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

This study is currently recruiting participants.
Verified November 2012 by Avanir Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Avanir Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01324232
First received: March 23, 2011
Last updated: November 7, 2012
Last verified: November 2012
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
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:

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 ]

Estimated Enrollment: 400
Study Start Date: September 2011
Estimated Primary Completion Date: March 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01324232

Contacts
Contact: Paul Shin 949.268.5930 PShin@avanir.com
Contact: Joao Siffert, MD 949.268.1174 JSiffert@avanir.com

  Hide Study Locations
Locations
United States, Alabama
North Central Neurology Associates PC Recruiting
Cullman, Alabama, United States, 35058
Contact: Christopher LaGanke, MD     256-739-1210     claganke@prn-inc.net    
Principal Investigator: Christopher LaGanke, MD            
United States, Arizona
St. Joseph's Hospital Medical Center Recruiting
Phoenix, Arizona, United States, 85013
Contact: Darin Okuda, MD     602-406-6211     darin.okuda@chw.edu    
Contact: Stacey Lent     (602) 406-6291     Stacey.Lent@chw.edu    
Principal Investigator: Darin Okuda, MD            
Neuromuscular Research Center Withdrawn
Scottsdale, Arizona, United States, 85258
United States, California
Alta Bates Summit Medical Center Recruiting
Berkeley, California, United States, 94705
Contact: Joanna Cooper, MD     510-204-8140     cooperj2@sutterhealth.org    
Contact: Vickie Nolan     (510) 204-1757     nolanvl@sutterhealth.org    
Principal Investigator: Joanna Cooper, MD            
University of California, Irvine Recruiting
Orange, California, United States, 92868
Contact: Tahseen Mozaffar, MD     714-456-2332     mozaffar@uci.edu    
Contact: Veronica Martin     (714) 456-7760     vero@uci.edu    
Principal Investigator: Tahseen Mozaffar, MD            
Coordinated Clinical Research Recruiting
San Diego, California, United States, 92103
Contact: Isaac Bakst, MD     858-455-5463     isaacbakst@gmail.com    
Contact: Luci Barbie     619-297-3023     lbarbie@sandiegotrials.com    
Principal Investigator: Isaac Bakst, MD            
University of California, San Francisco Recruiting
San Francisco, California, United States, 94158
Contact: Bruce Cree, MD     415-502-7219     bcree@ista.ucsf.edu    
Contact: Nancy Shum     (415) 502-7219     Nancy.Shum@ucsf.edu    
Principal Investigator: Bruce Cree, MD            
United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Timothy L. Vollmer, M.D.     303-724-2197     timothy.vollmer@ucdenver.edu    
Contact: Xuan Ly         Xuan.Ly@ucdenver.edu    
Principal Investigator: Timothy L. Vollmer, M.D.            
Advanced Neurosciences Research Withdrawn
Fort Collins, Colorado, United States, 80528
United States, Florida
Neurology Associates, PA Recruiting
Maitland, Florida, United States, 32751
Contact: William Honeycutt, MD     407-647-5996 ext 204     neurologyassoc@hotmail.com    
Contact: Marilyn Rivera     (407) 647-5996 ext 7     na@gmail.com    
Principal Investigator: William Honeycutt, MD            
University of Miami Withdrawn
Miami, Florida, United States, 33136
Collier Neurologic Specialists Recruiting
Naples, Florida, United States, 34102
Contact: Matthew J. Baker, MD     239-262-8971     clinicalresearch@collierneurologic.com    
Contact: Claudia Lennertz     (239) 434-0332     clennertz@CollierNeurologic.com    
Principal Investigator: Matthew J. Baker, MD            
Laszlo J. Mate, MD Recruiting
North Palm Beach, Florida, United States, 33408
Contact: Laszlo J. Mate, M.D.     561-626-5551     drmate@bellsouth.net    
Contact: Mary Sergalis     (561) 626-5551     sergalis@bellsouth.net    
Principal Investigator: Laszlo J. Mate, M.D.            
Neurology Associates of Ormond Beach Recruiting
Ormond Beach, Florida, United States, 32174
Contact: James Scott, MD     386-673-2500 ext 248     neurosgeyer@yahoo.com    
Contact: Sandra Geyer     (386) 673-2500 ext 248     neurosgeyer@yahoo.com    
Principal Investigator: James Scott, MD            
Neurological Associates Recruiting
Pompano Beach, Florida, United States, 33060
Contact: Brian Steingo, MD     954-928-0611     bsteingo@researchneurology.org    
Contact: Rebecca Radzivill     (954) 738-1686     rradzivill@infinityclinicalresearch.com    
Principal Investigator: Brian Steingo, MD            
Neurologique Foundation Active, not recruiting
Ponte Vedra Beach, Florida, United States, 32082-4040
Suncoast Neuroscience Associates, Inc. Recruiting
St. Petersburg, Florida, United States, 33713
Contact: Alberto Vasquez, MD     727-824-7135     abvmd@aol.com    
Contact: Suzanne, Lash     (727) 824-7135     slash@suncoastmed.com    
Principal Investigator: Alberto Vasquez, MD            
University of South Florida Recruiting
Tampa, Florida, United States, 33612
Contact: Stanley Krolczyk, DO     813-974-8859     skrolczy@health.usf.edu    
Contact: Angela Seevers     (813) 974-6378     aseevers@health.usf.edu    
Principal Investigator: Stanley Krolczyk, DO            
Geodyssey Research, LLC Recruiting
Vero Beach, Florida, United States, 32960
Contact: Stuart Shafer, MD     772-569-7039 ext 125     vbussey@geodysseyrsch.com    
Contact: Victoria Bussey     (772) 569-2330 ext 125     vbussey@geodysseyrsch.com    
Principal Investigator: Stuart Shafer, MD            
United States, Georgia
Shepard Center Recruiting
Atlanta, Georgia, United States, 30309
Contact: Ben Thrower, MD     404-350-7768     Ben_thrower@shepherd.org    
Contact: Issi Clesson     (404) 350-7651     Ismari_Clesson@shepherd.org    
Principal Investigator: Ben Thrower, MD            
United States, Illinois
Northwestern University Feinberg School of Medicine Withdrawn
Chicago, Illinois, United States, 60611
Rush-Presbyterian St. Luke's Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Dusan Stefoski     312-942-8011     dstefoski@rush.edu    
Contact: Cynthia Ballesteros     (312) 563-3181     cynthia_r_ballesteros@rush.edu    
Principal Investigator: Dusan Stefoski            
Northwest Neurology, LTD Withdrawn
Lake Barrington, Illinois, United States, 60010
Consultants in Neurology Recruiting
Northbrook, Illinois, United States, 60062
Contact: Daniel Wynn, MD     847-509-0270     research@cinltd.com    
Contact: Andrea Corsino     (847) 509-0270     research@cinltd.com    
Principal Investigator: Daniel Wynn, MD            
United States, Indiana
Josephson Wallack Munshower Neurology, P.C. Recruiting
Indianapolis, Indiana, United States, 46256
Contact: Craig Herrman, MD     317-537-6060     craig_herrman@yahoo.com    
Contact: Tammy Root     317-537-6088 x1250     troot@jwmneuro.com    
Principal Investigator: Craig Herrman            
United States, Kansas
MidAmerica Neuroscience Institute Recruiting
Lenexa, Kansas, United States, 66214
Contact: Vernon Rowe, MD     913-894-1500 ext 155     vrowe@neurokc.com    
Contact: Leigh Kreshel     (913) 894-1500 ext 155     lkreshel@neurokc.com    
Principal Investigator: Vernon Rowe, MD            
United States, Maryland
Johns Hopkins University School of Medicine Recruiting
Baltimore, Maryland, United States, 21287
Contact: Daniel M. Harrison, M.D.     410-502-8670     dharri90@jhmi.edu    
Contact: Laura Franklin     (443) 287-0400     laurabaileyfranklin@gmail.com    
Principal Investigator: Daniel M. Harrison, M.D.            
