A Multicenter, Double-Blind Study to Investigate the Safety and Efficacy of Arimoclomol in Volunteers With ALS
Public ClinicalTrials.gov record NCT00561366. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Double-Blind, Placebo-Controlled, Phase 2b Study to Investigate the Safety and Efficacy of Arimoclomol in Volunteers With Amyotrophic Lateral Sclerosis (ALS)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT00561366
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- Not listed
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Not listed
- Primary completion
- Not listed
- Completion
- Not listed
- Last update posted
- Feb 8, 2012
United States locations
- U.S. sites
- 31
- U.S. states
- 21
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California Los Angeles - Tier 2 Site | Pacific Palisades | California | 90272 | — |
| University of California - San Francisco - Tier 2 Site | San Francisco | California | 94117 | — |
| University of Colorado Health Sciences Center - Tier 2 Site | Denver | Colorado | 80262 | — |
| University of Miami - Tier 2 Site | Miami | Florida | 33136 | — |
| Emory University - Tier 2 site | Atlanta | Georgia | 30322 | — |
| Northwestern University, Dept. of Neurology - Tier 2 Site | Chicago | Illinois | 60611 | — |
| University of Kansas Medical Center - Tier 2 site | Kansas City | Kansas | 66160 | — |
| John Hopkins University - Tier 2 Site | Baltimore | Maryland | 21287 | — |
| Massachusetts General Hospital - Tier 1 Site | Boston | Massachusetts | 02114 | — |
| Baystate Medical Center - Tier 2 Site | Springfield | Massachusetts | 01199 | — |
| Saint Louis University, Neuromuscular Div. - Tier 2 Site | St Louis | Missouri | 63110 | — |
| Washington University - Tier 2 Site | St Louis | Missouri | 63110 | — |
| BryanLGH Medical Center - Tier 2 Site | Lincoln | Nebraska | 68506 | — |
| Upstate Clinical Research, LLC - Tier 2 Site | Albany | New York | 12205 | — |
| Mount Sinai School of Medicine - Tier 2 Site | New York | New York | 10029 | — |
| Columbia University Medical Center - Tier 2 site | New York | New York | 10032 | — |
| SUNY Downstate Medical Center - Tier 1 Site | Syracuse | New York | 13210 | — |
| Duke University Medical Center - Tier 1 Site | Durham | North Carolina | 27705 | — |
| Wake Forest University School of Medicine -Tier 2 Site | Winston-Salem | North Carolina | 27157 | — |
| Cleveland Clinic Foundation -Tier 2 site | Cleveland | Ohio | 44195 | — |
| Providence ALS Center - Tier 2 Site | Portland | Oregon | 97213 | — |
| Pennsylvania State University School of Medicine - Tier 2 Site | Hershey | Pennsylvania | 17033 | — |
| Drexel University College of Medicine - Tier 1 Site | Philadelphia | Pennsylvania | 19107 | — |
| University of Pittsburgh Medical Center - Tier 2 Site | Pittsburgh | Pennsylvania | 15213 | — |
| Vanderbilt University Medical Center - Tier 2 | Nashville | Tennessee | 37232-2551 | — |
| Texas Neurology, PA - Tier 2 Site | Dallas | Texas | 75214 | — |
| University of Texas Health Science Center - Tier 2 Site | San Antonio | Texas | 78229-3900 | — |
| University of Vermont, College of Medicine - Tier 2 | Burlington | Vermont | 05405 | — |
| University of Virginia - Tier 2 Sites | Charlottesville | Virginia | 22908 | — |
| Virginia Mason Clinic - Tier 2 Site | Seattle | Washington | 98101 | — |
| Medical College of Wisconsin - Tier 2 Site | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00561366, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 8, 2012 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00561366 live on ClinicalTrials.gov.