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

NCT01324232 | Completed Phase 2 Results

• 1 other identifier: 11-AVR-130
• Study Type: interventional
• Target: 209
• Locations: 5 countries
• Sites: 72

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.

Conditions

Central Neuropathic Pain; Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• 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

  PRS required participants to rate their pain over the past 12 hours (hrs) on a scale of 0 to 10 (0=no pain; 10=worst possible pain). Baseline (B) PRS was defined as the average of the PRS scores in the last 7 days collected prior to the B visit. If participants did not have at least 4 PRS scores during the last 7 days prior to the B visit, then the average of up to 7 of the most recent PRS scores available prior to the B visit was used. Post-B PRS was the average of Days 57 through 84 values. For participants who did not have any PRS scores during Days 57 through 84, the average of the last 7 available post-B PRS scores was used. Change from B was calculated as the post-B score minus B score. The average logarithms of dextromethorphan plasma concentrations (Cmax) on Days 22 and 50 are reported in primary outcome measure #2 below. Pearson correlation was calculated between Cmax as one group of data across the reporting groups and Change from Baseline in PRS score.

  Baseline; Days 57 through 84 (PRS score); Days 22 and 50 (dextromethorphan plasma concentrations)

• Average Logarithms of Dextromethorphan (DM) Plasma Concentrations (Cmax) on Days 22 and 50

  The average of the logarithms of the DM plasma concentrations on Days 22 and 50 were presented.

  0 to 3 hours post-dose on Day 22 and 50

Secondary Outcomes (10)

• Comparison of the Adjusted Mean Change From Baseline PRS Score to the Average PRS Score During Days 57 Through 84

  Baseline; Days 57 through 84

• Mean Change From Baseline in Fatigue Severity Scale (FSS) Scores at Days 57 Through 84

  Baseline; Days 57 through 84

• Mean Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at Days 22 and 85

  Baseline; Days 22 and 85

• Mean Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Scores at Day 85

  Baseline; Day 85

• Mean Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Scores at Day 85

  Baseline; Day 85

Other Outcomes (1)

• Change From Baseline in Modified Ashworth Scale (MAS) Scores

  Baseline; Day 85

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

AVP-923-45

EXPERIMENTAL

Drug: AVP-923-45

AVP-923-30

EXPERIMENTAL

Drug: AVP-923-30

AVP-923-20

EXPERIMENTAL

Drug: AVP-923-20

Interventions

AVP-923-45 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-923-45

AVP-923-30 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-923-30

AVP-923-20 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.

Also known as: Nuedexta

AVP-923-20

Placebo 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.

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Avanir Pharmaceuticals: lead

Study Sites (72)

North Central Neurology Associates PC

Cullman, Alabama, 35058, United States

Location

St. Joseph's Hospital Medical Center

Phoenix, Arizona, 85013, United States

Location

Alta Bates Summit Medical Center

Berkeley, California, 94705, United States

Location

University of California, Irvine

Orange, California, 92868, United States

Location

Coordinated Clinical Research

San Diego, California, 92103, United States

Location

University of California, San Francisco

San Francisco, California, 94158, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Neurology Associates, PA

Maitland, Florida, 32751, United States

Location

Collier Neurologic Specialists

Naples, Florida, 34102, United States

Location

Laszlo J. Mate, MD

North Palm Beach, Florida, 33408, United States

Location

Neurology Associates of Ormond Beach

Ormond Beach, Florida, 32174, United States

Location

Neurological Associates

Pompano Beach, Florida, 33060, United States

Location

Neurologique Foundation

Ponte Vedra Beach, Florida, 32082-4040, United States

Location

Suncoast Neuroscience Associates, Inc.

St. Petersburg, Florida, 33713, United States

Location

University of South Florida

Tampa, Florida, 33612, United States

Location

Geodyssey Research, LLC

Vero Beach, Florida, 32960, United States

Location

Shepard Center

Atlanta, Georgia, 30309, United States

Location

Rush-Presbyterian St. Luke's Medical Center

Chicago, Illinois, 60612, United States

Location

Consultants in Neurology

Northbrook, Illinois, 60062, United States

Location

Josephson Wallack Munshower Neurology, P.C.

Indianapolis, Indiana, 46256, United States

Location

MidAmerica Neuroscience Institute

Lenexa, Kansas, 66214, United States

Location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Michigan Neurology Associates, P.C.

