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This is a randomized, double-blind, placebo-controlled, parallel group, multi-center trial of a single administration of DaxibotulinumtoxinA (DAXI) (high-dose; low-dose) for injection versus placebo for the management of Plantar Fasciitis.
Approximately 150 subjects, recruited from approximately 20 study centers in the United States (US) will be randomized to DAXI (HIGH-dose; LOW-dose) or placebo group, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAXI 80 U | Experimental | LOW Dose Group |
|
| DAXI 120 U | Experimental | HIGH Dose Group |
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| Placebo | Placebo Comparator | Placebo Group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DAXI 80 U | Biological | DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) with 80 U (Low Dose Group) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline at Week 8 in the Numeric Pain Rating Scale (NPRS) Score | Change from baseline in the Numeric Pain Rating Scale (NPRS) score, which is recorded within 15 minutes after stepping out of bed in the morning and averaged over 5 days (defined as 4 days prior to study visit and on the study visit day), at Week 8. The outcome was measured by an 11-point scale scored from 0-10 where 0 is no pain and 10 is the worst pain imaginable. | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline at Week 8 in Foot Function Index (FFI) | The Foot Function Index (FFI) is a 23 item questionnaire divided into 3 subscales measuring pain, disability, and activity restriction. The scale was scored from 0 (no pain) to 10 (worst pain imaginable). Both total and sub-scale scores are produced. The total FFI equals the average of the 3 subscale scores. Pain, disability, and activity limitation subscale scores were normalized and the range is from 0 to 100. The total FFI equals the average of the 3 subscale scores. Pain, disability, and activity limitation subscale scores range from 0 to 100. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aung Foot Health Clinic | Tucson | Arizona | 85710 | United States | ||
| Sacramento Foot and Ankle Center, Inc |
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| ID | Title | Description |
|---|---|---|
| FG000 | DAXI 80 U | DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) with 80 U (Low Dose Group) |
| FG001 | DAXI 120 U | DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) 120 U (High Dose Group) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Jul 15, 2019 | Jun 1, 2023 |
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Subjects will be randomly assigned to 1 of 3 treatment groups: DAXI for injection LOW dose, DAXI for injection HIGH dose, Placebo
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Double Blinded
| DAXI 120 U | Biological | DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) 120 U (High Dose Group) |
|
| Placebo | Other | Placebo is a sterile lyophilized product consisting of inactive ingredients without the neurotoxin to be reconstituted with sterile, non-preserved 0.9% sodium chloride solution. |
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| Week 8 |
| Proportion of Subjects With a Decrease From Baseline of >= 20% in NPRS | For the proportion of subjects with a decrease from baseline of >= 20% in NPRS score at Week 8 | Week 8 |
| Carmichael |
| California |
| 95608 |
| United States |
| Bay Area Foot Care | Castro Valley | California | 94546 | United States |
| West Coast Foot and Ankle | Huntington Beach | California | 92648 | United States |
| Foot and Ankle Clinic | Los Angeles | California | 90057 | United States |
| Bay Area Foot Care | San Francisco | California | 94115 | United States |
| University Foot and Ankle Foundation | Santa Monica | California | 90403 | United States |
| LA Podiatry Group | West Palm Beach | Florida | 33406 | United States |
| Podiatry 1st | Belleville | Illinois | 62226 | United States |
| Rosalind Franklin University of Medicine & Science | North Chicago | Illinois | 60064 | United States |
| Kansas Institute of Research | Overland Park | Kansas | 66211-1358 | United States |
| Advanced Foot & Ankle Center | Las Vegas | Nevada | 89119 | United States |
| Medical Research International | Oklahoma City | Oklahoma | 73109 | United States |
| North Texas Institute of Neurology and Headache | Frisco | Texas | 75034 | United States |
| Hermann Drive Research Hospital | Houston | Texas | 77004 | United States |
| Futuro Clinical Trials, LLC | McAllen | Texas | 78501 | United States |
| Strash Foot and Ankle Care | San Antonio | Texas | 78209 | United States |
| The Podiatry Group of South Texas | San Antonio | Texas | 78295 | United States |
| Rocky Mountain Foot and Ankle, LLC | Salt Lake City | Utah | 84107 | United States |
| Wasatch Clinical Research | Salt Lake City | Utah | 84107 | United States |
| FG002 | Placebo | Placebo Group. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | DAXI 80 U | DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) with 80 U (Low Dose Group) |
| BG001 | DAXI 120 U | DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) with 120 U (High Dose Group) |
| BG002 | Placebo | Placebo Group |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 Numeric Pain Rating Scale (NPRS) Score | Change from baseline in the Numeric Pain Rating Scale (NPRS) score, which is recorded within 15 minutes after stepping out of bed in the morning and averaged over 5 days (defined as 4 days prior to study visit and on the study visit day), at Week 8. The outcome was measured by an 11-point scale scored from 0-10 where 0 is no pain and 10 is the worst pain imaginable. | Intent to treat population | Posted | Least Squares Mean | Standard Error | score on a scale | Week 8 |
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| Secondary | Change From Baseline at Week 8 in Foot Function Index (FFI) | The Foot Function Index (FFI) is a 23 item questionnaire divided into 3 subscales measuring pain, disability, and activity restriction. The scale was scored from 0 (no pain) to 10 (worst pain imaginable). Both total and sub-scale scores are produced. The total FFI equals the average of the 3 subscale scores. Pain, disability, and activity limitation subscale scores were normalized and the range is from 0 to 100. The total FFI equals the average of the 3 subscale scores. Pain, disability, and activity limitation subscale scores range from 0 to 100. | Intent to treat population | Posted | Least Squares Mean | Standard Error | score on a scale | Week 8 |
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| Secondary | Proportion of Subjects With a Decrease From Baseline of >= 20% in NPRS | For the proportion of subjects with a decrease from baseline of >= 20% in NPRS score at Week 8 | Intent to treat population | Posted | Count of Participants | Participants | Week 8 |
|
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The adverse events were collected throughout the entire study, through week 24.
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 80 U | DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) with 80 U (Low Dose Group) | 0 | 49 | 2 | 49 | 7 | 49 |
| EG001 | DAXI 120 U | DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) with 120 U (High Dose Group) | 0 | 54 | 2 | 54 | 12 | 54 |
| EG002 | Placebo | Placebo Group | 0 | 52 | 0 | 52 | 10 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infectious mononucleosis | Infections and infestations | Systematic Assessment |
| ||
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | Systematic Assessment |
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| Uterine haemorrhage | Reproductive system and breast disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Influenza | Infections and infestations | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Injection site pain | General disorders | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Todd Gross, PhD, VP, Clinical Development & Data Science | Revance Therapeutics, Inc. | 510-742-3400 | tgross@revance.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 4, 2020 | Jun 1, 2023 | 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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| > 50 years |
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| Male |
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| Black |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| White |
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| Multiple |
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| Other |
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| Not reported |
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| Units | Counts |
|---|---|
| Participants |
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