A Multicenter, Open-label Extension Study to Investigate the Long-term Safety of FAB122 in Patients With Amyotrophic Lateral Sclerosis
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Ferrer Internacional S.A.
- Enrollment
- 201
- Locations
- 1
- Primary Endpoint
- Number of Participants Experiencing Treatment Emergent Adverse Events
Study Overview
Brief Summary
A multicenter, open-label extension study to investigate the long-term safety of FAB122 in patients with Amyotrophic Lateral Sclerosis
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
All subjects were treated with FAB122 in ADOREXT study, arms from parent study ADORE have been analyzed.
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
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).
Intervention: FAB122 (Drug)
Placebo
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).
Intervention: FAB122 (Drug)
Outcomes
Primary Outcomes
Number of Participants Experiencing Treatment Emergent Adverse Events
Time Frame: 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 Outcomes
- 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)