Study to Investigate the Long-term Safety of FAB122 in Patients With Amyotrophic Lateral Sclerosis (ADOREXT)

Ferrer

Status and phase: Terminated; Phase 3

Conditions: Amyotrophic Lateral Sclerosis

Treatments: Drug: FAB122

Study type: Interventional

Funder types: Industry

Identifiers

NCT05866926

FAB122-CT-2201

Details and patient eligibility

About

A multicenter, open-label extension study to investigate the long-term safety of FAB122 in patients with Amyotrophic Lateral Sclerosis

Enrollment: 201 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. who completed the full study period in the main ADORE study (FAB122-CT-2001);

2. whom the investigator has no concern and judges tolerable for initiating or continuing treatment with FAB122 from a risk and benefit point of view;

3. a female subject should not be able to become pregnant up to 30 days after the last dose of FAB122 and needs to meet at least one of the following criteria:

   • female who is of reproductive potential and has a negative pregnancy test at baseline and is non-lactating.
   • female subject who is not of reproductive potential is eligible without requiring the use of contraception

4. a male patient must:

   • agree he will not donate sperm during the period he will be using FAB122, AND use a condom during sexual intercourse with pregnant or non-pregnant women of childbearing potential

Exclusion criteria

1. Patient who has a medical condition or personal circumstances which, in the opinion of the investigator, will make initiation or continuation of treatment with FAB122 not tolerable for them from a risk and benefit point of view.
2. Patient who discontinued study drug prematurely in the double-blind phase of the study (ADORE Study) for safety reasons.
3. Patient who has received any other investigational drug within the period between last visit of the main study and first visit of the extension study

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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201 participants in 2 patient groups

FAB122

Experimental group

Description:

Drug: FAB122 Daily dose 100 mg Data presented for the FAB122 study group correspond to subjects receiving FAB122 in the ADORE study as well as the ADOREXT study (FAB122-FAB122).

Treatment:

Drug: FAB122

Placebo

Experimental group

Description:

Drug: FAB122 Daily dose 100 mg Data presented for the placebo study group correspond to subjects receiving placebo in the ADORE study and FAB122in the ADOREXT study (placebo-FAB122).

Treatment:

Drug: FAB122