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An Intermediate Expanded Access Protocol with CNM-Au8for Amyotrophic Lateral Sclerosis for NIH Grant RFA-NS-23-012
The main purpose of this research study is to provide access to the investigational product, CNM-Au8 at a dose of 30mg per day, to up to 180 people living with ALS. The study wants to find out if CNM-Au8 is safe to take without causing too many side effects and can help people with ALS.
Participants will have a visit to see if they qualify to participate. Following this visit, they will return to the clinic for visits every 12 weeks and these visits will continue in 144-week periods until the treatment plan is discontinued. Participants will have one last visit 4 weeks after their last dose of the investigational medicine.
Yes
Neurology (HERSHEY)
All
18 year(s) or older
NCT06408727
STUDY00025011
Inclusion Criteria:
Able to understand and give written informed consentMale or female aged 18 years or greater at time of ALS diagnosis
Participants with a confirmed diagnosis of ALS as determined by a neurologist specializing in ALS
Participant is able to consume up to 240mL of investigational drug without substantial dsyhpagia or can take the investigational drug through a gastronomy tube
Exclusion Criteria:
Participant is eligible for any other interventional ALS drug clinical trialParticipant has a history of clinical significant or unstable medical condition that may interfere with assessment of safety or compromise the study objectives
Based on the investigator’s judgment, participants who may have difficulty complying with the protocol and/or any study procedures.
Within the prior 90-days the participant has had clinically significant findings on standard hepatic, hematologic, or renal safety assays.
Participant is currently involved in another placebo-controlled clinical trial (note: concomitant therapy with other investigational products is permitted with certain restrictions—see concomitant medications section below).
Neurology
Not applicable