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Safety testing of AVP-923 in the Treatment of Emotional Lability (Uncontrolled Laughter & Crying)

This study is currently recruiting patients.

Sponsored by: Avanir Pharmaceuticals
Information provided by: Avanir Pharmaceuticals

Purpose

The purpose of this study is to evaluate the safety of AVP-923 for the treatment of emotional lability.

Condition Treatment or Intervention Phase
Amyotrophic Lateral Sclerosis
Multiple Sclerosis
Alzheimer's Disease
Stroke
Traumatic Brain Injury
  Drug: AVP-923
 Phase III

MedlinePlus related topics:  Alzheimer's Caregivers;   Alzheimer's Disease;   Amyotrophic Lateral Sclerosis;   Head and Brain Injuries;   Multiple Sclerosis;   Stroke
Genetics Home Reference related topics:  Alzheimer disease;   amyotrophic lateral sclerosis

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Official Title: An Open-Label Multicenter Study to Assess the Safety of AVP-923 in the Treatment of Patients with Pseudobulbar Affect.

Further Study Details: 

Expected Total Enrollment:  300

Study start: February 2003

Eligibility

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion:

Exclusion:


Location and Contact Information


Arizona
      Barrow Neurological Institute, Phoenix,  Arizona,  85013,  United States; Recruiting
Louis DiCave  602-406-6292    ldicave@chw.edu 
Timothy L. Vollmer, MD,  Principal Investigator

California
      UCLA School of Medicine, Los Angeles,  California,  90095,  United States; Not yet recruiting
Connie Laurel  310-825-9816    mcgraves@ucla.edu 
Michael Graves, MD,  Principal Investigator

      UCSF, San Francisco,  California,  94117,  United States; Recruiting
Marni Hillinger  415-502-5064    marni@itsa.ucsf.edu 
Richard Olney, MD,  Principal Investigator

      Center for Neurologic Study, La Jolla,  California,  92037,  United States; Recruiting
Emily Adams  858-455-5463    cns@cts.com 
Richard Smith, MD,  Principal Investigator

District of Columbia
      George Washington University Medical Faculty Assoc., Washington,  District of Columbia,  20037,  United States; Recruiting
Joseph Choi  202-741-2717    jchoi@mfa.gwu.edu 
Raul Mandler, MD,  Principal Investigator

Florida
      Neurological Associates, Ft. Lauderdale,  Florida,  33334,  United States; Recruiting
Michele Fistel, LPN, CCRC  954-202-1278    neuroassoc@yahoo.com 
Brian Steingo, MD,  Principal Investigator

      University of Miami Dept. of Neurology, Miami,  Florida,  33136,  United States; Recruiting
Julie Steele, LPN, CCRC  305-243-7424    jsteele@med.miami.edu 
Walter Bradley, MD,  Principal Investigator

      Renstar Medical Research, Plantation,  Florida,  33324,  United States; Recruiting
Ellen Amigo, RN  954-915-9991    medicalresearch@att.net 
David B. Ross, MD,  Principal Investigator

      Suncoast Neuroscience Associates Inc., St. Petersburg,  Florida,  33701,  United States; Recruiting
Michele Richardson, CCRC  727-824-7135    m1rich@tampabay.rr.com 
Alberto Vazquez, M.D.,  Principal Investigator

Georgia
      Neurology & Headache Specialist of Atlanta, L.L.C., Decatur,  Georgia,  30033,  United States; Recruiting
Beverly A. Johnson-Finley, CRMA  404-294-3040  Ext. 106    beverlyfinley8@hotmail.com 
Howard Ehrenfeld, MD,  Principal Investigator

Illinois
      Consultants in Neurology LTD, Northbrook,  Illinois,  60062,  United States; Recruiting
Andrea Corsino  847-509-0270    dwynnmd@interaccess.com 
Daniel Wynn, MD,  Principal Investigator

      Radiant Research, Alexian Brothers, Elk Grove Village,  Illinois,  60007,  United States; Recruiting
Debra Robinson  847-640-9952    debrarobinson@radiantresearch.com 
Merrill Reiss, M.D.,  Principal Investigator

Montana
      Advanced Neurology Specialists, Great Falls,  Montana,  59405,  United States; Recruiting
Jamie Miller, RN  406-761-8673    ansresearch@yahool.com 
Dennis Dietrich, MD,  Principal Investigator

Nebraska
      Neurological Associates, P.C., Lincoln,  Nebraska,  68506,  United States; Recruiting
Kathie Allstot  215-762-5186    gpattee@polnet 
Gary Pattee, MD,  Principal Investigator

