A Multicenter, Dose Ranging Safety and Pharmacokinetics Study of Arimoclomol in ALS
NCT ID: NCT00244244
Last Updated: 2012-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
80 participants
INTERVENTIONAL
2005-10-31
2007-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Interventions
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arimoclomol
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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CytRx
INDUSTRY
Responsible Party
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Principal Investigators
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Merit Cudkowicz, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Jeremy Shefner, MD
Role: PRINCIPAL_INVESTIGATOR
State University of New York - Upstate Medical University
Locations
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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
Countries
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References
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Kieran D, Kalmar B, Dick JR, Riddoch-Contreras J, Burnstock G, Greensmith L. Treatment with arimoclomol, a coinducer of heat shock proteins, delays disease progression in ALS mice. Nat Med. 2004 Apr;10(4):402-5. doi: 10.1038/nm1021. Epub 2004 Mar 21.
Benn SC, Brown RH Jr. Putting the heat on ALS. Nat Med. 2004 Apr;10(4):345-7. doi: 10.1038/nm0404-345. No abstract available.
Kurthy M, Mogyorosi T, Nagy K, Kukorelli T, Jednakovits A, Talosi L, Biro K. Effect of BRX-220 against peripheral neuropathy and insulin resistance in diabetic rat models. Ann N Y Acad Sci. 2002 Jun;967:482-9. doi: 10.1111/j.1749-6632.2002.tb04306.x.
Kalmar B, Burnstock G, Vrbova G, Urbanics R, Csermely P, Greensmith L. Upregulation of heat shock proteins rescues motoneurones from axotomy-induced cell death in neonatal rats. Exp Neurol. 2002 Jul;176(1):87-97. doi: 10.1006/exnr.2002.7945.
Muchowski PJ, Wacker JL. Modulation of neurodegeneration by molecular chaperones. Nat Rev Neurosci. 2005 Jan;6(1):11-22. doi: 10.1038/nrn1587.
Kalmar B, Greensmith L, Malcangio M, McMahon SB, Csermely P, Burnstock G. The effect of treatment with BRX-220, a co-inducer of heat shock proteins, on sensory fibers of the rat following peripheral nerve injury. Exp Neurol. 2003 Dec;184(2):636-47. doi: 10.1016/S0014-4886(03)00343-1.
Other Identifiers
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AALS-001
Identifier Type: -
Identifier Source: org_study_id
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