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

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ClinicalTrials.gov Identifier: NCT03821402
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
Revance Therapeutics, Inc.

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 study is expected to last approximately 2 years, and the duration of individual subject participation will vary.

Condition or disease Intervention/treatment Phase
Upper Limb Spasticity Biological: DAXI for injection dose LOW DOSE Biological: DAXI for injection dose MEDIUM DOSE Biological: DAXI for injection Dose HIGH DOSE Other: Placebo Phase 2

Detailed Description:
Subjects will be randomly assigned to DAXI for Injection high dose, DAXI for Injection medium dose, DAXI for Injection low dose, or placebo group, respectively. Eligible subjects will have ULS characterized by a primary aggregate posture

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Eligible subjects will be randomized (1:1:1:1) to one of four treatment groups: Group 1: DAXI LOW DOSE (N=32); Group 2: DAXI MEDIUM DOSE (N=32); Group 3: DAXI HIGH DOSE (N=32); Group 4: Placebo (N=32).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes 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.
Primary Purpose: Treatment
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
Actual Study Start Date : December 12, 2018
Estimated Primary Completion Date : August 24, 2020
Estimated Study Completion Date : August 24, 2020

Arm Intervention/treatment
Experimental: DAXI for injection dose LOW DOSE
LOW dose group
Biological: DAXI for injection dose LOW DOSE
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

Experimental: DAXI for injection dose MEDIUM DOSE
MEDIUM dose group
Biological: DAXI for injection dose MEDIUM DOSE
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.

Experimental: DAXI for injection Dose HIGH DOSE
HIGH dose group
Biological: DAXI for injection Dose HIGH DOSE
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

Placebo Comparator: Placebo
Placebo group
Other: Placebo
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 Measures :
  1. Change from Baseline from suprahypertonic muscle group (SMG) score [ Time Frame: Week 6 ]
    Mean change from baseline in muscle tone measured with the Modified Ashworth Scale (MAS) in the suprahypertonic muscle group (SMG) of the elbow, wrist, OR finger flexors at Week 6. Score range: 0 (Normal tone, no in tone) to 4 (Affected part{s} rigid in flexion or extension)

  2. Change from Baseline Physician Global Impression of Change (PGIC) score [ Time Frame: Week 6 ]
    Mean score on of the the Physician Global Impression of Change (PGIC) at Week 6. Score range: -4 (Markedly worse) to +4 (Markedly improved).


Secondary Outcome Measures :
  1. Muscle tone improvement [ Time Frame: Weeks 6 and 24 ]
    Proportion 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)

  2. Physician Global Impression of Change (PGIC) improvement [ Time Frame: Weeks 6 and 24 ]
    Proportion of subjects with improvement (score ≥ 1) on the Physician Global Impression of Change (PGIC). Score range: 0 (Normal tone, no increase in tone) to 4 (Affected part{s} rigid in flexion or extension)

  3. Disability Assessment Scale (DAS) functional impairment [ Time Frame: Weeks 6 and 24 ]
    Change in functional impairment as measured by the Disability Assessment Scale (DAS) for the principal treatment target (PTT). Score range: 0 (No disability) to 3 (Severe disability - normal activities limited).

  4. Duration of effect [ Time Frame: Up to 36 weeks ]
    Duration of effect

  5. Safety and immunogenicity assessment [ Time Frame: Up to 36 weeks ]
    Number of subjects with potential Botulinum Toxin type A distant spread of toxin adverse events, and number of subjects who develop neutralizing antibodies to Botulinum Toxin Type A will be assessed.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 to 70 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821402


Contacts
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Contact: Daniel Snyder, PhD 510-742-3523 dsnyder@revance.com
Contact: Pat Kesslak, PhD 510.742.3616 pkesslak@revance.com

  Show 23 Study Locations
Sponsors and Collaborators
Revance Therapeutics, Inc.
Investigators
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Study Director: Roman Rubio, MD Revance Therapeutics, Inc.

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Responsible Party: Revance Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03821402     History of Changes
Other Study ID Numbers: 1820203
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Revance Therapeutics, Inc.:
ULS
JUNIPER
DAXI for injection
Botulinum toxin

Additional relevant MeSH terms:
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Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms