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An Open-label Extension of SPG302-ALS-001 Study to Evaluate the Long-term Safety and Efficacy of Daily Oral SPG302 Treatment in Participants With Amyotrophic Lateral Sclerosis
This study will evaluate the long-term safety and efficacy of participants enrolled in SPG302-ALS-101 with Amyotrophic Lateral Sclerosis (ALS)
This is an open-label extension study of SPG302-ALS-001 to investigate the long-term safety, tolerability, and efficacy of SPG302 administered orally in participants with Amyotrophic Lateral Sclerosis (ALS). This study will allow participants in the parent study to continue dosing. Enrolled participants will continue at the dose they received at the end of the first trial, and will self-administer SPG302 orally every day for up to 52 weeks. Participants will have an in-person clinic visit every 3 months (± 3 days) and a monthly phone visit. An end of treatment visit will occur within 7 days of the last dose of SPG302. A final visit to collect safety data will be conducted up to 1 month (± 3 days) post last dose.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
Macquarie University
North Ryde, New South Wales, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Flinders Medical Center
Adelaide, South Australia, Australia
Start Date
May 29, 2025
Primary Completion Date
June 30, 2025
Completion Date
August 31, 2025
Last Updated
December 17, 2025
16
ACTUAL participants
SPG302
DRUG
Lead Sponsor
Spinogenix
NCT07187388
NCT07202494
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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