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Jacob A. Sloane, M.D.     617-667-3742     jsloane@bidmc.harvard.edu    
Contact: Rosemary C. Bailey     (617) 667-3726     rcbailey@bidmc.harvard.edu    
Principal Investigator: Jacob A. Sloane, M.D.            
United States, Michigan
Michigan Neurology Associates, P.C. Recruiting
Clinton Twp, Michigan, United States, 48035
Contact: Thomas Giancarlo, DO     586-464-2026     jkwierant@mnapc.org    
Principal Investigator: Thomas Giancarlo, DO            
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Stanton Elias, MD     313-916-7207     elias@neuro.hfh.edu    
Contact: Jackie Reuther     (313) 916-1906     jreuthe1@hfhs.org    
Principal Investigator: Stanton Elias, MD            
Wayne State University Recruiting
Detroit, Michigan, United States, 48201
Contact: Evanthia Bernitsas, M.D.     312-966-9904     ebernits@med.wayne.edu    
Contact: Jessica Chorosteki-Vigrass     (313) 966-9407     jchorost@med.wayne.edu    
Principal Investigator: Evanthia Bernitsas, M.D.            
Michigan Institute For Neurological Disorders Withdrawn
Farmington Hills, Michigan, United States, 48334
United States, Montana
Advanced Neurology Specialists Recruiting
Great Falls, Montana, United States, 59405
Contact: Dennis Dietrich, MD     406-761-8673     dietrich@ansresearch.com    
Contact: Veronica Schaefer     (406) 761-8673     vmschaefer@ansresearch.com    
Principal Investigator: Dennis Dietrich, MD            
United States, Nebraska
Neurology Associates PC Recruiting
Lincoln, Nebraska, United States, 68506
Contact: Gary Pattee, MD     402-483-7226     gpattee@pol.net    
Contact: Kathie Allstot     (402) 483-7226     kallstotnapc@yahoo.com    
Principal Investigator: Gary Pattee, MD            
United States, New York
Upstate Clinical Research, LLC Withdrawn
Albany, New York, United States, 12205
Albany Medical Center Hospital Recruiting
Albany, New York, United States, 12208
Contact: Linda Graca     518-262-5868     gracal@mail.amc.edu    
Principal Investigator: James Wymer, PhD, MD            
NYU-Hospital for Joint Diseases Recruiting
New York, New York, United States, 10003
Contact: Joseph Herbert, MD     212-598-6305     joseph.herbert@med.nyu.edu    
Contact: Puspa Sari-Utomo     (212) 598-6151     Puspa.Utomo@nyumc.org    
Principal Investigator: Joseph Herbert, MD            
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Andrew Goodman, MD     585-275-7854     andrew_goodman@urmc.rochester.edu    
Contact: Eileen Scheid     (585) 275-6673     Eileen_scheid@urmc.rochester.edu    
Principal Investigator: Andrew Goodman, MD            
SUNY at Stony Brook Recruiting
Stony Brook, New York, United States, 11794
Contact: Patricia Coyle,, MD     631-444-8188     pcoyle@notes.cc.sunysb.edu    
Contact: Ruth Mahnken     (631) 444-8188     ruth.mahnken@stonybrook.edu    
Principal Investigator: Patricia Coyle, MD            
United States, North Carolina
Cornerstone Research Care Withdrawn
Advance, North Carolina, United States, 27006
Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Jill Conway, MD     704-446-1900     jill.conway@carolinashealthcare.org    
Contact: Natasha Swayne     (704) 446-0803     natasha.swayne@carolinashealthcare.org    
Principal Investigator: Jill Conway, MD            
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Alexander Rae-Grant, MD     216-342-4411     rae-gra@ccf.org    
Contact: Vinette Zinkand     (216) 444-4817     zinkanv@ccf.org    
Principal Investigator: Alexander Rae-Grant, MD            
United States, Oklahoma
Oklahoma Medical Research Foundation Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Gabriel Pardo, MD     405-271-6242     gabriel-pardo@omrf.org    
Contact: Micki Moore     (405) 271-6241     micki-moore@omrf.org    
Principal Investigator: Gabriel Pardo, MD            
United States, Pennsylvania
Lehigh Valley Hospital Withdrawn
Allentown, Pennsylvania, United States, 18103
Drexel University College of Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: David Tabby, DO     215-762-6915     david.tabby@drexelmed.edu    
Contact: Marjorie Hepler     (215) 762-8290     mhepler@drexelmed.edu    
Principal Investigator: David Tabby, MD            
Geisinger Health System Recruiting
Wilkes Barre, Pennsylvania, United States, 18711
Contact: Douglas Nathanson, MD     570-808-1001     dcnathanson@geisinger.edu    
Contact: Linda Casey     (570) 808-5896     lecasey@geisinger.edu    
Principal Investigator: Casey Nathanson, MD            
United States, Tennessee
Advanced Neurosciences Institute Recruiting
Franklin, Tennessee, United States, 37064
Contact: Samuel Hunter, MD     615-791-5470     sfhunter@neurosci.us    
Principal Investigator: Samuel Hunter, MD            
Vanderbilt University Medical Center Withdrawn
Nashville, Tennessee, United States, 37212
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: George Hutton, MD     713-798-8170     ghutton@bcm.tmc.edu    
Contact: Susan Hughes     (713) 798-6097     sh11@bcm.edu    
Principal Investigator: George Hutton, MD            
Central Texas Neurology Withdrawn
Round Rock, Texas, United States, 78681
United States, Utah
Rocky Mountain MS Clinic Recruiting
Salt Lake City, Utah, United States, 84103
Contact: John Foley, MD     801-408-5705        
Contact: Tammy Anderson     (801) 408-4584     tanderson@rockymountainmsclinic.com    
Principal Investigator: John Foley, MD            
United States, Virginia
Neurological Associates Recruiting
Henrico, Virginia, United States, 23226
Contact: Alan E. Schulman, MD     804-288-2742     aschulman@nairichmond.com    
Contact: Rebekah Adams     (804) 288-1972     radams@nairichmond.com    
Principal Investigator: Alan E. Schulman, MD            
MS Center of Greater Washington Recruiting
Vienna, Virginia, United States, 22182
Contact: Heidi Crayton, MD     202-444-2350     mymscenter@gmail.com    
Contact: Christina Magnotti     (703) 226-4030     mymscenter@gmail.com    
Principal Investigator: Heidi Crayton, MD            
United States, Washington
Swedish Medical Center Recruiting
Seattle, Washington, United States, 98122
