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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001076-58 | EudraCT Number |
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This study will evaluate the efficacy and safety of a single intra-articular injection of 2 doses of BOTOX® (onabotulinumtoxinA) compared with placebo as treatment for knee osteoarthritis symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OnabotulinumtoxinA 400 U | Experimental | OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1. |
|
| OnabotulinumtoxinA 200 U | Experimental | OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1. |
|
| Placebo | Placebo Comparator | Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| onabotulinumtoxinA | Biological | onabotulinumtoxinA (botulinum toxin Type A) injection into the intra-articular space of the study knee. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the 7-Day Average Daily Pain Score Using an 11-Point Scale | Participants recorded the pain in their knee during the previous 24 hours in a daily diary where: 0=no pain to 10= worst pain possible. The daily pain scores over 7-days were averaged. A negative change from Baseline indicates improvement. | Baseline, Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale | The WOMAC Pain Score consisted of 5 questions about pain completed by the participant where: 0=no pain to 10=extreme pain for a total possible Pain Score of 0 (best) to 50 (worst). A negative change from Baseline indicates improvement. | Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Artesia | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29753118 | Derived | McAlindon TE, Schmidt U, Bugarin D, Abrams S, Geib T, DeGryse RE, Kim K, Schnitzer TJ. Efficacy and safety of single-dose onabotulinumtoxinA in the treatment of symptoms of osteoarthritis of the knee: results of a placebo-controlled, double-blind study. Osteoarthritis Cartilage. 2018 Oct;26(10):1291-1299. doi: 10.1016/j.joca.2018.05.001. Epub 2018 May 9. |
| Label | URL |
|---|---|
| More Information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | OnabotulinumtoxinA 400 U | OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1. |
| FG001 | OnabotulinumtoxinA 200 U | OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1. |
| FG002 | Placebo | Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | OnabotulinumtoxinA 400 U | OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1. |
| BG001 | OnabotulinumtoxinA 200 U | OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1. |
| Units | Counts |
|---|---|
| Participants |
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| 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 the 7-Day Average Daily Pain Score Using an 11-Point Scale | Participants recorded the pain in their knee during the previous 24 hours in a daily diary where: 0=no pain to 10= worst pain possible. The daily pain scores over 7-days were averaged. A negative change from Baseline indicates improvement. | Safety population consisted of all randomized participants who received the study treatment and were analyzed by treatment actually received. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 8 |
|
Up to Day 172
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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 | OnabotulinumtoxinA 400 U | OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebrovascular accident | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | 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 |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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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 | Normal Saline (placebo) injection into the intra-articular space of the study knee. |
|
| Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale | The WOMAC Physical Function Score consisted of 17 questions about the difficulty of daily activities completed by the participant where: 0=no difficulty to 10=extreme difficulty for a total possible Physical Function Score of 0 (best) to 170 (worst). A negative change from Baseline indicates improvement. | Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24 |
| Patient Global Impression of Change (GIC) Using a 7-Point Scale | The participant rated the change in their health status since enrollment using a 7-point scale where: +3=very much improved, +2=much improved, +1=minimally improved, 0=no change, -1=minimally worse, -2=much worse and -3=very much worse. Negative scores indicate worsening and positive scores indicate improvement. | Weeks 1, 4, 8, 12, 16, 20 and 24 |
| Change From Baseline in the 7-Day Average Daily Worst Pain Score Using an 11-Point Scale | Participants recorded the pain in their knee during the previous 24 hours in a daily diary where: 0=no pain to 10= worst pain possible. The daily worst pain scores over 7-days were averaged. A negative change from Baseline indicates improvement. | Baseline, Week 24 |
| Pardubice |
| Czechia |
| Vejle | Denmark |
| Lost to Follow-up |
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| Personal Reasons |
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| Protocol Violation |
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| Other Miscellaneous Reason |
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| BG002 | Placebo | Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1. |
| OG002 | Placebo | Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1. |
|
|
| Secondary | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale | The WOMAC Pain Score consisted of 5 questions about pain completed by the participant where: 0=no pain to 10=extreme pain for a total possible Pain Score of 0 (best) to 50 (worst). A negative change from Baseline indicates improvement. | Safety population consisted of all randomized participants who received the study treatment and were analyzed by treatment actually received. "n" in the category is the number of participants with data available at the given time-point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24 |
|
|
|
| Secondary | Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale | The WOMAC Physical Function Score consisted of 17 questions about the difficulty of daily activities completed by the participant where: 0=no difficulty to 10=extreme difficulty for a total possible Physical Function Score of 0 (best) to 170 (worst). A negative change from Baseline indicates improvement. | Safety population consisted of all randomized participants who received the study treatment and were analyzed by treatment actually received. "n" in the category is the number of participants with data available at the given time-point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24 |
|
|
|
| Secondary | Patient Global Impression of Change (GIC) Using a 7-Point Scale | The participant rated the change in their health status since enrollment using a 7-point scale where: +3=very much improved, +2=much improved, +1=minimally improved, 0=no change, -1=minimally worse, -2=much worse and -3=very much worse. Negative scores indicate worsening and positive scores indicate improvement. | Safety population consisted of all randomized participants who received the study treatment and were analyzed by treatment actually received. "n" in the category is the number of participants with data available at the given time-point. | Posted | Mean | Standard Deviation | score on a scale | Weeks 1, 4, 8, 12, 16, 20 and 24 |
|
|
|
| Secondary | Change From Baseline in the 7-Day Average Daily Worst Pain Score Using an 11-Point Scale | Participants recorded the pain in their knee during the previous 24 hours in a daily diary where: 0=no pain to 10= worst pain possible. The daily worst pain scores over 7-days were averaged. A negative change from Baseline indicates improvement. | Safety population consisted of all randomized participants who received the study treatment and were analyzed by treatment actually received. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 24 |
|
|
|
| 6 |
| 44 |
| 9 |
| 44 |
| EG001 | OnabotulinumtoxinA 200 U | OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1. | 4 | 43 | 15 | 43 |
| EG002 | Placebo | Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1. | 6 | 89 | 26 | 89 |
| Dizziness | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
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| Basal ganglia infarction | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Incision site infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Retinal detachment | Eye disorders | MedDRA 18.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
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| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
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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.
| 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 |
| Change from Baseline at Week 1 |
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