Extension Study of Participants From SPG302-ALS-001

NCT06903286 | Terminated Phase 2 FDA Drug

• 1 other identifier: SPG302-ALS-002 OLE
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Keywords

Amyotrophic Lateral Sclerosis; regenerative; synapse

Outcome Measures

Primary Outcomes (2)

• Treatment emergent adverse events and serious adverse events

  Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)

  Up to 52 weeks

• C-SSRS (Columbia Suicide Severity Rating Scale)

  Prospective suicidality assessment is performed using the Columbia-Suicide Severity Rating Scale (C-SSRS), a questionnaire to evaluate suicidal ideation and behavior. Answer "yes" on item 4 or 5 of the Suicidal Ideation section or "yes" on any item of the Suicidal Behavior section is considered positive. The suicidal behavior lethality sub-scale evaluates the level of actual or potential medical damage

  Up to 52 weeks

Secondary Outcomes (3)

• Change in the Amyotrophic Lateral Sclerosis Functional Rating Scale-revised (ALSFRS-R) scores

  up to 52 weeks

• Change in Edinburgh Cognitive and Behavioural ALS Screen (ECAS)

  up to 52 weeks

• Changes from baseline in neurofilament light biomarker (NfL)

  up to 52 weeks.

Study Arms (1)

Experimental: Open Label Extension

EXPERIMENTAL

Active SPG302 to be administered to adult participants with ALS who completed initial study. Dose to be administered to be dose received during previous study.

Drug: SPG302

Interventions

SPG302 DRUG

Open label SPG302 to be self-administered daily by eligible participants for 52 weeks.

Experimental: Open Label Extension

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have participated in all study activities of SPG302-ALS-001, the parent study

You may not qualify if:

• 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

Sponsors & Collaborators

• Spinogenix: lead

Study Sites (3)

Macquarie University

North Ryde, New South Wales, 2109, Australia

Location

Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

Location

Flinders Medical Center

Adelaide, South Australia, 5042, Australia

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open Label extension

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: March 30, 2025
• Study Start: May 29, 2025
• Primary Completion: June 30, 2025
• Study Completion: August 31, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)