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

Amyotrophic Lateral Sclerosis Clinical Trial

— ADOREXT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05866926
• Other study ID #: FAB122-CT-2201
• Status: Terminated
• Phase: Phase 3
• Start date: March 6, 2023
• Est. completion date: February 22, 2024

Study information

• Verified date: May 2023
• Source: Ferrer Internacional S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 206
• Est. completion date: February 22, 2024
• Est. primary completion date: January 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Drug:
• FAB122
FAB122 Daily dose 100 mg

Locations

Country	Name	City	State
Spain	Hospital Universitari de Bellvitge	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Ferrer Internacional S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nature, frequency and severity of Treatment Emergent Adverse Events.		3 years