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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Avanir Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01324232

First received: March 23, 2011

Last updated: April 15, 2014

Last verified: April 2014

History of Changes

Purpose

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 patients with multiple sclerosis.

Condition	Intervention	Phase
Central Neuropathic Pain Multiple Sclerosis	Drug: AVP-923	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: multiple sclerosis

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Nuedexta

U.S. FDA Resources

Further study details as provided by Avanir Pharmaceuticals:

Primary Outcome Measures:

Pain Rating Scale (PRS) [ Time Frame: 12 weeks ]

Secondary Outcome Measures:

Fatigue Severity Scale (FSS) [ Time Frame: 12 weeks ]
Expanded Disability Status Scale (EDSS) [ Time Frame: 12 weeks ]
Multiple Sclerosis Impact Scale-29 (MSIS-29) [ Time Frame: 12 weeks ]
Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 12 weeks ]
MS Neuropsychological Screening Questionnaire (MSNQ) [ Time Frame: 12 weeks ]
Beck Depression Inventory (BDI-II). [ Time Frame: 12 weeks ]
Symbol Digit Modalities Test (SDMT) [ Time Frame: 12 weeks ]
Modified Ashworth Scale (MAS) [ Time Frame: 12 Weeks ]
7-point Numerical Rating Scale (NRS) [ Time Frame: 12 Weeks ]
Patient Global Impression of Change (PGIC) [ Time Frame: 12 Weeks ]


Enrollment:	200
Study Start Date:	September 2011
Study Completion Date:	September 2013
Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo	Drug: AVP-923 AVP-923 capsules administered twice-a-day, over a 12 week period Other Name: Nuedexta (AVP-923-20)
Experimental: AVP-923-45	Drug: AVP-923 AVP-923 capsules administered twice-a-day, over a 12 week period Other Name: Nuedexta (AVP-923-20)
Experimental: AVP-923-30	Drug: AVP-923 AVP-923 capsules administered twice-a-day, over a 12 week period Other Name: Nuedexta (AVP-923-20)
Experimental: AVP-923-20	Drug: AVP-923 AVP-923 capsules administered twice-a-day, over a 12 week period Other Name: Nuedexta (AVP-923-20)

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 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 patients with multiple sclerosis (MS) over a 12-week period. The MS patients population enrolled includes patients with relapsing-remitting multiple sclerosis (RRMS) and patients with secondary progressive multiple sclerosis (SPMS).

Eligibility


Ages Eligible for Study:	18 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Main Inclusion Criteria:

Multiple Sclerosis (RRMS or SPMS), Clinical history and symptoms of central neuropathic pain (dysesthetic pain)for at least 3 months prior to screening, PRS baseline score = or > 4, No MS relapse within previous 30 days.

Main Exclusion Criteria:

Personal history of complete heart block, QTc prolongation, or torsades de pointes, family history of congenital QT interval prolongation syndrome, Myasthenia Gravis, BDI score > 19

