Study Purpose:
The primary purpose of this study is to evaluate the safety and tolerability of arimoclomol in ALS patients following 90 days of dosing. In addition, the amount of arimoclomol in blood and cerebrospinal fluid will be measured.Study Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis (ALS)
Study Type:
Interventional
Type of Intervention:
Drug
Intervention Name:
arimoclomol
Placebo:
Phase:
Phase 2
Study Chair(s)/Principal Investigator(s):
Merit Cudkowicz, MD, Massachusetts General Hospital, Jeremy Shefner, MD, State University of New York - Upstate Medical University
Clinicaltrials.gov ID:
Neals Affiliated?
Yes
Coordinating Center Contact Information
United States
Full Study Summary:
Study Sponsor:
CytRx
Estimated Enrollment:
84
Estimated Study Start Date:
11 / 02 / 2016
Estimated Study Completion Date:
01 / 01 / 2007
Posting Last Modified Date:
02 / 09 / 2012
Date Study Added to neals.org:
10 / 26 / 2005
Minimum Age:
18 Years
Maximum Age:
N/A
Inclusion Criteria:- Familial or sporadic ALS
- Vital capacity equal to or more than 60% predicted value for gender, height and age at the screening visit
- First ALS symptoms occurred no more than five years prior to screening
- Must be able to take oral medication
Exclusion Criteria:
- Dependence on mechanical ventilation
University of California, Irvine Medical Center
Irvine, California
92868
United States
University of Miami School of Medicine
Miami, Florida
33136
United States
University of Kansas Medical Center
Kansas City, Kansas
66160
United States
Massachusetts General Hospital
Boston, Massachusetts
02129
United States
Hennepin Faculty Associates/Berman Center
Minneapolis, Minnesota
55404
United States
SUNY Upstate Medical University
Syracuse, New York
13210
United States
Duke University
Durham, North Carolina
27705
United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania
17033
United States
Drexel University College of Medicine
Philadelphia, Pennsylvania
19107
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas
78229
United States