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After the analysis of the main ADORE study it is concluded that there is no clinical benefit for the patients.
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A multicenter, open-label extension study to investigate the long-term safety of FAB122 in patients with Amyotrophic Lateral Sclerosis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FAB122 | Drug | FAB122 Daily dose 100 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | approximately 44 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 45 weeks |
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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:
a male patient must:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari de Bellvitge | Barcelona | Spain |
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| ID | Title | Description |
|---|---|---|
| FG000 | FAB122 | Drug: FAB122(ADORE)-FAB122(ADOREXT) FAB122: 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). |
| FG001 | Placebo | Drug: Placebo(ADORE)-FAB122(ADOREXT) FAB122: FAB122 Daily dose 100 mg Data presented for the FAB122 study group correspond to subjects receiving Placebo in the ADORE study and FAB122 in the ADOREXT study (Placebo-FAB122). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Data presented for the FAB122 study group correspond to subjects receiving FAB122 in the ADORE study as well as in 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).
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| ID | Title | Description |
|---|---|---|
| BG000 | FAB122 | Drug: FAB122(ADORE)-FAB122(ADOREXT) FAB122: 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). |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Data presented for the FAB122 study group correspond to subjects receiving FAB122 in the ADORE study as well as in 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). | Posted | Number | Participants | approximately 44 weeks |
|
45 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FAB122 | Drug: FAB122(ADORE)-FAB122(ADOREXT) FAB122 Daily dose 100 mg Data presented for the FAB122 study group correspond to subjects receiving FAB122 in the ADORE study as well as in the ADOREXT study (FAB122-FAB122). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary track infectious | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations Head | Ferrer | 649442389 | nalbareda@ferrer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 10, 2023 | Sep 4, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 19, 2024 | Sep 4, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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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).
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All subjects were treated with FAB122 in ADOREXT study, arms from parent study ADORE have been analyzed.
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| Adverse Event |
|
| Withdrawal by Subject |
|
| Disease progression |
|
| other causes |
|
Drug: Placebo(ADORE)-FAB122(ADOREXT) FAB122 Daily dose 100 mg Data presented for the Placebo study group correspond to subjects receiving Placebo in the ADORE study and FAB122 in the ADOREXT study (Placebo-FAB122). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Weight | Mean | Standard Deviation | KG |
|
| Height | Mean | Standard Deviation | CM |
|
| OG001 | Placebo | Drug: Placebo(ADORE)-FAB122(ADOREXT) FAB122 Daily dose 100 mg Data presented for the Placebo study group correspond to subjects receiving Placebo in the ADORE study and FAB122 in the ADOREXT study (Placebo-FAB122). |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 45 weeks |
|
|
|
| 16 |
| 135 |
| 29 |
| 135 |
| 77 |
| 135 |
| EG001 | Placebo | Drug: Placebo(ADORE)-FAB122(ADOREXT) FAB122 Daily dose 100 mg Data presented for the Placebo study group correspond to subjects receiving Placebo in the ADORE study and FAB122 in the ADOREXT study (Placebo-FAB122). | 9 | 66 | 15 | 66 | 41 | 66 |
| Dysponea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Chronic respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Pneumonia aspiration | Infections and infestations | Systematic Assessment |
|
| COVID-19 | Infections and infestations | Systematic Assessment |
|
| Lower respiratory track infection | Infections and infestations | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | Systematic Assessment |
|
| Craniocerebral injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Death | General disorders | Systematic Assessment |
|
| Amyotrophic Lateral Sclerosis | Nervous system disorders | Systematic Assessment |
|
| Hospitalization | Surgical and medical procedures | Systematic Assessment |
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| Hypertensive crisis | Vascular disorders | Systematic Assessment |
|
| Accute respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Tooth infection | Infections and infestations | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Lypoprotein increased | Investigations | Systematic Assessment |
|
| Weight decreased | Investigations | Systematic Assessment |
|
| Cognitive disorder | Nervous system disorders | Systematic Assessment |
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| Apathy | Psychiatric disorders | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| COVID-19 | Infections and infestations | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Influenza | Infections and infestations | Systematic Assessment |
|
| Lower respiratory track infection | Infections and infestations | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Syncope | Nervous system disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Death | General disorders | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Renal Colic | Renal and urinary disorders | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
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| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |