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
|
Sponsor:
Avanir Pharmaceuticals
Information provided by (Responsible Party):
Avanir Pharmaceuticals
- Study Details
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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 patients with multiple sclerosis.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Central Neuropathic Pain Multiple Sclerosis | Drug: AVP-923 Drug: Placebo | Phase 2 |
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).
| 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 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
Drug Information available for:
Nuedexta
U.S. FDA Resources
| 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)
|
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 ]
Information from the National Library of Medicine
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| 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
Information from the National Library of Medicine
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
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. | |
| 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 | |
Sponsors and Collaborators
Avanir Pharmaceuticals
| 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 |