Plantar Fasciitis
Conditions
Keywords
DAXI for injection,, Plantar Fasciitis,, Heel Pain,, BotulinumtoxinA
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALDAXI 80 U
DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) with 80 U (Low Dose Group)
BIOLOGICALDAXI 120 U
DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) 120 U (High Dose Group)
OTHERPlacebo
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.
Sponsors
Revance Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double Blinded
Intervention model description
Subjects will be randomly assigned to 1 of 3 treatment groups: DAXI for injection LOW dose, DAXI for injection HIGH dose, Placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Written informed consent, including authorization to release health information. * Male or female subjects 18 to 65 years of age with diagnosis of unilateral plantar fasciitis. * Persistent heel pain. * Women of child bearing potential must have a negative pregnancy test at Screening and Injection Visits and must use an effective method of contraception during the course of the study.
Exclusion criteria
* Previous injection of botulinum toxin in the lower extremities or feet. * Previously suffered a partial or full thickness tear or surgery of the plantar fascia within the 5 years preceding participation in the investigation. * Pregnant, nursing, or planning a pregnancy during the study. * Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to first visit. * Any condition or situation which, in the Investigator's opinion, puts the subject at significant risk, could confound the trial results, or may interfere significantly with the subject's participation in the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline at Week 8 in the Numeric Pain Rating Scale (NPRS) Score | Week 8 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline at Week 8 in Foot Function Index (FFI) | Week 8 | 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. |
| Proportion of Subjects With a Decrease From Baseline of >= 20% in NPRS | Week 8 | For the proportion of subjects with a decrease from baseline of \>= 20% in NPRS score at Week 8 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DAXI 80 U DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) with 80 U (Low Dose Group) | 49 |
| DAXI 120 U DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) with 120 U (High Dose Group) | 54 |
| Placebo Placebo Group | 52 |
| Total | 155 |
Baseline characteristics
| Characteristic | DAXI 80 U | DAXI 120 U | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 48.7 years STANDARD_DEVIATION 9.06 | 47.1 years STANDARD_DEVIATION 8.17 | 48.5 years STANDARD_DEVIATION 8.02 | 48.1 years STANDARD_DEVIATION 8.38 |
| Age, Customized <= 50 years | 26 Participants | 34 Participants | 34 Participants | 94 Participants |
| Age, Customized > 50 years | 23 Participants | 20 Participants | 18 Participants | 61 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 2 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized Black | 3 Participants | 4 Participants | 3 Participants | 10 Participants |
| Race/Ethnicity, Customized Multiple | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Not reported | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 44 Participants | 44 Participants | 47 Participants | 135 Participants |
| Sex: Female, Male Female | 35 Participants | 32 Participants | 36 Participants | 103 Participants |
| Sex: Female, Male Male | 14 Participants | 22 Participants | 16 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 54 | 0 / 52 |
| other Total, other adverse events | 7 / 49 | 12 / 54 | 10 / 52 |
| serious Total, serious adverse events | 2 / 49 | 2 / 54 | 0 / 52 |
Outcome results
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.
Time frame: Week 8
Population: Intent to treat population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| DAXI 80 U | Change From Baseline at Week 8 in the Numeric Pain Rating Scale (NPRS) Score | -3.29 score on a scale | Standard Error 0.329 |
| DAXI 120 U | Change From Baseline at Week 8 in the Numeric Pain Rating Scale (NPRS) Score | -3.25 score on a scale | Standard Error 0.298 |
| Placebo | Change From Baseline at Week 8 in the Numeric Pain Rating Scale (NPRS) Score | -2.75 score on a scale | Standard Error 0.302 |
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.
Time frame: Week 8
Population: Intent to treat population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| DAXI 80 U | Change From Baseline at Week 8 in Foot Function Index (FFI) | -29.02 score on a scale | Standard Error 2.202 |
| DAXI 120 U | Change From Baseline at Week 8 in Foot Function Index (FFI) | -27.37 score on a scale | Standard Error 2.149 |
| Placebo | Change From Baseline at Week 8 in Foot Function Index (FFI) | -23.63 score on a scale | Standard Error 2.185 |
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
Time frame: Week 8
Population: Intent to treat population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DAXI 80 U | Proportion of Subjects With a Decrease From Baseline of >= 20% in NPRS | 35 Participants |
| DAXI 120 U | Proportion of Subjects With a Decrease From Baseline of >= 20% in NPRS | 41 Participants |
| Placebo | Proportion of Subjects With a Decrease From Baseline of >= 20% in NPRS | 34 Participants |