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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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
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 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.

City, postcode or hospital

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

Other trials in United States

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 groups in NCT03821402
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.

12 Dec 201823 Nov 2020

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities
Centreal Neurological Condition, Acquired Brain Injury (Including Stroke)
Not yet recruitingObservational study
Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy.
Cerebral Palsy Infantile, Upper Limb Spasticity
RecruitingPhase 2
A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spasticity
Multiple Sclerosis Spasticity
RecruitingPhase 1
Shockwave for Elbow and Wrist Spasticity in People With Spinal Cord Injury
Spinal Cord Injury, Spasticity
Active, not recruitingPhase 3
Study to Compare the Efficacy and Safety of NT 201 (Botulinum Toxin) With Placebo for the Treatment of Lower Limb Spasticity Caused by Stroke or Traumatic Brain Injury
Lower Limb or Combined Lower Limb and Upper Limb Spasticity Due to Stroke or Traumatic Brain Injury

All Upper Limb Spasticity trials

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 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
ClinicalTrials.gov ID: NCT03821402
Acronym / sponsor ID: JUNIPER / 1820203
Conditions: Upper Limb Spasticity
Keywords: ULS, JUNIPER, DAXI for injection, Botulinum toxin
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 83 participants (actual)
Lead sponsor: Revance Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 12 Dec 2018 (actual)
Primary completion: 23 Nov 2020 (actual)
Study completion: 23 Nov 2020 (actual)
First posted: 29 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.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4
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).

Arm	Type	Receives
DAXI 250 U	Experimental	Biological: DAXI for injection 250 UDAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 250 U dose
DAXI 375 U	Experimental	Biological: DAXI for injection 375 UDAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 375 U
DAXI 500 U	Experimental	Biological: DAXI for injection 500 UDAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 500 U
Placebo	Placebo comparator	Other: PlaceboPlacebo group

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (7 listed)

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

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 for injection 250 UDaxibotulinumtoxinA 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	Biological	DAXI 250 U
DAXI for injection 375 UDaxibotulinumtoxinA 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.	Biological	DAXI 375 U
DAXI for injection 500 UDaxibotulinumtoxinA 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	Biological	DAXI 500 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 6 on the Modified Ashworth Scale (MAS) in the Suprahypertonic Muscle Group (SMG) Score
Time frame: Week 6
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).
Physician Global Impression of Change (PGIC) Score
Time frame: Week 6
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).

4 secondary outcomes

Muscle Tone Improvement Responder Rate
Time frame: Weeks 6 and 12
Physician Global Impression of Change (PGIC) Responder Rate
Time frame: Weeks 6 and 12
Change From Baseline at Weeks 6 and 12 on the Disability Assessment Scale (DAS) Functional Impairment
Time frame: Weeks 6 and 12
Duration of Effect
Time frame: Up to 36 weeks

Results and safety

Results posted to the registry on 21 Sep 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DAXI 250 U	22	15
DAXI 375 U	19	12
DAXI 500 U	18	15
Placebo	24	18

Primary outcome: Change From Baseline at Week 6 on the Modified Ashworth Scale (MAS) in the Suprahypertonic Muscle Group (SMG) Score

Time frame: Week 6. Least squares mean (Standard Error). Unit: score on a scale

Measure	DAXI 250 U n = 22	DAXI 375 U n = 19	DAXI 500 U n = 18	Placebo n = 24
Value	-0.9 (0.25)	-1.0 (0.26)	-1.5 (0.27)	-0.8 (0.26)

DAXI 250 U vs Placebo: p = 0.7645, ANCOVA
DAXI 375 U vs Placebo: p = 0.5509, ANCOVA
DAXI 500 U vs Placebo: p = 0.0488, ANCOVA

Population analysed: Intent to treat population

Primary outcome: Physician Global Impression of Change (PGIC) Score

Time frame: Week 6. Least squares mean (Standard Error). Unit: score on a scale

Measure	DAXI 250 U n = 22	DAXI 375 U n = 19	DAXI 500 U n = 18	Placebo n = 24
Value	1.5 (0.29)	1.7 (0.30)	1.7 (0.32)	1.2 (0.28)

DAXI 250 U vs Placebo: p = 0.3698, ANCOVA
DAXI 375 U vs Placebo: p = 0.1972, ANCOVA
DAXI 500 U vs Placebo: p = 0.2037, ANCOVA

Population analysed: Intent to treat population

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: The adverse events were collected throughout the entire study, up to 36 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DAXI 250 U	2 of 22 (9.1%)	4 of 22 (18.2%)	0 of 22
DAXI 375 U	0 of 19 (0%)	12 of 19 (63.2%)	0 of 19
DAXI 500 U	1 of 18 (5.6%)	6 of 18 (33.3%)	0 of 18
Placebo	2 of 24 (8.3%)	4 of 24 (16.7%)	0 of 24

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

Related trials for Upper Limb Spasticity

RecruitingPhase 4
Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities
Centreal Neurological Condition, Acquired Brain Injury (Including Stroke)
Not yet recruitingObservational study
Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy.
Cerebral Palsy Infantile, Upper Limb Spasticity
RecruitingPhase 2
A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spasticity
Multiple Sclerosis Spasticity
RecruitingPhase 1
Shockwave for Elbow and Wrist Spasticity in People With Spinal Cord Injury
Spinal Cord Injury, Spasticity
Active, not recruitingPhase 3
Study to Compare the Efficacy and Safety of NT 201 (Botulinum Toxin) With Placebo for the Treatment of Lower Limb Spasticity Caused by Stroke or Traumatic Brain Injury
Lower Limb or Combined Lower Limb and Upper Limb Spasticity Due to Stroke or Traumatic Brain Injury

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.

26 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 7 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 26 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 6 on the Modified Ashworth Scale (MAS) in the Suprahypertonic Muscle Group (SMG) Score (time frame: Week 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03821402.

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.