Extension Study of Participants From SPG302-ALS-001

Spinogenix

Status and phase: Begins enrollment this month; Phase 2

Conditions: Amyotrophic Lateral Sclerosis (ALS)

Treatments: Drug: SPG302

Study type: Interventional

Funder types: Industry

Identifiers

NCT06903286

SPG302-ALS-002 OLE

Details and patient eligibility

About

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

Full 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.

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Experimental: Open Label Extension

Experimental group

Description:

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.

Treatment:

Drug: SPG302