Contact: Angeli Mayadev, MD     206-386-3880     yuriko.courtney@swedish.org    
Contact: Yuriko Courtney     (206) 320-2647     Yuriko.Courtney@swedish.org    
Principal Investigator: Angeli Mayadev, MD            
MultiCare Health System Recruiting
Tacoma, Washington, United States, 98405
Contact: John Huddlestone, MD     253-274-1103     sandra.reilley@multicare.org    
Contact: Sandra Reilley     (253) 403-7440     sandra.reilley@multicare.org    
Principal Investigator: John Huddlestone, MD            
United States, Wisconsin
Aurora Health Care Withdrawn
Milwaukee, Wisconsin, United States, 53215
Argentina
Hospital Britanico de Buenos Aires Recruiting
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1280AEB
Contact: Adriana Carra, MD     +54114309640026 ext 31     adrianacarra@fibertel.com.ar    
Principal Investigator: Adriana Carra, MD            
FACENE Withdrawn
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1117ABE
Instituto de Neurologia Cognitiva Recruiting
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1126AAB
Contact: Vladimiro Sinay, MD     +5491130177818     vladimirosinay@gmail.com    
Contact: Sergio Buscazzo     +5491130177818     sbuscazzo@ineco.org.ar    
Principal Investigator: Vladimiro Sinay, MD            
Hospital Italiano Recruiting
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1181ACH
Contact: Edgardo Cristiano, MD     +549111444150828     edgardo.cristiano@hospitalitaliano.org.ar    
Contact: Luz Doldan     +541149590322     luzdoldan@gmail.com    
Principal Investigator: Edgardo Cristiano, MD            
Instituto Argentino de Investigacion Neurologica Recruiting
Ciudad de Buenos Aires, Buenos Aires, Argentina, C1015ABR
Contact: Roberto Rey, MD     +541148162044     robertorey@iadin.com.ar    
Contact: Sofia Estrada     +541148162044     sofiaestrada@iadin.com.ar    
Principal Investigator: Roberto Rey, MD            
Hospital Churruca-Visca Recruiting
Buenos Aires, Argentina, C1437JCH
Contact: Guillermo P. Povedano, M.D.     +541149121067     guillepovedano@gmail.com    
Principal Investigator: Guillermo P. Povedano, M.D.            
Fundación Argentina Contra las Enfermedades Neurológicas del Envejecimiento - FACENE Recruiting
Buenos Aires, Argentina, CP1117ABD
Contact: Mónica Pagano     +54 11 4823 8559     movipagano@hotmail.com    
Principal Investigator: Norma Haydeé Deri            
Medeos - Centro de Medicina Integral e Investigación Clínica Recruiting
Ciudad Autonoma de Buenos Aires, Argentina
Contact: Adriana N. Tarulla     +54 114 788 2566     adriana_tarulla@hotmail.com    
Contact: Alejandra Chaieb     +54 114 788 2566     centromedeos@gmail.com    
Principal Investigator: Adriana N. Tarulla            
Instituto de Neurología y Neurorrehabilitación del Litoral Not yet recruiting
Santa Fe, Argentina
Contact: Gustavo A. Saredo, M.D.     +54 342 452 5975     gsaredo@gmail.com    
Contact: Lucrecia Ciardola     +54 342 452 5975        
Principal Investigator: Gustavo A. Saredo, M.D.            
Czech Republic
Fakultni nemocnice u sv. Anny v Brne Recruiting
