Study of Safety, Tolerability & Efficacy of CK-2017357 in Amyotrophic Lateral Sclerosis (ALS)

Study of Safety, Tolerability & Efficacy of CK-2017357 in Amyotrophic Lateral Sclerosis (ALS)

Quick Info:

Status:
This study has been completed
Estimated Enrollment:
680
Phase:
IIB
Treatment Type:
oral tablets
Trial Type:
randomized, double blind, placebo-controlled
Sponsor:
Cytokinetics
Primary Investigator:
Contact Information:

Enrollment Criteria:

Forced Ventilation

Breathing Ability

Percent lung function (FVC) or (SVC)
> 60%
Months/Onset

Months Since Onset

Number of months since first
symptoms of ALS
N/A
BiPap Allowed

Non-Invasive Ventilation (NIV)

Can PALS use a BiPAP in the trial?
No
DPS Allowed

Diaphragm Pacer (DPS)

an PALS use a DPS in the trial?
No

Update Notes:

12/15/2016No significant updated
11/3/2015No significant updates.
4/17/2014Study completed.
12/10/2013Recruitment status updated
8/28/2013New location added
8/22/2013New locations added
7/23/2013Expected enrollment: 680
7/3/2013No significant updates
6/25/2013No significant changes
6/14/2013Enrollment criteria updated.
5/13/2013New locations added.
4/18/2013New locations added.
3/27/2013Enrollment criteria updated.
3/12/2013New locations added.
3/6/2013New locations added.
3/1/2013New locations added.
2/21/2013New locations added.
2/19/2013New locations added.
2/12/2013New locations added.
2/5/2013New locations added.
2/1/2013New locations added.
1/31/2013New locations added.
1/28/2013New locations added.
1/24/2013New locations added.
1/18/2013New locations added
1/14/2013New locations added

Locations:

University of Michigan, ann arbor, 48109
Emory University, School of Medicine, Atlanta, 30322
Georgia Health Sciences University, Augusta, 30912
Johns Hopkins University, Baltimore, 21205
Massachusetts General Hospital, Boston, 02114
Carolinas Medical Center Department of Neurology, Charlotte, 27406
University of Virginia, Charlottesville, 22908
Ohio State University Department of Neurology, Columbus, 43221
Texas Neurology, Dallas, 75214
Henry Ford Hospital, Detroit, 48202
Duke University, Durham, 27705
St Mary's Healthcare, Grand Rapids, 49503
Penn State Hershey Neuroscience Clinics , Hershey, 17033
Baylor College of Medicine, Houston, 77030
Indiana University Department of Neurology, Indianapolis, 46202
University of Iowa Hospitals and Clinics, Iowa City, 52242
Mayo Clinic Florida Department of Neurology, Jacksonville, 32224
University of Kansas, Kansas City, 66160
University of California, San Diego, La Jolla, 92093
Dartmouth Hitchcock Medical Center, Lebanon, 03756
Neurology Associates, Lincoln, 68506
Medical College of Wisconsin, Milwaukee, 53226
Hennepin County Medical Center, Minneapolis, 55415
West Virginia University, Morgantown, 26506
Hospital for Special Care, New Britain, 06053
Hospital for Special Surgery, New York, 10021
UC Irvine ALS & Neuromuscular Center, Orange, 92868
Drexel Neurology, Philadelphia, 19107
Barrow Neurology, Phoenix, 85013
University of Pittsburgh, Pittsburgh, 15213
Oregon Health & Science University, Portland, 97239
Providence ALS Center, Portland, 97213
University of Rochester, Rochester, 14642
UTHSCSA Department of Neurology, San Antonio, 78229
Coordinated Clinical Research, San Diego, 92103
California Pacific Medical Center Forbes Norris, San Francisco , 94115
Washington University, St Louis, 63110
Saint Louis University, St Louis, 63104
SUNY Upstate Medical University, Syracuse, 13120
George Washington University, Washington, 20037
Wake Forest University, School of Medicine, Winston-Salem, 27157
University of Massachusetts Medical School, Worcester, 01655
CHU de Quebec: Hopital l'Enfant-Jesus, G1J 1Z4
Heritage Medical Research, Calgary, T2N 4Z6
University of Alberta Hospital, Edmonton, B3H 3A7
Stan Cassidy Centre for Rehabilitation, Fredericton, E3B 0C7
QE II Health Sciences Centre, Halifax, B3H 3A7
McMaster University Medical Centre, Hamilton, L8S 4K1
Kingston, Kingston, K7L 2V7
London Health Sciences, London, N6A 5A5
Montreal Neurological Institute, Montreal, H3A 2B4
Hôpital Notre Dame (CHUM) Centre Hospitalier de l', Montreal, H2L4M1
McMaster University Medical Centre, Ontario, L8S 4K1
Univ. of Toronto - Sunnybrook Health Sciences Cent, Toronto, M4N 3M5
University of British Columbia, Vancouver, V5Z 2G9
CHRU de Lille - Hôpital Roger Salengro, Lille
CHU de Limoges - Hôpital Dupuytren, Limoges
CHU Montepellier, Montpellier
Hôpital Archet 1, Nice, 06602
Hôpital de la Salpêtrière, Paris
Hôpital Bretonneau, Tours, 37000
Charite Universitätsmedizin, Berlin, 13353
Hannover Medical School, Hannover, 30625
University of Ulm, Ulm, 89081
Trinity College, Beaumont Hospital, Dublin, 9
Universitair Medisch Centrum Utrecht, Utrecht, 3584 CX
Hospital Carlos III, Madrid, 28029
Walton Centre for Neurology and Neurosurgery, Liverpool
Kings College Hospital NHS Foundation Trust, London
Barts and the London MND & the Centre Royal London Whitechaple, London
John Radcliffe Hospital, Oxford
Plymouth Hospitals NHS Trust, Plymouth, PL6 8DH
Sheffield Institute for Translational Neuroscience, Sheffield, S10 2HQ
Sheffield Institute for Translational Neuroscience, Sheffield, S10 2HQ
Barts and the London MND & the Centre Royal London, Whitechapel

Other Information:

Purpose: To evaluate the safety, tolerability and efficacy of potential muscle booster tirasemtiv (CK-2017357) in people with ALS.
Eligibility: 18 years or older, possible, laboratory-supported probable, probable, or definite ALS, and SVC > 60%, see protocol
Details: The length of the study, including screening, dosing, and follow-up, is approximately 20 weeks. After a one-week open-label phase during which all patients will receive CK-2017357 125 milligrams (mg) twice daily, patients will be randomized one to one (fifty-fifty) to receive double-blind CK-2017357 or matching placebo. The CK-2017357/placebo dose will be increased no faster than weekly to each patient's highest tolerated daily dose, with a maximum of 250 mg twice daily. The dose may be decreased based on tolerability. Patients will continue treatment at the highest tolerated dose to complete a total of 12 weeks of double-blind treatment. Patients may be on riluzole or not on riluzole at study entry. Patients not on riluzole must stay off riluzole. Patients on riluzole who are getting double-blind CK-2017357 will be given riluzole at half the labeled dosage (50 mg once a day instead of 50 mg twice a day). Blood tests for safety will be performed. Information about any side effects that may occur will also be collected.
Collaborator(s):
ALS Forum:
First Published on Clinicaltrials.gov: 10/16/2012
ClinicalTrials.gov ID: NCT01709149
Trial Protocol as Published on Clinicaltrials.gov:
ClinicalTrials.gov