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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05866926
Recruitment Status : Terminated (After the analysis of the main ADORE study it is concluded that there is no clinical benefit for the patients.)
First Posted : May 19, 2023
Last Update Posted : February 28, 2024
Sponsor:
Information provided by (Responsible Party):
Ferrer Internacional S.A.

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

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Drug: FAB122 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 206 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label Extension Study to Investigate the Long-term Safety of FAB122 in Patients With Amyotrophic Lateral Sclerosis
Actual Study Start Date : March 6, 2023
Actual Primary Completion Date : January 9, 2024
Actual Study Completion Date : February 22, 2024

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Open Label
Drug: FAB122 Daily dose 100 mg
 Drug: FAB122
FAB122 Daily dose 100 mg


Outcome Measures
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Primary Outcome Measures :
  1. Nature, frequency and severity of Treatment Emergent Adverse Events. [ Time Frame: 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05866926


Locations
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Spain
Hospital Universitari de Bellvitge
Barcelona, Spain
Sponsors and Collaborators
Ferrer Internacional S.A.
More Information
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Responsible Party: Ferrer Internacional S.A.
ClinicalTrials.gov Identifier: NCT05866926    
Other Study ID Numbers: FAB122-CT-2201
First Posted: May 19, 2023    Key Record Dates
Last Update Posted: February 28, 2024
Last Verified: May 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
 Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases