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Open-Label, Safety and Tolerability Extension Study of KNS-760704 in Amyotrophic Lateral Sclerosis (ALS) (CL211)

Study Purpose:

This is an open-label, multi-center study designed to extend the evaluation of the safety, tolerability, and clinical effects of oral administration of KNS-760704 in patients with ALS.

Disease:

Amyotrophic Lateral Sclerosis (ALS)

Study Type:

Interventional Trial

Study Category:

Drug Trial

Study Status:

Not enrolling

Phase:

Phase II

Study Chair(s)/Principal Investigator(s):

Merit Cudkowicz MD, MSc, (Massachusetts General Hospital)

Clinicaltrials.gov ID (11 digit #):

NCT00931944

Neals Affiliated?

Yes

Coordinating Center Contact Information

MGH NCRI
Daniela Grasso / .(JavaScript must be enabled to view this email address) / 617-726-0842
.(JavaScript must be enabled to view this email address) 149 13th Street, Bldg 149, MGH East
Room 2274
Charlestown, Massachusetts 02129 United States

Full Study Summary:

This is an open-label extension study of KNS-760704-CL201, a phase 2 study conducted by Knopp Biosciences.

ALS Patients who complete the Part 2 Week 28 visit in study KNS-760704-CL201 and ALS patients who were receiving RTPB under Research IND #60,948 were eligible to to be considered for participation in this study.

Eligible patients receive 1 tablet of KNS-760704 150 mg every 12 hours (Q12H) (300 mg total daily dose) for up to 180 weeks.

Primary Outcome Measures:
• The primary objective of the study is to extend the evaluation of long-term safety and tolerability of KNS-760704 300 mg daily.

Secondary Outcome Measures:
• The secondary objective of the study is to evaluate the long-term effects of KNS-760704 300 mg daily on measures of clinical function.

Study Sponsor:

Knopp Biosciences, LLC

Participant Duration:

up to 180 weeks

Estimated Enrollment:

74

Estimated Study Start Date:

05/31/2009

Estimated Study Completion Date:

01/31/2010

Posting Last Modified Date:

09/30/2011

Date Study Added to alsconsortium.org:

10/12/2011
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    21

    Maximum Age:

    80

    Time since Symptom Onset:

    N/A

    Time since Diagnosis:

    N/A

    Can participants use Riluzole?

    Yes


    Inclusion Criteria:
    1. Patient has provided signed informed consent for this trial before the commencement of any study-related procedure
    2. Patient is actively participating in Knopp Protocol KNS-760704-CL201 and has completed the Part 2 Week 28 visit in that study or patient is actively receiving RTPB under Research IND #60,948

    Exclusion Criteria:
    1. Patient did not participate in Knopp Protocol KNS-760704-CL201 or patient did not receive RTPB under Research IND #60,948.
    2. Patient discontinued from KNS-760704-CL201 for any reason other than enrollment into this study (applies to patients enrolled in KNS-760704-CL201 only)
    3. Patient was not taking RTPB under Research IND #60,948 prior to April 30, 2009 (applies to patients enrolled under Research IND #60,948 only)

  • Site Contact Information

    UCLA
    Michael Graves / .(JavaScript must be enabled to view this email address) / 310-825-2087
    David Geffen School of Medicine at UCLA
    Los Angeles, California 90095
    United States

    California Pacific Medical Center
    Jonathan Katz / .(JavaScript must be enabled to view this email address) / 415-600-3982
    2324 Sacramento St Suite 111
    San Francisco, California 94115
    United States

    University of Colorado Health Sciences Center
    Yvonne Rollins / .(JavaScript must be enabled to view this email address) / 303-724-2186
    12631 E 17th Ave Room 5113
    Aurora, Colorado 80045
    United States

    University of Miami Miller School of Medicine
    Khema Sharma / .(JavaScript must be enabled to view this email address) / 305-243-5586
    Kessenich Center
    Miami, Florida 33136
    United States

    University of Kansas Medical Center
    Richard Barohn / .(JavaScript must be enabled to view this email address) / 913-588-6094
    3599 Rainbow Blvd
    Kansas City, Kansas 66160
    United States

    Johns Hopkins University School of Medicine
    Jeffrey Rothstein / .(JavaScript must be enabled to view this email address) / 410-614-5972
    601 N Caroline Street Suite 5070
    Baltimore, Maryland 21287
    United States

    MGH
    Merit Cudkowicz MD / .(JavaScript must be enabled to view this email address) / 617-724-1873
    Bldg 149 Room 2274
    Charlestown, Massachusetts 02129
    United States

    Washington University School of Medicine
    Alan Pestronk / .(JavaScript must be enabled to view this email address) / 314-362-6981
    Box 8111 Neurology
    St Louis, Missouri 63110
    United States

    Neurology Associates P.C.
    Gary Pattee / .(JavaScript must be enabled to view this email address) / 402-483-7226
    2631 S. 70th Street
    Lincoln, Nebraska 68506
    United States

    Columbia University
    Hiroshi Mitsumoto / .(JavaScript must be enabled to view this email address) / 212-305-2940
    Lou Gehrig MDA/ALS Research Center
    New York, New York 10032
    United States

    SUNY Upstate Medical University
    Jeremy Shefner / .(JavaScript must be enabled to view this email address) / 315-464-5022
    175 Elizabeth Blackwell Street
    Syracuse, New York 13210
    United States

    Penn State Hershey Medical Center
    Zachary Simmons / .(JavaScript must be enabled to view this email address) / 717-531-1802
    30 Hope Dr PO Box 859
    Hershey, Pennsylvania 17033
    United States

    Drexel University College of Medicine
    Terry Heiman-Patterson / .(JavaScript must be enabled to view this email address) / 215-762-7692
    MDA/ALS Center of Hope
    Philadelphia, Pennsylvania 19107
    United States

    University of Pittsburgh School of Medicine
    David Lacomis / .(JavaScript must be enabled to view this email address) / 412-647-1706
    Center for ALS Research
    Pittsburgh, Pennsylvania 15213
    United States

    Vanderbilt University Medical Center
    Peter Donofrio / .(JavaScript must be enabled to view this email address) / 615-936-0060
    A-0118 Medical Center North
    Nashville, Tennessee 37232
    United States

    University of Texas Health Sciences Center of San Antonio
    Carlayne Jackson / .(JavaScript must be enabled to view this email address) / 210-450-0520
    8300 Floyd Curt Dr. MSC 7883
    San Antonio, Texas 78229
    United States

    University of Utah
    Mark Bromberg / .(JavaScript must be enabled to view this email address) / 801-585-5885
    Room 3R152
    Salt Lake City, Utah 84132
    United States

    University of Virginia Health System
    Ted Burns / .(JavaScript must be enabled to view this email address) / 434-982-0170
    c/o Kristen Keller
    Charlottesville, Virginia 22908
    United States

    University of Washington
    Michael Weiss / .(JavaScript must be enabled to view this email address) / 206-598-2134
    1959 NE Pacific St
    Seattle, Washington 98195
    United States

  • Study Results
    http://www.nature...T.ec_id=NM-201112