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Trial record 9 of 11 for:    Arimoclomol

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00244244
Recruitment Status : Completed
First Posted : October 26, 2005
Last Update Posted : February 9, 2012
Sponsor:
Information provided by (Responsible Party):
CytRx

Tracking Information
First Submitted Date  ICMJE October 25, 2005
First Posted Date  ICMJE October 26, 2005
Last Update Posted Date February 9, 2012
Study Start Date  ICMJE October 2005
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2005)
Safety
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00244244 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2005)
  • Pharmacokinetics
  • ALSFRS-R
  • Vital Capacity
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Multicenter, Dose Ranging Safety and Pharmacokinetics Study of Arimoclomol in ALS
Official Title  ICMJE A Multicenter, Dose Ranging Safety and Pharmacokinetics Study of Arimoclomol in Amyotrophic Lateral Sclerosis (ALS)
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 cerebrospinal fluid will be measured.
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 mutant superoxide dismutase (SOD1) transgenic mouse model of ALS. Furthermore, it has been demonstrated to have neuroprotective and neuroregenerative effects in other rat models of nerve damage. Molecular chaperone proteins are critical in the cellular response to stress and protein misfolding. Recent data suggest that the SOD1 mutation responsible for ALS in some patients with familial disease reduces the availability of a variety of molecular chaperones, and thus weakens their ability to respond to cellular stress. Protein misfolding and consequent aggregation may play a role in the pathogenesis of both the familial and sporadic forms of ALS. Therapeutic agents such as arimoclomol that improve cellular chaperone response to protein misfolding may be helpful in ALS.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Amyotrophic Lateral Sclerosis (ALS)
Intervention  ICMJE Drug: arimoclomol
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: October 25, 2005)
80
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2007
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00244244
Other Study ID Numbers  ICMJE AALS-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party CytRx
Study Sponsor  ICMJE CytRx
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Merit Cudkowicz, MD Massachusetts General Hospital
Principal Investigator: Jeremy Shefner, MD State University of New York - Upstate Medical University
PRS Account CytRx
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP