Amyotrophic Lateral SclerosisPhase 3ADOREXTNCT05866926
Study to Investigate the Long-term Safety of FAB122 in Patients With Amyotrophic Lateral Sclerosis
A Phase 3 study testing FAB122 in people with Amyotrophic Lateral Sclerosis, run by Ferrer Internacional S.A. at 1 site in Spain.
Trial summary
A multicenter, open-label extension study to investigate the long-term safety of FAB122 in patients with Amyotrophic Lateral Sclerosis Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- FAB122
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteSpain
- Study dates
- 6 Mar 2023to 22 Feb 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Open-label Extension Study to Investigate the Long-term Safety of FAB122 in Patients With Amyotrophic Lateral Sclerosis
A multicenter, open-label extension study to investigate the long-term safety of FAB122 in patients with Amyotrophic Lateral Sclerosis
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- FAB122
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAB122Drug
FAB122 Daily dose 100 mg
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Drug: FAB122 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Change from baseline in ALSFRS-R total score until the end of the study. Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R), Maximum value is 48 points and represents better outcome. Minimum value is 0 and represents worse outcome.
Measured: 45 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start6 Mar 2023
- Primary completion9 Jan 2024
- Study completion22 Feb 2024
Why it stopped: After the analysis of the main ADORE study it is concluded that there is no clinical benefit for the patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferrer Internacional S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866926
- Sponsor's protocol ID
- FAB122-CT-2201
- Acronym
- ADOREXT
- Status last verified
- Feb 2025
- First submitted
- 10 May 2023
- Last updated
- 4 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label Extension Study to Investigate the Long-term Safety of FAB122 in Patients With Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT05866926
- Acronym / sponsor ID
- ADOREXT / FAB122-CT-2201
- Conditions
- Amyotrophic Lateral Sclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After the analysis of the main ADORE study it is concluded that there is no clinical benefit for the patients.
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Ferrer Internacional S.A.Industry (pharma, biotech, devices)
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 9 Jan 2024 (actual)
- Study completion
- 22 Feb 2024 (actual)
- First posted
- 19 May 2023 (actual)
- Results
- Posted 4 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter, open-label extension study to investigate the long-term safety of FAB122 in patients with Amyotrophic Lateral Sclerosis
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| FAB122 | Experimental | Drug: FAB122Drug: 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). |
| Placebo | Experimental | Drug: FAB122Drug: 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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- a male patient must:
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FAB122FAB122 Daily dose 100 mg | Drug | FAB122, Placebo |
Primary outcome
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.
1 secondary outcome
The Secondary Efficacy Objective to Evaluate the Effect of Treatment With FAB122 Based on Change From Baseline in ALSFRS-R Until End of Study
Time frame: 45 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FAB122 in people with Amyotrophic Lateral Sclerosis, run by Ferrer Internacional S.A. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing Treatment Emergent Adverse Events (time frame: approximately 44 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.