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Safety and Efficacy of AVP-923 in PBA Patients With ALS or MS (STAR)

Primary Purpose

Pseudobulbar Affect (PBA)

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg
dextromethorphan hydrobromide 30 mg and quinidine sulfate 10 mg
Placebo
Sponsored by
Avanir Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pseudobulbar Affect (PBA) focused on measuring Amyotrophic Lateral Sclerosis (Lou Gehrig's disease, ALS), Multiple Sclerosis (MS)

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Main Inclusion Criteria:

  • The patient has a diagnosis of Amyotrophic Lateral Sclerosis (according to El Escorial Criteria, WFN, 1998) and the time from diagnosis of ALS is not be longer than 30 months, or the patient has a diagnosis of multiple sclerosis or probable multiple sclerosis (according to McDonald criteria, 2001)
  • The patient has a clinical history and clinical relevant symptoms of Pseudobulbar Affect (PBA)
  • CNS-LS score at baseline is 13 or greater

Main Exclusion Criteria:

  • Patients with myasthenia gravis
  • Any personal history of complete heart block, QTc prolongation, or torsades de pointes
  • Any family history of congenital QT interval prolongation syndrome
  • Patients with known sensitivity to quinidine, dextromethorphan or opiate drugs (codeine, etc.)

Sites / Locations

  • St. Joseph's Hospital and Medical Center
  • Neuromuscular Research Center
  • South Coast Clinical Trials
  • UCI Medical Center
  • Center for Neurologic Study
  • UCLA School of Medicine
  • The Forbes Norris MDA/ALS Research Center - California Pacific Medical Center
  • The ALS Center at UCSF
  • University of Colorado at Denver & Health Science Center
  • Neuroscience Center
  • Mayo Clinic
  • University of Miami
  • Suncoast Neuroscience Associates
  • The ALS Center at Emory University
  • Neurology Specialists of Decatur of Decatur
  • Northwestern University
  • Consultants in Neurology
  • University of Kentucky Health Care - Dept. of Neurology
  • The John Hopkins Universitiy
  • Massachusets General Hospital
  • Baystate Medical Center
  • University of Michigan
  • Henry Ford Hospital
  • St.Louis University - Neuromuscular Clinic
  • Advanced Neurology Specialists
  • Neurology Associates
  • Universitiy of Nevada
  • Upstate Clinical Research
  • Jacobs Neurological Institute
  • Mount Sinai Medical Center
  • Neurological Institute - Columbia Presbyterian Center
  • Carolinas Medical Center
  • Duke Universitiy Medical Center
  • Department of Neurology - The Cleveland Clinic Foundation
  • Ohio State Universitiy
  • Oregon Health Science University
  • Drexel University - Department of Neurology
  • The ALS Center - Penn Neurological Institute - The University of Pennsylvania
  • Vanderbilt University
  • The Methodist Hospital - Baylor College of Medicine
  • Department of Neuropsychiatry - Texas Tech University
  • University of Texas Health Science Center
  • Universitiy of Vermont
  • West Virginia University
  • Dean Foundation
  • FACENE
  • IADIN
  • Hospital Italiano
  • INEBA
  • Hospital Ramos Mejia
  • Hospital Britanico
  • Policlinico Bancario
  • FLENI
  • Instituto Medico Rodriguez Alfici
  • Instituto de Neurociencias Rosario
  • Hospital Militar Regional de Cordoba
  • Santa Casa de Misericordia de Belo Horizonte
  • Hospital da Restauração
  • Hospital de Clínicas-UFPR
  • Hospital Universitário Clementino Fraga Filho
  • Hospital Moinhos de Vento
  • Hospital das Clínicas da Faculdade de Medicina da Universidade São Paulo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

DM 30 mg/Q 10 mg

DM 20 mg/ Q 10 mg

Placebo

Arm Description

AVP-923-30/10 Capsules (30 mg dextromethorphan/10 mg quinidine)administered once daily for 1 week and then twice daily for 11 weeks

AVP-923-20/10 Capsules (20 mg dextromethorphan/10 mg quinidine)administered once daily for 1 week and then twice daily for 11 weeks

Placebo Capsules once daily for 1 week and then twice daily for an additional 11 weeks

Outcomes

Primary Outcome Measures

PBA Episode Rate Ratio (Post/Pre), Regression Adjusted
Episodes were counted each day and recorded in a daily diary. The outcome measure is the ratio of the episode rate over the 84-day treatment period to the rate during the baseline period, adjusted for study site, and underlying disease using longitudinal negative binomial regression.

