Intermediate Expanded Access Protocol CNMAu8.EAP03
- Conditions
- Multiple Sclerosis
- Registration Number
- NCT04081714
- Lead Sponsor
- Clene Nanomedicine
- Brief Summary
This is a single-center intermediate expanded access program to provide access to the investigational product, CNM-Au8, up to 25 participants diagnosed with Multiple Sclerosis.
- Detailed Description
This is an intermediate expanded access program to provide access to the investigational product, CNM-Au8, for up to 25 participants. All participants will receive open label treatment with CNM-Au8 30 mg orally.
The safety and efficacy of CNM-Au8 treatment in MS participants will be evaluated. Scheduled visits will occur at the baseline visit, week 6 visit, week 12, and then every 12-weeks thereafter at the participating clinic(s). Optional remote data collection via telemedicine and/or home healthcare visits are permitted commencing with the week 12 visit. Clinical safety laboratory monitoring including urinalysis, a chemistry panel (e.g., CMP) and a hematology panel (e.g., CBC) will be conducted at the screening/baseline visit and at each scheduled visit incorporating safety laboratory assessments.
Participants who meet the inclusion criteria and none of the exclusionary criteria may be enrolled into the EAP.
The program and participant visits will continue for a total of 96-weeks of treatment. Four weeks following treatment discontinuation, a safety follow-up visit will be conducted.
Investigational product may be shipped by the site to participants who do not attend an in-clinic visit.
The EAP may be discontinued at the Sponsor's sole discretion if: (i) there is insufficient funding to maintain the EAP, (ii) the Sponsor is unable to produce sufficient supply of the investigational product to meet clinical trial obligations, (iii) CNM-Au8 receives marketing authorization within the United States, or (iv) continued support of the EAP risks further clinical development of CNM-Au8.
Recruitment & Eligibility
- Status
- AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Texas Southwestern
🇺🇸Dallas, Texas, United States