Treatment Continuation Study for Patients With ALS/MND Who Completed Study CMD-2019-001

Collaborative Medicinal Development

Status and phase: Completed; Phase 2

Conditions: Amyotrophic Lateral Sclerosis

Treatments: Drug: Cu(II)ATSM

Study type: Interventional

Funder types: Industry

Identifiers

NCT04313166

CMD-2020-001

Details and patient eligibility

About

Provides up to six months treatment with CuATSM for subjects who have successfully completed study CMD-2019-001

Full description

Provides up to six months treatment with CuATSM for subjects who have successffulyl completed study CMD-2019-001. [This allows subjects randomized to placebo on study CMD-2019-001 to receive up to six months treatment with CuATSM and provides an up to an additional six months treatment with CuATSM for subjects randomized to CuATSM on study CMD-2019-001]

Enrollment: 55 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• signed informed consent prior to initiation of any study-specific procedures and treatment
• documented completion of protocol-specified assessments following completion of 24 weeks treatment on study CMD-2019-002
• Investigator considers patient has been tolerating treatment on study CMD-2019-001 and may benefit from continued treatment with CuATSM

Exclusion criteria

• not dependent on mechanical ventilation

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

Cu(II)ATSM

Experimental group

Description:

copper-containing synthetic small molecule

Treatment:

Drug: Cu(II)ATSM