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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-19

Study Completion Date

2022-02-15

Brief Summary

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

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Detailed Description

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

Conditions

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Amyotrophic Lateral Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cu(II)ATSM

copper-containing synthetic small molecule

Group Type EXPERIMENTAL

Cu(II)ATSM

Intervention Type DRUG

cooper-containing synthetic small molecule

Interventions

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Cu(II)ATSM

cooper-containing synthetic small molecule

Intervention Type DRUG

Other Intervention Names

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diacetylbis(N(4)-methylthiosemicarbazonato) copper(II)

Eligibility Criteria

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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