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Quick Info
Status
This study has been completed
Phase
1
Trial Type
Double-Blind, Randomized, Placebo-Controlled
Treatment Type
Administered Orally
Randomization
Unknown
Enrollment
54
Start Date
5/31/2016
Sponsor
Contact Information
Locations
Canada, Quebec
MUCH - Montreal Neurological Institute & Hospital, Montreal, QC, H3A 2B4, Canada
Netherlands, Other
UMC Utrecht, Utrecht, 3508 GA, Netherlands
United States, California
Forbes Norris Mda/als Ctr; Research Center, San Francisco, CA, 94115, United States
United States, Florida
Mayo Clinic Hospital - Florida, Jacksonville, FL, 32224, United States
University of Miami Miller School of Medicine, Miami, FL, 33136, United States
Bioclinica Research, Orlando, FL, 32806, United States
United States, Georgia
The Emory ALS Clinic, Atlanta, GA, 30322, United States
United States, Maryland
Johns Hopkins University School of Medicine, Baltimore, MD, 21205, United States
United States, Massachusetts
Massachusetts General Hospital, Boston, MA, 02114, United States
United States, North Carolina
Wake Research Associates, Raleigh, NC, 27612, United States
United States, Tennessee
New Orleans Center for Clinical Research, Knoxville, TN, 37920, United States
United States, Texas
Methodist Neurological Institute, Houston, TX, 77030, United States
Enrollment Criteria
Breathing Ability
Percent lung function (FVC) or (SVC)
>50%
Months Since Onset
Number of months since first symptoms of ALS.
n/a
Non-Invasive Ventilation (NIV)
Can PALS use a BiPAP in the trial?
n/a
Diaphragm Pacer (DPS)
Can PALS use a DPS in the trial?
n/a
Edaravone Usage
Can a PALS use edaravone (Radicut/Radicava) while enrolled in the trial?
Yes
Open Label
Unknown
Update Notes
Trial is completed
8/7/2020
No significant changes.
5/18/2020
Updated recruitment status.
2/20/2020
No significant updates
1/23/2020
Updated recruitment locations
12/23/2019
No significant Updates
10/21/2019
recruitment status updated
9/23/2019
Recruitment status update.
8/6/2019
No significant updates.
7/8/2019
No significant updates
6/5/2019
No significant updates
5/6/2019
No significant updates
4/8/2019
Recruitment status updated
3/11/2019
No significant updates
2/5/2019
No significant updates
1/2/2019
No significant updates
12/6/2018
No significant updates
11/9/2018
No significant updates
10/26/2018
Recruitment status updated
9/10/2018
No significant updates
4/26/2018
No significant updates
4/2/2018
Recruitment status updated
3/9/2018
Description updated
2/20/2018
No significant updates
1/26/2018
No significant updates
1/3/2018
No significant updates
11/29/2017
Enrollment criteria updated
10/5/2017
Location updated
8/29/2017
Location Updated
8/1/2017
No significant updates
7/11/2017
No significant updates
6/5/2017
No significant updates
5/10/2017
No significant updates
4/14/2017
Location and description updated
4/3/2017
No significant updates
11/3/2016
Location updated
10/5/2016
No significant updates
9/6/2016
No significant updates
8/2/2016
No significant updates
7/6/2016
No Significant Updates
6/2/2016
No significant updates.
2/2/2016
Clinical trial added.
1/14/2016

Other Information

Purpose
This first-in-human, double-blind, placebo-controlled Phase I study will be conducted in participants with amyotrophic lateral sclerosis (ALS) to explore safety, tolerability, and pharmacokinetic (PK) properties of GDC-0134. It will include three components: a Single-Ascending-Dose (SAD) stage, a Multiple-Ascending-Dose (MAD) stage, and an Open-Label Safety Expansion (OSE) stage.
Eligibility
18 years and older; both genders; no healthy volunteers, Currently taking edaravone unless after completion of at least the second 14-day drug-treatment period, as long as Day 1 occurs during a drug-free period at least 24 hours after the last edaravone dose and at least 5 days prior to the first dose of the next cycle
Details
In the experimental arm of the study, participants in multiple cohorts and treatment periods will receive single doses of GDC-0134 under fed/fasting conditions. In the placebo arm, participants in multiple cohorts and treatment periods will receive single doses of placebo under fed/fasting conditions.
Collaborator(s)
    -
Trial Protocol as Published on Clinicaltrials.gov
NCT02655614 (First Published: 1/7/2016)