- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06408727
Intermediate Expanded Access Protocol CNMAu8.EAP04
May 13, 2024 updated by: Clene Nanomedicine
An Intermediate Expanded Access Protocol With CNM-Au8 for Amyotrophic Lateral Sclerosis for NIH Grant RFA-NS-23-012
An Intermediate Expanded Access Protocol (EAP) with CNM-Au8 for Amyotrophic Lateral Sclerosis for NIH Grant RFA-NS-23-012
Study Overview
Status
Available
Conditions
Intervention / Treatment
Detailed Description
An Intermediate Expanded Access Protocol (EAP) with CNM-Au8 for Amyotrophic Lateral Sclerosis for NIH Grant RFA-NS-23-012.
The primary objective of this intermediate EAP is to provide access to the investigational product, CNM-Au8 30mg, for up to 180 people living with ALS.
Study Type
Expanded Access
Expanded Access Type
- Treatment IND/Protocol
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Description
Inclusion Criteria:
- Able to understand and give written informed consent.
- Male or female participants aged 18 years or greater (inclusive) at the time of informed consent completion.
- Participants with a confirmed diagnosis of ALS per Gold Coast criteria as determined by a neurologist specializing in ALS (e.g., the site principal investigator or sub-investigator for this study).
- Participant is able to daily consume up to 60 mL of the investigational drug suspension without substantial dysphagia, OR can intake the investigational product through a feeding tube.
- Participant must have completed standard clinical safety labs within the prior 90 days from the Baseline visit, including a chemistry panel (e.g., CMP) and a hematology panel (e.g., CBC).
- Participant has a baseline score by the TRICALS risk calculator that is less than -2 (i.e., participant is not at increased risk of early death; https://tricals.shinyapps.io/risk-profile/).
Participant meets the following criteria:
- Baseline Vital Capacity >15% predicted,
- Baseline ALSFRS-R Score >8, and,
- Baseline BMI >17.5 kg/m2
- Participants have established care with a neurologist at the specialized ALS center or remotely enrolling site involved in the study and will maintain this clinical care throughout the duration of the EAP within the United States.
Exclusion Criteria:
- Participant is eligible for participation in any double-blind placebo-controlled study the treatment of ALS at the same research site.
- Participant has a history of any clinically significant or unstable medical condition (other than ALS) 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, including but not limited to: (i) ALT or AST ≥ 3 times upper limits of normal, (ii) direct (conjugated) with bilirubin ≥2 times upper limits of normal, (iii) low platelet counts (< 150 x 109 per liter) or eosinophilia (absolute eosinophil count of ≥ 500 eosinophils per microliter), (iv) serum creatinine >1.2 mg/dL, or (v) eGFR < 45 ml/min per 1.73 m2.
- 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 below).
- Females who are pregnant or nursing or who plan to get pregnant during the EAP, or within 6 months of the end of this trial.
- Females of child-bearing potential, or men, who are unwilling or unable to use accepted methods of birth control.
- History of gold allergy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
April 24, 2024
First Submitted That Met QC Criteria
May 9, 2024
First Posted (Actual)
May 10, 2024
Study Record Updates
Last Update Posted (Actual)
May 16, 2024
Last Update Submitted That Met QC Criteria
May 13, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CNMAu8.EAP04
- 1U01NS136023-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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