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New trial with same indication initiated
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| Name | Class |
|---|---|
| Wake Forest University Health Sciences | OTHER |
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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 |
|---|---|---|---|---|
| daxibotulinumtoxin type A | Biological | Intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in the American Orthopaedic Foot and Ankle Score (AOFAS) | The American Orthopaedic Foot and Ankle Score (AOFAS) is a 9-item questionnaire that evaluates pain, function, and alignment of the foot and ankle. The total score ranges from 0 to 100, with lower scores representing greater pain and disability, and higher scores representing better function. | 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest School of Medicine | Winston-Salem | North Carolina | 27157 | United States |
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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 |
|
All enrolled subjects
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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, Categorical | Count of Participants |
| 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 | Improvement in the American Orthopaedic Foot and Ankle Score (AOFAS) | The American Orthopaedic Foot and Ankle Score (AOFAS) is a 9-item questionnaire that evaluates pain, function, and alignment of the foot and ankle. The total score ranges from 0 to 100, with lower scores representing greater pain and disability, and higher scores representing better function. | The Intent-to-Treat population includes all patients randomized to treatment. | Posted | Mean | Standard Deviation | units on a scale | 16 weeks |
|
Up to 16 weeks
The Safety Population includes all subjects who received at least 1 study treatment injection and was used to assess AEs and SAEs
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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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Weakness | Musculoskeletal and connective tissue 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 13, 2017 | Aug 29, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D036981 | Fasciitis, Plantar |
| ID | Term |
|---|---|
| D005208 | Fasciitis |
| D009140 | Musculoskeletal Diseases |
| D005534 | Foot Diseases |
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| Placebo | Biological | Intramuscular injection |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| AOFAS total score | Mean | Standard Deviation | units on a scale |
|
Placebo group
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 1 |
| 3 |
| EG001 | Placebo | Placebo group | 0 | 4 | 0 | 4 | 1 | 4 |
| Muscle cramps | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
The Study Center and/or Investigator shall submit to Revance a copy of the proposed publication at least sixty (45) 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.