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| Descriptive Information Fields | |||||
| Brief Title † | Safety and Efficacy of AVP-923 in PBA Patients With ALS or MS | ||||
| Official Title † | A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy and to Determine the Pharmacokinetics of Two Doses of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Pseudobulbar Affect (PBA) in Patients With Amyotrophic Lateral Sclerosis and Multiple Sclerosis | ||||
| Brief Summary | 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 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 is a known potent inhibitor of cytochrome CYP2D6, that decreases the metabolism of dextromethorphan and helps to achieve sustained and therapeutic levels of this drug. |
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| Detailed Description | |||||
| Study Phase | Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | The primary efficacy endpoint is the number of laughing and/or crying episodes as recorded in the patient diary. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | The main secondary endpoint is the mean change in CNS-LS score. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] | ||||
| Condition † | Pseudobulbar Affect (PBA) | ||||
| Intervention † | Drug: AVP-923 | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 306 | ||||
| Start Date † | December 2007 | ||||
| Completion Date | June 2009 | ||||
| Eligibility Criteria † | Main Inclusion Criteria:
Main Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States, Argentina, Brazil | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00573443 | ||||
| Organization ID | 07-AVR-123 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Avanir Pharmaceuticals | ||||
| Collaborators †† | Kendle International | ||||
| Investigators † |
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| Information Provided By | Avanir Pharmaceuticals | ||||
| Verification Date | November 2008 | ||||
| First Received Date † | December 13, 2007 | ||||
| Last Updated Date | November 11, 2008 | ||||
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