Tolcapone

Generic Name: Tolcapone

Brand Names: Tasmar

Drug Type: Small Molecule

Chemical Formula: C_₁₄H_₁₁NO_₅

CAS Number: 134308-13-7

Unique Ingredient Identifier: CIF6334OLY

Background: Tolcapone is a drug that inhibits the enzyme catechol-O-methyl transferase (COMT). It is used in the treatment of Parkinson's disease as an adjunct to levodopa/carbidopa medication. It is a yellow, odorless, non-hygroscopic, crystalline compound. Tolcapone is associated with a risk of hepatotoxicity.

Indication: Used as an adjunct to levodopa/carbidopa therapy for the symptomatic treatment of Parkinson's Disease. This drug is generally reserved for patients with parkinsonian syndrome receiving levodopa/carbidopa who are experiencing symptom fluctuations and are not responding adequately to or are not candidates for other adjunctive therapies.

Associated Conditions: Idiopathic Parkinson's Disease

Associated Therapies: -

Clinical Trials

Evaluation of Tolcapone as a Cognitive Enhancer in Schizophrenia

Phase 2

Recruiting

Conditions: Schizophrenia

Interventions: Drug: Tolcapone

First Posted Date: 2024-04-29

Last Posted Date: 2024-04-29

Lead Sponsor: Clinica Universidad de Navarra, Universidad de Navarra

Target Recruit Count: 20

Registration Number: NCT06387771

Locations: 🇪🇸
Clinica Universidad de Navarra, Pamplona, Navarra, Spain

A Clinical Trial of Tolcapone in Obsessive Compulsive Disorder

Phase 2

Recruiting

Conditions: Obsessive-Compulsive Disorder
OCD

Interventions: Drug: Placebo
Drug: Tolcapone

First Posted Date: 2022-11-22

Last Posted Date: 2024-08-09

Lead Sponsor: University of Chicago

Target Recruit Count: 85

Registration Number: NCT05624528

Locations: 🇺🇸
University of Chicago Medical Center, Chicago, Illinois, United States

COMT Inhibition Among Individuals With Comorbid AUD/ADHD

Phase 2

Recruiting

Conditions: Attention Deficit Hyperactivity Disorder
Alcohol Use Disorder

Interventions: Drug: Tolcapone
Drug: Placebo

First Posted Date: 2019-04-05

Last Posted Date: 2024-11-25

Lead Sponsor: University of Colorado, Denver

Target Recruit Count: 62

Registration Number: NCT03904498

Locations: 🇺🇸
University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States

A Study Assessing the Safety and Pharmacokinetic Profile of Modified Release Formulations of Tolcapone

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Tolcapone
Drug: Tolcapone Modified Release Prototype
Drug: Tolcapone Divided Dose

First Posted Date: 2018-08-16

Last Posted Date: 2019-01-31

Lead Sponsor: Corino Therapeutics, Inc.

Target Recruit Count: 12

Registration Number: NCT03633591

Locations: 🇬🇧
Quotient Sciences, Ruddington, Nottingham, United Kingdom

Short-term Effects of TOLCAPONE on Transthyretin Stability in Subjects With Leptomeningeal TTR Amyloidosis (ATTR)

Early Phase 1

Completed

Conditions: Amyloidosis, Leptomeningeal, Transthyretin-Related
Transthyretin Amyloidosis

Interventions: Drug: Tolcapone

First Posted Date: 2018-07-19

Last Posted Date: 2019-06-14

Lead Sponsor: Boston University

Target Recruit Count: 10

Registration Number: NCT03591757

Locations: 🇺🇸
Amyloidosis Center, Boston Medical Center, Boston, Massachusetts, United States

Effects of Cortical Dopamine Regulation on Drinking, Craving, and Cognitive Control

Phase 2

Completed

Conditions: Alcohol Use Disorder

Interventions: Drug: Placebo
Drug: Tolcapone

First Posted Date: 2016-10-31

Last Posted Date: 2023-06-09

Lead Sponsor: Medical University of South Carolina

Target Recruit Count: 90

Registration Number: NCT02949934

Locations: 🇺🇸
Medical University of South Carolina, Charleston, South Carolina, United States

Dopaminergic Modulation of Frontostriatal Function With a Dopamine Agonist and COMT Inhibitor

Phase 4

Withdrawn

Conditions: Addiction

Interventions: Drug: Placebo
Drug: Bromocriptine
Drug: Tolcapone

First Posted Date: 2016-10-11

Last Posted Date: 2021-11-16

Lead Sponsor: University of California, Berkeley

Registration Number: NCT02929485

Locations: 🇺🇸
University of California, San Francisco, San Francisco, California, United States
🇺🇸
University of California, Berkeley, Berkeley, California, United States

Dopamine Responsivity in Gamblers

Not Applicable

Completed

Conditions: Pathological Gambling

Interventions: Drug: Placebo
Drug: Tolcapone

First Posted Date: 2016-05-16

Last Posted Date: 2021-02-16

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 19

Registration Number: NCT02772978

Effects of Tolcapone on Decision Making and Alcohol Intake in Alcohol Users

Phase 2

Completed

Conditions: Alcohol Abuse
Impulsive Behavior

Interventions: Drug: Tolcapone
Drug: Placebo

First Posted Date: 2016-04-15

Last Posted Date: 2020-09-21

Lead Sponsor: Jennifer Mitchell

Target Recruit Count: 62

Registration Number: NCT02740582

Locations: 🇺🇸
University of California, Berkeley, Berkeley, California, United States
🇺🇸
University of California, San Francisco, San Francisco, California, United States

Evaluate the Effects of Tolcapone on Cognitive and Behavioral Dysfunction in Patients With BI and NCD

Phase 2

Conditions: Neurocognitive Disorders
Brain Injuries, Traumatic
Brain Injuries

Interventions: Drug: Tolcapone

First Posted Date: 2016-01-12

Last Posted Date: 2017-01-19

Lead Sponsor: Sheppard Pratt Health System

Target Recruit Count: 100

Registration Number: NCT02652598

Locations: 🇺🇸
Sheppard Pratt Health System, Baltimore, Maryland, United States

Drug Development Updates

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