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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
AVP-923
Sponsored by
Avanir Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Pseudobulbar Affect, Uncontrolled, Laughing, Crying

Eligibility Criteria

18 Years - 68 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Barrow Neurological Institute
  • George Washington University Medical Faculty Associates
  • Neurological Associates
  • Neurology & Headache Specialist of Atlanta, L.L.C.
  • Radiant Research Alexian Brothers
  • Consultants in Neurology LTD
  • Advanced Neurology Specialists
  • Neurological Associates, P.C.
  • Upstate Clinical Research
  • DENT Neurologic Group L.L.P.
  • Hospital for Joint Diseases - MS Care Center
  • Institute for Human Performance
  • Raleigh Neurology Associates, P.A.
  • NeuroCare Center, Inc.
  • Leheigh Valley Neurosciences and Pain Research Center
  • Westmorland Neurology
  • Neurological Associates of Delaware Valley
  • FACH-UHC Department of Neurological Services
  • Swedish Medical Center
  • Neurology and Neurosurgery Associates of Tacoma

Outcomes

Primary Outcome Measures

emotional control

Secondary Outcome Measures

Full Information

First Posted
December 2, 2002
Last Updated
July 13, 2016
Sponsor
Avanir Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00050232
Brief Title
Safety and Efficacy of AVP-923 for Pseudobulbar Affect in Multiple Sclerosis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
June 2004 (Actual)
Study Completion Date
June 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Avanir Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Pseudobulbar Affect, Uncontrolled, Laughing, Crying

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
96 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
AVP-923
Primary Outcome Measure Information:
Title
emotional control

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Barrow Neurological Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
George Washington University Medical Faculty Associates
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Neurological Associates
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
Neurology & Headache Specialist of Atlanta, L.L.C.
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Radiant Research Alexian Brothers
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Consultants in Neurology LTD
City
Northbrook
State/Province
Illinois
ZIP/Postal Code
60062
Country
United States
Facility Name
Advanced Neurology Specialists
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Neurological Associates, P.C.
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
Upstate Clinical Research
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
Facility Name
DENT Neurologic Group L.L.P.
City
Amherst
State/Province
New York
ZIP/Postal Code
14266
Country
United States
Facility Name
Hospital for Joint Diseases - MS Care Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Institute for Human Performance
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Raleigh Neurology Associates, P.A.
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
NeuroCare Center, Inc.
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Leheigh Valley Neurosciences and Pain Research Center
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Westmorland Neurology
City
Greensburg
State/Province
Pennsylvania
ZIP/Postal Code
15601
Country
United States
Facility Name
Neurological Associates of Delaware Valley
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013
Country
United States
Facility Name
FACH-UHC Department of Neurological Services
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Neurology and Neurosurgery Associates of Tacoma
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16634036
Citation
Panitch HS, Thisted RA, Smith RA, Wynn DR, Wymer JP, Achiron A, Vollmer TL, Mandler RN, Dietrich DW, Fletcher M, Pope LE, Berg JE, Miller A; Psuedobulbar Affect in Multiple Sclerosis Study Group. Randomized, controlled trial of dextromethorphan/quinidine for pseudobulbar affect in multiple sclerosis. Ann Neurol. 2006 May;59(5):780-7. doi: 10.1002/ana.20828.
Results Reference
result
Links:
URL
http://www.nmss.org
Description
National Multiple Sclerosis Society

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

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