A Phase 2 interventional study of SPG302 in Amyotrophic Lateral Sclerosis (ALS), sponsored by Spinogenix. Terminated at 3 sites in Australia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-12-17.
Sponsored by Spinogenix · Phase 2, Interventional, and Treatment
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.
981 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 283 are open to participants now.
This study's enrollment of 16 is below the median of 36 across 667 interventional studies indexed under Amyotrophic Lateral Sclerosis.
Browse Amyotrophic Lateral Sclerosis studies →Spinogenix is the lead sponsor of 9 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Open label SPG302 to be self-administered daily by eligible participants for 52 weeks.
Treatment emergent adverse events and serious adverse events
Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time frame: 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
Time frame: Up to 52 weeks
Change in the Amyotrophic Lateral Sclerosis Functional Rating Scale-revised (ALSFRS-R) scores
Questionnaire administered by a clinician that includes a series of questions about participants' ability to function in certain daily activities. Each type of function is scored from 4 (normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0. Patients with higher scores have more physical function. This outcome would evaluate these scores based on patient demographics including clinical presentation at outset of study, presence of ventilation assistance, and patient demographics. Results will be compared to matched historical controls
Time frame: up to 52 weeks
Change in Edinburgh Cognitive and Behavioural ALS Screen (ECAS)
The Edinburgh Cognitive and Behavioural ALS Screen (ECAS) assesses cognitive and behavioral changes in people with (ALS) through a 136-point test covering language, verbal fluency, executive function, memory, and visuospatial cognitive domains. A lower score indicates worsening of symptoms.
Time frame: up to 52 weeks
Changes from baseline in neurofilament light biomarker (NfL)
To assess the effect of SGP302 on NfL, a biomarker of neurodegeneration. A higher level of this biomarker indicates a progression of this disease.
Time frame: up to 52 weeks.
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Amyotrophic Lateral Sclerosis→
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