A Multicenter, Dose Ranging Safety and Pharmacokinetics Study of Arimoclomol in ALS

Completed · Phase 2

Conditions studied: Amyotrophic Lateral Sclerosis (ALS)

In brief

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.

Key facts

Study ID

NCT00244244

Run by

CytRx

People needed

80

Starts

2005-10-01

Expected to finish

2007-01-01

Last updated by the study team

2012-02-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Dependence on mechanical ventilation

Where it is running

• University of California, Irvine Medical Center — Irvine, California, United States
• University of Miami School of Medicine — Miami, Florida, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Hennepin Faculty Associates/Berman Center — Minneapolis, Minnesota, United States
• SUNY Upstate Medical University — Syracuse, New York, United States
• Duke University — Durham, North Carolina, United States
• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• Drexel University College of Medicine — Philadelphia, Pennsylvania, United States
• University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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