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NCT06903286 | NOT YET RECRUITING | Amyotrophic Lateral Sclerosis (ALS)

Extension Study of Participants From SPG302-ALS-001
Sponsor:

Spinogenix

Brief Summary:

This study will evaluate the long-term safety and efficacy of participants enrolled in SPG302-ALS-101 with Amyotrophic Lateral Sclerosis (ALS)

Condition or disease

Amyotrophic Lateral Sclerosis (ALS)

Intervention/treatment

SPG302

Phase

PHASE2

Detailed Description:

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 16 participants
Masking : NONE
Masking Description : None (Open Label)
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2025-04-29
Estimated Primary Completion Date : 2026-05-30
Estimated Study Completion Date : 2026-08-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • • Must have participated in all study activities of SPG302-ALS-001, the parent study
Exclusion Criteria
  • * Unable to reliably and regularly swallow whole oral medications on a daily basis.
  • * Medical conditions that investigator or sponsor determine would interfere with participation in clinical trial
Extension Study of Participants From SPG302-ALS-001

Location Details

NCT06903286

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Australia, New South Wales

Macquarie University

North Ryde, New South Wales, Australia, 2109

Not yet recruiting

Australia, Queensland

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia, 4029

Not yet recruiting

Australia, South Australia

Flinders Medical Center

Adelaide, South Australia, Australia, 5042