Brno, Czech Republic
Contact: Michal Dufek, M.D.     +420 543 182 673     michal.dufek@fnusa.cz    
Contact: Ilona Buckova     +420 543 182 673     buckova@fnusa.cz    
Principal Investigator: Michal Dufek            
Fakultni nemocnice Hradec Kralove Recruiting
Hradec Kralove, Czech Republic, 500 0
Contact: Radomir Talab, MD     +420495837214     radomir.talab@gmail.com    
Principal Investigator: Radomir Talab, MD            
Nemocnice Jihlava, prispevkova organizace Recruiting
Jihlava, Czech Republic, 586 33
Contact: Radek Ampapa, MD     +420567157664     ampapa@centrum.cz    
Contact: Lenka Vesela     +420567157262     veselal@nemji.cz    
Principal Investigator: Radek Ampapa, MD            
Fakultni Nemocnice Ostrava Recruiting
Ostrava, Czech Republic, 708 52
Contact: Pavel Hradilek, MD     +420597373383     pavel.hradilek@fnspo.cz    
Principal Investigator: Pavel Hradilek, MD            
Pardubicka krajska nemocnice, a.s. Withdrawn
Pardubice, Czech Republic, 532 03
Vseobecna fakultni nemocnice v Praze Recruiting
Praha 2, Czech Republic, 128 21
Contact: Iveta Novakova     +420224966515     iveta.novakova@vfn.cz    
Contact: Frantiska Kubikova     +420224966515     rantiska.kubikova@vfn.cz    
Principal Investigator: Iveta Novakova, MD            
Germany
Klinikum Bayreuth GmbH Withdrawn
Bayreuth, Germany, 95445
Praxis Dr. Wilfried Lüer Withdrawn
Berlin, Germany, 12163
Heinrich Heine Universität Düsseldorf Withdrawn
Düsseldorf, Germany, 40225
Universitätsklinikum Gießen und Marburg GmbH Withdrawn
Giessen, Germany, 35392
Neurologische Praxis Dr. Gereon Nelles Withdrawn
Köln, Germany, 50935
Universitätskinderklinik Mainz Withdrawn
Mainz, Germany, 55101
Neuro Center Albrecht Not yet recruiting
München, Germany, 81829
Contact: Holger Albrecht, M.D.     +49 89 4522 8170     nca@neuro-center-albrecht.de    
Contact: Corbinian Dollinger     +49 89 45230 8415        
Principal Investigator: Holger Albrecht, M.D.            
Universitätsklinikum Münster Withdrawn
Münster, Germany, 48149
Universitätsklinik Rostock Withdrawn
Rostock, Germany, 18147
Asklepios Fachklinikum Teupitz Withdrawn
Teupitz, Germany, 15755
Deutsche Klinik für Diagnostik GmbH Withdrawn
Wiesbaden, Germany, 65191
Poland
Szpital Powiatowy w Czeladzi Recruiting
Czeladz, Poland, 41-250
Contact: Pawel Gruenpeter, MD     +48(32)2651581     p.gruenpeter@hipokrates.org    
Contact: Renata Bakalarz     +48(32)2651581        
Principal Investigator: Pawel Gruenpeter, MD            
Pomorskie Centrum Traumatologii im. M. Kopernika w Gdansku Not yet recruiting
Gdansk, Poland, 80-803
Contact: Waldemar Fryze, MD     +48587640292     w.fryze@wp.pl    
Contact: Katarzyna Rynas     +48587640292     wojnarowskaanna@wp.pl    
Principal Investigator: Waldemar Fryze, MD            
Niepubliczny Zaklad Opieki Zdrowotnej PROFILAKTYKA Recruiting
Katowice, Poland
Contact: Krystyna Pierzchala, M.D.     +48(32) 271 09 75     neurozab@sum.edu.pl    
Contact: Monika Adamczyk-Sowa     +48(32) 350 75 50     m.adamczyk.sowa@gmail.com    
Principal Investigator: Krystyna Pierzchala, M.D.            
