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

PHASE2CompletedINTERVENTIONAL
Enrollment

83

Participants

Timeline

Start Date

December 12, 2018

Primary Completion Date

November 23, 2020

Study Completion Date

November 23, 2020

Conditions
Upper Limb Spasticity
Interventions
BIOLOGICAL

DAXI for injection 250 U

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

BIOLOGICAL

DAXI for injection 375 U

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.

BIOLOGICAL

DAXI for injection 500 U

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

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.

Trial Locations (26)

10029

Icahn School of Medicine at Mount Sinai, New York

15213

University of Pittsburgh School of Medicine, Pittsburgh

20010

MedStar National Rehabilitation Hospital, Washington D.C.

27157

Wake Forest University School of Medicine, Salem

28203

Carolinas Rehabilitation, Charlotte

33024

Infinity Clinical Research, Hollywood

33486

Parkinsons Disease and Movement Disorders Center, Boca Raton

37232

Vanderbilt University Medical Center, Nashville

48073

William Beaumont Hospital, Royal Oak

65203

Rusk Rehabilitation Hospital, Columbia

75034

North Texas Institute of Neurology and Headache, Frisco

77030

University of Texas Health Science Center at Houston, Houston

84132

University of Utah, Salt Lake City

90242

Rancho Research Institute at Rancho Los Amigos National Rehab Center, Downey

90806

Collaborative Neuroscience Network LLC, Long Beach

91105

SC3 Research, Pasadena

92708-5153

The Parkinsons and Movement Disorder Institute, Fountain Valley

06824-5340

Yale University, Fairfield

06762

Waterbury Neurologists, Middlebury

06905-1206

Ki Health Partners LLC DBA New England Institute for Clinical Research, Stamford

32561-4458

NW FL Clinical Research Group, LLC, Gulf Breeze

33980-8421

Parkinsons Disease Treatment Center of Southwest Florida, Port Charlotte

60611-2654

Shirley Ryan AbilityLab, Chicago

66211-1358

Kansas Institute of Research, Overland Park

10065-4870

Weill Cornell Medical College, New York

19027-2220

MossRehab, Elkins Park

All Listed Sponsors
lead

Revance Therapeutics, Inc.

INDUSTRY

NCT03821402 - Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Adult Upper Limb Spasticity | Biotech Hunter | Biotech Hunter