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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004980-63 | EudraCT Number |
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This study will evaluate the safety and efficacy of BOTOX® in the treatment of adult post-stroke lower limb spasticity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| botulinum toxin Type A | Experimental | Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period. |
|
| Normal Saline (Placebo) Followed by botulinum toxin Type A | Other | Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| botulinum toxin Type A | Biological | Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of Ankle Plantar Flexors Using a 6-Point Scale | The MAS-B is a 6-point scale used to evaluate spasticity based on grading the resistance encountered in the ankle flexors by passively moving the ankle plantar flexor muscles through their range of motion. The score ranges from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Scores are converted to a 0 to 5 grade. The average of the weeks 4 and 6 MAS-B ankle change from baseline is the primary end point. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening. | Baseline, 6 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression (CGI) of Overall Change by Physician Using a 9-Point Scale | The CGI is a 9-point scale evaluating change from baseline status by the Physician. Scores range from +4 (very marked improvement) to -4 (very marked worsening). The average of the weeks 4 and 6 CGI by Physician score is used as a secondary end point. Higher scores indicate a greater improvement from baseline. | Baseline, 6 weeks |
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Inclusion Criteria:
Diagnosis of post-stroke lower limb spasticity for at least 3 months
Minimum body weight of 50 kg
Never treated with botulinum toxin of any serotype for any reason, or if previously treated with botulinum toxin of any serotype, if previously treated for spasticity in the affected lower limb, must have been administered
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Downey | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29330071 | Derived | Wein T, Esquenazi A, Jost WH, Ward AB, Pan G, Dimitrova R. OnabotulinumtoxinA for the Treatment of Poststroke Distal Lower Limb Spasticity: A Randomized Trial. PM R. 2018 Jul;10(7):693-703. doi: 10.1016/j.pmrj.2017.12.006. Epub 2018 Jan 9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Botulinum Toxin Type A | Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period. |
| FG001 | Normal Saline (Placebo) Followed by Botulinum Toxin Type A | Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Botulinum Toxin Type A | Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period. |
| 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 Modified Ashworth Scale-Bohannon (MAS-B) Score of Ankle Plantar Flexors Using a 6-Point Scale | The MAS-B is a 6-point scale used to evaluate spasticity based on grading the resistance encountered in the ankle flexors by passively moving the ankle plantar flexor muscles through their range of motion. The score ranges from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Scores are converted to a 0 to 5 grade. The average of the weeks 4 and 6 MAS-B ankle change from baseline is the primary end point. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening. | Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received | Posted | Least Squares Mean | Standard Deviation | Scores on a Scale | Baseline, 6 Weeks |
|
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The safety population during the 12-week double-blind phase included all enrolled patients who received at least 1 treatment injection in the study. The double-blind safety population is used to assess adverse events and serious adverse events.
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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 | Botulinum Toxin Type A | Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bifascicular block | Cardiac disorders | MedDRA version 18.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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|
|
| Normal Saline | Drug | Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. |
|
| Goal Attainment Scores on the 6-Point Physician-Assessed Goal Attainment Scale (GAS) | The physician-assessed GAS is an individualized, goal-oriented 6-point scale used to track functional improvement toward active and passive goals. GAS scoring ranged from -3 to 2 (-3 = worse than start; 0 = expected goal/attained the defined therapeutic goal; 2 = much more than expected/improvements clearly exceeded the defined therapeutic goal). Active and Passive Goal scores are presented. | Week 8 |
| Change From Baseline in Average Pain Score While Walking on the 11-Point Pain Scale | The patient is asked to select a number that best describes his/her pain while walking on an 11-point scale from 0 = "no pain" to 10 = "pain as bad as can be imagined". Patients are instructed to recall their average pain in the study limb during the 48-hour period prior to the visit. Patients with a baseline pain score >0 are included in the analyses. | Baseline, Week 6 |
| Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of Optional Muscles Using a 6-Point Scale | The MAS-B is a 6-point scale used to evaluate spasticity based on grading the resistance encountered in the optional muscles by passively moving the muscles through their range of motion. Optional muscles treated include: Rectus Femoris, Flexor Digitorum Longus, Flexor Hallucis Longus, and Extensor Hallucis. The scores range from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Scores are converted to a 0 to 5 grade. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening. | Baseline, Week 6 |