Secondary Outcome Measures

Mean Change From Baseline in CNS-LS Total Score by Visit
Center for Neurologic Studies-Lability Scale (CNS-LS) is an instrument for the measurement of PBA that has been validated for the use in patients with ALS and MS. It is a 7-item self-report questionnaire that measures the frequency and severity of PBA episodes, including assessments of labile laughter and labile tearfulness,and provides a score for total PBA (total score can range from 7-35). The following 5-point scoring was used: 1=Applies never, 2=Applies rarely, 3=Applies occasionally, 4=Applies frequently, 5=Applies most of the time. A score of 13 or higher may suggest PBA, and the higher the score the more severe the episodes.
Mean Change From Baseline to Day 84 in Neuropsychiatric Inventory (NPI-Q) Frequency and Severity Score (EE Population)
The NPI is a retrospective (to 1 month) caregiver-informant interview assessing frequency and severity of 12 neuropsychiatric symptom domains. The NPI score is based on the sum of the severity ratings (0=absent, 1=mild, 3=severe). The 12 symptom domains include delusions, hallucinations, agitation/aggression, dysphoria/depression, anxiety, euphoria/elation, apathy/indifference, disinhibition, irritability/lability, aberrant motor behaviors, nighttime behavioral disturbances, and appetite/eating abnormalities. The NPI severity score is based on severity ratings (0=absent, 1=mild to 3=severe).
Mean Change From Baseline to Day 84 in Neuropsychiatric Inventory (NPI-Q) Frequency and Severity Score (ITT Population)
The NPI is a retrospective (to 1 month) caregiver-informant interview assessing frequency and severity of 12 neuropsychiatric symptom domains. The NPI score is based on the sum of the severity ratings (0=absent, 1=mild, 3=severe). The 12 symptom domains include delusions, hallucinations, agitation/aggression, dysphoria/depression, anxiety, euphoria/elation, apathy/indifference, disinhibition, irritability/lability, aberrant motor behaviors, nighttime behavioral disturbances, and appetite/eating abnormalities. The NPI severity score is based on severity ratings (0=absent, 1=mild to 3=severe).
Mean Change From Baseline at Day 84 in SF-36 (Short-Form) Health Survey Medical Outcome Score by Category
The SF-36 is designed to examine a person's perceived health status. The SF-36 includes one multi-item scale measuring eight health concepts: vitality, physical functioning, bodily pain, general health perceptions, physical role-, emotional role-, social role functioning, and mental health. Answers to each question are scored and summed to produce raw scale scores for each health concept which are then transformed to a 0 - 100 scale, a high score defining a more favorable health state. An aggregate summary measure is calculated by averaging the scores from the eight health concepts.
Mean Change From Baseline at Day 84 in Beck Depression Inventory (BDI-II) Total Score
The BDI-II is a 21-item self report instrument intended to assess the existence and severity of symptoms of depression, summed to give a single score. The BDI-II uses a 4-point for each item ranging from 0 to 3. A total score of 0-13 is considered minimal range, 14 to 19 is mild, 20 to 28 is moderate, and 29 to 63 is severe.
Mean Change From Baseline to Day 84 in Pain Rating Scale (PRS) of MS Subjects
Subjects with MS were instructed to also record daily the pain they experienced using the PRS. After evaluating the subject's ability to comply with these requirements, the investigator determined if a caregiver should complete the study diary and assessments. Subjects rated their pain over the past 12 hours on a scale of 0 to 10 (0=none, 10=worst pain ever experienced).

Full Information

First Posted
December 13, 2007
Last Updated
March 15, 2017
Sponsor
Avanir Pharmaceuticals
Collaborators
Syneos Health
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1. Study Identification

Unique Protocol Identification Number
NCT00573443
Brief Title
Safety and Efficacy of AVP-923 in PBA Patients With ALS or MS
Acronym
STAR
Official Title
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy and to Determine the Pharmacokinetics of Two Doses of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Pseudobulbar Affect (PBA) in Patients With Amyotrophic Lateral Sclerosis (ALS) and Multiple Sclerosis (MS)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avanir Pharmaceuticals
Collaborators
Syneos Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Objectives of the study are to evaluate the safety, tolerability, and efficacy of two different doses of AVP-923 (capsules containing either 30 mg of dextromethorphan hydrobromide and 10 mg of quinidine sulfate [AVP-923-30] or 20 mg of dextromethorphan hydrobromide and 10 mg of quinidine sulfate [AVP-923-20]) when compared to placebo, for the treatment of PBA in a population of patients with amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS) over a 12-week period. An additional objective is to determine the pharmacokinetic parameters of the two different doses of AVP-923 in a subset of the study population. Pseudobulbar Affect (PBA) is a condition characterized by involuntary, sudden and frequent episodes of laughing and/or crying out of proportion or incongruous to the underlying emotion of happiness or sadness Other terms used to describe this condition include emotional lability, emotionalism, emotional incontinence, emotional discontrol, excessive emotionalism, and pathological laughing and crying. The outbursts can occur spontaneously or in response to provocative stimuli such as questions or events. A body of evidence suggests that PBA can be modulated through pharmacologic intervention. Dextromethorphan (DM) is a low-affinity uncompetitive antagonist of the N-Methyl-D-aspartate (NMDA) receptor, reducing the level of excitatory activity. DM also acts at the phencyclidine-binding site, which is part of the NMDA receptor complex. DM is a sigma receptor agonist, suppressing the release of excitatory neurotransmitters. Quinidine (Q) is a known potent inhibitor of cytochrome P450 2D6 (CYP2D6), that decreases the metabolism of dextromethorphan and helps to achieve sustained and therapeutic levels of this drug.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pseudobulbar Affect (PBA)
Keywords
Amyotrophic Lateral Sclerosis (Lou Gehrig's disease, ALS), Multiple Sclerosis (MS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
326 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DM 30 mg/Q 10 mg
Arm Type
Experimental
Arm Description
AVP-923-30/10 Capsules (30 mg dextromethorphan/10 mg quinidine)administered once daily for 1 week and then twice daily for 11 weeks
Arm Title
DM 20 mg/ Q 10 mg
Arm Type
Experimental
Arm Description
AVP-923-20/10 Capsules (20 mg dextromethorphan/10 mg quinidine)administered once daily for 1 week and then twice daily for 11 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Capsules once daily for 1 week and then twice daily for an additional 11 weeks
Intervention Type
Drug
Intervention Name(s)
dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg
Other Intervention Name(s)
AVP-923, Nuedexta™, DM 20 mg/ Q 10 mg, DMQ
Intervention Description
Dextromethorphan hydrobromide (DM) and quinidine sulfate (Q) capsules (AVP-923 capsules), containing DM 20 mg/ Q 10 mg, taken once daily for 1 week and then twice daily for 11 consecutive weeks to complete a 12-week period
Intervention Type
Drug
Intervention Name(s)
dextromethorphan hydrobromide 30 mg and quinidine sulfate 10 mg
Other Intervention Name(s)
AVP-923, DM 30 mg/ Q 10 mg, DMQ
Intervention Description
Dextromethorphan hydrobromide (DM) and quinidine sulfate (Q) capsules (AVP-923 capsules), containing DM 30 mg/ Q 10 mg taken once daily for 1 week and then twice daily for 11 consecutive weeks to complete a 12-week period
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsules (identical in appearance to AVP-923 capsules being studied in this trial), taken once daily for 1 week and then twice daily for 11 consecutive weeks to complete a 12-week period
Primary Outcome Measure Information:
Title
PBA Episode Rate Ratio (Post/Pre), Regression Adjusted
Description
Episodes were counted each day and recorded in a daily diary. The outcome measure is the ratio of the episode rate over the 84-day treatment period to the rate during the baseline period, adjusted for study site, and underlying disease using longitudinal negative binomial regression.
Time Frame
Baseline to Day 84
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in CNS-LS Total Score by Visit
Description
Center for Neurologic Studies-Lability Scale (CNS-LS) is an instrument for the measurement of PBA that has been validated for the use in patients with ALS and MS. It is a 7-item self-report questionnaire that measures the frequency and severity of PBA episodes, including assessments of labile laughter and labile tearfulness,and provides a score for total PBA (total score can range from 7-35). The following 5-point scoring was used: 1=Applies never, 2=Applies rarely, 3=Applies occasionally, 4=Applies frequently, 5=Applies most of the time. A score of 13 or higher may suggest PBA, and the higher the score the more severe the episodes.
Time Frame
Baseline, Day 15, Day 29, Day 57, Day 84
Title
Mean Change From Baseline to Day 84 in Neuropsychiatric Inventory (NPI-Q) Frequency and Severity Score (EE Population)
Description
The NPI is a retrospective (to 1 month) caregiver-informant interview assessing frequency and severity of 12 neuropsychiatric symptom domains. The NPI score is based on the sum of the severity ratings (0=absent, 1=mild, 3=severe). The 12 symptom domains include delusions, hallucinations, agitation/aggression, dysphoria/depression, anxiety, euphoria/elation, apathy/indifference, disinhibition, irritability/lability, aberrant motor behaviors, nighttime behavioral disturbances, and appetite/eating abnormalities. The NPI severity score is based on severity ratings (0=absent, 1=mild to 3=severe).
Time Frame
Baseline to Day 84
Title
Mean Change From Baseline to Day 84 in Neuropsychiatric Inventory (NPI-Q) Frequency and Severity Score (ITT Population)
Description
The NPI is a retrospective (to 1 month) caregiver-informant interview assessing frequency and severity of 12 neuropsychiatric symptom domains. The NPI score is based on the sum of the severity ratings (0=absent, 1=mild, 3=severe). The 12 symptom domains include delusions, hallucinations, agitation/aggression, dysphoria/depression, anxiety, euphoria/elation, apathy/indifference, disinhibition, irritability/lability, aberrant motor behaviors, nighttime behavioral disturbances, and appetite/eating abnormalities. The NPI severity score is based on severity ratings (0=absent, 1=mild to 3=severe).
Time Frame
Baseline to Day 84
Title
Mean Change From Baseline at Day 84 in SF-36 (Short-Form) Health Survey Medical Outcome Score by Category
Description
The SF-36 is designed to examine a person's perceived health status. The SF-36 includes one multi-item scale measuring eight health concepts: vitality, physical functioning, bodily pain, general health perceptions, physical role-, emotional role-, social role functioning, and mental health. Answers to each question are scored and summed to produce raw scale scores for each health concept which are then transformed to a 0 - 100 scale, a high score defining a more favorable health state. An aggregate summary measure is calculated by averaging the scores from the eight health concepts.
Time Frame
Baseline and Day 84
Title
Mean Change From Baseline at Day 84 in Beck Depression Inventory (BDI-II) Total Score
Description
The BDI-II is a 21-item self report instrument intended to assess the existence and severity of symptoms of depression, summed to give a single score. The BDI-II uses a 4-point for each item ranging from 0 to 3. A total score of 0-13 is considered minimal range, 14 to 19 is mild, 20 to 28 is moderate, and 29 to 63 is severe.
Time Frame
Baseline and Day 84
Title
Mean Change From Baseline to Day 84 in Pain Rating Scale (PRS) of MS Subjects
Description
Subjects with MS were instructed to also record daily the pain they experienced using the PRS. After evaluating the subject's ability to comply with these requirements, the investigator determined if a caregiver should complete the study diary and assessments. Subjects rated their pain over the past 12 hours on a scale of 0 to 10 (0=none, 10=worst pain ever experienced).
Time Frame
Baseline, Day 15, Day 29, Day 57, Day 84

