Upper Limb SpasticityPhase 2JUNIPERNCT03821402
Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Adult Upper Limb Spasticity
A Phase 2 study testing DAXI for injection 250 U, DAXI for injection 375 U and DAXI for injection 500 U in people with Upper Limb Spasticity, run by Revance Therapeutics, Inc. at 26 sites in United States.
Trial summary
This is a randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Ranging, trial to Evaluate the Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Upper Limb Spasticity in Adults After Stroke or Traumatic Brain Injury. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Upper Limb Spasticity
- What is being tested?
- DAXI for injection 250 U, DAXI for injection 375 U and DAXI for injection 500 U
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 26 sitesUnited States
- Study dates
- 12 Dec 2018to 23 Nov 2020
- Phase
- Phase 2
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 75 years of age
- Written informed consent including authorization to release health information
- Focal upper limb spasticity (ULS) after a stroke (as defined by WHO criteria) or traumatic brain injury (TBI), last stroke or TBI > 24 weeks prior to Screening
- ULS with the primary aggregate posture
- Moderate to severe ULS with a MAS score ≥ 2 at the elbow, wrist, and finger flexors
- Moderate to severe functional disability (Disability Assessment Score [DAS] score ≥2) on the principal target of treatment
- Has sufficient cognitive and communication ability to be able to give informed consent
Who cannot join
- Upper limb spasticity attributable to an etiology other than stroke or TBI.
- Bilateral upper limb paresis or quadriplegia.
- Initiated in physiotherapy of the upper extremities ≤ 30 days prior to Screening or planned to start physiotherapy of the upper extremities during the course of the study.
- Previous or planned treatment of the spastic upper limb with phenol, alcohol injection, or surgery
- Profound muscular atrophy or fixed contracture leading to marked limitation on range of motion
- Prior treatment with intrathecal baclofen
- Any neuromuscular neurologic conditions (amyotrophic lateral sclerosis, Lambert- Eaton, myasthenia gravis)
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
Parkinsons Disease and Movement Disorders Center
Boca Raton, Florida, 33486
Carolinas Rehabilitation
Charlotte, North Carolina, 28203
Shirley Ryan AbilityLab
Chicago, Illinois, 60611-2654
Rusk Rehabilitation Hospital
Columbia, Missouri, 65203
Rancho Research Institute at Rancho Los Amigos National Rehab Center
Downey, California, 90242
MossRehab
Elkins Park, Pennsylvania, 19027-2220
Yale University
Fairfield, Connecticut, 06824-5340
The Parkinsons and Movement Disorder Institute
Fountain Valley, California, 92708-5153
North Texas Institute of Neurology and Headache
Frisco, Texas, 75034
NW FL Clinical Research Group, LLC
Gulf Breeze, Florida, 32561-4458
Infinity Clinical Research
Hollywood, Florida, 33024
University of Texas Health Science Center at Houston
Houston, Texas, 77030
Collaborative Neuroscience Network LLC
Long Beach, California, 90806
Waterbury Neurologists
Middlebury, Connecticut, 06762
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Weill Cornell Medical College
New York, New York, 10065-4870
Kansas Institute of Research
Overland Park, Kansas, 66211-1358
SC3 Research
Pasadena, California, 91105
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, 15213
Parkinsons Disease Treatment Center of Southwest Florida
Port Charlotte, Florida, 33980-8421
William Beaumont Hospital
Royal Oak, Michigan, 48073
Wake Forest University School of Medicine
Salem, North Carolina, 27157
University of Utah
Salt Lake City, Utah, 84132
Ki Health Partners LLC DBA New England Institute for Clinical Research
Stamford, Connecticut, 06905-1206
MedStar National Rehabilitation Hospital
Washington D.C., District of Columbia, 20010
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Ranging, Multi-Center Trial to Evaluate the Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Upper Limb Spasticity in Adults After Stroke or Traumatic Brain Injury
This is a randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Ranging, trial to Evaluate the Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Upper Limb Spasticity in Adults After Stroke or Traumatic Brain Injury. The study will be conducted in the U.S.A., approximately 128 adult subjects from approximately 30 study centers will be randomly assigned (1:1:1:1) to one of four treatment groups. The study consists of a 21-day screening period, a treatment visit and follow-up visits.