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01324232

Hide Study Locations

Locations


United States, Alabama
North Central Neurology Associates PC
Cullman, Alabama, United States, 35058
United States, Arizona
St. Joseph's Hospital Medical Center
Phoenix, Arizona, United States, 85013
United States, California
Alta Bates Summit Medical Center
Berkeley, California, United States, 94705
University of California, Irvine
Orange, California, United States, 92868
Coordinated Clinical Research
San Diego, California, United States, 92103
University of California, San Francisco
San Francisco, California, United States, 94158
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
United States, Florida
Neurology Associates, PA
Maitland, Florida, United States, 32751
Collier Neurologic Specialists
Naples, Florida, United States, 34102
Laszlo J. Mate, MD
North Palm Beach, Florida, United States, 33408
Neurology Associates of Ormond Beach
Ormond Beach, Florida, United States, 32174
Neurological Associates
Pompano Beach, Florida, United States, 33060
Neurologique Foundation
Ponte Vedra Beach, Florida, United States, 32082-4040
Suncoast Neuroscience Associates, Inc.
St. Petersburg, Florida, United States, 33713
University of South Florida
Tampa, Florida, United States, 33612
Geodyssey Research, LLC
Vero Beach, Florida, United States, 32960
United States, Georgia
Shepard Center
Atlanta, Georgia, United States, 30309
United States, Illinois
Rush-Presbyterian St. Luke's Medical Center
Chicago, Illinois, United States, 60612
Consultants in Neurology
Northbrook, Illinois, United States, 60062
United States, Indiana
Josephson Wallack Munshower Neurology, P.C.
Indianapolis, Indiana, United States, 46256
United States, Kansas
MidAmerica Neuroscience Institute
Lenexa, Kansas, United States, 66214
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
Michigan Neurology Associates, P.C.
Clinton Twp, Michigan, United States, 48035
Wayne State University
Detroit, Michigan, United States, 48201
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Montana
Advanced Neurology Specialists
Great Falls, Montana, United States, 59405
United States, Nebraska
Neurology Associates PC
Lincoln, Nebraska, United States, 68506
United States, New York
Albany Medical Center Hospital
Albany, New York, United States, 12208
NYU-Hospital for Joint Diseases
New York, New York, United States, 10003
University of Rochester
Rochester, New York, United States, 14642
SUNY at Stony Brook
Stony Brook, New York, United States, 11794
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28207
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Oklahoma
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States, 19107
Geisinger Health System
Wilkes Barre, Pennsylvania, United States, 18711
United States, Tennessee
Advanced Neurosciences Institute
Franklin, Tennessee, United States, 37064
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Utah
Rocky Mountain MS Clinic
Salt Lake City, Utah, United States, 84103
United States, Virginia
Neurological Associates
Henrico, Virginia, United States, 23226
MS Center of Greater Washington
Vienna, Virginia, United States, 22182
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98122
MultiCare Health System
Tacoma, Washington, United States, 98405
Argentina
Instituto de Neurologia Cognitiva
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1126AAB
Hospital Britanico de Buenos Aires
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1280AEB
Hospital Italiano
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1181ACH
Instituto Argentino de Investigacion Neurologica
Ciudad de Buenos Aires, Buenos Aires, Argentina, C1015ABR
Hospital Churruca-Visca
Buenos Aires, Argentina, C1437JCH
Fundación Argentina Contra las Enfermedades Neurológicas del Envejecimiento - FACENE
Buenos Aires, Argentina, CP1117ABD
Medeos - Centro de Medicina Integral e Investigación Clínica
Ciudad Autonoma de Buenos Aires, Argentina
Instituto de Neurología y Neurorrehabilitación del Litoral
Santa Fe, Argentina
Czech Republic
Fakultni nemocnice u sv. Anny v Brne
Brno, Czech Republic
Fakultni nemocnice Hradec Kralove
Hradec Kralove, Czech Republic, 500 0
Nemocnice Jihlava, prispevkova organizace
Jihlava, Czech Republic, 586 33
Fakultni Nemocnice Ostrava
Ostrava, Czech Republic, 708 52
Vseobecna fakultni nemocnice v Praze
Praha 2, Czech Republic, 128 21
Poland
Szpital Powiatowy w Czeladzi
Czeladz, Poland, 41-250
Pomorskie Centrum Traumatologii im. M. Kopernika w Gdansku
Gdansk, Poland, 80-803
Diagnomed Clinical Research Sp. z.o.o.
Katowice, Poland, 40-594
Niepubliczny Zaklad Opieki Zdrowotnej NEURO-MEDIC
Katowice, Poland, 40-752
Niepubliczny Zaklad Opieki Zdrowotnej PROFILAKTYKA
Katowice, Poland
Zespol Opieki Zdrowotnej w Konskich
Konskie, Poland, 26-200
Specjalistyczny Gabinet Neurologiczny
Plewiska, Poland, 62-064
Niepubliczny Zaklad Opieki Zdrowotnej NEURO-KARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy
Poznan, Poland, 61-289
Osrodek Badan Klinicznych Indywidualnej Specjalistycznej Praktyki Lekarskiej
Szczecin, Poland, 70-215
Spain
Hospital del Mar
Barcelona, Cataluña, Spain, 08003
Hospital Vall D´Hebron
Barcelona, Cataluña, Spain, 08035
Hospital Universitari de Girona Dr. Josep Trueta
Girona, Cataluña, Spain, 17007
Hospital Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain, 30120
Hospital Univ. Nuestra Sra. De La Candelaria
Canarias, Spain, 38009
Hospital Universitario Vírgen Macarena
Sevilla, Spain, 41009

Sponsors and Collaborators

Avanir Pharmaceuticals

More Information


Responsible Party:	Avanir Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01324232 History of Changes
Other Study ID Numbers:	11-AVR-130
Study First Received:	March 23, 2011
Last Updated:	April 15, 2014

Additional relevant MeSH terms:


Sclerosis Multiple Sclerosis Neuralgia Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pain Neurologic Manifestations Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms	Dextromethorphan Quinidine Antitussive Agents Respiratory System Agents Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents Anti-Arrhythmia Agents Antimalarials Antiprotozoal Agents

ClinicalTrials.gov processed this record on June 23, 2017

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