Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety of injections of botulinum toxin Type A in patients with reduced lung function and focal upper limb poststroke spasticity
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| botulinum toxin Type A | Biological | botulinum toxin Type A 240 U injection on Day 1, Week 12, Week 18 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Forced Vital Capacity (FVC) | Change from baseline in observed FVC. FVC is the maximum amount of air exhaled from the lungs after taking the deepest breath possible. Patients perform three to eight exhalations into a spirometer with the highest value recorded at Baseline and Week 6. | Baseline, Week 6 |
| Change From Baseline in Forced Expiratory Volume (FEV1) | Change from baseline in observed FEV1 at one second. FEV1 is the maximum amount of air exhaled in one second. Patients perform three to eight exhalations into a spirometer with the highest value recorded at Baseline and Week 6. | Baseline, Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in FEV1/FVC Ratio | Change from baseline in FEV1/FVC ratio. This ratio is calculated by dividing the FEV1 value by the FVC value. This represents that portion (or ratio) of FVC exhaled in one second. | Baseline, Week 6 |
| Change From Baseline in Ashworth Scale |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami | Florida | United States | ||||
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo |
| FG001 | Botulinum Toxin Type A 240 U | botulinum toxin Type A 240 U |
| FG002 | Botulinum Toxin Type A 360 U | botulinum toxin Type A 360 U |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo |
| BG001 | Botulinum Toxin Type A 240 U | botulinum toxin Type A 240 U |
| 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 | Change From Baseline in Forced Vital Capacity (FVC) | Change from baseline in observed FVC. FVC is the maximum amount of air exhaled from the lungs after taking the deepest breath possible. Patients perform three to eight exhalations into a spirometer with the highest value recorded at Baseline and Week 6. | Safety | Posted | Mean | Standard Deviation | Liters of air | Baseline, Week 6 |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abscess | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Allergan, Inc. | 714-246-4500 | clinicaltrials@allergan.com |
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| D009128 | Muscle Spasticity |
| D016472 | Motor Neuron Disease |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| botulinum toxin Type A | Biological | botulinum toxin Type A 360 U injection at Day 1, Week 12, Week 18 |
|
|
| saline | Drug | Saline injection at Day 1, Week 12, Week 18 |
|
Change from Baseline in worst upper limb scores using the Ashworth Scale at Week 6 from Baseline. Upper limb includes finger, wrist, thumb, and elbow. Worst score was the highest value measured from the finger, wrist, thumb, or elbow at Baseline and Week 6 based on treated areas. The Ashworth Scale assesses the degree of muscle tone. It is a 5-point scale where 0 equals no increase in muscle tone and 4 equals very severe muscle rigidity. A low score indicates little or no stiffness. A high score indicates severe stiffness. A negative change from baseline score indicates improvement. |
| Baseline, Week 6 |
| Prague |
| Czechia |
| Szeged | Hungary |
| Warsaw | Poland |
| BG002 |
| Botulinum Toxin Type A 360 U |
botulinum toxin Type A 360 U |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Botulinum Toxin Type A 360 U |
botulinum toxin Type A 360 U |
|
|
| Primary | Change From Baseline in Forced Expiratory Volume (FEV1) | Change from baseline in observed FEV1 at one second. FEV1 is the maximum amount of air exhaled in one second. Patients perform three to eight exhalations into a spirometer with the highest value recorded at Baseline and Week 6. | Safety | Posted | Mean | Standard Deviation | Liters of air | Baseline, Week 6 |
|
|
|
| Secondary | Change From Baseline in FEV1/FVC Ratio | Change from baseline in FEV1/FVC ratio. This ratio is calculated by dividing the FEV1 value by the FVC value. This represents that portion (or ratio) of FVC exhaled in one second. | Safety | Posted | Mean | Standard Deviation | Ratio | Baseline, Week 6 |
|
|
|
| Secondary | Change From Baseline in Ashworth Scale | Change from Baseline in worst upper limb scores using the Ashworth Scale at Week 6 from Baseline. Upper limb includes finger, wrist, thumb, and elbow. Worst score was the highest value measured from the finger, wrist, thumb, or elbow at Baseline and Week 6 based on treated areas. The Ashworth Scale assesses the degree of muscle tone. It is a 5-point scale where 0 equals no increase in muscle tone and 4 equals very severe muscle rigidity. A low score indicates little or no stiffness. A high score indicates severe stiffness. A negative change from baseline score indicates improvement. | Intent to Treat | Posted | Mean | Standard Deviation | Number on a scale | Baseline, Week 6 |
|
|
|
| 7 |
| 48 |
| 18 |
| 48 |
| EG001 | Botulinum Toxin Type A 240 U | botulinum toxin Type A 240 U | 9 | 52 | 15 | 52 |
| EG002 | Botulinum Toxin Type A 360 U | botulinum toxin Type A 360 U | 6 | 55 | 17 | 55 |
| Acute endocarditis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Splenic abscess | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Cognitive disorder | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Encephalitis | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
|
| Angina Pectoris | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Meningocele | Congenital, familial and genetic disorders | MedDRA (12.0) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Heart rate decreased | Investigations | MedDRA (12.0) | Systematic Assessment |
|
| Mobility decreased | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Muscle spasticity | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019636 | Neurodegenerative Diseases |
| D009468 | Neuromuscular Diseases |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
|
|
|