The protocol was amended and the study was completed with fewer subjects than described in the initial protocol due to impact of COVID-19 on enrollment.
Read the detailed description
Subjects will be randomly assigned to DAXI for Injection 250 U, DAXI for Injection 375 U, DAXI for Injection 500 U, or placebo group, respectively. Eligible subjects will have ULS characterized by a primary aggregate posture
- Conditions
- Upper Limb Spasticity
- Being tested
- DAXI for injection 250 U, DAXI for injection 375 U, DAXI for injection 500 U, Placebo
- Keywords
- ULS, JUNIPER, DAXI for injection, Botulinum toxin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAXI for injection 250 UBiological
DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline
DAXI for injection 375 UBiological
DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline.
DAXI for injection 500 UBiological
DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline
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 250 U | Experimental | DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 250 U dose Receives: Biological: DAXI for injection 250 U |
| DAXI 375 U | Experimental | DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 375 U Receives: Biological: DAXI for injection 375 U |
| DAXI 500 U | Experimental | DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 500 U Receives: Biological: DAXI for injection 500 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 6 on the Modified Ashworth Scale (MAS) in the Suprahypertonic Muscle Group (SMG) Score
Mean change from baseline at Week 6 in muscle tone measured with the Modified Ashworth Scale (MAS) in the Suprahypertonic Muscle Group (SMG) in one of the following: elbow, wrist, or finger flexors. Score range: 0 (Normal tone, no in tone) to 4 (Affected part{s} rigid in flexion or extension).
Measured: Week 6
Physician Global Impression of Change (PGIC) Score
Mean score on the Physician Global Impression of Change (PGIC) score at week 6. The PGIC is a single-item, 9-point scale that measures the physician's impression of improvement following treatment. Score range: -4 (Markedly worse) to +4 (Markedly improved).
Measured: Week 6
Secondary outcomes (4)
Muscle Tone Improvement Responder Rate
Percentage of subjects who improve by a full point on the Modified Ashworth Scale (MAS) in the Suprahypertonic Muscle Group (SMG). Score range: 0 (Normal tone, no increase in tone) to 4 (Affected part(s) rigid in flexion or extension)
Measured: Weeks 6 and 12
Physician Global Impression of Change (PGIC) Responder Rate
Percentage of subjects with improvement (i.e., a score of 1 to 4) on the Physician Global Impression of Change (PGIC). The PGIC is a single-item, 9-point scale that measures the physician's impression of improvement following treatment. Score range: -4 (Markedly worse) to +4 (Markedly improved). Scores of 1 or more indicate improvement following treatment.
Measured: Weeks 6 and 12
Change From Baseline at Weeks 6 and 12 on the Disability Assessment Scale (DAS) Functional Impairment
Change from Baseline at Weeks 6 and 12 in functional impairment as measured by the Disability Assessment Scale (DAS) for the principal treatment target (PTT). DAS score range: 0 (No disability) to 3 (Severe disability - normal activities limited).
Measured: Weeks 6 and 12
Duration of Effect
Duration of effect is defined as time from injection (in weeks) until loss of muscle tone improvement in the SMG, as indicated by a reduction from baseline in MAS score of < 1-point and PGIC score is ≤ 0.
Measured: Up to 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start12 Dec 2018
- Primary completion23 Nov 2020
- Study completion23 Nov 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 Upper Limb SpasticityStudies 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
- Eligible subjects will be randomized (1:1:1:1) to one of four treatment groups: Group 1: DAXI 250 U (N=32); Group 2: DAXI 375 U (N=32); Group 3: DAXI 500 U (N=32); Group 4: Placebo (N=32).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 83 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
- NCT03821402
- Sponsor's protocol ID
- 1820203
- Acronym
- JUNIPER
- 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