Clinton Township, Michigan, 48035, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Advanced Neurology Specialists

Great Falls, Montana, 59405, United States

Location

Neurology Associates PC

Lincoln, Nebraska, 68506, United States

Location

Albany Medical Center Hospital

Albany, New York, 12208, United States

Location

NYU-Hospital for Joint Diseases

New York, New York, 10003, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

SUNY at Stony Brook

Stony Brook, New York, 11794, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28207, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, 73104, United States

Location

Drexel University College of Medicine

Philadelphia, Pennsylvania, 19107, United States

Location

Geisinger Health System

Wilkes-Barre, Pennsylvania, 18711, United States

Location

Advanced Neurosciences Institute

Franklin, Tennessee, 37064, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Rocky Mountain MS Clinic

Salt Lake City, Utah, 84103, United States

Location

Neurological Associates

Henrico, Virginia, 23226, United States

Location

MS Center of Greater Washington

Vienna, Virginia, 22182, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

MultiCare Health System

Tacoma, Washington, 98405, United States

Location

Instituto de Neurologia Cognitiva

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1126AAB, Argentina

Location

Hospital Britanico de Buenos Aires

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1280AEB, Argentina

Location

Hospital Italiano

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1181ACH, Argentina

Location

Instituto Argentino de Investigacion Neurologica

Ciudad de Buenos Aires, Buenos Aires, C1015ABR, Argentina

Location

Hospital Churruca-Visca

Buenos Aires, C1437JCH, Argentina

Location

Fundación Argentina Contra las Enfermedades Neurológicas del Envejecimiento - FACENE

Buenos Aires, CP1117ABD, Argentina

Location

Medeos - Centro de Medicina Integral e Investigación Clínica

Buenos Aires, Argentina

Location

Instituto de Neurología y Neurorrehabilitación del Litoral

Santa Fe, Argentina

Location

Fakultni nemocnice u sv. Anny v Brne

Brno, Czechia

Location

Fakultni nemocnice Hradec Kralove

Hradec Králové, 500 0, Czechia

Location

Nemocnice Jihlava, prispevkova organizace

Jihlava, 586 33, Czechia

Location

Fakultni Nemocnice Ostrava

Ostrava, 708 52, Czechia

Location

Vseobecna fakultni nemocnice v Praze

Prague, 128 21, Czechia

Location

Szpital Powiatowy w Czeladzi

Czeladź, 41-250, Poland

Location

Pomorskie Centrum Traumatologii im. M. Kopernika w Gdansku

Gdansk, 80-803, Poland

Location

Zespol Opieki Zdrowotnej w Konskich

Gmina Końskie, 26-200, Poland

Location

Diagnomed Clinical Research Sp. z.o.o.

Katowice, 40-594, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej NEURO-MEDIC

Katowice, 40-752, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej PROFILAKTYKA

Katowice, Poland

Location

Specjalistyczny Gabinet Neurologiczny

Plewiska, 62-064, Poland

Location

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

Poznan, 61-289, Poland

Location

Osrodek Badan Klinicznych Indywidualnej Specjalistycznej Praktyki Lekarskiej

Szczecin, 70-215, Poland

Location

Hospital del Mar

Barcelona, Catalonia, 08003, Spain

Location

Hospital Vall D´Hebron

Barcelona, Catalonia, 08035, Spain

Location

Hospital Universitari de Girona Dr. Josep Trueta

Girona, Catalonia, 17007, Spain

Location

Hospital Universitario Virgen de la Arrixaca

El Palmar, Murcia, 30120, Spain

Location

Hospital Univ. Nuestra Sra. De La Candelaria

Santa Cruz de Tenerife, 38010, Spain

Location

Hospital Universitario Vírgen Macarena

Seville, 41009, Spain

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

dextromethorphan - quinidine combination

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Avanir Medical Information
• Organization: Avanir Pharmaceuticals

medinfo@avanir.com

855-572-2722

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2011
• First Posted: March 28, 2011
• Study Start: September 8, 2011
• Primary Completion: September 26, 2013
• Study Completion: September 26, 2013
• Last Updated: November 22, 2021
• Results First Posted: November 22, 2021

Record last verified: 2021-10

Locations

AR (8); PL (9); ES (6); US (44); CZ (5)