A Multicenter, Double-Blind Study to Investigate the Safety and Efficacy of Arimoclomol in Volunteers With ALS
NCT ID: NCT00561366
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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WITHDRAWN
PHASE2
INTERVENTIONAL
Brief Summary
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Detailed Description
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Tier I (Safety Lead-in): During the enrollment period for the safety lead-in phase, 24 volunteers meeting inclusion/exclusion criteria will be randomized at 4 investigative sites. These volunteers will have weekly visits during the first 4 weeks after starting treatment. Pharmacokinetics (PK) will be performed at various timepoints throughout these 4 weeks. After the initial 4 weeks of treatment, visits will continue at 4-week intervals up to Week 36, subsequently visits will occur every 8 weeks up to Week 68. A final visit will occur at Week 72. There will be a 28-day post study medication Follow-Up Telephone Call to assess medical status and adverse events.
Tier II: After the Tier I volunteers finish 4 weeks of treatment, their data will be reviewed by the IDMC and, if no serious safety issues are identified, the recommendation will be made to start the second enrollment period (Tier II). During Tier II enrollment, volunteers recruited from approximately 30 to 40 centers in the US and Canada will be randomized. After screening and randomization, volunteers will be followed every 4 weeks for 9 months. Subsequently visits will occur every 8 weeks up to Week 68, with interim Follow-Up Telephone Calls at Weeks 16, 24, and 32 and a final visit at Week 72. A Week 76 Follow-Up Telephone Call to assess medical status and adverse events will occur at 28 days post last dose of study medication.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Placebo
Placebo t.i.d.
2
Arimoclomol
capsule, 400 mg t.i.d.
Interventions
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Placebo
Placebo t.i.d.
Arimoclomol
capsule, 400 mg t.i.d.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with laboratory-supported probable, probable or definite ALS according to the World Federation of Neurology El Escorial criteria for less than or equal to 36 months' duration prior to the Screening Visit.
* Vital capacity (VC) equal to or greater than 70% predicted value for gender, height and age at the Screening Visit.
* Geographic accessibility to the study site.
* Ability to take oral medication at the Screening Visit, based on verbal report.
* Fluency in English, Spanish or Canadian French.
Exclusion Criteria
* Prior exposure to arimoclomol through a clinical trial or physician-sponsored IND.
* Exposure to any investigational agent within 30 days of the Screening Visit.
* Presence of any of the following clinical conditions:
1. Substance abuse within the past year
2. Unstable cardiac, pulmonary, renal, hepatic, endocrine, hematologic, or active malignancy or infectious disease
3. AIDS or AIDS-related complex
4. Unstable psychiatric illness defined as psychosis (hallucinations or delusions), untreated major depression within 90 days of the Screening Visit.
* Laboratory values: Screening serum creatinine greater than or equal to 1.5 mg/dL, creatinine clearance less than 70 cc/min, alanine aminotransferase (ALT) greater than 3.0 times the upper limit of normal, total bilirubin greater than 1.5 times the upper limit of normal, white blood cell (WBC) count less than 3,500/mm3, platelet concentration of \<100,000/ul, hematocrit level of less than 33 % for female or less than 35 % for male, or coagulation tests (PT, PTT) greater than or equal to 1.5 times upper limit of normal.
* Female volunteers who are breast-feeding.
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, MSc
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Jeremy Shefner, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
State University of New York - Upstate Medical University
Locations
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University of California Los Angeles - Tier 2 Site
Pacific Palisades, California, United States
University of California - San Francisco - Tier 2 Site
San Francisco, California, United States
University of Colorado Health Sciences Center - Tier 2 Site
Denver, Colorado, United States
University of Miami - Tier 2 Site
Miami, Florida, United States
Emory University - Tier 2 site
Atlanta, Georgia, United States
Northwestern University, Dept. of Neurology - Tier 2 Site
Chicago, Illinois, United States
University of Kansas Medical Center - Tier 2 site
Kansas City, Kansas, United States
John Hopkins University - Tier 2 Site
Baltimore, Maryland, United States
Massachusetts General Hospital - Tier 1 Site
Boston, Massachusetts, United States
Baystate Medical Center - Tier 2 Site
Springfield, Massachusetts, United States
Saint Louis University, Neuromuscular Div. - Tier 2 Site
St Louis, Missouri, United States
Washington University - Tier 2 Site
St Louis, Missouri, United States
BryanLGH Medical Center - Tier 2 Site
Lincoln, Nebraska, United States
Upstate Clinical Research, LLC - Tier 2 Site
Albany, New York, United States
Mount Sinai School of Medicine - Tier 2 Site
New York, New York, United States
Columbia University Medical Center - Tier 2 site
New York, New York, United States
SUNY Downstate Medical Center - Tier 1 Site
Syracuse, New York, United States
Duke University Medical Center - Tier 1 Site
Durham, North Carolina, United States
Wake Forest University School of Medicine -Tier 2 Site
Winston-Salem, North Carolina, United States
Cleveland Clinic Foundation -Tier 2 site
Cleveland, Ohio, United States
Providence ALS Center - Tier 2 Site
Portland, Oregon, United States
Pennsylvania State University School of Medicine - Tier 2 Site
Hershey, Pennsylvania, United States
Drexel University College of Medicine - Tier 1 Site
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center - Tier 2 Site
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center - Tier 2
Nashville, Tennessee, United States
Texas Neurology, PA - Tier 2 Site
Dallas, Texas, United States
University of Texas Health Science Center - Tier 2 Site
San Antonio, Texas, United States
University of Vermont, College of Medicine - Tier 2
Burlington, Vermont, United States
University of Virginia - Tier 2 Sites
Charlottesville, Virginia, United States
Virginia Mason Clinic - Tier 2 Site
Seattle, Washington, United States
Medical College of Wisconsin - Tier 2 Site
Milwaukee, Wisconsin, United States
University of British Columbia, Gordon and Leslie Diamond Health Care Centre - Tier 2 Site
Vancouver, British Columbia, Canada
London Health Science Center - Tier 2 Site
London, Ontario, Canada
University of Toronto, Sunnybrook Health Sciences Centre - Tier 2 Site
Toronto, Ontario, Canada
Montreal Neurological Institute - Tier 2
Montreal, Quebec, Canada
Countries
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Other Identifiers
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AALS-003
Identifier Type: -
Identifier Source: org_study_id
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