Arimoclomol in Amyotropic Lateral Sclerosis



Status:Recruiting
Conditions:Neurology, Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:July 31, 2018
End Date:January 2021
Contact:Requests at Orphazyme A/S
Email:Request@orphazyme.com
Phone:+45 39 17 82 72

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A Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotropic Lateral Sclerosis

A multicenter, randomized, double-blind, placebo-controlled, parallel group trial to evaluate
the efficacy and safety of arimoclomol in amyotropic lateral sclerosis (ALS)

Screening of up to 4 weeks Treatment of up to 76 weeks

Inclusion Criteria:

- Subject meets revised El Escorial criteria for clinically possible, clinically
probable / Clinically probable ALS laboratory-supported or clinically definite ALS, or
familial ALS

- 18 months or less since first appearance of weakness (e.g. limb weakness, dysarthria,
dysphagia, shortness of breath).

- ALSFRS-R equal to or above 35 and erect (seated) SVC% predicted equal to or above 80%
at screening

Exclusion Criteria:

- Tracheostomy or use of non-invasive ventilation for more than 2 hours during waking
hours at the time of screening or baseline

- pregnant or breast-feeding

- current or anticipated use of diaphragmatic pacing

- Any other relevant medically significant condition which could present risk to the
subject or interfere with the assessment of safety or has an increased risk of causing
death during the trial
We found this trial at
12
sites
Portland, Oregon 97225
Principal Investigator: Kimberly L Goslin, MD, PhD
Phone: 503-962-1171
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Miami, Florida 33124
(305) 284-2211
Principal Investigator: Michael Benatar, MD, PhD
Phone: 305-243-7336
University of Miami A private research university with more than 15,000 students from around the...
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Miami, FL
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
Principal Investigator: Matthew Elliott, MD
Phone: 434-924-5541
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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Charlottesville, VA
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Principal Investigator: Sharon Nations, MD
Phone: 213-648-9380
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Dallas, TX
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Iowa City, Iowa 52242
Principal Investigator: Andrea Swenson, MD
Phone: 319-356-8744
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Iowa City, IA
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Kansas City, Kansas 66160
Principal Investigator: Duaa Jabari, MD
Phone: 913-945-9942
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Kansas City, KS
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Leuven,
Principal Investigator: Phillip Van Damme, MD
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Leuven,
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535 E 70th St
New York, New York 10021
(212) 606-1000
Principal Investigator: Dale J. Lange, MD
Phone: 646-797-8657
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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New York, NY
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Orange, California 92868
Principal Investigator: Namita Goyal, MD
Phone: 714-456-7760
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Orange, CA
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Philadelphia, Pennsylvania 19107
Principal Investigator: Colin Quinn, MD
Phone: 215-829-5041
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Philadelphia, PA
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Phoenix, AZ
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Phoenix, Arizona 85018
Principal Investigator: Todd Levine, MD
Phone: 480-882-4916
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Phoenix, AZ
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