Intermediate-size Patient Population Expanded Access Protocol

Spinogenix

Status

Conditions: ALS (Amyotrophic Lateral Sclerosis)

Treatments: Drug: SPG302

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT07088159

SPG302-ALS-ISEAP

Details and patient eligibility

About

The purpose of this Expanded Access Program is to provide SPG302 to ALS patients who are not eligible to enroll in an ALS clinical trial. This Expanded Access Program will assess safety and tolerability, and clinical efficacy of SPG302.

Full description

This is a multi-site, intermediate-size patient population expanded access protocol developed to provide compassionate use access to SPG302 to adult patients with ALS who have progressed following available standard of care.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ALS diagnosis
• Age 18 -80 years at time of signing informed consent form
• Ineligible for other interventional ALS clinical research participation
• Vital Capacity less than 50% of predicted capacity for age, height, and sex
• If currently taking standard of care treatment for ALS, must be on stable dose for at least 30 days prior to taking SPG302.
• Life expectancy of at least 6 months, according to Investigator's judgement

Exclusion criteria

• Clinically significant and/or unstable medical condition (other than ALS) that would pose a risk to the patient
• Known ongoing or clinically uncontrolled cardiac disease
• Clinically significant liver disease
• Clinical significant cognitive impairment or neurological disorder, as determined by Investigator judgement
• Concomitant use of another investigational medical product for treatment of ALS
• Unable to reliably and regularly swallow whole oral medications on a daily basis