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Intermediate Expanded Access Protocol for ALS

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ClinicalTrials.gov Identifier: NCT04081714
Expanded Access Status : Available
First Posted : September 9, 2019
Last Update Posted : September 9, 2019
Sponsor:
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
Clene Nanomedicine

Tracking Information
First Submitted Date September 5, 2019
First Posted Date September 9, 2019
Last Update Posted Date September 9, 2019
 
Descriptive Information
Brief Title Intermediate Expanded Access Protocol for ALS
Brief Summary This is a single-center intermediate expanded access program to provide access to the investigational product, CNM-Au8, up to twenty participants diagnosed with ALS who are otherwise ineligible for participation in clinical studies with CNM-Au8.
Detailed Description This is a single-center intermediate expanded access program to provide access to the investigational product, CNM-Au8, up to twenty participants diagnosed with ALS. Safety, pharmacokinetics, and pharmacodynamics of CNM-Au8 treatment in ALS participants will be evaluated. Visits will occur at Massachusetts General Hospital or via tele-visit. Participants will be screened over up to a 4-week period prior to treatment initiation. Participants who meet the inclusion criteria and none of the exclusionary criteria may be enrolled into the EAP. Per protocol all participants will receive open label oral treatment daily up to 24-weeks during Treatment Period 1.
Study Type Expanded Access
Expanded Access Type Intermediate-size Population
Intervention Drug: CNM-Au8
CNM-Au8 is a dark red/purple-colored liquid formulation consisting of a stable suspension of faceted clean surfaced elemental gold nanocrystals in buffered USP water with a concentration of up to 0.5 mg/mL of gold. The formulation is buffered by sodium bicarbonate present at a concentration of 0.546 mg/mL. There are no other excipients. The drug product is formulated to be taken orally and will be provided in single dose HDPE containers.
Other Name: Nanocrystalline gold
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status Available
Contacts
Contact: Robert Glanzman, MD +1 (801) 676-9695 info@clene.com
Contact: Austin Rynders, BS +1 (801) 676-9695 info@clene.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04081714
Responsible Party Clene Nanomedicine
Study Sponsor Clene Nanomedicine
Collaborators Massachusetts General Hospital
Investigators Not Provided
PRS Account Clene Nanomedicine
Verification Date September 2019