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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05866926
Other study ID # FAB122-CT-2201
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


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
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