Alzheimer's DiseasePhase 3NCT00056524
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)
A Phase 3 study testing AVP-923 in people with Alzheimer's Disease and Stroke, run by Avanir Pharmaceuticals at 39 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Alzheimer's Disease, Stroke, Parkinson's Disease
- What is being tested?
- AVP-923
- How many people
- 600 participants
- Where
- 39 sitesUnited States
- Study dates
- Feb 2003to Jun 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 75 years of age, inclusive
- Clinical diagnosis of PBA (pseudobulbar affect)
- If female, must not be pregnant or breast feeding
Who cannot join
- 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
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
United States39 sites
Upstate Clinical Research
Albany, New York, 12205
Lehigh Valley Neurosciences and Pain Research Center
Allentown, Pennsylvania, 18103
DENT Neurologic Group L.L.P.
Amherst, New York, 14266
Claghorn-Lesem Research Clinic
Bellaire, Texas, 77401
Fletcher Allen Health Care
Burlington, Vermont, 05401
NeuroCare Center, Inc.
Canton, Ohio, 44718
Carolinas Medical Center
Charlotte, North Carolina, 28203
MetroHealth Medical Center
Cleveland, Ohio, 44109
University Memory and Aging Center
Cleveland, Ohio, 44120
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Research Center for Clinical Studies, Inc.
Darien, Connecticut, 06820
Neurology & Headache Specialist of Atlanta, L.L.C.
Decatur, Georgia, 30033
Neurological Associates
Fort Lauderdale, Florida, 33334
Advanced Neurology Specialists
Great Falls, Montana, 59405
Westmoreland Neurology
Greensburg, Pennsylvania, 15601
Methodist Neurological Institute
Houston, Texas, 77030
Study site
Jenkintown, Pennsylvania, 19046
Center for Neurologic Study
La Jolla, California, 92037
Neurological Associates, P.C.
Lincoln, Nebraska, 68506
UCLA School of Medicine
Los Angeles, California, 90095
University of Wisconsin
Madison, Wisconsin, 53792
University of Miami Dept. of Neurology
Miami, Florida, 33136
Miami Jewish Home & Hospital for the Aged
Miami, Florida, 33137
Allied Clinical Trials
Miami, Florida, 33181
Hospital for Joint Diseases MS Care Center
New York, New York, 10003
Consultants in Neurology LTD
Northbrook, Illinois, 60062
MCP-Hahnemann University
Philadelphia, Pennsylvania, 19107
Penn Neurological Institute
Philadelphia, Pennsylvania, 19107
Barrow Neurological Institute
Phoenix, Arizona, 85013
Renstar Medical Research
Plantation, Florida, 33324
Raleigh Neurology Associates, PA
Raleigh, North Carolina, 27607
UCSF
San Francisco, California, 94117
Suncoast Neuroscience Associates Inc.
St. Petersburg, Florida, 33701
SUNY Upstate Medical University
Syracuse, New York, 13210
Neurology and Neurosurgery Associates of Tacoma
Tacoma, Washington, 98405
Study site
Tampa, Florida, 33606
Clinical Pharmaceutical Trials, Inc.
Tulsa, Oklahoma, 74104
Neurological Associates of Delaware Valley
Upland, Pennsylvania, 19013
George Washington University Medical Faculty Assoc.
Washington D.C., District of Columbia, 20037
About this study
Official title: 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).
Read the 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.
- Being tested
- AVP-923
- Keywords
- ALS, MS, CNS, AD, TBI, Dextromethorphan, IEED, Emotional
- Medical subject headings
- Alzheimer Disease, Stroke, Parkinson Disease, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVP-923Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
emotional control
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2003 (estimated)
- Study startFeb 2003
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Avanir Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00056524
- Sponsor's protocol ID
- 02-AVR-107
- Other IDs
- AVP-923
- Status last verified
- Jul 2016
- First submitted
- 15 Mar 2003
- Last updated
- 14 Jul 2016
- Results posted
- No
Publications
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.
PubMed 25062507
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Multicenter Study to Assess the Safety of AVP-923 in the Treatment of Patients With Pseudobulbar Affect.
- ClinicalTrials.gov ID
- NCT00056524
- Acronym / sponsor ID
- 02-AVR-107
- Keywords
- ALS, MS, CNS, AD, TBI, Dextromethorphan, IEED, Emotional
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Avanir PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 18 Mar 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 to 75 years of age, inclusive
- Clinical diagnosis of PBA (pseudobulbar affect)
- If female, must not be pregnant or breast feeding
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVP-923 | Drug | – |
Primary outcome
emotional control
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2016.
- Derived from this study: PubMed 25062507Pattee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AVP-923 in people with Alzheimer's Disease and Stroke, run by Avanir Pharmaceuticals at 39 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
emotional control. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00056524, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2016.