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

• ClinicalTrials.gov Identifier: NCT05866926
• Recruitment Status: Terminated
• First Posted: May 19, 2023
• Last Update Posted: February 28, 2024
• Sponsor: Ferrer Internacional S.A.
• Information provided by (Responsible Party): Ferrer Internacional S.A.

Tracking Information

• First Submitted Date: May 10, 2023
• First Posted Date: May 19, 2023
• Last Update Posted Date: February 28, 2024
• Actual Study Start Date: March 6, 2023
• Actual Primary Completion Date: January 9, 2024 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 10, 2023): Nature, frequency and severity of Treatment Emergent Adverse Events. [ Time Frame: 3 years ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study to Investigate the Long-term Safety of FAB122 in Patients With Amyotrophic Lateral Sclerosis
• Official Title: A Multicenter, Open-label Extension Study to Investigate the Long-term Safety of FAB122 in Patients With Amyotrophic Lateral Sclerosis
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Amyotrophic Lateral Sclerosis

Intervention

Drug: FAB122

FAB122 Daily dose 100 mg

Study Arms

Experimental: Open Label

Drug: FAB122 Daily dose 100 mg

Intervention: Drug: FAB122

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: February 13, 2024): 206
• Original Estimated Enrollment (submitted: May 10, 2023): 225
• Actual Study Completion Date: February 22, 2024
• Actual Primary Completion Date: January 9, 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT05866926
• Other Study ID Numbers: FAB122-CT-2201
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Ferrer Internacional S.A.
• Original Responsible Party: Same as current
• Current Study Sponsor: Ferrer Internacional S.A.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Ferrer Internacional S.A.
• Verification Date: May 2023