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)

July 13, 2016 updated by: Avanir Pharmaceuticals

An Open-Label Multicenter Study to Assess the Safety of AVP-923 in the Treatment of Patients With Pseudobulbar Affect.

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Barrow Neurological Institute
    • California
      • La Jolla, California, United States, 92037
        • Center for Neurologic Study
      • Los Angeles, California, United States, 90095
        • UCLA School of Medicine
      • San Francisco, California, United States, 94117
        • UCSF
    • Connecticut
      • Darien, Connecticut, United States, 06820
        • Research Center for Clinical Studies, Inc.
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington University Medical Faculty Assoc.
    • Florida
      • Ft. Lauderdale, Florida, United States, 33334
        • Neurological Associates
      • Miami, Florida, United States, 33136
        • University of Miami Dept. of Neurology
      • Miami, Florida, United States, 33137
        • Miami Jewish Home & Hospital for the Aged
      • Miami, Florida, United States, 33181
        • Allied Clinical Trials
      • Plantation, Florida, United States, 33324
        • Renstar Medical Research
      • St. Petersburg, Florida, United States, 33701
        • Suncoast Neuroscience Associates Inc.
      • Tampa, Florida, United States, 33606
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Neurology & Headache Specialist of Atlanta, L.L.C.
    • Illinois
      • Northbrook, Illinois, United States, 60062
        • Consultants in Neurology Ltd
    • Montana
      • Great Falls, Montana, United States, 59405
        • Advanced Neurology Specialists
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Neurological Associates, P.C.
    • New York
      • Albany, New York, United States, 12205
        • Upstate Clinical Research
      • Amherst, New York, United States, 14266
        • DENT Neurologic Group L.L.P.
      • New York, New York, United States, 10003
        • Hospital for Joint Diseases MS Care Center
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Medical Center
      • Raleigh, North Carolina, United States, 27607
        • Raleigh Neurology Associates, Pa
    • Ohio
      • Canton, Ohio, United States, 44718
        • NeuroCare Center, Inc.
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation
      • Cleveland, Ohio, United States, 44120
        • University Memory and Aging Center
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Clinical Pharmaceutical Trials, Inc.
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Neurosciences and Pain Research Center
      • Greensburg, Pennsylvania, United States, 15601
        • Westmoreland Neurology
      • Jenkintown, Pennsylvania, United States, 19046
      • Philadelphia, Pennsylvania, United States, 19107
        • Penn Neurological Institute
      • Philadelphia, Pennsylvania, United States, 19107
        • MCP-Hahnemann University
      • Upland, Pennsylvania, United States, 19013
        • Neurological Associates of Delaware Valley
    • Texas
      • Bellaire, Texas, United States, 77401
        • Claghorn-Lesem Research Clinic
      • Houston, Texas, United States, 77030
        • Methodist Neurological Institute
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Fletcher Allen Health Care
    • Washington
      • Tacoma, Washington, United States, 98405
        • Neurology and Neurosurgery Associates of Tacoma
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University Of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
emotional control

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Avanir Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2003

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2007

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2003

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2003

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2003

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 02-AVR-107
  • AVP-923

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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