Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis (PRIME)
This study has been completed.
Sponsor:
Avanir Pharmaceuticals
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Fatigue Severity Scale (FSS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Expanded Disability Status Scale (EDSS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Multiple Sclerosis Impact Scale-29 (MSIS-29) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- MS Neuropsychological Screening Questionnaire (MSNQ) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Beck Depression Inventory (BDI-II). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Symbol Digit Modalities Test (SDMT) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Modified Ashworth Scale (MAS) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
- 7-point Numerical Rating Scale (NRS) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
- Patient Global Impression of Change (PGIC) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
| 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 |
| Genders Eligible for Study: | Both |
| 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
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 | |
| Hospital Britanico de Buenos Aires | |
| Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1280AEB | |
| Instituto de Neurologia Cognitiva | |
| Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1126AAB | |
| Hospital Italiano | |
| Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1181ACH | |
| Instituto Argentino de Investigacion Neurologica | |
| Ciudad de Buenos Aires, Buenos Aires, Argentina, C1015ABR | |
| Fundación Argentina Contra las Enfermedades Neurológicas del Envejecimiento - FACENE | |
| Buenos Aires, Argentina, CP1117ABD | |
| Hospital Churruca-Visca | |
| Buenos Aires, Argentina, C1437JCH | |
| 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 | |
| Niepubliczny Zaklad Opieki Zdrowotnej NEURO-MEDIC | |
| Katowice, Poland, 40-752 | |
| Niepubliczny Zaklad Opieki Zdrowotnej PROFILAKTYKA | |
| Katowice, Poland | |
| Diagnomed Clinical Research Sp. z.o.o. | |
| Katowice, Poland, 40-594 | |
| 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 Vall D´Hebron | |
| Barcelona, Cataluña, Spain, 08035 | |
| Hospital del Mar | |
| Barcelona, Cataluña, Spain, 08003 | |
| 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
No publications provided
| 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 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Multiple Sclerosis Neuralgia Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases |
Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathologic Processes Peripheral Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on March 03, 2015