Quinidine

Generic Name: Quinidine

Brand Names: Nuedexta

Drug Type: Small Molecule

Chemical Formula: C_₂₀H_₂₄N_₂O_₂

CAS Number: 56-54-2

Unique Ingredient Identifier: ITX08688JL

Background: Quinidine is a D-isomer of quinine present in the bark of the Cinchona tree and similar plant species. This alkaloid was first described in 1848 and has a long history as an antiarrhythmic medication. Quinidine is considered the first antiarrhythmic drug (class Ia) and is moderately efficacious in the acute conversion of atrial fibrillation to normal sinus rhythm. It prolongs cellular action potential by blocking sodium and potassium currents. A phenomenon known as “quinidine syncope” was first described in the 1950s, characterized by syncopal attacks and ventricular fibrillation in patients treated with this drug. Due to its side effects and increased risk of mortality, the use of quinidine was reduced over the next few decades. However, it continues to be used in the treatment of Brugada syndrome, short QT syndrome and idiopathic ventricular fibrillation.

Indication: Quinidine is indicated for the management and prophylactic therapy of atrial fibrillation/flutter, as well as the suppression of recurrent documented ventricular arrhythmias. It is also used in the treatment of Brugada syndrome, short QT syndrome and idiopathic ventricular fibrillation..

Associated Conditions: Atrial Fibrillation or Flutter, Malaria caused by Plasmodium falciparum, Pseudobulbar Affect (PBA), Ventricular Arrhythmia

Clinical Trials

Drug-drug Interaction Study Between EDP-305, Fluconazole and Quinidine in Healthy Volunteers

Phase 1

Completed

Conditions: NASH - Nonalcoholic Steatohepatitis

Interventions: Drug: Fluconazole
Drug: Quinidine
Drug: EDP-305

First Posted Date: 2018-08-01

Last Posted Date: 2018-12-05

Lead Sponsor: Enanta Pharmaceuticals, Inc

Target Recruit Count: 48

Registration Number: NCT03610945

Locations: 🇺🇸
Pharmaceutical Research Associates, Inc.,, Salt Lake City, Utah, United States

Effectiveness, Safety, and Health-Related Outcomes of NUEDEXTA® in Nursing Home Patients With Pseudobulbar Affect (PBA)

Phase 4

Terminated

Conditions: Pseudobulbar Affect (Involuntary Laughing and/or Crying)

Interventions: Drug: NUEDEXTA®

First Posted Date: 2015-07-14

Last Posted Date: 2017-07-03

Lead Sponsor: Avanir Pharmaceuticals

Target Recruit Count: 5

Registration Number: NCT02496039

Safety and Pharmacokinetics of Quinidine Alone and in Combination With Dabigatran Etexilate

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: dabigatran etexilate
Drug: quinidine

First Posted Date: 2014-06-24

Last Posted Date: 2014-06-24

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 42

Registration Number: NCT02171624

Relative Bioavailability of Dabigatran Etexilate Capsules With and Without Quinidine Sulfate Tablets and to Measure the Effect of Quinidine on the Absorption of Fexofenadine in Healthy Male and Female Volunteers

Phase 1

Terminated

Conditions: Healthy

Interventions: Drug: Dabigatran etexilate capsules
Drug: Fexofenadine tablets
Drug: Quinidine sulfate tablets

First Posted Date: 2014-06-24

Last Posted Date: 2014-06-24

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 42

Registration Number: NCT02171546

Study of the Electrocardiographic Effects of Ranolazine, Dofetilide, Verapamil, and Quinidine in Healthy Subjects

Phase 1

Completed

Conditions: Drug-induced Surface ECG Changes

Interventions: Drug: Placebo
Drug: Ranolazine
Drug: Dofetilide
Drug: Verapamil
Drug: Quinidine sulfate

First Posted Date: 2013-06-10

Last Posted Date: 2018-03-08

Lead Sponsor: Food and Drug Administration (FDA)

Target Recruit Count: 22

Registration Number: NCT01873950

Nuedexta in the Treatment of Pseudobulbar Affect in Patients With Alzheimer's Disease

Phase 4

Terminated

Conditions: Alzheimer's Disease
Pseudobulbar Affect (PBA)

Interventions: Drug: Nuedexta (20/10)

First Posted Date: 2013-04-16

Last Posted Date: 2019-10-29

Lead Sponsor: St. Joseph's Hospital and Medical Center, Phoenix

Target Recruit Count: 34

Registration Number: NCT01832350

Locations: 🇺🇸
Barrow Neurological Institute, Phoenix, Arizona, United States

Clinical Trial Nuedexta in Subjects With ALS

Phase 2

Completed

Conditions: Amyotrophic Lateral Sclerosis (ALS)

Interventions: Drug: Nuedexta
Drug: Matching Placebo

First Posted Date: 2013-03-07

Last Posted Date: 2017-03-24

Lead Sponsor: Center for Neurologic Study, La Jolla, California,

Target Recruit Count: 90

Registration Number: NCT01806857

Locations: 🇺🇸
Neurology Associates, P.C., Lincoln, Nebraska, United States
🇺🇸
California Pacific Medical Center, San Francisco, California, United States
🇺🇸
The Cleveland Clinic, Cleveland, Ohio, United States

and more 4 locations