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Last Updated: June 28, 2022

CLINICAL TRIALS PROFILE FOR DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE


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All Clinical Trials for Dextromethorphan Hydrobromide And Quinidine Sulfate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00573443 ↗ Safety and Efficacy of AVP-923 in PBA Patients With ALS or MS Completed INC Research Phase 3 2007-12-01 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 Syneos Health Phase 3 2007-12-01 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 2007-12-01 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Dextromethorphan Hydrobromide And Quinidine Sulfate

Condition Name

Condition Name for Dextromethorphan Hydrobromide And Quinidine Sulfate
Intervention Trials
Agitation in Patients With Dementia of the Alzheimer's Type 3
Pseudobulbar Affect (Involuntary Laughing and/or Crying) 1
Pseudobulbar Affect (PBA) 1
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Condition MeSH

Condition MeSH for Dextromethorphan Hydrobromide And Quinidine Sulfate
Intervention Trials
Psychomotor Agitation 3
Dementia 3
Alzheimer Disease 3
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Clinical Trial Locations for Dextromethorphan Hydrobromide And Quinidine Sulfate

Trials by Country

Trials by Country for Dextromethorphan Hydrobromide And Quinidine Sulfate
Location Trials
United States 138
Brazil 6
Argentina 4
Canada 3
Australia 2
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Trials by US State

Trials by US State for Dextromethorphan Hydrobromide And Quinidine Sulfate
Location Trials
Florida 7
New York 6
Massachusetts 6
Illinois 6
Georgia 6
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Clinical Trial Progress for Dextromethorphan Hydrobromide And Quinidine Sulfate

Clinical Trial Phase

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

Clinical Trial Status for Dextromethorphan Hydrobromide And Quinidine Sulfate
Clinical Trial Phase Trials
Completed 9
Recruiting 1
Terminated 1
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Clinical Trial Sponsors for Dextromethorphan Hydrobromide And Quinidine Sulfate

Sponsor Name

Sponsor Name for Dextromethorphan Hydrobromide And Quinidine Sulfate
Sponsor Trials
Avanir Pharmaceuticals 11
INC Research 1
Syneos Health 1
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Sponsor Type

Sponsor Type for Dextromethorphan Hydrobromide And Quinidine Sulfate
Sponsor Trials
Industry 11
Other 2
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