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

NCT05866926 | Terminated Phase 3 Results

• 1 other identifier: FAB122-CT-2201
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants Experiencing Treatment Emergent Adverse Events

  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.

  approximately 44 weeks

Secondary Outcomes (1)

• 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

Study Arms (2)

FAB122

EXPERIMENTAL

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).

Drug: FAB122

Placebo

EXPERIMENTAL

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).

Drug: FAB122

Interventions

FAB122 DRUG

FAB122 Daily dose 100 mg

FAB122; Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• who completed the full study period in the main ADORE study (FAB122-CT-2001);
• whom the investigator has no concern and judges tolerable for initiating or continuing treatment with FAB122 from a risk and benefit point of view;
• 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
• 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

You may not qualify if:

• 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.
• Patient who discontinued study drug prematurely in the double-blind phase of the study (ADORE Study) for safety reasons.
• 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

Sponsors & Collaborators

• Ferrer Internacional S.A.: lead

Study Sites (1)

Hospital Universitari de Bellvitge

Barcelona, Spain

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Clinical Operations Head
• Organization: Ferrer

nalbareda@ferrer.com

649442389

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: All subjects were treated with FAB122 in ADOREXT study, arms from parent study ADORE have been analyzed.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: For ADOREXT study, arms from parent study ADORE have been analyzed. Data presented for the FAB122 study group correspond to subjects receiving FAB122 in the ADORE study as well as the ADOREXT study (FAB122-FAB122). Data presented for the placebo study group correspond to subjects receiving placebo in the ADORE study and FAB122 in the ADOREXT study (placebo-FAB122).

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: May 19, 2023
• Study Start: March 6, 2023
• Primary Completion: January 9, 2024
• Study Completion: February 22, 2024
• Last Updated: March 4, 2025
• Results First Posted: March 4, 2025

Record last verified: 2025-02

Locations

ES (1)