Plantar FasciitisPhase 2NCT03825315
DaxibotulinumtoxinA for Injection for the Treatment of Plantar Fasciitis
A Phase 2 study testing DAXI 80 U and DAXI 120 U in people with Plantar Fasciitis, run by Revance Therapeutics, Inc. at 20 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- DAXI 80 U and DAXI 120 U
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 155 participants
- Where
- 20 sitesUnited States
- Study dates
- 31 Dec 2018to 4 Jun 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Podiatry 1st
Belleville, Illinois, 62226
Sacramento Foot and Ankle Center, Inc
Carmichael, California, 95608
Bay Area Foot Care
Castro Valley, California, 94546
North Texas Institute of Neurology and Headache
Frisco, Texas, 75034
Hermann Drive Research Hospital
Houston, Texas, 77004
West Coast Foot and Ankle
Huntington Beach, California, 92648
Advanced Foot & Ankle Center
Las Vegas, Nevada, 89119
Foot and Ankle Clinic
Los Angeles, California, 90057
Futuro Clinical Trials, LLC
McAllen, Texas, 78501
Rosalind Franklin University of Medicine & Science
North Chicago, Illinois, 60064
Medical Research International
Oklahoma City, Oklahoma, 73109
Kansas Institute of Research
Overland Park, Kansas, 66211-1358
Rocky Mountain Foot and Ankle, LLC
Salt Lake City, Utah, 84107
Wasatch Clinical Research
Salt Lake City, Utah, 84107
Strash Foot and Ankle Care
San Antonio, Texas, 78209
The Podiatry Group of South Texas
San Antonio, Texas, 78295
Bay Area Foot Care
San Francisco, California, 94115
University Foot and Ankle Foundation
Santa Monica, California, 90403
Aung Foot Health Clinic
Tucson, Arizona, 85710
LA Podiatry Group
West Palm Beach, Florida, 33406
About this study
Official title: A Phase II, Prospective, Randomized, Double-Blind, Multi-center, Placebo-Controlled Trial of DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis
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.
Read the 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.
- Conditions
- Plantar Fasciitis
- Being tested
- DAXI 80 U, DAXI 120 U, Placebo
- Keywords
- DAXI for injection,, Plantar Fasciitis,, Heel Pain,, BotulinumtoxinA
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAXI 80 UBiological
DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) with 80 U (Low Dose Group)
DAXI 120 UBiological
DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) 120 U (High Dose Group)
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| DAXI 80 U | Experimental | LOW Dose Group Receives: Biological: DAXI 80 U |
| DAXI 120 U | Experimental | HIGH Dose Group Receives: Biological: DAXI 120 U |
| Placebo | Placebo comparator | Placebo Group. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 8
Secondary outcomes (2)
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.
Measured: 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
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start31 Dec 2018
- Primary completion4 Jun 2020
- Study completion4 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Plantar FasciitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomly assigned to 1 of 3 treatment groups: DAXI for injection LOW dose, DAXI for injection HIGH dose, Placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revance Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03825315
- Sponsor's protocol ID
- 1820201
- Status last verified
- Aug 2023
- First submitted
- 15 Jan 2019
- Last updated
- 21 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Prospective, Randomized, Double-Blind, Multi-center, Placebo-Controlled Trial of DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT03825315
- Acronym / sponsor ID
- 1820201
- Conditions
- Plantar Fasciitis
- Keywords
- DAXI for injection,, Plantar Fasciitis,, Heel Pain,, BotulinumtoxinA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Revance Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Dec 2018 (actual)
- Primary completion
- 4 Jun 2020 (actual)
- Study completion
- 4 Jun 2020 (actual)
- First posted
- 31 Jan 2019 (actual)
- Results
- Posted 21 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Subjects will be randomly assigned to 1 of 3 treatment groups: DAXI for injection LOW dose, DAXI for injection HIGH dose, Placebo
| Arm | Type | Receives |
|---|---|---|
| DAXI 80 U | Experimental | Biological: DAXI 80 ULOW Dose Group |
| DAXI 120 U | Experimental | Biological: DAXI 120 UHIGH Dose Group |
| Placebo | Placebo comparator | Other: PlaceboPlacebo Group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DAXI 80 UDaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) with 80 U (Low Dose Group) | Biological | DAXI 80 U |
| DAXI 120 UDaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) 120 U (High Dose Group) | Biological | DAXI 120 U |
| PlaceboPlacebo is a sterile lyophilized product consisting of inactive ingredients without the neurotoxin to be reconstituted with sterile, non-preserved 0.9% sodium chloride solution. | Other | Placebo |
Primary outcome
Change From Baseline at Week 8 in the Numeric Pain Rating Scale (NPRS) Score
Time frame: 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.
2 secondary outcomes
Change From Baseline at Week 8 in Foot Function Index (FFI)
Time frame: Week 8
Proportion of Subjects With a Decrease From Baseline of >= 20% in NPRS
Time frame: Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DAXI 80 U and DAXI 120 U in people with Plantar Fasciitis, run by Revance Therapeutics, Inc. at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline at Week 8 in the Numeric Pain Rating Scale (NPRS) Score (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.