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Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis

NCT ID: NCT01324232

Last Updated: 2021-11-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

209 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-08

Study Completion Date

2013-09-26

Brief Summary

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The objectives of the study are to evaluate the safety, tolerability, and efficacy of 3 doses of AVP-923 capsules in the treatment of central neuropathic pain in participants with multiple sclerosis.

Detailed Description

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The objectives of the study are to evaluate the safety, tolerability, and efficacy of 3 doses of AVP-923 (dextromethorphan \[DM\]/quinidine \[Q\]) capsules containing either 45 mg DM and 10 mg Q (AVP-923-45) or 30 mg DM and 10 mg Q (AVP-923-30) or 20 mg DM and 10 mg Q (AVP-923-20) compared to placebo, for the treatment of central neuropathic pain in a population of participants with multiple sclerosis (MS) over a 12-week period. The MS participant population enrolled includes participants with relapsing-remitting multiple sclerosis (RRMS) and participants with secondary progressive multiple sclerosis (SPMS).

Conditions

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Central Neuropathic Pain Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo capsules administered once daily for first 7 days followed by twice daily for 11 weeks of the study to complete 12 weeks of treatment.

AVP-923-45

Group Type EXPERIMENTAL

AVP-923-45

Intervention Type DRUG

AVP-923-45 (dextromethorphan 45 mg/quinidine 10 mg) capsules administered once daily for first 7 days followed by twice daily for 11 weeks of the study to complete 12 weeks of treatment.

AVP-923-30

Group Type EXPERIMENTAL

AVP-923-30

Intervention Type DRUG

AVP-923-30 (dextromethorphan 30 mg/quinidine 10 mg) capsules administered once daily for first 7 days followed by twice daily for 11 weeks of the study to complete 12 weeks of treatment.

AVP-923-20

Group Type EXPERIMENTAL

AVP-923-20

Intervention Type DRUG

AVP-923-20 (dextromethorphan 20 mg/quinidine 10 mg) capsules administered once daily for first 7 days followed by twice daily for 11 weeks of the study to complete 12 weeks of treatment.

Interventions

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AVP-923-45

AVP-923-45 (dextromethorphan 45 mg/quinidine 10 mg) capsules administered once daily for first 7 days followed by twice daily for 11 weeks of the study to complete 12 weeks of treatment.

Intervention Type DRUG

AVP-923-30

AVP-923-30 (dextromethorphan 30 mg/quinidine 10 mg) capsules administered once daily for first 7 days followed by twice daily for 11 weeks of the study to complete 12 weeks of treatment.

Intervention Type DRUG

AVP-923-20

AVP-923-20 (dextromethorphan 20 mg/quinidine 10 mg) capsules administered once daily for first 7 days followed by twice daily for 11 weeks of the study to complete 12 weeks of treatment.

Intervention Type DRUG

Placebo

Matching placebo capsules administered once daily for first 7 days followed by twice daily for 11 weeks of the study to complete 12 weeks of treatment.

Intervention Type DRUG

Other Intervention Names

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Nuedexta

Eligibility Criteria

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Inclusion Criteria

Multiple Sclerosis (relapsing-remitting multiple sclerosis \[RRMS\] or secondary progressive multiple sclerosis \[SPMS\]), Clinical history and symptoms of central neuropathic pain (dysesthetic pain) for at least 3 months prior to screening, pain rating scale (PRS) baseline score = or \> 4, No MS relapse within previous 30 days.

Exclusion Criteria

Personal history of complete heart block, QT interval corrected for heart rate (QTc) prolongation, or torsades de pointes, family history of congenital QT interval prolongation syndrome, Myasthenia Gravis, Beck Depression Inventory Second Edition (BDI-II) score \> 19
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Avanir Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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North Central Neurology Associates PC

Cullman, Alabama, United States

Site Status

St. Joseph's Hospital Medical Center

Phoenix, Arizona, United States

Site Status

Alta Bates Summit Medical Center

Berkeley, California, United States

Site Status

University of California, Irvine

Orange, California, United States

Site Status

Coordinated Clinical Research

San Diego, California, United States

Site Status

University of California, San Francisco

San Francisco, California, United States

Site Status

University of Colorado

Aurora, Colorado, United States

Site Status

Neurology Associates, PA

Maitland, Florida, United States

Site Status

Collier Neurologic Specialists

Naples, Florida, United States

Site Status

Laszlo J. Mate, MD

North Palm Beach, Florida, United States

Site Status

Neurology Associates of Ormond Beach

Ormond Beach, Florida, United States

Site Status

Neurological Associates

Pompano Beach, Florida, United States

Site Status

Neurologique Foundation

Ponte Vedra Beach, Florida, United States

Site Status

Suncoast Neuroscience Associates, Inc.

