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Safety and Efficacy of AVP-923 for Pseudobulbar Affect in Multiple Sclerosis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00050232
Recruitment Status : Completed
First Posted : December 3, 2002
Last Update Posted : July 14, 2016
Sponsor:
Information provided by:
Avanir Pharmaceuticals

Study Description
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Brief Summary:
Pseudobulbar Affect is a condition characterized by frequent episodes of laughing and crying out of proportion. Other terms used to describe this condition include emotional lability, emotionalism, emotion incontinence, emotional discontrol, excessive emotionalism and pathological laughing and crying. AVP-923 is a new experimental drug that may assist in the reduction of uncontrolled episodes. This study will test the safety and efficacy of AVP-923 in the treatment of MS patients suffering from pseudobulbar affect.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: AVP-923 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : December 2002
Actual Primary Completion Date : June 2004
Actual Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Nuedexta

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. emotional control

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 to 68 years of age
  • Confirmed diagnosis of Multiple Sclerosis
  • Clinical history of pseudobulbar affect

Exclusion Criteria:

  • Sensitivity to quinidine or opiate drugs
  • Recent diagnosed within 2 months with Multiple Sclerosis
  • Patient on anti-depressants
  • Patient with liver or kidney disease
  • Patient with hypotension
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00050232


Locations
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Sponsors and Collaborators
Avanir Pharmaceuticals
More Information
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Additional Information:

Publications of Results:

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ClinicalTrials.gov Identifier: NCT00050232    
Other Study ID Numbers: 02-AVR-106
First Posted: December 3, 2002    Key Record Dates
Last Update Posted: July 14, 2016
Last Verified: July 2016
Keywords provided by Avanir Pharmaceuticals:
Pseudobulbar Affect
Uncontrolled
Laughing
Crying
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases