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Teva is developing 40 mg/ml Glatiramer Acetate (GA) Injection , administered once daily under the skin, for the treatment of ALS. The study drug is a higher dose formulation of Copaxone® (20 mg/ml GA), a marketed medication, approved for the treatment of relapsing-remitting multiple sclerosis. GA is an immunomodulating drug that has anti inflammatory and neuroprotective properties, which are believed to be of therapeutic value in ALS. The study treatment duration is 1 year (52 weeks).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 40 mg glatiramer acetate (GA) | Experimental | Pre-filled syringe of 40 mg glatiramer acetate (GA) for injection, administered subcutaneously once a day. |
|
| Placebo | Placebo Comparator | Pre-filled syringe of matching placebo, administered subcutaneously once a day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 40 mg glatiramer acetate | Drug | parenteral drug |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Slope of Change From Baseline in the ALS Functional Rating Scale (ALSFRS-R) | The ALSFRS-R is a questionnaire-based scale for monitoring the progression of disability in patients with ALS. It is composed of 12 items, each scored between 0 and 4.The total score, calculated as the sum of these 12 items, ranges from 0 to 48. The higher the score, the less disabled the participant. Timepoints after baseline were included in calculation of slope of change in ALSFRS-R. Slope is derived from the time by treatment interaction term from the Repeated Measures Analysis of Covariance model. Descriptive statistics of the slope are reported. | Baseline, Weeks 4, 8, 12, 17, 22, 26, 31, 36, 40, 44, 48, 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Event: Death, Tracheostomy, Permanent Assisted Ventilation | Composite endpoint of time to death, tracheostomy, or permanent assisted ventilation analyzed using the Cox's proportional hazards model to compare the risk of death, tracheostomy, or permanent assisted ventilation between treatment groups. The model includes center country, Riluzole© use, site of ALS onset, time from ALS onset, and baseline ALSFRS-R score, baseline slow VC and baseline BMI as covariates. Because less than 50% of participants experienced the event, the median time to event (i.e. the descriptive statistic for the day for which 50% of participants experienced the event) could not be calculated. Hence the days are reported as not available. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Merav Bassan, PhD. | Teva Pharmaceuticals Industries LTD | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teva Benelux | Haarlem | Belgium | ||||
| Teva Benelux |
366 participants were randomized in a 1:1 ratio to one of two treatment groups, Glatiramer Acetate 40 mg or matching placebo. The study duration was 52 weeks with a follow up period of up to 44 weeks.
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| ID | Title | Description |
|---|---|---|
| FG000 | Glatiramer Acetate 40mg | Pre-filled syringe of 40 mg glatiramer acetate (GA) for injection, administered subcutaneously once a day |
| FG001 | Placebo | Pre-filled syringe of matching placebo, administered subcutaneously once a day |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The intent to treat (ITT) analysis set included all randomized participants who took at least one dose of the study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Glatiramer Acetate 40mg | Pre-filled syringe of 40 mg glatiramer acetate (GA) for injection, administered subcutaneously once a day |
| BG001 | Placebo | Pre-filled syringe of matching placebo, administered subcutaneously once a day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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 | Slope of Change From Baseline in the ALS Functional Rating Scale (ALSFRS-R) | The ALSFRS-R is a questionnaire-based scale for monitoring the progression of disability in patients with ALS. It is composed of 12 items, each scored between 0 and 4.The total score, calculated as the sum of these 12 items, ranges from 0 to 48. The higher the score, the less disabled the participant. Timepoints after baseline were included in calculation of slope of change in ALSFRS-R. Slope is derived from the time by treatment interaction term from the Repeated Measures Analysis of Covariance model. Descriptive statistics of the slope are reported. | The intent-to-treat (ITT) analysis set consisted of all randomized participants who took at least one dose of the study drug. | Posted | Mean | Standard Error | Units on a Scale per Month | Baseline, Weeks 4, 8, 12, 17, 22, 26, 31, 36, 40, 44, 48, 52 |
|
Baseline up to 96 weeks.
