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Study to Investigate the Efficacy and Safety of FAB122 (Daily Oral Edaravone) in Patients With Amyotrophic Lateral Sclerosis (ADORE)

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: NCT05178810
Recruitment Status : Active, not recruiting
First Posted : January 5, 2022
Last Update Posted : January 11, 2023
Sponsor:
Collaborators:
Julius Clinical
Stichting TRICALS Foundation
Information provided by (Responsible Party):
Ferrer Internacional S.A.

Brief Summary:
Multicenter, multinational, double-blind, randomized (2:1), placebo-controlled Phase III study to investigate the efficacy and safety of 100 mg FAB122 once daily as oral formulation in ALS patients.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of FAB122 in Patients With Amyotrophic Lateral Sclerosis
Actual Study Start Date : October 18, 2021
Estimated Primary Completion Date : June 20, 2024
Estimated Study Completion Date : June 20, 2024


Arm Intervention/treatment
Experimental: FAB122 Drug: FAB122
Daily dose 100 mg

Placebo Comparator: Placebo Drug: Placebo
Daily dose




Primary Outcome Measures :
  1. Change from baseline in Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R) [ Time Frame: 48 weeks ]
    The total score ranges from 48 (no limitation in daily activities) to 0 (total inability).



Information from the National Library of Medicine

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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

Main Inclusion Criteria:

  • Age 18 - 80 years (both inclusive), male or female;
  • Diagnosis of definite, probable, probable laboratory supported or possible ALS as based on the El Escorial and the revised Airlie House diagnostic criteria for ALS;
  • Onset of first symptoms* no longer than 24 months prior to randomization;

    *Date of onset is the date the patient reported one or more of the following symptoms:

  • Muscle weakness in limbs
  • Speech/swallowing difficulties
  • Respiratory symptoms: dyspnea was noticed
  • SVC equal to or more than 70% of the predicted normal value for gender, height and age at screening visit;
  • Change in ALSFRS-R score between 0.35 points and 1.5 points per month (both inclusive) in the period from onset of first symptoms to the Screening visit;
  • Capable of providing informed consent and complying with trial procedures.

Main Exclusion Criteria:

  • Diagnosis of Primary Lateral Sclerosis;
  • Diagnosis of Frontotemporal Dementia;
  • Diagnosis of other neurodegenerative diseases (e.g. Parkinson disease, Alzheimer disease);
  • Diagnosis of polyneuropathy;
  • Other causes of neuromuscular weakness;
  • Have a significant pulmonary disorder not attributed to ALS and/or require treatment interfering with the evaluation of ALS on respiratory function;
  • Use of intravenous (IV) edaravone within 6 months of the screening visit;
  • Depend on mechanical ventilation (invasive or non-invasive) or require tracheostomy at Screening;
  • Renal impairment as indicated by a creatinine clearance of less than 50 mL/min as calculated by the Cockcroft Gault equation;
  • Subject has a history of clinically significant hepatic disease, hepatitis or biliary tract disease, or subject has a positive screening test for HIV, hepatitis B or C;

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): NCT05178810


Locations
Show Show 38 study locations
Sponsors and Collaborators
Ferrer Internacional S.A.
Julius Clinical
Stichting TRICALS Foundation
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Responsible Party: Ferrer Internacional S.A.
ClinicalTrials.gov Identifier: NCT05178810    
Other Study ID Numbers: FAB122-CT-2001
First Posted: January 5, 2022    Key Record Dates
Last Update Posted: January 11, 2023
Last Verified: January 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