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The specific aim of the study is to compare the safety and efficacy of a single administration of DaxibotulinumtoxinA for Injection versus placebo for managing plantar fasciitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAXI 240 U | Experimental | DaxibotulinumtoxinA for injection for the treatment of plantar fasciitis (PF) with 240 U |
|
| Placebo | Placebo Comparator | Placebo Intramuscular Injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxins, Type A | Biological | Intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline at Week 8 in the Visual Analog Scale (VAS) for Pain for the Foot | The primary efficacy endpoint, as identified in the Statistical Analysis Plan (SAP) was the change from baseline in the visual analog scale (VAS) for pain for the affected foot at Week 8. The outcome was measured by means of a 100 mm VAS (0= no pain, 100= maximum pain) and higher reduction from baseline VAS pain scores means a better outcome. | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Foot Pain as Measured by the Visual Analog Scale (VAS) Through Week 16 | Reduction in foot pain was assessed as the change from baseline in the Visual Analog Scale (VAS) at weeks 1, 2, 4, 8, and 16. The outcome was measured by means of a 100 mm VAS (0= no pain, 100= maximum pain) and higher reduction from baseline VAS pain scores means a better outcome. | Weeks 1, 2, 4, 8, and 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Village Podiatry Centers | Duluth | Georgia | 30096 | United States | ||
| Weil Foot and Ankle Institute |
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| ID | Title | Description |
|---|---|---|
| FG000 | DAXI 240 U | DaxibotulinumtoxinA for injection for the treatment of plantar fasciitis (PF) with 240 U |
| FG001 | Placebo | Placebo group |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
59 subjects were enrolled. Subjects were assigned to study if they met all inclusion and none of the exclusion criteria. All subjects enrolled were randomized and received study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | DAXI 240 U | DaxibotulinumtoxinA for injection for the treatment of plantar fasciitis (PF) with 240 U |
| BG001 | Placebo | Placebo group |
| 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 at Week 8 in the Visual Analog Scale (VAS) for Pain for the Foot | The primary efficacy endpoint, as identified in the Statistical Analysis Plan (SAP) was the change from baseline in the visual analog scale (VAS) for pain for the affected foot at Week 8. The outcome was measured by means of a 100 mm VAS (0= no pain, 100= maximum pain) and higher reduction from baseline VAS pain scores means a better outcome. | Intent to treat population | Posted | Mean | Standard Deviation | score on a scale | Week 8 |
|
Up to week 16
Adverse events are summarized in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized (59) patients who received study treatment and were assessed for safety at least once after baseline
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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 | DAXI 240 U | DaxibotulinumtoxinA for injection for the treatment of plantar fasciitis (PF) with 240 U |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flank pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular block first degree | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Todd Gross, PhD, VP, Clinical Development & Data Science | Revance Therapeutics, Inc. | 510-742-3400 | tgross@revance.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 14, 2017 | Oct 5, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 18, 2017 | Oct 5, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D036981 | Fasciitis, Plantar |
| ID | Term |
|---|---|
| D005208 | Fasciitis |
| D009140 | Musculoskeletal Diseases |
| D005534 | Foot Diseases |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| Placebo | Biological | Intramuscular injection |
|
| Change From Baseline Through Week 16 for the American Orthopaedic Foot and Ankle Score (AOFAS) | The American Orthopaedic Foot and Ankle Score (AOFAS) measures foot and ankle conditions in 3 categories, pain, function, and alignment. The scale includes 9 items and the total score ranges from a minimum of 0 to a maximum of 100, with higher scores indicating a better outcome. | Weeks 1, 2, 4, 8, and 16 |
| Change From Baseline Through Week 16 for the Foot and Ankle Disability Index | The Foot and Ankle Disability Index is a 26 item questionnaire that measures disability and measures a total value minimum of 0 to a maximum of 104, with higher scores indicating greater disability. | Weeks 1, 2, 4, 8, and 16 |
| Des Plaines |
| Illinois |
| 60016 |
| United States |
| Kansas City Bone & Joint Clinic | Overland Park | Kansas | 66211 | United States |
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| Element Research Group | San Antonio | Texas | 78212 | United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
Placebo Intramuscular Injection
Placebo: Intramuscular injection
|
|
| Secondary | Change From Baseline in Foot Pain as Measured by the Visual Analog Scale (VAS) Through Week 16 | Reduction in foot pain was assessed as the change from baseline in the Visual Analog Scale (VAS) at weeks 1, 2, 4, 8, and 16. The outcome was measured by means of a 100 mm VAS (0= no pain, 100= maximum pain) and higher reduction from baseline VAS pain scores means a better outcome. | Intent to treat population | Posted | Mean | Standard Deviation | score on a scale | Weeks 1, 2, 4, 8, and 16 |
|
|
|
| Secondary | Change From Baseline Through Week 16 for the American Orthopaedic Foot and Ankle Score (AOFAS) | The American Orthopaedic Foot and Ankle Score (AOFAS) measures foot and ankle conditions in 3 categories, pain, function, and alignment. The scale includes 9 items and the total score ranges from a minimum of 0 to a maximum of 100, with higher scores indicating a better outcome. | Intent to treat population | Posted | Mean | Standard Deviation | score on a scale | Weeks 1, 2, 4, 8, and 16 |
|
|
|
| Secondary | Change From Baseline Through Week 16 for the Foot and Ankle Disability Index | The Foot and Ankle Disability Index is a 26 item questionnaire that measures disability and measures a total value minimum of 0 to a maximum of 104, with higher scores indicating greater disability. | Intent to treat population | Posted | Mean | Standard Deviation | score on a scale | Weeks 1, 2, 4, 8, and 16 |
|
|
|
| 0 |
| 30 |
| 1 |
| 30 |
| 20 |
| 30 |
| EG001 | Placebo | Placebo group | 0 | 29 | 0 | 29 | 16 | 29 |
| Injection Site Hemorrhage | General disorders | Systematic Assessment |
|
| Injection Site Pain | General disorders | Systematic Assessment |
|
| Injection site bruising | General disorders | Systematic Assessment |
|
| Injection site edema | General disorders | Systematic Assessment |
|
| Injection site erythema | General disorders | Systematic Assessment |
|
| Paronychia | Infections and infestations | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Muscle tightness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | Systematic Assessment |
|
The Study Center and/or Investigator shall submit to Revance a copy of the proposed publication at least sixty (60) days prior to the submission thereof for publication or disclosure to a third party: (i)to provide Revance with the opportunity to review and comment on the contents thereof, (ii)to identify any Confidential Information to be deleted from the proposed publication or disclosure, and (iii)or delay the publication or disclosure 90 days to allow Revance to pursue patent protections.
| 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 |
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| Week 4 |
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| Week 8 |
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| Week 16 |
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| Week 4 |
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| Week 16 |
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