Multiple Sclerosis Clinical Trial

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

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Summary

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.

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Full Description

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).

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Eligibility Criteria

Main 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.

Main 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

Study is for people with:

Multiple Sclerosis

Phase:

Phase 2

Estimated Enrollment:

209

Study ID:

NCT01324232

Recruitment Status:

Completed

Sponsor:

Avanir Pharmaceuticals

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There are 68 Locations for this study

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North Central Neurology Associates PC
Cullman Alabama, 35058, United States
St. Joseph's Hospital Medical Center
Phoenix Arizona, 85013, United States
Alta Bates Summit Medical Center
Berkeley California, 94705, United States
University of California, Irvine
Orange California, 92868, United States
Coordinated Clinical Research
San Diego California, 92103, United States
University of California, San Francisco
San Francisco California, 94158, United States
University of Colorado
Aurora Colorado, 80045, United States
Neurology Associates, PA
Maitland Florida, 32751, United States
Collier Neurologic Specialists
Naples Florida, 34102, United States
Laszlo J. Mate, MD
North Palm Beach Florida, 33408, United States
Neurology Associates of Ormond Beach
Ormond Beach Florida, 32174, United States
Neurological Associates
Pompano Beach Florida, 33060, United States
Neurologique Foundation
Ponte Vedra Beach Florida, 32082, United States
Suncoast Neuroscience Associates, Inc.
Saint Petersburg Florida, 33713, United States
University of South Florida
Tampa Florida, 33612, United States
Geodyssey Research, LLC
Vero Beach Florida, 32960, United States
Shepard Center
Atlanta Georgia, 30309, United States
Rush-Presbyterian St. Luke's Medical Center
Chicago Illinois, 60612, United States
Consultants in Neurology
Northbrook Illinois, 60062, United States
Josephson Wallack Munshower Neurology, P.C.
Indianapolis Indiana, 46256, United States
MidAmerica Neuroscience Institute
Lenexa Kansas, 66214, United States
Johns Hopkins University School of Medicine
Baltimore Maryland, 21287, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Michigan Neurology Associates, P.C.
Clinton Township Michigan, 48035, United States
Wayne State University
Detroit Michigan, 48201, United States
Henry Ford Health System
Detroit Michigan, 48202, United States
Advanced Neurology Specialists
Great Falls Montana, 59405, United States
Neurology Associates PC
Lincoln Nebraska, 68506, United States
Albany Medical Center Hospital
Albany New York, 12208, United States
NYU-Hospital for Joint Diseases
New York New York, 10003, United States
University of Rochester
Rochester New York, 14642, United States
SUNY at Stony Brook
Stony Brook New York, 11794, United States
Carolinas Medical Center
Charlotte North Carolina, 28207, United States
Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States
Oklahoma Medical Research Foundation
Oklahoma City Oklahoma, 73104, United States
Drexel University College of Medicine
Philadelphia Pennsylvania, 19107, United States
Geisinger Health System
Wilkes-Barre Pennsylvania, 18711, United States
Advanced Neurosciences Institute
Franklin Tennessee, 37064, United States
Baylor College of Medicine
Houston Texas, 77030, United States
Rocky Mountain MS Clinic
Salt Lake City Utah, 84103, United States
Neurological Associates
Henrico Virginia, 23226, United States
MS Center of Greater Washington
Vienna Virginia, 22182, United States
Swedish Medical Center
Seattle Washington, 98122, United States
MultiCare Health System
Tacoma Washington, 98405, United States
Instituto de Neurologia Cognitiva
Ciudad Autonoma de Buenos Aires Buenos Aires, C1126, Argentina
Hospital Britanico de Buenos Aires
Ciudad Autonoma de Buenos Aires Buenos Aires, C1280, Argentina
Hospital Italiano
Ciudad Autónoma de Buenos Aires Buenos Aires, C1181, Argentina
Instituto Argentino de Investigacion Neurologica
Ciudad de Buenos Aires Buenos Aires, C1015, Argentina
Hospital Churruca-Visca
Buenos Aires , C1437, Argentina
Fundación Argentina Contra las Enfermedades Neurológicas del Envejecimiento - FACENE
Buenos Aires , CP111, Argentina
Medeos - Centro de Medicina Integral e Investigación Clínica
Ciudad Autonoma de Buenos Aires , , Argentina
Instituto de Neurología y Neurorrehabilitación del Litoral
Santa Fe , , Argentina
Fakultni nemocnice u sv. Anny v Brne
Brno , , Czechia
Fakultni nemocnice Hradec Kralove
Hradec Kralove , 500 0, Czechia
Nemocnice Jihlava, prispevkova organizace
Jihlava , 586 3, Czechia
Fakultni Nemocnice Ostrava
Ostrava , 708 5, Czechia
Vseobecna fakultni nemocnice v Praze
Praha 2 , 128 2, Czechia
Szpital Powiatowy w Czeladzi
Czeladz , 41-25, Poland
Pomorskie Centrum Traumatologii im. M. Kopernika w Gdansku
Gdansk , 80-80, Poland
Diagnomed Clinical Research Sp. z.o.o.
Katowice , 40-59, Poland
Niepubliczny Zaklad Opieki Zdrowotnej NEURO-MEDIC
Katowice , 40-75, Poland
Niepubliczny Zaklad Opieki Zdrowotnej PROFILAKTYKA
Katowice , , Poland
Zespol Opieki Zdrowotnej w Konskich
Konskie , 26-20, Poland
Specjalistyczny Gabinet Neurologiczny
Plewiska , 62-06, Poland
Niepubliczny Zaklad Opieki Zdrowotnej NEURO-KARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy
Poznan , 61-28, Poland
Osrodek Badan Klinicznych Indywidualnej Specjalistycznej Praktyki Lekarskiej
Szczecin , 70-21, Poland
Hospital del Mar
Barcelona Cataluña, 08003, Spain
Hospital Vall D´Hebron
Barcelona Cataluña, 08035, Spain
Hospital Universitari de Girona Dr. Josep Trueta
Girona Cataluña, 17007, Spain
Hospital Universitario Virgen de la Arrixaca
El Palmar Murcia, 30120, Spain
Hospital Univ. Nuestra Sra. De La Candelaria
Santa Cruz De Tenerife , 38010, Spain
Hospital Universitario Vírgen Macarena
Sevilla , 41009, Spain
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How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 2

Estimated Enrollment:

209

Study ID:

NCT01324232

Recruitment Status:

Completed

Sponsor:


Avanir Pharmaceuticals

How clear is this clinincal trial information?

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