A Study for Patients Who Completed VITALITY-ALS (CY 4031)



Status:Completed
Conditions:Neurology, Neurology, Neurology, ALS
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - Any
Updated:2/20/2019
Start Date:October 17, 2016
End Date:October 26, 2018

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A Phase 3, Open-Label Extension Study of Tirasemtiv for Patients With Amyotrophic Lateral Sclerosis (ALS) Who Completed VITALITY-ALS (CY 4031)

The purpose of this study is to assess the long-term safety and tolerability of tirasemtiv in
patients with ALS.

Enrolled participants will begin dosing of tirasemtiv 125 mg twice daily (250 mg/day) for a
period of 4 weeks and will titrate to their tolerated dose, the maximum dose being 250 mg
twice daily (500 mg/day). This study will also compare the clinical course of patients who
completed treatment with tirasemtiv in CY 4031 with those who completed treatment with
placebo in CY 4031 during continued treatment of both groups with tirasemtiv during CY 4033,
compare the clinical course of patients who completed treatment with tirasemtiv in CY 4031
during that study with their clinical course during continued treatment with tirasemtiv
during CY 4033, and compare the clinical course of patients who completed treatment with
placebo in CY 4031 during that study with their clinical course during treatment with
tirasemtiv during CY 4033.

Inclusion Criteria:

- Able to comprehend and willing to sign an Informed Consent Form (ICF). If verbal
consent is given, a Legal Designee of the patient must sign the ICF form

- Completed participation on study drug and the Follow-Up Visit in the CY 4031 study

- Male patients, who have not had a vasectomy AND confirmed zero sperm count, must agree
for the duration of their participation in the study to either:

- Use a condom during sexual intercourse with female partners who are of
childbearing potential AND to have female partners use a highly effective means
of contraception OR

- Abstain from sexual intercourse during participation in the study

- Female patients who are not post-menopausal (≥ 1 year) or sterilized, must:

- Not be breastfeeding

- Have a negative pregnancy test

- Have no intention to become pregnant during participation in the study AND

- Practice sexual abstinence, defined as refraining from intercourse during the
duration of the study OR if male partners are not vasectomized with a confirmed
zero sperm count, require use of a condom AND use of a highly effective
contraceptive measure

Exclusion Criteria:

- Has a diaphragm pacing system (DPS) at study entry or anticipate DPS placement during
the course of the study

- Has taken an investigational study drug (other than tirasemtiv) prior to dosing,
within 30 days or five half-lives of the prior agent, whichever is greater

- Use of tizanidine and theophylline-containing medications during study participation

- Participation or planning to participate in any form of stem cell therapy for the
treatment of ALS or another investigational drug
We found this trial at
42
sites
Sacramento, California 95814
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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4201 Belfort Road
Jacksonville, Florida 32216
(408) 293-2336
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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1601 Northwest 12th Avenue
Miami, Florida 33136
(305) 243-6545
University of Miami Miller School of Medicine The University of Miami Leonard M. Miller School...
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2150 Corbin Avenue
New Britain, Connecticut 06053
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
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Atlanta, Georgia 30322
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Charlotte, North Carolina 28207
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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Dallas, Texas 75214
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Detroit, Michigan 48202
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Durham, North Carolina 27705
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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49 Herestraat
Leuven, Vlaams Brabant 3000
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Milwaukee, Wisconsin 53226
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Minneapolis, Minnesota 55414
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1 Medical Center Drive
Morgantown, West Virginia 26506
304-598-4800
West Virginia University Hospitals Inc. WVU Healthcare is two corporations, University Health Associates and WVU...
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1211 Medical Center Drive
Nashville, Tennessee 37232
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535 E 70th St
New York, New York 10021
(212) 606-1000
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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710 West 168th Street
New York, New York 10032
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Orange, California 92868
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Philadelphia, Pennsylvania 19140
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4805 Northeast Glisan Street
Portland, Oregon 97213
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1438 South Grand Boulevard
Saint Louis, Missouri 63104
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Saint Louis, Missouri 63110
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7703 Floyd Curl Drive
San Antonio, Texas 78229
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San Francisco, California 94115
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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Stanford, California 94305
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750 East Adams Street
Syracuse, New York 13210
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Washington, District of Columbia
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
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