Trial record 1 of 1 for:
ULS 1820203
Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Adult Upper Limb Spasticity (JUNIPER)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03821402 |
|
Recruitment Status :
Completed
First Posted : January 29, 2019
Last Update Posted : March 1, 2021
|
Sponsor:
Revance Therapeutics, Inc.
Information provided by (Responsible Party):
Revance Therapeutics, Inc.
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| 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 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 83 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 |
| Actual Primary Completion Date : | November 23, 2020 |
| Actual Study Completion Date : | November 23, 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 :
- 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)
- 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 :
- Muscle tone improvement [ Time Frame: Weeks 6 and 12 ]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)
- Physician Global Impression of Change (PGIC) improvement [ Time Frame: Weeks 6 and 12 ]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)
- Disability Assessment Scale (DAS) functional impairment [ Time Frame: Weeks 6 and 12 ]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).
- Duration of effect [ Time Frame: Up to 36 weeks ]Duration of effect
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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)
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
Locations
Show 26 study locations
Sponsors and Collaborators
Revance Therapeutics, Inc.
Investigators
| Study Director: | Roman Rubio, MD | Revance Therapeutics, Inc. |
| Responsible Party: | Revance Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT03821402 |
| Other Study ID Numbers: |
1820203 |
| First Posted: | January 29, 2019 Key Record Dates |
| Last Update Posted: | March 1, 2021 |
| Last Verified: | January 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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:
|
Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Muscle Hypertonia |
Neuromuscular Manifestations Neurologic Manifestations Nervous System Diseases |