ADOREXT: A Multicenter, Open-label Extension Study to Investigate the Long-term Safety of FAB122 in Patients With Amyotrophic Lateral Sclerosis

• Sponsor: Ferrer Internacional S.A. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05866926
• Collaborator: (none)
• Enrollment: 225
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 39.8
• Patients Per Site Per Month: 5.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Amyotrophic Lateral Sclerosis	Drug: FAB122	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 225 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Open-label Extension Study to Investigate the Long-term Safety of FAB122 in Patients With Amyotrophic Lateral Sclerosis
• Actual Study Start Date: Mar 6, 2023
• Anticipated Primary Completion Date: Jun 30, 2026
• Anticipated Study Completion Date: Jun 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Open Label Drug: FAB122 Daily dose 100 mg	Drug: FAB122; FAB122 Daily dose 100 mg

Outcome Measures

Primary Outcome Measures

1. Nature, frequency and severity of Treatment Emergent Adverse Events. [3 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitari de Bellvitge	Barcelona		Spain

Sponsors and Collaborators

• Ferrer Internacional S.A.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ferrer Internacional S.A.
• ClinicalTrials.gov Identifier: NCT05866926
• Other Study ID Numbers: FAB122-CT-2201
• First Posted: May 19, 2023
• Last Update Posted: May 19, 2023
• Last Verified: May 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis

Study Results

No Results Posted as of May 19, 2023