Amyotrophic Lateral Sclerosis (ALS)Phase 2NCT06903286
Extension Study of Participants From SPG302-ALS-001
A Phase 2 study testing SPG302 in people with Amyotrophic Lateral Sclerosis (ALS), run by Spinogenix at 3 sites in Australia.
Trial summary
This study will evaluate the long-term safety and efficacy of participants enrolled in SPG302-ALS-101 with Amyotrophic Lateral Sclerosis (ALS) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis (ALS)
- What is being tested?
- SPG302
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 3 sitesAustralia
- Study dates
- 29 May 2025to 31 Aug 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have participated in all study activities of SPG302-ALS-001, the parent study
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
Flinders Medical Center
Adelaide, South Australia, 5042
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029
Macquarie University
North Ryde, New South Wales, 2109
About this study
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
This study will evaluate the long-term safety and efficacy of participants enrolled in SPG302-ALS-101 with Amyotrophic Lateral Sclerosis (ALS)
Read the 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.
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Being tested
- SPG302
- Keywords
- Amyotrophic Lateral Sclerosis, regenerative, synapse
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPG302Drug
Open label SPG302 to be self-administered daily by eligible participants for 52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: SPG302 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment emergent adverse events and serious adverse events
Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Measured: 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
Measured: Up to 52 weeks
Secondary outcomes (3)
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
Measured: 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.
Measured: 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.
Measured: up to 52 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start29 May 2025
- Primary completion30 Jun 2025
- Study completion31 Aug 2025
Why it stopped: patients treated through compassionate use program
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral Sclerosis (ALS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open Label extension
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spinogenix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06903286
- Sponsor's protocol ID
- SPG302-ALS-002 OLE
- Status last verified
- Dec 2025
- First submitted
- 24 Mar 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06903286
- Acronym / sponsor ID
- SPG302-ALS-002 OLE
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Keywords
- Amyotrophic Lateral Sclerosis, regenerative, synapse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: patients treated through compassionate use program
- Enrolment
- 16 participants (actual)
- Lead sponsor
- SpinogenixIndustry (pharma, biotech, devices)
- Study start
- 29 May 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 30 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the long-term safety and efficacy of participants enrolled in SPG302-ALS-101 with Amyotrophic Lateral Sclerosis (ALS)
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open Label extension
| Arm | Type | Receives |
|---|---|---|
| Experimental: Open Label Extension | Experimental | Drug: SPG302Active SPG302 to be administered to adult participants with ALS who completed initial study. Dose to be administered to be dose received during previous study. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Must have participated in all study activities of SPG302-ALS-001, the parent study
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPG302Open label SPG302 to be self-administered daily by eligible participants for 52 weeks. | Drug | Experimental: Open Label Extension |
Primary outcome
Treatment emergent adverse events and serious adverse events
Time frame: Up to 52 weeks
Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
C-SSRS (Columbia Suicide Severity Rating Scale)
Time frame: Up to 52 weeks
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
3 secondary outcomes
Change in the Amyotrophic Lateral Sclerosis Functional Rating Scale-revised (ALSFRS-R) scores
Time frame: up to 52 weeks
Change in Edinburgh Cognitive and Behavioural ALS Screen (ECAS)
Time frame: up to 52 weeks
Changes from baseline in neurofilament light biomarker (NfL)
Time frame: up to 52 weeks.
Results and safety
The study was stopped early (reason given: patients treated through compassionate use program). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SPG302 in people with Amyotrophic Lateral Sclerosis (ALS), run by Spinogenix at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: patients treated through compassionate use program). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment emergent adverse events and serious adverse events (time frame: Up to 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.