Clinical trial NCT01324232: Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis
Official title: A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Central Neuropathic Pain
Multiple Sclerosis
Lead sponsor: Avanir Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-03-28
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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).

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

Primary outcomes:
measure: Association Between the Dextromethorphan Plasma Concentration and the Change From Baseline Pain Rating Scale (PRS) Score to the Average Pain Rating Scale Score During Days 57 Through 84
timeFrame: Baseline; Days 57 through 84 (PRS score); Days 22 and 50 (dextromethorphan plasma concentrations)
measure: Average Logarithms of Dextromethorphan (DM) Plasma Concentrations (Cmax) on Days 22 and 50
timeFrame: 0 to 3 hours post-dose on Day 22 and 50
Secondary outcomes:
measure: Comparison of the Adjusted Mean Change From Baseline PRS Score to the Average PRS Score During Days 57 Through 84
timeFrame: Baseline; Days 57 through 84
measure: Mean Change From Baseline in Fatigue Severity Scale (FSS) Scores at Days 57 Through 84
timeFrame: Baseline; Days 57 through 84
measure: Mean Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at Days 22 and 85
timeFrame: Baseline; Days 22 and 85
measure: Mean Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Scores at Day 85
timeFrame: Baseline; Day 85
measure: Mean Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Scores at Day 85
timeFrame: Baseline; Day 85
measure: Mean Change From Baseline in MS Neuropsychological Screening Questionnaire (MSNQ) Scores at Day 85
timeFrame: Baseline; Day 85
measure: Mean Change From Baseline in Beck Depression Inventory (BDI-II) Scores at Day 85
timeFrame: Baseline; Day 85
measure: Mean Change From Baseline in Symbol Digit Modalities Test (SDMT) Scores at Day 85
timeFrame: Baseline; Day 85
measure: Mean Numerical Rating Scale (NRS) Scores at Days 22, 50, and 85
timeFrame: Days 22, 50, and 85
measure: Mean Overall Patient Global Impression of Change (PGIC) Scores at Day 85
timeFrame: Day 85
Other outcomes:
measure: Change From Baseline in Modified Ashworth Scale (MAS) Scores
timeFrame: Baseline; Day 85
Locations:
city: Cullman
country: United States
facility: North Central Neurology Associates PC
state: Alabama
city: Phoenix
country: United States
facility: St. Joseph's Hospital Medical Center
state: Arizona
city: Berkeley
country: United States
facility: Alta Bates Summit Medical Center
state: California
city: Orange
country: United States
facility: University of California, Irvine
state: California
city: San Diego
country: United States
facility: Coordinated Clinical Research
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Maitland
country: United States
facility: Neurology Associates, PA
state: Florida
city: Naples
country: United States
facility: Collier Neurologic Specialists
state: Florida
city: North Palm Beach
country: United States
facility: Laszlo J. Mate, MD
state: Florida
city: Ormond Beach
country: United States
facility: Neurology Associates of Ormond Beach
state: Florida
city: Pompano Beach
country: United States
facility: Neurological Associates
state: Florida
city: Ponte Vedra Beach
country: United States
facility: Neurologique Foundation
state: Florida
city: Saint Petersburg
country: United States
facility: Suncoast Neuroscience Associates, Inc.
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Vero Beach
country: United States
facility: Geodyssey Research, LLC
state: Florida
city: Atlanta
country: United States
facility: Shepard Center
state: Georgia
city: Chicago
country: United States
facility: Rush-Presbyterian St. Luke's Medical Center
state: Illinois
city: Northbrook
country: United States
facility: Consultants in Neurology
state: Illinois
city: Indianapolis
country: United States
facility: Josephson Wallack Munshower Neurology, P.C.
state: Indiana
city: Lenexa
country: United States
facility: MidAmerica Neuroscience Institute
state: Kansas
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Clinton Township
country: United States
facility: Michigan Neurology Associates, P.C.
state: Michigan
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Great Falls
country: United States
facility: Advanced Neurology Specialists
state: Montana
city: Lincoln
country: United States
facility: Neurology Associates PC
state: Nebraska
city: Albany
country: United States
facility: Albany Medical Center Hospital
state: New York
city: New York
country: United States
facility: NYU-Hospital for Joint Diseases
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Stony Brook
country: United States
facility: SUNY at Stony Brook
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Medical Research Foundation
state: Oklahoma
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Geisinger Health System
state: Pennsylvania
city: Franklin
country: United States
facility: Advanced Neurosciences Institute
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Salt Lake City
country: United States
facility: Rocky Mountain MS Clinic
state: Utah
city: Henrico
country: United States
facility: Neurological Associates
state: Virginia
city: Vienna
country: United States
facility: MS Center of Greater Washington
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Tacoma
country: United States
facility: MultiCare Health System
state: Washington
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Instituto de Neurologia Cognitiva
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Hospital Britanico de Buenos Aires
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Hospital Italiano
state: Buenos Aires
city: Ciudad de Buenos Aires
country: Argentina
facility: Instituto Argentino de Investigacion Neurologica
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Churruca-Visca
city: Buenos Aires
country: Argentina
facility: Fundación Argentina Contra las Enfermedades Neurológicas del Envejecimiento - FACENE
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Medeos - Centro de Medicina Integral e Investigación Clínica
city: Santa Fe
country: Argentina
facility: Instituto de Neurología y Neurorrehabilitación del Litoral
city: Brno
country: Czechia
facility: Fakultni nemocnice u sv. Anny v Brne
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Jihlava
country: Czechia
facility: Nemocnice Jihlava, prispevkova organizace
city: Ostrava
country: Czechia
facility: Fakultni Nemocnice Ostrava
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
city: Czeladz
country: Poland
facility: Szpital Powiatowy w Czeladzi
city: Gdansk
country: Poland
facility: Pomorskie Centrum Traumatologii im. M. Kopernika w Gdansku
city: Katowice
country: Poland
facility: Diagnomed Clinical Research Sp. z.o.o.
city: Katowice
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej NEURO-MEDIC
city: Katowice
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej PROFILAKTYKA
city: Konskie
country: Poland
facility: Zespol Opieki Zdrowotnej w Konskich
city: Plewiska
country: Poland
facility: Specjalistyczny Gabinet Neurologiczny
city: Poznan
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej NEURO-KARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy
city: Szczecin
country: Poland
facility: Osrodek Badan Klinicznych Indywidualnej Specjalistycznej Praktyki Lekarskiej
city: Barcelona
country: Spain
facility: Hospital del Mar
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital Vall D´Hebron
state: Cataluña
city: Girona
country: Spain
facility: Hospital Universitari de Girona Dr. Josep Trueta
state: Cataluña
city: El Palmar
country: Spain
facility: Hospital Universitario Virgen de la Arrixaca
state: Murcia
city: Santa Cruz De Tenerife
country: Spain
facility: Hospital Univ. Nuestra Sra. De La Candelaria
city: Sevilla
country: Spain
facility: Hospital Universitario Vírgen Macarena
Study officials:
References: