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Quick Info
Status
Ongoing, But Not Recruiting
Phase
2
Trial Type
Interventional
Treatment Type
Drug Trials
Randomization
Not Available
Enrollment
45
Start Date
9/2/2021
Sponsor
Alector Inc.
Contact Information
    Contact information unknown.
Locations
United States, Arizona
Barrow Neurological Instiute, Phoenix, AZ, 85013, United States
United States, California
University of California, San Francisco, San Francisco, CA, 94117, United States
United States, Colorado
University of Colorado, Aurora, CO, 80045, United States
United States, Florida
Mayo Clinic Florida, Jacksonville, FL, 32224, United States
University of South Florida, Tampa, FL, 33612, United States
United States, Indiana
Indiana University, Indianapolis, IN, 46202, United States
United States, Maryland
Johns Hopkins University, Baltimore, MD, 21205, United States
United States, Massachusetts
Massachusetts General Hospital, Boston, MA, 02114, United States
United States, Michigan
University of Michigan, Ann Arbor, MI, 48109, United States
United States, Missouri
Washington University School of Medicine, Saint Louis, MO, 63110, United States
United States, Pennsylvania
Jefferson University, Philadelphia, PA, 19107, United States
United States, Washington
University of Washington, Seattle, WA, 98195, United States
Enrollment Criteria
Breathing Ability
Percent lung function (FVC) or (SVC)
≥50% (SVC)
Months Since Onset
Number of months since first symptoms of ALS.
≤36 months
Non-Invasive Ventilation (NIV)
Can PALS use a BiPAP in the trial?
Yes
Diaphragm Pacer (DPS)
Can PALS use a DPS in the trial?
Yes
Edaravone Usage
Can a PALS use edaravone (Radicut/Radicava) while enrolled in the trial?
Yes
Open Label
No
Update Notes
Study no longer recruiting
4/19/2022

Other Information

Purpose
A phase 2 double-blind, placebo-controlled study of AL001 in participants with C9orf72-associated ALS.
Eligibility
Inclusion Criteria:
- Confirmation of C9orf72 mutation - Diagnosis of ALS by revised El Escorial criteria - Time since onset of muscle weakness due to ALS ≤36 months at the time of the Screening Visit - Slow Vital Capacity (VC) ≥50% of predicted capacity at the time of the Screening Visit - If taking riluzole, must be on a stable dose of riluzole for at least 30 days prior to the Screening Visit. Riluzole naive participants are allowed.
- If taking edaravone, must have completed at least one cycle of edaravone prior to the Screening Visit and plan to continue edaravone during the study. Edaravone naive participants are allowed.
- Females must not be pregnant, breastfeeding or planning to conceive within the study period. Males must agree to use acceptable contraception - Capable of providing informed consent at the Screening visit and complying with study procedures throughout the study Exclusion Criteria:
- Clinically significant, unstable, medical condition (other than ALS) - Clinically significant heart disease, liver disease or kidney disease - Cognitive impairment or dementia - Current uncontrolled hypertension - History of unresolved cancer - Any experimental gene therapy - Any experimental vaccine (any vaccine against COVID-19 either approved or administered under an Emergency Use Authorization is allowed)
Details
This is a phase 2 double-blind, placebo-controlled trial to test the safety, tolerability, pharmacokinetics, and pharmacodynamics of AL001 in participants with C9orf72-associated Amyotrophic Lateral Sclerosis.
Collaborator(s)
  • Alector Inc.
Trial Protocol as Published on Clinicaltrials.gov
NCT05053035 (First Published: 9/1/2021)