St. Petersburg, Florida, United States

Site Status

University of South Florida

Tampa, Florida, United States

Site Status

Geodyssey Research, LLC

Vero Beach, Florida, United States

Site Status

Shepard Center

Atlanta, Georgia, United States

Site Status

Rush-Presbyterian St. Luke's Medical Center

Chicago, Illinois, United States

Site Status

Consultants in Neurology

Northbrook, Illinois, United States

Site Status

Josephson Wallack Munshower Neurology, P.C.

Indianapolis, Indiana, United States

Site Status

MidAmerica Neuroscience Institute

Lenexa, Kansas, United States

Site Status

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Michigan Neurology Associates, P.C.

Clinton Township, Michigan, United States

Site Status

Wayne State University

Detroit, Michigan, United States

Site Status

Henry Ford Health System

Detroit, Michigan, United States

Site Status

Advanced Neurology Specialists

Great Falls, Montana, United States

Site Status

Neurology Associates PC

Lincoln, Nebraska, United States

Site Status

Albany Medical Center Hospital

Albany, New York, United States

Site Status

NYU-Hospital for Joint Diseases

New York, New York, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

SUNY at Stony Brook

Stony Brook, New York, United States

Site Status

Carolinas Medical Center

Charlotte, North Carolina, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, United States

Site Status

Drexel University College of Medicine

Philadelphia, Pennsylvania, United States

Site Status

Geisinger Health System

Wilkes-Barre, Pennsylvania, United States

Site Status

Advanced Neurosciences Institute

Franklin, Tennessee, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

Rocky Mountain MS Clinic

Salt Lake City, Utah, United States

Site Status

Neurological Associates

Henrico, Virginia, United States

Site Status

MS Center of Greater Washington

Vienna, Virginia, United States

Site Status

Swedish Medical Center

Seattle, Washington, United States

Site Status

MultiCare Health System

Tacoma, Washington, United States

Site Status

Instituto de Neurologia Cognitiva

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Site Status

Hospital Britanico de Buenos Aires

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Site Status

Hospital Italiano

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Site Status

Instituto Argentino de Investigacion Neurologica

Ciudad de Buenos Aires, Buenos Aires, Argentina

Site Status

Hospital Churruca-Visca

Buenos Aires, , Argentina

Site Status

Fundación Argentina Contra las Enfermedades Neurológicas del Envejecimiento - FACENE

Buenos Aires, , Argentina

Site Status

Medeos - Centro de Medicina Integral e Investigación Clínica

Buenos Aires, , Argentina

Site Status

Instituto de Neurología y Neurorrehabilitación del Litoral

Santa Fe, , Argentina

Site Status

Fakultni nemocnice u sv. Anny v Brne

Brno, , Czechia

Site Status

Fakultni nemocnice Hradec Kralove

Hradec Králové, , Czechia

Site Status

Nemocnice Jihlava, prispevkova organizace

Jihlava, , Czechia

Site Status

Fakultni Nemocnice Ostrava

Ostrava, , Czechia

Site Status

Vseobecna fakultni nemocnice v Praze

Prague, , Czechia

Site Status

Szpital Powiatowy w Czeladzi

Czeladź, , Poland

Site Status

Pomorskie Centrum Traumatologii im. M. Kopernika w Gdansku

Gdansk, , Poland

Site Status

Zespol Opieki Zdrowotnej w Konskich

Gmina Końskie, , Poland

Site Status

Diagnomed Clinical Research Sp. z.o.o.

Katowice, , Poland

Site Status

Niepubliczny Zaklad Opieki Zdrowotnej NEURO-MEDIC

Katowice, , Poland

Site Status

Niepubliczny Zaklad Opieki Zdrowotnej PROFILAKTYKA

Katowice, , Poland

Site Status

Specjalistyczny Gabinet Neurologiczny

Plewiska, , Poland

Site Status

Niepubliczny Zaklad Opieki Zdrowotnej NEURO-KARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy

Poznan, , Poland

Site Status

Osrodek Badan Klinicznych Indywidualnej Specjalistycznej Praktyki Lekarskiej

Szczecin, , Poland

Site Status

Hospital del Mar

Barcelona, Catalonia, Spain

Site Status

Hospital Vall D´Hebron

Barcelona, Catalonia, Spain

Site Status

Hospital Universitari de Girona Dr. Josep Trueta

Girona, Catalonia, Spain

Site Status

Hospital Universitario Virgen de la Arrixaca

El Palmar, Murcia, Spain

Site Status

Hospital Univ. Nuestra Sra. De La Candelaria

Santa Cruz de Tenerife, , Spain

Site Status

Hospital Universitario Vírgen Macarena

Seville, , Spain

Site Status

Countries

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Germany United Kingdom United States Argentina Czechia Poland Spain

Other Identifiers

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11-AVR-130

Identifier Type: -

Identifier Source: org_study_id