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A Multicenter, Open-label Extension Study to Investigate the Long-term Safety of FAB122 in Patients With Amyotrophic Lateral Sclerosis (ADOREXT)

Primary Purpose

Amyotrophic Lateral Sclerosis

Status
Recruiting
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
FAB122
Sponsored by
Ferrer Internacional S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitari de BellvitgeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open Label

Arm Description

Drug: FAB122 Daily dose 100 mg

Outcomes

Primary Outcome Measures

Nature, frequency and severity of Treatment Emergent Adverse Events.

Secondary Outcome Measures

Full Information

First Posted
May 10, 2023
Last Updated
May 10, 2023
Sponsor
Ferrer Internacional S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT05866926
Brief Title
A Multicenter, Open-label Extension Study to Investigate the Long-term Safety of FAB122 in Patients With Amyotrophic Lateral Sclerosis
Acronym
ADOREXT
Official Title
A Multicenter, Open-label Extension Study to Investigate the Long-term Safety of FAB122 in Patients With Amyotrophic Lateral Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 6, 2023 (Actual)
Primary Completion Date
June 30, 2026 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferrer Internacional S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
225 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open Label
Arm Type
Experimental
Arm Description
Drug: FAB122 Daily dose 100 mg
Intervention Type
Drug
Intervention Name(s)
FAB122
Intervention Description
FAB122 Daily dose 100 mg
Primary Outcome Measure Information:
Title
Nature, frequency and severity of Treatment Emergent Adverse Events.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ferrer MedInfo
Phone
+34 609 850 565
Email
medinfo@ferrer.com
Facility Information:
Facility Name
Hospital Universitari de Bellvitge
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Povedano

12. IPD Sharing Statement

Learn more about this trial

A Multicenter, Open-label Extension Study to Investigate the Long-term Safety of FAB122 in Patients With Amyotrophic Lateral Sclerosis

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