NCT05299658

An Open-Label Extension for the Phase 2 Study in Early Symptomatic Amyotrophic Lateral Sclerosis Patients on Stable Background Therapy to Assess Bioenergetic Catalysis With CNM-Au8 to Slow Disease Progression in ALS

An Open-Label Extension for the Phase 2, Randomised, Double-Blind, Placebo-Controlled Study in Early Symptomatic Amyotrophic Lateral Sclerosis Patients on Stable Background Therapy to Assess Bioenergetic Catalysis With CNM-Au8 to Slow Disease Progression in ALS

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Clene Nanomedicine · Industry
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is an optional open-label extension to participants that have completed the clinical trial CNMAu8.205.

Detailed description

A forty-eight (48) week optional open-label extension period (Open- Label Period), which may be extended by 12-week increments until discontinued by the Sponsor for participants that have completed protocol CNMAu8.205.

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
DRUG	CNMAu8	CNM-Au8 is an aqueous suspension of clean surfaced faceted nanocrystals consisting of gold atoms self-organized into crystals of various geometrical shapes (hexagonal bi-pyramid, pentagonal bi-pyramid, tetrahedron, decahedron, planar spheroids). Those choosing to participate in the OLE period will orally receive 30 mg of CNM-Au8, once daily.

Timeline

• Start date: 2021-11-13
• Primary completion: 2026-06-01
• Completion: 2026-08-01
• First posted: 2022-03-29
• Last updated: 2025-12-19

Locations

2 sites across 1 country: Australia

Regulatory

• FDA-regulated drug study