Status:
COMPLETED
A Multicenter, Dose Ranging Safety and Pharmacokinetics Study of Arimoclomol in ALS
Lead Sponsor:
CytRx
Conditions:
Amyotrophic Lateral Sclerosis (ALS)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 cerebrospin...
Detailed Description
Arimoclomol is a small molecule that upregulates "molecular chaperones" in cells under stress. Arimoclomol extends survival by five weeks when given both pre-symptomatically and at disease onset in a ...
Eligibility Criteria
Inclusion
- 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
- Dependence on mechanical ventilation
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00244244
Start Date
October 1 2005
End Date
January 1 2007
Last Update
February 9 2012
Active Locations (10)
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1
University of California, Irvine Medical Center
Irvine, California, United States, 92868
2
University of Miami School of Medicine
Miami, Florida, United States, 33136
3
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02129