The safety analysis set included all participants that took at least one dose of study drug.
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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 | Glatiramer Acetate 40mg | Pre-filled syringe of 40 mg glatiramer acetate (GA) for injection, administered subcutaneously once a day |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research | Teva Branded Pharmaceutical Products, R&D Inc. | 1-888-483-8279 | USMedInfo@tevapharm.com |
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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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| ID | Term |
|---|---|
| D000068717 | Glatiramer Acetate |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Placebo |
| Drug |
|
| Baseline up to 52 weeks |
| Leuven |
| Belgium |
| Teva France | Paris | France |
| Teva Germany | Mörfelden-Walldorf | Germany |
| Teva Israel | Tel Aviv | Israel |
| Teva Italy | Milan | Italy |
| Teva UK | Aylesbury | United Kingdom |
| Death |
|
| Lost to Follow-up |
|
| prescheduled medical intervention |
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
Pre-filled syringe of 40 mg glatiramer acetate (GA) for injection, administered subcutaneously once a day
| OG001 | Placebo | Pre-filled syringe of matching placebo, administered subcutaneously once a day |
|
|
|
| Secondary | Time to Event: Death, Tracheostomy, Permanent Assisted Ventilation | Composite endpoint of time to death, tracheostomy, or permanent assisted ventilation analyzed using the Cox's proportional hazards model to compare the risk of death, tracheostomy, or permanent assisted ventilation between treatment groups. The model includes center country, Riluzole© use, site of ALS onset, time from ALS onset, and baseline ALSFRS-R score, baseline slow VC and baseline BMI as covariates. Because less than 50% of participants experienced the event, the median time to event (i.e. the descriptive statistic for the day for which 50% of participants experienced the event) could not be calculated. Hence the days are reported as not available. | The intent-to-treat (ITT) analysis set consisted of all randomized participants who took at least one dose of the study drug. | Posted | Median | Inter-Quartile Range | Days | Baseline up to 52 weeks |
|
|
|
|
| 22 |
| 184 |
| 55 |
| 184 |
| 167 |
| 184 |
| EG001 | Placebo | Pre-filled syringe of matching placebo, administered subcutaneously once a day | 17 | 182 | 54 | 182 | 133 | 182 |
| Cardiac failure acute | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cyanosis | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Haemorrhoids thrombosed | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Subileus | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Catheter site haemorrhage | General disorders | MedDRA | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA | Systematic Assessment |
|
| Chills | General disorders | MedDRA | Systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA | Systematic Assessment |
|
| Death | General disorders | MedDRA | Systematic Assessment |
|
| Disease progression | General disorders | MedDRA | Systematic Assessment |
|
| General physical health deteriora | General disorders | MedDRA | Systematic Assessment |
|
| Hyperthermia | General disorders | MedDRA | Systematic Assessment |
|
| Malaise | General disorders | MedDRA | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA | Systematic Assessment |
|
| Type IV hypersensitivity reaction | Immune system disorders | MedDRA | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Peritonitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Peritonsillar abscess | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Bone fissure | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Brain contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Jaw fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Pneumocephalus | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Gamma-glutamyltransferase increas | Investigations | MedDRA | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Torticollis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Amyotrophic lateral sclerosis | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Brain oedema | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Coma | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Meningorrhagia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Completed suicide | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Nephrotic syndrome | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Renal colic | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Chronic obstructive pulmonary dis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Hypoventilation | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Increased bronchial secretion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Increased viscosity of bronchial | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Orthopnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Sputum discoloured | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Endotracheal intubation | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Gastrostomy | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Haemorrhoid operation | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Laparotomy | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Laryngeal polypectomy | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Mechanical ventilation | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Tracheostomy | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Embolism | Vascular disorders | MedDRA | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA | Systematic Assessment |
|
| Injection site mass | General disorders | MedDRA | Systematic Assessment |
|
| Injection site nodule | General disorders | MedDRA | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA | Systematic Assessment |
|
| Malaise | General disorders | MedDRA | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA | Systematic Assessment |
|
Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |