Intermediate Expanded Access Protocol for ALS

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2024
• Main ID: NCT04081714
• Date of registration: 05/09/2019
• Prospective Registration: Yes
• Primary sponsor: Clene Nanomedicine
• Public title: Intermediate Expanded Access Protocol for ALS
• Scientific title: An Intermediate Expanded Access Protocol for Amyotrophic Lateral Sclerosis With CNM-Au8
• Date of first enrolment: September 30, 2019
• Recruitment status: Available
• URL: https://clinicaltrials.gov/ct2/show/NCT04081714
• Study type: Expanded Access

Countries of recruitment

United States

Contacts

• Name: Austin Rynders, BS

• Name: Mary McCormack, RN

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Able to understand and give written informed consent.

2. Male or female participants aged 18 years or greater (inclusive) at the time of ALS
diagnosis.

3. Participants whose conditions are defined as "definite ALS" or "probable ALS" or
"possible ALS" diagnostic criteria by the revised El Escorial Criteria as determined
by a neurologist specializing in ALS (e.g., the Principal Investigator or
subinvestigator at the site).

4. Participant is able to daily consume 60 mL of the investigational drug suspension
without substantial dysphagia, OR can intake the drug through a gastrostomy tube.

5. In the judgement of the Investigator, the participant's expected survival is greater
than six- months.

6. Participants who have established care with a neurologist at the specialized ALS
center involved in the study and will maintain this clinical care throughout the
duration of the EAP.

Exclusion Criteria:

1. Participant is eligible for a clinical study with CNM-Au8 for the treatment of ALS.

2. Participant with a history of any clinically significant or unstable medical condition
based on the Investigator's judgment that may interfere with assessment of the study
objectives.

3. Based on the investigator's judgment, participants who may have difficulty complying
with the protocol and/or any study procedures.

4. Participant with clinically significant abnormalities in hematology, blood chemistry,
ECG, or physical examination not resolved by the Baseline visit which according to
Investigator can interfere with EAP participation1.

5. Participants with clinically significant hepatic or renal dysfunction or clinical
laboratory findings that would limit the interpretability of change in liver or kidney
function, or those with low platelet counts (< 150 x 109 per liter) or eosinophilia
(absolute eosinophil count of = 500 eosinophils per microliter) at Screening.

6. Participants with a prior history of, or positive serological assay for the presence
of HIV infection, or laboratory evidence of active or chronic infection with hepatitis
C (HCV) or hepatitis B (HBV). Note, participants who have been vaccinated for HBV and
have detectable HB antibodies are not excluded unless positive for surface antigen
(HBsAg).

7. Participant has participated in any other investigational drug trial (within 4-weeks
prior to screening or at least five-half lives of the investigational product), unless
waived at the discretion of the Sponsor (e.g., for other investigational drug trials
with no known interaction with CNM-Au8).

8. Females who are pregnant or nursing or who plan to get pregnant during the course of
this clinical trial or within 6 months of the end of this trial.

9. Females of child-bearing potential, or men, who are unwilling or unable to use
accepted methods of birth control.

10. History of gold allergy.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Amyotrophic Lateral Sclerosis

Intervention(s)

Drug: CNM-Au8

Secondary ID(s)

CNMAu8.EAP01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Massachusetts General Hospital