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)
| Status: | Completed |
|---|---|
| Conditions: | Alzheimer Disease, Parkinsons Disease, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 7/15/2016 |
| Start Date: | February 2003 |
| End Date: | June 2007 |
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).
Involuntary Emotional Expression Disorder (IEED) also known as Pseudobulbar Affect (episodes
of uncontrolled crying and/or laughter).
This is an "open label" study which means there is no placebo group. Each subject enrolled
into the study will receive AVP-923.
into the study will receive AVP-923.
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
We found this trial at
39
sites
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Fletcher Allen Health Care As Vermont’s University Medical Center, we at Fletcher Allen are committed...
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MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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