New York
      Hospital for Joint Diseases MS Care Center, New York,  New York,  10003,  United States; Recruiting
Lisa Capolino, RN  212-598-6118    lisa.capolino@med.nyu.edu 
Joseph Herbert, MD,  Principal Investigator

      SUNY Upstate Medical University, Syracuse,  New York,  13210,  United States; Recruiting
Deborah Kolb  315-464-3935    kolbd@upstate.edu 
Cornelia Mihai, MD, Ph.D.,  Principal Investigator

      Upstate Clinical Research, Albany,  New York,  12205,  United States; Recruiting
Suzanne Alterman  518-533-1500    salterman@upstateneurology.com 
James Wymer, MD,  Principal Investigator

      DENT Neurologic Group L.L.P., Amherst,  New York,  14266,  United States; Recruiting
Roseann Oakes  716-250-2007    roakes@dentinstitute.com 
Malti Patel, MD,  Principal Investigator

North Carolina
      Raleigh Neurology Associates, PA, Raleigh,  North Carolina,  27607,  United States; Recruiting
Tippi Garris, RN  919-420-1658    ralneuro@aol.com 
David Konanc, MD,  Principal Investigator

      Carolinas Medical Center, Charlotte,  North Carolina,  28203,  United States; Recruiting
Ruth King  704-355-8699    ruth.king@carolinashealthcare.org 
Jeffrey Rosenfeld, MD, Ph.D.,  Principal Investigator

Ohio
      NeuroCare Center, Inc., Canton,  Ohio,  44718,  United States; Recruiting
Fran Duszynski, RN  330-494-2097  Ext. 133    neurocare-fran@neo.rr.com 
James Burkholder, MD,  Principal Investigator

      MetroHealth Medical Center, Cleveland,  Ohio,  44109,  United States; Recruiting
Alice Liskay, RN  216-778-5420    aliskay@metrohealth.org 
Nimish Thakore, MD, DM,  Principal Investigator

Oklahoma
      Clinical Pharmaceutical Trials, Inc., Tulsa,  Oklahoma,  74104,  United States; Recruiting
Jamie St. Clair  918-743-4374    rwrichter@silverback.gorilla.net 
Ralph Richter, MD,  Principal Investigator

Pennsylvania
      Lehigh Valley Neurosciences and Pain Research Center, Allentown,  Pennsylvania,  18103,  United States; Recruiting
Nancy J Eckert  610-402-9001    nancy.eckert@lvh.com 
Alexander Rae-Grant, MD,  Principal Investigator

      Neurological Associates of Delaware Valley, Upland,  Pennsylvania,  19013,  United States; Recruiting
Kathleen Dermott  610-876-4800    kfd57@yahoo.com 
Joan D. Sweeney, MD,  Principal Investigator

      Penn Neurological Institute, Philadelphia,  Pennsylvania,  19107,  United States; Recruiting
Mary Kelly  215-829-3709    mkelley@pahosp.com 
Leo McCluskey, MD,  Principal Investigator

      Westmoreland Neurology, Greensburg,  Pennsylvania,  15601,  United States; Recruiting
Norma Skillings, RN  724-836-1921    sauter@westol.com 
Michael Sauter, MD,  Principal Investigator

      MCP-Hahnemann University, Philadelphia,  Pennsylvania,  19107,  United States; Recruiting
Kellie Lind  215-762-5186    kal39@drexel.edu 
Terry Heiman-Patterson, MD,  Principal Investigator

Vermont
      Fletcher Allen Health Care, Burlington,  Vermont,  05401,  United States; Recruiting
Randy Buermann  802-847-4256    randall.buermann@vtmednet.org 
Hillel Panitch, MD,  Principal Investigator

Washington
      Swedish Medical Center, Seattle,  Washington,  98122,  United States; Recruiting
Dennis Kuder  206-215-2027    dennis.kuder@swedish.org 
Craig Smith, MD,  Principal Investigator

      Neurology and Neurosurgery Associates of Tacoma, Tacoma,  Washington,  98405,  United States; Recruiting
Susan Kingrey  253-274-1103    skingrey@americasdoctor.com 
John Huddlestone, MD,  Principal Investigator

Wisconsin
      University of Wisconsin, Madison,  Wisconsin,  53792,  United States; Recruiting
Kathy Roelke, RN  608-262-7175    roelke@neurology.wisc.edu 
Andrew Waclawik, MD,  Principal Investigator

More Information

Study ID Numbers:  02-AVR-107; AVP-923
Record last reviewed:  August 2004
Record first received:  March 15, 2003
ClinicalTrials.gov Identifier:  NCT00056524
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10
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