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Quick Info
Status
Currently 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
Contact: Study Coordinator
United States, California
University of California, San Francisco, San Francisco, CA, 94117, United States
Contact: Study Coordinator
United States, Colorado
University of Colorado, Aurora, CO, 80045, United States
Contact: Study Coordinator
United States, Florida
Mayo Clinic Florida, Jacksonville, FL, 32224, United States
Contact: Study Coordinator
University of South Florida, Tampa, FL, 33612, United States
Contact: Study Coordinator
United States, Indiana
Indiana University, Indianapolis, IN, 46202, United States
Contact: Study Coordinator
United States, Maryland
Johns Hopkins University, Baltimore, MD, 21205, United States
Contact: Study Coordinator
United States, Massachusetts
Massachusetts General Hospital, Boston, MA, 02114, United States
Contact: Study Coordinator
United States, Michigan
University of Michigan, Ann Arbor, MI, 48109, United States
Contact: Study Coordinator
United States, Missouri
Washington University School of Medicine, Saint Louis, MO, 63110, United States
Contact: Study Coordinator
United States, Pennsylvania
Jefferson University, Philadelphia, PA, 19107, United States
Contact: Study Coordinator
United States, Washington
University of Washington, Seattle, WA, 98195, United States
Contact: Study Coordinator
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
There are no update notes for this clinical trial.

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)