Clinical trial NCT03821402: Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Adult Upper Limb Spasticity
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Upper Limb Spasticity
Keywords: ULS
JUNIPER
DAXI for injection
Botulinum toxin
Lead sponsor: Revance Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-01-29
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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

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)

Primary outcomes:
measure: Change From Baseline at Week 6 on the Modified Ashworth Scale (MAS) in the Suprahypertonic Muscle Group (SMG) Score
timeFrame: Week 6
measure: Physician Global Impression of Change (PGIC) Score
timeFrame: Week 6
Secondary outcomes:
measure: Muscle Tone Improvement Responder Rate
timeFrame: Weeks 6 and 12
measure: Physician Global Impression of Change (PGIC) Responder Rate
timeFrame: Weeks 6 and 12
measure: Change From Baseline at Weeks 6 and 12 on the Disability Assessment Scale (DAS) Functional Impairment
timeFrame: Weeks 6 and 12
measure: Duration of Effect
timeFrame: Up to 36 weeks
Other outcomes:
Locations:
city: Downey
country: United States
facility: Rancho Research Institute at Rancho Los Amigos National Rehab Center
state: California
city: Fountain Valley
country: United States
facility: The Parkinsons and Movement Disorder Institute
state: California
city: Long Beach
country: United States
facility: Collaborative Neuroscience Network LLC
state: California
city: Pasadena
country: United States
facility: SC3 Research
state: California
city: Fairfield
country: United States
facility: Yale University
state: Connecticut
city: Middlebury
country: United States
facility: Waterbury Neurologists
state: Connecticut
city: Stamford
country: United States
facility: Ki Health Partners LLC DBA New England Institute for Clinical Research
state: Connecticut
city: Washington
country: United States
facility: MedStar National Rehabilitation Hospital
state: District of Columbia
city: Boca Raton
country: United States
facility: Parkinsons Disease and Movement Disorders Center
state: Florida
city: Gulf Breeze
country: United States
facility: NW FL Clinical Research Group, LLC
state: Florida
city: Hollywood
country: United States
facility: Infinity Clinical Research
state: Florida
city: Port Charlotte
country: United States
facility: Parkinsons Disease Treatment Center of Southwest Florida
state: Florida
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
city: Overland Park
country: United States
facility: Kansas Institute of Research
state: Kansas
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Columbia
country: United States
facility: Rusk Rehabilitation Hospital
state: Missouri
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Charlotte
country: United States
facility: Carolinas Rehabilitation
state: North Carolina
city: Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
city: Elkins Park
country: United States
facility: MossRehab
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh School of Medicine
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Frisco
country: United States
facility: North Texas Institute of Neurology and Headache
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References: