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

NCT ID: NCT05866926

Last Updated: 2025-03-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 201 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-06
• Study Completion Date: 2024-02-22

Brief Summary

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

Conditions

Amyotrophic Lateral Sclerosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FAB122

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).

Group Type: EXPERIMENTAL

FAB122

Intervention Type: DRUG

FAB122 Daily dose 100 mg

Placebo

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).

Group Type: EXPERIMENTAL

FAB122

Intervention Type: DRUG

FAB122 Daily dose 100 mg

Interventions

FAB122

FAB122 Daily dose 100 mg

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ferrer Internacional S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Universitari de Bellvitge

Barcelona, , Spain

Countries

Spain

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

FAB122-CT-2201

Identifier Type: -

Identifier Source: org_study_id