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

Phase 3

Terminated

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Drug: FAB122

• Registration Number: NCT05866926
• Lead Sponsor: Ferrer Internacional S.A.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-06
• Study First Submitted: 2023-05-10
• Study First Submitted QC: 2023-05-10
• Study First Posted: 2023-05-19
• Primary Completion: 2024-01-09
• Study Completion: 2024-02-22
• Results First Submitted: 2025-01-09
• Status Verified: 2025-02
• Results First Submitted QC: 2025-02-25
• Last Update Submitted: 2025-02-25
• Results First Posted: 2025-03-04
• Last Update Posted: 2025-03-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 201

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	FAB122	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).
FAB122	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).

Primary Outcome Measures

Name	Time	Method
Number of Participants Experiencing Treatment Emergent Adverse Events	approximately 44 weeks	To evaluate the long-term safety of FAB122 in patients with ALS by assessing Number of Participants experiencing Treatment Emergent Adverse Events, evaluating nature and severity.; The study duration for these subjects, and therefore the duration of FAB122 treatment, was variable depending on the subject's start date, ranging from 3 to approximately 44 weeks.

Secondary Outcome Measures

Name	Time	Method
The Secondary Efficacy Objective to Evaluate the Effect of Treatment With FAB122 Based on Change From Baseline in ALSFRS-R Until End of Study	45 weeks	Change from baseline in ALSFRS-R total score until the end of the study. Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R), Maximum value is 48 points and represents better outcome. Minimum value is 0 and represents worse outcome.

Trial Locations

Locations (1)

Hospital Universitari de Bellvitge; 🇪🇸 Barcelona, Spain