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This study will evaluate the efficacy and safety of a single intra-articular (IA) injection of botulinum toxin Type A compared with placebo as treatment for osteoarthritis (OA) knee pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| botulinum toxin Type A | Experimental | A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1. |
|
| Placebo | Placebo Comparator | A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| botulinum toxin Type A | Biological | A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 4 | The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement. | Baseline, Week 4 |
| Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 8 | The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement. | Baseline, Week 8 |
| Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 12 | The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Western Ontario and McMaster Universities Arthritis (WOMAC™) Total Index Score | The WOMAC Total Index Score consisted of 24 components rated on a scale of 0 to 10. The Total Index Score included the WOMAC Pain Score (5 questions about pain where: 0=no pain to 10=extreme pain), the WOMAC Physical Function score (17 questions about the difficulty of daily activities where: 0=no difficulty to 10=extreme difficulty) and the WOMAC Stiffness Score (2 questions about stiffness where: 0=no stiffness to 10=extreme stiffness) for a total possible Index Score of 0 (best) to 240 (worst). A negative change from Baseline indicated improvement. |
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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 |
|---|---|---|---|---|---|---|
| Aalborg | Denmark |
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| ID | Title | Description |
|---|---|---|
| FG000 | Botulinum Toxin Type A | A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1. |
| FG001 | Placebo | A single 2 mL dose of Normal Saline (placebo) injected 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 | Botulinum Toxin Type A | A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1. |
| BG001 | Placebo | A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 Average Daily Worst Pain Intensity Score at Week 4 | The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement. | Safety population included all treated participants based on the actual treatment received. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 4 |
|
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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 | A single 200U (2 mL) dose of botulinum toxin Type A injected 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 (15.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (15.1) | 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 | A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1. |
|
| Baseline, Week 8 |
| Change From Baseline in WOMAC Pain Score | The WOMAC Pain Score included 5 questions about pain where: 0=no pain to 10=extreme pain for a total possible score of 0 (best) to 50 (worst). A negative change from Baseline indicated improvement. | Baseline, Week 8 |
| Change From Baseline in WOMAC Physical Function Score | The WOMAC Physical Function Score included 17 questions about the difficulty of daily activities where: 0=no difficulty to 10=extreme difficulty for a total possible score of 0 (best) to 170 (worst). A negative change from Baseline indicated improvement. | Baseline, Week 8 |
| Patient Global Impression of Change Score | The participants 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 indicated worsening and positive scores indicated improvement. | Week 8 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
|
|
| Secondary | Change From Baseline in Western Ontario and McMaster Universities Arthritis (WOMAC™) Total Index Score | The WOMAC Total Index Score consisted of 24 components rated on a scale of 0 to 10. The Total Index Score included the WOMAC Pain Score (5 questions about pain where: 0=no pain to 10=extreme pain), the WOMAC Physical Function score (17 questions about the difficulty of daily activities where: 0=no difficulty to 10=extreme difficulty) and the WOMAC Stiffness Score (2 questions about stiffness where: 0=no stiffness to 10=extreme stiffness) for a total possible Index Score of 0 (best) to 240 (worst). A negative change from Baseline indicated improvement. | Safety population included all treated participants based on the actual treatment received. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 8 |
|
|
|
| Secondary | Change From Baseline in WOMAC Pain Score | The WOMAC Pain Score included 5 questions about pain where: 0=no pain to 10=extreme pain for a total possible score of 0 (best) to 50 (worst). A negative change from Baseline indicated improvement. | Safety population included all treated participants based on the actual treatment received. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 8 |
|
|
|
| Secondary | Change From Baseline in WOMAC Physical Function Score | The WOMAC Physical Function Score included 17 questions about the difficulty of daily activities where: 0=no difficulty to 10=extreme difficulty for a total possible score of 0 (best) to 170 (worst). A negative change from Baseline indicated improvement. | Safety population included all treated participants based on the actual treatment received. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 8 |
|
|
|
| Secondary | Patient Global Impression of Change Score | The participants 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 indicated worsening and positive scores indicated improvement. | Participants from the Safety population (all treated participants based on the actual treatment received) with data available for this outcome measure. | Posted | Mean | Standard Deviation | Score on a scale | Week 8 |
|
|
|
| Primary | Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 8 | The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement. | Safety population included all treated participants based on the actual treatment received. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 8 |
|
|
|
| Primary | Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 12 | The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement. | Safety population included all treated participants based on the actual treatment received. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 12 |
|
|
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| Post-Hoc | Change From Baseline in the Average Daily Worst Pain Intensity Score in the Nociceptive Pain Group | The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement. | Participants from the Safety population (all treated participants based on the actual treatment received) in a subgroup of patients with nociceptive pain (pain that is caused by nerves that react to injury or damage) at Baseline. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Weeks 4, 8 and 12 |
|
|
|
| Post-Hoc | Change From Baseline in WOMAC Pain Score in the Nociceptive Pain Group | The WOMAC Pain Score included 5 questions about pain where: 0=no pain to 10=extreme pain for a total possible score of 0 (best) to 50 (worst). A negative change from Baseline indicated improvement. | Participants from the Safety population (all treated participants based on the actual treatment received) in a subgroup of patients with nociceptive pain (pain that is caused by nerves that react to injury or damage) at Baseline. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 8 |
|
|
|
| 1 |
| 61 |
| 7 |
| 61 |
| EG001 | Placebo | A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1. | 0 | 60 | 14 | 60 |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | 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 30 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 8 |
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| Change from Baseline at Week 12 |
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