → May 2009 nicotine dependence University of Pennsylvania Completed No outcome recorded
Phase 2 NCT00044083 Comparator Aug 2002 → Dec 2015 schizophrenia National Institute of Mental Health (NIMH) Terminated No outcome recorded
Phase not applicable2 trials
NCT02448654 Comparator Oct 2015 → Jun 2019 nicotine dependence Yale University Completed No outcome recorded
NCT02772978 Comparator Aug 2014 → Sep 2015 pathological gambling University of California, San Francisco Completed No outcome recorded

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 27 sources stand behind the page.

FieldValueCited text
Known as Tolcapone ClinicalTrials.gov intervention name — accepted as the source's own label NCT02652598
25

NCT02448654

NCT00927563

NCT02929485

NCT01001520

NCT03273062

NCT02772978

NCT03633591

NCT00604591

NCT02949934

NCT05065671

NCT03591757

NCT02740582

NCT02630043

NCT04205994

NCT06387771

NCT02260570

NCT00044083

NCT03348930

NCT00033059

NCT03904498

NCT01158950

NCT01202955

NCT02080715

NCT00906828

NCT05624528

Action Inhibit “pharmacological reduction of COMT activity” PMID 23794107 Aug 2013
Route Oral “tolcapone (Tasmar, tablets, 100 mg three times a day for 1 day and then 200 mg three times a day for 6 days; ClinicalTrials.gov identifier: NCT00044083)” PMID 23794107 Aug 2013
Target COMT “tolcapone, a CNS penetrant COMT inhibitor that increases cortical dopamine levels” PMID 23794107 Aug 2013