| Daytona Beach |
| Florida |
| United States |
| Montreal | Quebec | Canada |
| Prague | Czechia |
| Wiesbaden | Germany |
| Würzburg | Germany |
| Budapest | Hungary |
| Krakow | Poland |
| Krasnoyarsk | Russia |
| Gyeonggi-do | South Korea |
| Stoke-on-Trent | England | United Kingdom |
| Fazakerley | Liverpool | United Kingdom |
| Personal Reasons |
|
| Lost to Follow-up |
|
| Adverse Event |
|
| BG001 | Normal Saline (Placebo) Followed by Botulinum Toxin Type A | Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period. |
| OG001 | Normal Saline (Placebo) Followed by Botulinum Toxin Type A | Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period. |
|
|
| Secondary | Clinical Global Impression (CGI) of Overall Change by Physician Using a 9-Point Scale | The CGI is a 9-point scale evaluating change from baseline status by the Physician. Scores range from +4 (very marked improvement) to -4 (very marked worsening). The average of the weeks 4 and 6 CGI by Physician score is used as a secondary end point. Higher scores indicate a greater improvement from baseline. | Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received | Posted | Least Squares Mean | Standard Deviation | Scores on a Scale | Baseline, 6 weeks |
|
|
|
| Secondary | Goal Attainment Scores on the 6-Point Physician-Assessed Goal Attainment Scale (GAS) | The physician-assessed GAS is an individualized, goal-oriented 6-point scale used to track functional improvement toward active and passive goals. GAS scoring ranged from -3 to 2 (-3 = worse than start; 0 = expected goal/attained the defined therapeutic goal; 2 = much more than expected/improvements clearly exceeded the defined therapeutic goal). Active and Passive Goal scores are presented. | Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received | Posted | Least Squares Mean | Standard Deviation | Scores on a Scale | Week 8 |
|
|
|
| Secondary | Change From Baseline in Average Pain Score While Walking on the 11-Point Pain Scale | The patient is asked to select a number that best describes his/her pain while walking on an 11-point scale from 0 = "no pain" to 10 = "pain as bad as can be imagined". Patients are instructed to recall their average pain in the study limb during the 48-hour period prior to the visit. Patients with a baseline pain score >0 are included in the analyses. | Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received | Posted | Least Squares Mean | Standard Deviation | Scores on a Scale | Baseline, Week 6 |
|
|
|
| Secondary | Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of Optional Muscles Using a 6-Point Scale | The MAS-B is a 6-point scale used to evaluate spasticity based on grading the resistance encountered in the optional muscles by passively moving the muscles through their range of motion. Optional muscles treated include: Rectus Femoris, Flexor Digitorum Longus, Flexor Hallucis Longus, and Extensor Hallucis. The scores range from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Scores are converted to a 0 to 5 grade. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening. | Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received | Posted | Least Squares Mean | Standard Deviation | Scores on a Scale | Baseline, Week 6 |
|
|
|
| 10 |
| 231 |
| 0 |
| 231 |
| EG001 | Normal Saline (Placebo) | Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. | 9 | 233 | 0 | 233 |
| Bradycardia | Cardiac disorders | MedDRA version 18.0 | Systematic Assessment |
|
| Bundle branch block left | Cardiac disorders | MedDRA version 18.0 | Systematic Assessment |
|
| Bundle branch block right | Cardiac disorders | MedDRA version 18.0 | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA version 18.0 | Systematic Assessment |
|
| Mitral valve incompetence | Cardiac disorders | MedDRA version 18.0 | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
|
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA version 18.0 | Systematic Assessment |
|
| Chronic sinusitis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
|
| Pilonidal cyst | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA version 18.0 | Systematic Assessment |
|
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA version 18.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA version 18.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA version 18.0 | Systematic Assessment |
|
| Barbiturates positive | Investigations | MedDRA version 18.0 | Systematic Assessment |
|
| Opiates positive | Investigations | MedDRA version 18.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 18.0 | Non-systematic Assessment |
|
| Hepatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA version 18.0 | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA version 18.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA version 18.0 | Systematic Assessment |
|
| Drug abuse | Psychiatric disorders | MedDRA version 18.0 | Non-systematic Assessment |
|
| Schizoaffective disorder | Psychiatric disorders | MedDRA version 18.0 | Systematic Assessment |
|
| Bullous lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
|
| Mediastinal haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA version 18.0 | Systematic Assessment |
|
| Peripheral ischaemia | Vascular disorders | MedDRA version 18.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA version 18.0 | 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.
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| Baseline Flexor Digitorum Longus (N=86,88) |
|
| Chng from BL at Wk6 in Digitorum Longus (N=85,84) |
|
| Baseline Flexor Hallucis Longus (N=73,67) |
|
| Chng frm BL at Wk6 Flexor Hallucis Longus(N=72,66) |
|
| Baseline Extensor Hallucis (N=23,13) |
|
| Chng from BL at Wk6 in Extensor Hallucis (N=23,13) |
|