Diagnomed Clinical Research Sp. z.o.o. Recruiting
Katowice, Poland, 40-594
Contact: Maciej Maciejowski, MD     +48322062669     maciejmaciejowski@poczta.onet.pl    
Principal Investigator: Maciej Maciejowski, MD            
Niepubliczny Zaklad Opieki Zdrowotnej NEURO-MEDIC Recruiting
Katowice, Poland, 40-752
Contact: Janusz Zbrojkiewicz, MD     +48322521420     neuromedic@op.pl    
Contact: Alina Patalong     +483225214 20        
Principal Investigator: Janusz Zbrojkiewicz, MD            
Zespol Opieki Zdrowotnej w Konskich Recruiting
Konskie, Poland, 26-200
Contact: Waldemar Brola, MD     +48413902259     wbrola@wp.pl    
Contact: Jadwiga Opala     +48413902362        
Principal Investigator: Waldemar Brola, MD            
Specjalistyczny Gabinet Neurologiczny Recruiting
Plewiska, Poland, 62-064
Contact: Hanka Hertmanowska, MD     +48508143124     hertmanowska@wp.pl    
Contact: Krzysztof Szepke     +48508143124        
Principal Investigator: Hanka Hertmanowska, MD            
Niepubliczny Zaklad Opieki Zdrowotnej NEURO-KARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy Recruiting
Poznan, Poland, 61-289
Contact: Jan Ilkowski, MD     +48609517676     janilkowski@poczta.onet.pl    
Contact: Ewa Perzak     +48609517676        
Principal Investigator: Jan Ilkowski, MD            
Osrodek Badan Klinicznych Indywidualnej Specjalistycznej Praktyki Lekarskiej Recruiting
Szczecin, Poland, 70-215
Contact: Andrzej Potemkowski, MD     +48914844582     andrzej.potemkowski@wp.pl    
Contact: Agnieszka Dubaj     +48914844582        
Principal Investigator: Andrzej Potemkowski, MD            
Spain
Hospital del Mar Recruiting
Barcelona, Cataluña, Spain, 08003
Contact: José Enrique Martínez Rodríguez, MD     +34932483235     95917@parcdesalutmar.cat    
Contact: Mireia Llop Trujillano     +34932483235        
Principal Investigator: José Enrique Martínez Rodríguez, MD            
Hospital Vall D´Hebron Recruiting
Barcelona, Cataluña, Spain, 08035
Contact: Xavier Montalban, MD     +34934894114     ctrials@cem-cat.org    
Contact: Marta Sallen     +34 934894114     msallen@vhebron.net    
Principal Investigator: Xavier Montalban, MD            
Hospital Universitari de Girona Dr. Josep Trueta Recruiting
Girona, Cataluña, Spain, 17007
Contact: Lluís Ramió Torrentà, MD     +34972940262     llramio.girona.ics@gencat.cat    
Contact: Judith Guerrero     +34972940262        
Principal Investigator: Lluís Ramió Torrentà, MD            
Hospital General Universitario de Alicante Withdrawn
Alicante, Comunidad Valenciana, Spain, 03010
Hospital Universitario Virgen de la Arrixaca Recruiting
El Palmar, Murcia, Spain, 30120
Contact: José Eustasio Meca Lallana, MD     +34968369500 X29 ext 389     pmecal@gmail.com    
Principal Investigator: José Eustasio Meca Lallana, MD            
Hospital Univ. Nuestra Sra. De La Candelaria Not yet recruiting
Canarias, Spain, 38009
Contact: Miguel Angel Hernández Pérez, M.D.     +34 92 260 0664     mhernandezp78@hotmail.com    
Contact: Yaiza M. Perez     +34 92 260 0664     yaizaneuro@hotmail.com    
Principal Investigator: Miguel Angel Hernández Pérez, M.D.            
Hospital Universitario Vírgen Macarena Recruiting
Sevilla, Spain, 41009
Contact: Guillermo Izquierdo, MD     +34955008686     gia@us.es    
Contact: Yaiza Montserrat     +34955008686     yaiza.montserrat@neuroinvest.net    
Principal Investigator: Guillermo Izquierdo, MD            
United Kingdom
Western General Hospital Withdrawn
Edingurgh, United Kingdom, EH4 2XU
The Walton Centre For Neurology And Neurosurgery Withdrawn
Liverpool, United Kingdom, L9 7LJ
King's College Hospital Withdrawn
London, United Kingdom, SE5 9RS
Charing Cross Hospital Withdrawn
London, United Kingdom, W6 8RF
Royal Victoria Infirmary Withdrawn
Newcastle upon Tyne, United Kingdom, NE1 4LP
Salford Royal Hospital Withdrawn
Salford, United Kingdom, M6 8HD
Royal Hallamshire Hospital Withdrawn
Sheffield, United Kingdom, S102JF
University Hospital of North Staffordshire Withdrawn
Stoke on Trent, United Kingdom, ST4 7LN
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: November 7, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Sclerosis
Neuralgia
Sclerosis
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
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013