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     303  0 Kommentare Revance Highlights Recent Regulatory Progress and Provides Anticipated 2019 Milestones - Seite 4

    Trial Design - The company’s JUNIPER Phase 2 clinical trial of upper limb spasticity is a randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of RT002 injectable at three dose levels versus placebo in reducing muscle tone of adult patients with upper limb spasticity due to stroke or traumatic brain injury over 36 weeks. The program is expected to enroll a total of approximately 128 patients, 18-70 years of age, at 25 sites in the United States.

    Patients will be randomized to one of three active treatment groups of RT002 or placebo. Post-treatment, patients will be followed for a maximum of 36 weeks. The co-primary efficacy endpoints of the trial will be the mean change from baseline in muscle tone using the Modified Ashworth Score (MAS) scale in the suprahypertonic muscle group (SMG – highest degree for muscle tone) of the elbow, wrist, or finger flexors at Week 6, and the mean score on the Physician Global Impression of Change (PGIC) scale at Week 6.

    Additional information, including patient eligibility criteria, will be posted shortly at www.clinicaltrials.gov.

    About Revance Therapeutics, Inc.

    Revance Therapeutics is an emerging Silicon Valley biotechnology leader developing neuromodulators for the treatment of aesthetic and therapeutic conditions. Revance uses a unique proprietary, peptide excipient technology to create development for a broad range of aesthetic and therapeutic indications, including glabellar lines, cervical dystonia, plantar fasciitis, upper limb spasticity and chronic migraine. RT002 has the potential to be the first long-acting neuromodulator. The company is advancing a robust pipeline of injectable and topical formulations of daxibotulinumtoxinA. More information on Revance may be found at www.revance.com.

    “Revance Therapeutics” and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

    BOTOX is a registered trademark of Allergan, Inc.

    Forward-Looking Statements

    This press release contains forward-looking statements, including statements related to the process and timing of, and ability to complete, current and anticipated future clinical development of our investigational drug product candidates, the initiation, enrollment, design, timing and results of our clinical studies, including the SAKURA Phase 3, ASPEN Phase 3, JUNIPER Phase 2 and other clinical programs relating to RT002, and related results and reporting of such results; and statements about our anticipated 2019 objectives, our commercial collaborations, our ability to obtain, and timing relating to, regulatory approval with respect to our drug candidates; and potential market form and benefits of our drug product candidates and our excipient peptide and other technologies.

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    Revance Highlights Recent Regulatory Progress and Provides Anticipated 2019 Milestones - Seite 4 Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company developing next-generation neuromodulators for use in treating aesthetic and therapeutic conditions, today announced updates on meetings with the U.S. Food and …