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CompletedPhase 3

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)

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

Asset

Nuedexta

Listed sites

39

Recruiting sites

-

Enrollment

600

estimated

Study population

Alzheimer’s disease

Key I/E criterion

•Age 18-80

Primary endpoint

•Emotional control

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID02-AVR-107
SecondaryAVP-923
NCT IDNCT00056524

Timeline

Milestones

Study start2003-02 (month precision)
Study first posted2003-03-18estimated
Primary completion2007-06actual (month precision)
Study completion2007-06actual (month precision)
Last update posted2016-07-14estimated

Assets

Drug assets

Nuedexta

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

emotional control

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.