NCT04626921

A Multi-Center, Open-Label Long-Term Extension Study of CNM-Au8 In Patients With Stable Relapsing Multiple Sclerosis

VISIONARY-MS LTE: A Multi-Center, Open-Label Long-Term Extension Study Assessing the Safety, Efficacy, Tolerability, and Pharmacokinetics of CNM-Au8 In Patients With Stable Relapsing Multiple Sclerosis

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Clene Nanomedicine · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

Open-label, long-term extension study available to participants who have completed CNMAu8.201.

Detailed description

This open-label, long-term extension study is only available to participants who have completed CNMAu8.201 (VISIONARY-MS). The Week 48/End-of-Study Visit for study CNMAu8.201 (VISIONARY-MS) will serve to establish the Baseline for electrophysiological, functional, morphological vision testing, as well as the neurological and outcome assessments. Participants will receive open-label CNM-Au8 throughout the study. All participants will receive a daily dose of 30 mg CNM-Au8 for the entire open-label, long-term extension study. The dose for participants may be adjusted once efficacy and safety data from study CNMAu8.201 becomes available, which may occur after participants have already started this study. Based upon a review of data and Sponsor or PI recommendation, this open-label, long-term extension study may be discontinued once each participant reaches her/his 48-week visit.

Conditions

• Relapsing Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	CNM-Au8	30 mg of CNM-Au8

Timeline

• Start date: 2020-10-22
• Primary completion: 2023-05-29
• Completion: 2023-09-06
• First posted: 2020-11-13
• Last updated: 2023-12-08

Locations

5 sites across 1 country: Australia

Regulatory

• FDA-regulated drug study