Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis (PRIME)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01324232 |
Recruitment Status
:
Completed
First Posted
: March 28, 2011
Last Update Posted
: January 16, 2018
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Central Neuropathic Pain Multiple Sclerosis | Drug: AVP-923 Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (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 |
Study Start Date : | September 2011 |
Actual Primary Completion Date : | September 2013 |
Actual Study Completion Date : | September 2013 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo |
Drug: Placebo
Matching placebo
|
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)
|
- Pain Rating Scale (PRS) [ Time Frame: 12 weeks ]
- 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 ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01324232

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. | |
Saint 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 Township, 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 | |
Czechia | |
Fakultni nemocnice u sv. Anny v Brne | |
Brno, Czechia | |
Fakultni nemocnice Hradec Kralove | |
Hradec Kralove, Czechia, 500 0 | |
Nemocnice Jihlava, prispevkova organizace | |
Jihlava, Czechia, 586 33 | |
Fakultni Nemocnice Ostrava | |
Ostrava, Czechia, 708 52 | |
Vseobecna fakultni nemocnice v Praze | |
Praha 2, Czechia, 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 |
Responsible Party: | Avanir Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT01324232 History of Changes |
Other Study ID Numbers: |
11-AVR-130 |
First Posted: | March 28, 2011 Key Record Dates |
Last Update Posted: | January 16, 2018 |
Last Verified: | January 2018 |
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 |