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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

November 13, 2021

Primary Completion Date

June 30, 2025

Study Completion Date

August 31, 2025

Conditions
Amyotrophic Lateral Sclerosis
Interventions
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.

Trial Locations (2)

2031

Neuroscience Research Australia, Randwick

2139

Concord Hospital, Concord

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Clene Nanomedicine

INDUSTRY

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 | Biotech Hunter | Biotech Hunter