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Safety Study of AVP-923 in the Treatment of IEED (Involuntary Emotional Expression Disorder) Also Known as Pseudobulbar Affect (Episodes of Uncontrolled Crying and/or Laughter)

Primary Purpose

Alzheimer's Disease, Stroke, Parkinson's Disease

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 Alzheimer's Disease focused on measuring ALS, MS, CNS, AD, TBI, Dextromethorphan, IEED, Emotional

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 18 to 75 years of age, inclusive Clinical diagnosis of PBA (pseudobulbar affect) If female, must not be pregnant or breast feeding Exclusion Criteria: Sensitivity to quinidine or any opiate drugs Current or prior history of major psychiatric disturbance Currently participated in a trial within the past 30 days

Sites / Locations

  • Barrow Neurological Institute
  • Center for Neurologic Study
  • UCLA School of Medicine
  • UCSF
  • Research Center for Clinical Studies, Inc.
  • George Washington University Medical Faculty Assoc.
  • Neurological Associates
  • University of Miami Dept. of Neurology
  • Miami Jewish Home & Hospital for the Aged
  • Allied Clinical Trials
  • Renstar Medical Research
  • Suncoast Neuroscience Associates Inc.
  • Neurology & Headache Specialist of Atlanta, L.L.C.
  • 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
  • SUNY Upstate Medical University
  • Carolinas Medical Center
  • Raleigh Neurology Associates, PA
  • NeuroCare Center, Inc.
  • MetroHealth Medical Center
  • University Memory and Aging Center
  • The Cleveland Clinic Foundation
  • Clinical Pharmaceutical Trials, Inc.
  • Lehigh Valley Neurosciences and Pain Research Center
  • Westmoreland Neurology
  • MCP-Hahnemann University
  • Penn Neurological Institute
  • Neurological Associates of Delaware Valley
  • Claghorn-Lesem Research Clinic
  • Methodist Neurological Institute
  • Fletcher Allen Health Care
  • Neurology and Neurosurgery Associates of Tacoma
  • University of Wisconsin

Outcomes

Primary Outcome Measures

emotional control

Secondary Outcome Measures

Full Information

First Posted
March 15, 2003
Last Updated
July 13, 2016
Sponsor
Avanir Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00056524
Brief Title
Safety Study of AVP-923 in the Treatment of IEED (Involuntary Emotional Expression Disorder) Also Known as Pseudobulbar Affect (Episodes of Uncontrolled Crying and/or Laughter)
Official Title
An Open-Label Multicenter Study to Assess the Safety of AVP-923 in the Treatment of Patients With Pseudobulbar Affect.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Avanir Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the long-term safety of AVP-923 in the treatment of Involuntary Emotional Expression Disorder (IEED) also known as Pseudobulbar Affect (episodes of uncontrolled crying and/or laughter).
Detailed Description
This is an "open label" study which means there is no placebo group. Each subject enrolled into the study will receive AVP-923.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Stroke, Parkinson's Disease, Traumatic Brain Injury
Keywords
ALS, MS, CNS, AD, TBI, Dextromethorphan, IEED, Emotional

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
600 (Anticipated)

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
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 to 75 years of age, inclusive Clinical diagnosis of PBA (pseudobulbar affect) If female, must not be pregnant or breast feeding Exclusion Criteria: Sensitivity to quinidine or any opiate drugs Current or prior history of major psychiatric disturbance Currently participated in a trial within the past 30 days
Facility Information:
Facility Name
Barrow Neurological Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Center for Neurologic Study
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
UCLA School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States
Facility Name
Research Center for Clinical Studies, Inc.
City
Darien
State/Province
Connecticut
ZIP/Postal Code
06820
Country
United States
Facility Name
George Washington University Medical Faculty Assoc.
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
University of Miami Dept. of Neurology
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Miami Jewish Home & Hospital for the Aged
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Facility Name
Allied Clinical Trials
City
Miami
State/Province
Florida
ZIP/Postal Code
33181
Country
United States
Facility Name
Renstar Medical Research
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Suncoast Neuroscience Associates Inc.
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
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
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
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Raleigh Neurology Associates, PA
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
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
University Memory and Aging Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44120
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Clinical Pharmaceutical Trials, Inc.
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Lehigh Valley Neurosciences and Pain Research Center
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Westmoreland Neurology
City
Greensburg
State/Province
Pennsylvania
ZIP/Postal Code
15601
Country
United States
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
MCP-Hahnemann University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Penn Neurological Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Neurological Associates of Delaware Valley
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013
Country
United States
Facility Name
Claghorn-Lesem Research Clinic
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Methodist Neurological Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Fletcher Allen Health Care
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Neurology and Neurosurgery Associates of Tacoma
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25062507
Citation
Pattee GL, Wymer JP, Lomen-Hoerth C, Appel SH, Formella AE, Pope LE. An open-label multicenter study to assess the safety of dextromethorphan/quinidine in patients with pseudobulbar affect associated with a range of underlying neurological conditions. Curr Med Res Opin. 2014 Nov;30(11):2255-65. doi: 10.1185/03007995.2014.940040. Epub 2014 Jul 28.
Results Reference
derived

Learn more about this trial

Safety Study of AVP-923 in the Treatment of IEED (Involuntary Emotional Expression Disorder) Also Known as Pseudobulbar Affect (Episodes of Uncontrolled Crying and/or Laughter)

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