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Extension Study of Participants From SPG302-ALS-001

NCT ID: NCT06903286

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-29

Study Completion Date

2025-08-31

Brief Summary

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

Detailed Description

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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

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Amyotrophic Lateral Sclerosis (ALS)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open Label extension
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

None (Open Label)

Study Groups

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Experimental: Open Label Extension

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.

Group Type EXPERIMENTAL

SPG302

Intervention Type DRUG

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

Interventions

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SPG302

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Spinogenix

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Macquarie University

North Ryde, New South Wales, Australia

Site Status

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

Site Status

Flinders Medical Center

Adelaide, South Australia, Australia

Site Status

Countries

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Australia

Other Identifiers

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SPG302-ALS-002 OLE

Identifier Type: -

Identifier Source: org_study_id