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Generated: December 16, 2018

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CLINICAL TRIALS PROFILE FOR QUINIDINE SULFATE

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Clinical Trials for Quinidine Sulfate

Trial ID Title Status Sponsor Phase Summary
NCT00573443 Safety and Efficacy of AVP-923 in PBA Patients With ALS or MS Completed INC Research Phase 3 Objectives of the study are to evaluate the safety, tolerability, and efficacy of two different doses of AVP-923 (capsules containing either 30 mg of dextromethorphan hydrobromide and 10 mg of quinidine sulfate [AVP-923-30] or 20 mg of dextromethorphan hydrobromide and 10 mg of quinidine sulfate [AVP-923-20]) when compared to placebo, for the treatment of PBA in a population of patients with amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS) over a 12-week period. An additional objective is to determine the pharmacokinetic parameters of the two different doses of AVP-923 in a subset of the study population. Pseudobulbar Affect (PBA) is a condition characterized by involuntary, sudden and frequent episodes of laughing and/or crying out of proportion or incongruous to the underlying emotion of happiness or sadness Other terms used to describe this condition include emotional lability, emotionalism, emotional incontinence, emotional discontrol, excessive emotionalism, and pathological laughing and crying. The outbursts can occur spontaneously or in response to provocative stimuli such as questions or events. A body of evidence suggests that PBA can be modulated through pharmacologic intervention. Dextromethorphan (DM) is a low-affinity uncompetitive antagonist of the N-Methyl-D-aspartate (NMDA) receptor, reducing the level of excitatory activity. DM also acts at the phencyclidine-binding site, which is part of the NMDA receptor complex. DM is a sigma receptor agonist, suppressing the release of excitatory neurotransmitters. Quinidine (Q) is a known potent inhibitor of cytochrome P450 2D6 (CYP2D6), that decreases the metabolism of dextromethorphan and helps to achieve sustained and therapeutic levels of this drug.
NCT00573443 Safety and Efficacy of AVP-923 in PBA Patients With ALS or MS Completed Avanir Pharmaceuticals Phase 3 Objectives of the study are to evaluate the safety, tolerability, and efficacy of two different doses of AVP-923 (capsules containing either 30 mg of dextromethorphan hydrobromide and 10 mg of quinidine sulfate [AVP-923-30] or 20 mg of dextromethorphan hydrobromide and 10 mg of quinidine sulfate [AVP-923-20]) when compared to placebo, for the treatment of PBA in a population of patients with amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS) over a 12-week period. An additional objective is to determine the pharmacokinetic parameters of the two different doses of AVP-923 in a subset of the study population. Pseudobulbar Affect (PBA) is a condition characterized by involuntary, sudden and frequent episodes of laughing and/or crying out of proportion or incongruous to the underlying emotion of happiness or sadness Other terms used to describe this condition include emotional lability, emotionalism, emotional incontinence, emotional discontrol, excessive emotionalism, and pathological laughing and crying. The outbursts can occur spontaneously or in response to provocative stimuli such as questions or events. A body of evidence suggests that PBA can be modulated through pharmacologic intervention. Dextromethorphan (DM) is a low-affinity uncompetitive antagonist of the N-Methyl-D-aspartate (NMDA) receptor, reducing the level of excitatory activity. DM also acts at the phencyclidine-binding site, which is part of the NMDA receptor complex. DM is a sigma receptor agonist, suppressing the release of excitatory neurotransmitters. Quinidine (Q) is a known potent inhibitor of cytochrome P450 2D6 (CYP2D6), that decreases the metabolism of dextromethorphan and helps to achieve sustained and therapeutic levels of this drug.
NCT02153502 Efficacy, Safety, and Tolerability Study of AVP-786 as an Adjunctive Therapy in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment Recruiting Avanir Pharmaceuticals Phase 2 The objectives of this 10-week study are to evaluate the efficacy, safety, and tolerability of AVP 786 as an adjunctive therapy compared with placebo in patients with major depressive disorder (MDD) who have shown an inadequate response to standard antidepressant treatment. A secondary objective of this study is to assess the pharmacokinetics (PK) of AVP-786 and potential correlations with pharmacodynamic effects.
NCT02171546 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 Terminated Boehringer Ingelheim Phase 1 Part 1: To investigate the effect of quinidine, a P-glycoprotein (P-gp) probe inhibitor on the bioavailability of dabigatran etexilate, Part 2: To determine the effect of quinidine on the bioavailability of fexofenadine, a probe substrate for P-gp
NCT02171624 Safety and Pharmacokinetics of Quinidine Alone and in Combination With Dabigatran Etexilate Completed Boehringer Ingelheim Phase 1 Open-label, two-way crossover design with a quinidine sulfate run-in period followed by a randomised sequence of dabigatran etexilate plus quinidine sulfate or dabigatran etexilate alone to evaluate the safety of co-administration of dabigatran etexilate and quinidine. and the pharmacokinetic interaction between quinidine and dabigatran etexilate.
NCT02174822 A Phase 1, Drug Interaction Study Between AVP-786 and Paroxetine and Between AVP-786 and Duloxetine in Healthy Subjects Completed Avanir Pharmaceuticals Phase 1 To assess steady state pharmacokinetics (PK), safety and tolerability between AVP-786 (deuterated [d6] dextromethorphan hydrobromide [DM]/quinidine sulfate [Q]) and paroxetine and between AVP-786 and duloxetine.
NCT02174835 A Phase-1 Study to Assess the Pharmacokinetics, Safety and Tolerability of AVP-786 in Healthy Volunteers Completed Avanir Pharmaceuticals Phase 1 To assess the multiple-dose pharmacokinetics (PK), safety and tolerability of AVP-786 (deuterated [d6] dextromethorphan hydrobromide [DM]/quinidine sulfate [Q]) in healthy volunteers.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Quinidine Sulfate

Condition Name

Condition Name for Quinidine Sulfate
Intervention Trials
Healthy 3
Agitation in Patients With Dementia of the Alzheimer's Type 2
Neurobehavioral Disinhibition 1
Agitation in Alzheimer's Disease 1
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Condition MeSH

Condition MeSH for Quinidine Sulfate
Intervention Trials
Psychomotor Agitation 4
Dementia 3
Alzheimer Disease 3
Disease 2
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Clinical Trial Locations for Quinidine Sulfate

Trials by Country

Trials by Country for Quinidine Sulfate
Location Trials
United States 154
Brazil 6
Argentina 4
Australia 2
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Trials by US State

Trials by US State for Quinidine Sulfate
Location Trials
Florida 9
Ohio 8
New York 8
Georgia 8
Illinois 7
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Clinical Trial Progress for Quinidine Sulfate

Clinical Trial Phase

Clinical Trial Phase for Quinidine Sulfate
Clinical Trial Phase Trials
Phase 4 1
Phase 3 4
Phase 2 4
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Clinical Trial Status

Clinical Trial Status for Quinidine Sulfate
Clinical Trial Phase Trials
Recruiting 6
Completed 5
Terminated 2
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Clinical Trial Sponsors for Quinidine Sulfate

Sponsor Name

Sponsor Name for Quinidine Sulfate
Sponsor Trials
Avanir Pharmaceuticals 12
Boehringer Ingelheim 2
INC Research 1
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Sponsor Type

Sponsor Type for Quinidine Sulfate
Sponsor Trials
Industry 14
Other 1
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