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Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Adult Upper Limb Spasticity (JUNIPER)

Primary Purpose

Upper Limb Spasticity

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DAXI for injection 250 U
DAXI for injection 375 U
DAXI for injection 500 U
Placebo
Sponsored by
Revance Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Upper Limb Spasticity focused on measuring ULS, JUNIPER, DAXI for injection, Botulinum toxin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Sites / Locations

  • Rancho Research Institute at Rancho Los Amigos National Rehab Center
  • The Parkinsons and Movement Disorder Institute
  • Collaborative Neuroscience Network LLC
  • SC3 Research
  • Yale University
  • Waterbury Neurologists
  • Ki Health Partners LLC DBA New England Institute for Clinical Research
  • MedStar National Rehabilitation Hospital
  • Parkinsons Disease and Movement Disorders Center
  • NW FL Clinical Research Group, LLC
  • Infinity Clinical Research
  • Parkinsons Disease Treatment Center of Southwest Florida
  • Shirley Ryan AbilityLab
  • Kansas Institute of Research
  • William Beaumont Hospital
  • Rusk Rehabilitation Hospital
  • Icahn School of Medicine at Mount Sinai
  • Weill Cornell Medical College
  • Carolinas Rehabilitation
  • Wake Forest University School of Medicine
  • MossRehab
  • University of Pittsburgh School of Medicine
  • Vanderbilt University Medical Center
  • North Texas Institute of Neurology and Headache
  • University of Texas Health Science Center at Houston
  • University of Utah

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

DAXI 250 U

DAXI 375 U

DAXI 500 U

Placebo

Arm Description

DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 250 U dose

DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 375 U

DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 500 U

Placebo group

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

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)
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.
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).
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.

Full Information

First Posted
January 15, 2019
Last Updated
August 25, 2023
Sponsor
Revance Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03821402
Brief Title
Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Adult Upper Limb Spasticity
Acronym
JUNIPER
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 12, 2018 (Actual)
Primary Completion Date
November 23, 2020 (Actual)
Study Completion Date
November 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Revance Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Limb Spasticity
Keywords
ULS, JUNIPER, DAXI for injection, Botulinum toxin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double Blinded. The subject, Sponsor, and study site research personnel will be blinded to the identity of the subject's assigned treatment.
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DAXI 250 U
Arm Type
Experimental
Arm Description
DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 250 U dose
Arm Title
DAXI 375 U
Arm Type
Experimental
Arm Description
DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 375 U
Arm Title
DAXI 500 U
Arm Type
Experimental
Arm Description
DAXI for injection for the treatment of Upper Limb Spasticity (ULS) in Adults with 500 U
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo group
Intervention Type
Biological
Intervention Name(s)
DAXI for injection 250 U
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
DAXI for injection 375 U
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
DAXI for injection 500 U
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline at Week 6 on the Modified Ashworth Scale (MAS) in the Suprahypertonic Muscle Group (SMG) Score
Description
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).
Time Frame
Week 6
Title
Physician Global Impression of Change (PGIC) Score
Description
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).
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
Muscle Tone Improvement Responder Rate
Description
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)
Time Frame
Weeks 6 and 12
Title
Physician Global Impression of Change (PGIC) Responder Rate
Description
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.
Time Frame
Weeks 6 and 12
Title
Change From Baseline at Weeks 6 and 12 on the Disability Assessment Scale (DAS) Functional Impairment
Description
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).
Time Frame
Weeks 6 and 12
Title
Duration of Effect
Description
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.
Time Frame
Up to 36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Facility Information:
Facility Name
Rancho Research Institute at Rancho Los Amigos National Rehab Center
City
Downey
State/Province
California
ZIP/Postal Code
90242
Country
United States
Facility Name
The Parkinsons and Movement Disorder Institute
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708-5153
Country
United States
Facility Name
Collaborative Neuroscience Network LLC
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
SC3 Research
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Yale University
City
Fairfield
State/Province
Connecticut
ZIP/Postal Code
06824-5340
Country
United States
Facility Name
Waterbury Neurologists
City
Middlebury
State/Province
Connecticut
ZIP/Postal Code
06762
Country
United States
Facility Name
Ki Health Partners LLC DBA New England Institute for Clinical Research
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905-1206
Country
United States
Facility Name
MedStar National Rehabilitation Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Parkinsons Disease and Movement Disorders Center
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
NW FL Clinical Research Group, LLC
City
Gulf Breeze
State/Province
Florida
ZIP/Postal Code
32561-4458
Country
United States
Facility Name
Infinity Clinical Research
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Parkinsons Disease Treatment Center of Southwest Florida
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33980-8421
Country
United States
Facility Name
Shirley Ryan AbilityLab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-2654
Country
United States
Facility Name
Kansas Institute of Research
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211-1358
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Rusk Rehabilitation Hospital
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065-4870
Country
United States
Facility Name
Carolinas Rehabilitation
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Wake Forest University School of Medicine
City
Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
MossRehab
City
Elkins Park
State/Province
Pennsylvania
ZIP/Postal Code
19027-2220
Country
United States
Facility Name
University of Pittsburgh School of Medicine
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
North Texas Institute of Neurology and Headache
City
Frisco
State/Province
Texas
ZIP/Postal Code
75034
Country
United States
Facility Name
University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Adult Upper Limb Spasticity

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