Intermediate-size Patient Population Expanded Access Protocol
ConditionALS (Amyotrophic Lateral Sclerosis)
Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age18-85
SponsorSpinogenix
About this trial
The purpose of this Expanded Access Program is to provide tazbentetol 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 tazbentelol.
Eligibility criteria
Qualifiers
ALS diagnosis
Age 18 -85 years at time of signing informed consent form
Ineligible for other interventional ALS clinical research participation
Vital Capacity greater than 35% of predicted capacity for age, height, and sex
Disqualifiers
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
Trial design
Treatments tested in this trial
- Tazbentetol
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov