Multiple SclerosisPhase 3NCT00050232
Safety and Efficacy of AVP-923 for Pseudobulbar Affect in Multiple Sclerosis Patients
A Phase 3 study testing AVP-923 in people with Multiple Sclerosis, run by Avanir Pharmaceuticals at 20 sites in United States.
Trial summary
Pseudobulbar Affect is a condition characterized by frequent episodes of laughing and crying out of proportion. Other terms used to describe this condition include emotional lability, emotionalism, emotion incontinence, emotional discontrol, excessive emotionalism and pathological laughing and crying. Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- AVP-923
- How many people
- 96 participants
- Where
- 20 sitesUnited States
- Study dates
- Dec 2002to Jun 2004
- 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 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 68 years of age
- Confirmed diagnosis of Multiple Sclerosis
- Clinical history of pseudobulbar affect
Who cannot join
- Sensitivity to quinidine or opiate drugs
- Recent diagnosed within 2 months with Multiple Sclerosis
- Patient on anti-depressants
- Patient with liver or kidney disease
- Patient with hypotension
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Upstate Clinical Research
Albany, New York, 12205
Leheigh Valley Neurosciences and Pain Research Center
Allentown, Pennsylvania, 18103
DENT Neurologic Group L.L.P.
Amherst, New York, 14266
FACH-UHC Department of Neurological Services
Burlington, Vermont, 05401
NeuroCare Center, Inc.
Canton, Ohio, 44718
Neurology & Headache Specialist of Atlanta, L.L.C.
Decatur, Georgia, 30033
Radiant Research Alexian Brothers
Elk Grove Village, Illinois, 60007
Neurological Associates
Fort Lauderdale, Florida, 33334
Advanced Neurology Specialists
Great Falls, Montana, 59405
Westmorland Neurology
Greensburg, Pennsylvania, 15601
Neurological Associates, P.C.
Lincoln, Nebraska, 68506
Hospital for Joint Diseases - MS Care Center
New York, New York, 10003
Consultants in Neurology LTD
Northbrook, Illinois, 60062
Barrow Neurological Institute
Phoenix, Arizona, 85013
Raleigh Neurology Associates, P.A.
Raleigh, North Carolina, 27607
Swedish Medical Center
Seattle, Washington, 98122
Institute for Human Performance
Syracuse, New York, 13210
Neurology and Neurosurgery Associates of Tacoma
Tacoma, Washington, 98405
Neurological Associates of Delaware Valley
Upland, Pennsylvania, 19013
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, 20037
About this study
Pseudobulbar Affect is a condition characterized by frequent episodes of laughing and crying out of proportion. Other terms used to describe this condition include emotional lability, emotionalism, emotion incontinence, emotional discontrol, excessive emotionalism and pathological laughing and crying. AVP-923 is a new experimental drug that may assist in the reduction of uncontrolled episodes. This study will test the safety and efficacy of AVP-923 in the treatment of MS patients suffering from pseudobulbar affect.
- Conditions
- Multiple Sclerosis
- Being tested
- AVP-923
- Keywords
- Pseudobulbar Affect, Uncontrolled, Laughing, Crying
- Medical subject headings
- Multiple Sclerosis, Laughter, Crying
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 posted3 Dec 2002 (estimated)
- Study startDec 2002
- Primary completionJun 2004
- Study completionJun 2004
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 Multiple SclerosisStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 96 participants
Sponsor and investigators
- Lead sponsor
- Avanir Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00050232
- Sponsor's protocol ID
- 02-AVR-106
- Status last verified
- Jul 2016
- First submitted
- 2 Dec 2002
- Last updated
- 14 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Panitch HS, Thisted RA, Smith RA, Wynn DR, Wymer JP, Achiron A, Vollmer TL, Mandler RN, Dietrich DW, Fletcher M, Pope LE, Berg JE, Miller A; Psuedobulbar Affect in Multiple Sclerosis Study Group. Randomized, controlled trial of dextromethorphan/quinidine for pseudobulbar affect in multiple sclerosis. Ann Neurol. 2006 May;59(5):780-7. doi: 10.1002/ana.20828.
PubMed 16634036
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
- Safety and Efficacy of AVP-923 for Pseudobulbar Affect in Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT00050232
- Acronym / sponsor ID
- 02-AVR-106
- Conditions
- Multiple Sclerosis
- Keywords
- Pseudobulbar Affect, Uncontrolled, Laughing, Crying
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants
- Lead sponsor
- Avanir PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Primary completion
- Jun 2004 (actual)
- Study completion
- Jun 2004 (actual)
- First posted
- 3 Dec 2002 (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.
Pseudobulbar Affect is a condition characterized by frequent episodes of laughing and crying out of proportion. Other terms used to describe this condition include emotional lability, emotionalism, emotion incontinence, emotional discontrol, excessive emotionalism and pathological laughing and crying. AVP-923 is a new experimental drug that may assist in the reduction of uncontrolled episodes. This study will test the safety and efficacy of AVP-923 in the treatment of MS patients suffering from pseudobulbar affect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 to 68 years of age
- Confirmed diagnosis of Multiple Sclerosis
- Clinical history of pseudobulbar affect
Key exclusion criteria (5 listed)
- Sensitivity to quinidine or opiate drugs
- Recent diagnosed within 2 months with Multiple Sclerosis
- Patient on anti-depressants
- Patient with liver or kidney disease
- Patient with hypotension
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.
- Results publication: PubMed 16634036Panitch HS, Thisted RA, Smith RA, Wynn DR, Wymer JP, Achiron A, Vollmer TL, Mandler RN, Dietrich DW, Fletcher M, Pope LE, Berg JE, Miller A; Psuedobulbar Affect in Multiple Sclerosis Study Group. Randomized, controlled trial of dextromethorphan/quinidine for pseudobulbar affect in multiple sclerosis. Ann Neurol. 2006 May;59(5):780-7. doi: 10.1002/ana.20828.
- National Multiple Sclerosis SocietyLink provided by the sponsor.
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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.
20 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 Multiple Sclerosis, run by Avanir Pharmaceuticals at 20 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 5 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 20 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 NCT00050232, 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.