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria: The patient has a diagnosis of Amyotrophic Lateral Sclerosis (according to El Escorial Criteria, WFN, 1998) and the time from diagnosis of ALS is not be longer than 30 months, or the patient has a diagnosis of multiple sclerosis or probable multiple sclerosis (according to McDonald criteria, 2001) The patient has a clinical history and clinical relevant symptoms of Pseudobulbar Affect (PBA) CNS-LS score at baseline is 13 or greater Main Exclusion Criteria: Patients with myasthenia gravis Any personal history of complete heart block, QTc prolongation, or torsades de pointes Any family history of congenital QT interval prolongation syndrome Patients with known sensitivity to quinidine, dextromethorphan or opiate drugs (codeine, etc.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian Hepner, M.D.
Organizational Affiliation
Avanir Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
St. Joseph's Hospital and Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Neuromuscular Research Center
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
South Coast Clinical Trials
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
Facility Name
UCI Medical Center
City
Irvine
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Center for Neurologic Study
City
La Jolla
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
UCLA School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
The Forbes Norris MDA/ALS Research Center - California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
The ALS Center at UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States
Facility Name
University of Colorado at Denver & Health Science Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Neuroscience Center
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Suncoast Neuroscience Associates
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
The ALS Center at Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Neurology Specialists of Decatur of Decatur
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Consultants in Neurology
City
Northbrook
State/Province
Illinois
ZIP/Postal Code
60062
Country
United States
Facility Name
University of Kentucky Health Care - Dept. of Neurology
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
The John Hopkins Universitiy
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusets General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
St.Louis University - Neuromuscular Clinic
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Advanced Neurology Specialists
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Neurology Associates
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
Universitiy of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Upstate Clinical Research
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
Facility Name
Jacobs Neurological Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Neurological Institute - Columbia Presbyterian Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Duke Universitiy Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Department of Neurology - The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State Universitiy
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Oregon Health Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Drexel University - Department of Neurology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
The ALS Center - Penn Neurological Institute - The University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
The Methodist Hospital - Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Department of Neuropsychiatry - Texas Tech University
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79430
Country
United States
Facility Name
University of Texas Health Science Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Universitiy of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Dean Foundation
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States
Facility Name
FACENE
City
Buenos Aires
State/Province
Ciudad de Buenos Aires
ZIP/Postal Code
1117ABD
Country
Argentina
Facility Name
IADIN
City
Buenos Aires
State/Province
Ciudad de Buenos Aires
ZIP/Postal Code
C1055AAD
Country
Argentina
Facility Name
Hospital Italiano
City
Buenos Aires
State/Province
Ciudad de Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
Facility Name
INEBA
City
Buenos Aires
State/Province
Ciudad de Buenos Aires
ZIP/Postal Code
C1192AAW
Country
Argentina
Facility Name
Hospital Ramos Mejia
City
Buenos Aires
State/Province
Ciudad de Buenos Aires
ZIP/Postal Code
C1221ADC
Country
Argentina
Facility Name
Hospital Britanico
City
Buenos Aires
State/Province
Ciudad de Buenos Aires
ZIP/Postal Code
C1280AEB
Country
Argentina
Facility Name
Policlinico Bancario
City
Buenos Aires
State/Province
Ciudad de Buenos Aires
ZIP/Postal Code
C1416DRJ
Country
Argentina
Facility Name
FLENI
City
Buenos Aires
State/Province
Ciudad de Buenos Aires
ZIP/Postal Code
C1428AQK
Country
Argentina
Facility Name
Instituto Medico Rodriguez Alfici
City
Godoy Cruz
State/Province
Mendoza
ZIP/Postal Code
M5501AAP
Country
Argentina
Facility Name
Instituto de Neurociencias Rosario
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2002KQJ
Country
Argentina
Facility Name
Hospital Militar Regional de Cordoba
City
Cordoba
ZIP/Postal Code
X5000HGX
Country
Argentina
Facility Name
Santa Casa de Misericordia de Belo Horizonte
City
Belo Horizonte
State/Province
M G
ZIP/Postal Code
30.150-221
Country
Brazil
Facility Name
Hospital da Restauração
City
Recife
State/Province
PE
ZIP/Postal Code
52.010-040
Country
Brazil
Facility Name
Hospital de Clínicas-UFPR
City
Curitiba
State/Province
PR
ZIP/Postal Code
80.060.900
Country
Brazil
Facility Name
Hospital Universitário Clementino Fraga Filho
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
21941-913
Country
Brazil
Facility Name
Hospital Moinhos de Vento
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90.560.030
Country
Brazil
Facility Name
Hospital das Clínicas da Faculdade de Medicina da Universidade São Paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05.403-000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
20839238
Citation
Pioro EP, Brooks BR, Cummings J, Schiffer R, Thisted RA, Wynn D, Hepner A, Kaye R; Safety, Tolerability, and Efficacy Results Trial of AVP-923 in PBA Investigators. Dextromethorphan plus ultra low-dose quinidine reduces pseudobulbar affect. Ann Neurol. 2010 Nov;68(5):693-702. doi: 10.1002/ana.22093.
Results Reference
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Safety and Efficacy of AVP-923 in PBA Patients With ALS or MS

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