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A Phase 3 Study of TAS-205 in Patients With Duchenne Muscular Dystrophy(REACH-DMD)

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ClinicalTrials.gov Identifier: NCT04587908
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : February 9, 2021
Sponsor:
Information provided by (Responsible Party):
Taiho Pharmaceutical Co., Ltd.

Tracking Information
First Submitted Date  ICMJE October 13, 2020
First Posted Date  ICMJE October 14, 2020
Last Update Posted Date February 9, 2021
Actual Study Start Date  ICMJE November 1, 2020
Estimated Primary Completion Date May 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2020)
Mean change from baseline to Week 52 in the time to rise from the floor [ Time Frame: Baseline to Week 52 of treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2020)
  • Time measured in the time to rise from the floor test, as well as the change from baseline in each measured value [ Time Frame: Baseline to 52 weeks of treatment ]
  • Change from baseline in the Timed Up and Go Test (TUG) [ Time Frame: Baseline to 52 weeks of treatment ]
    Timed Up and Go Test (TUG) The time required for the subject to stand up from a sitting position on a table (chair), walk to a cone placed 3 m ahead as quickly as possible, and then return to the table will be evaluated.
  • Change from baseline in North Star Ambulatory Assessment (NSAA) [ Time Frame: Baseline to 52 weeks of treatment ]
  • Change from baseline in Six-minutes Walk Test (6MWT) [ Time Frame: Baseline to 52 weeks of treatment ]
  • Measured values of Muscle volume index (MVI), Percent Muscle volume index (%MVI) and skeletal muscle mass in skeletal muscle computed tomography (CT), as well as the change from baseline in each measured value [ Time Frame: Baseline to 52 weeks of treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 3 Study of TAS-205 in Patients With Duchenne Muscular Dystrophy(REACH-DMD)
Official Title  ICMJE A Phase 3, Randomized, Placebo-controlled, Double-blind and Open-label, Extension Study of TAS-205 in Patients With Duchenne Muscular Dystrophy
Brief Summary The purpose of this study is to evaluate the efficacy and safety of TAS-205 in patients with Duchenne muscular dystrophy
Detailed Description The main purpose of this study is to assess the efficacy of TAS-205 in patients with Duchenne muscular dystrophy (DMD) compared with placebo as measured by the mean change from baseline to 52 weeks in the time to rise from the floor. Following completion of the treatment period, patients may elect to continue in open-label extension study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Duchenne Muscular Dystrophy
Intervention  ICMJE
  • Drug: TAS-205
    ・Treatment period:oral administration for 52 weeks, BID after meal
  • Drug: Placebo
    • Observation period:oral administration for 2 weeks, BID after meal
    • Treatment period:oral administration for 52 weeks, BID after meal
Study Arms  ICMJE
  • Experimental: TAS-205
    Intervention: Drug: TAS-205
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 13, 2020)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2027
Estimated Primary Completion Date May 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Patients with a diagnosis of dystrophinopathy as determined by a dystrophin genetic test at the time of informed consent, symptoms or signs characteristic to DMD (e.g., proximal muscular weakness, waddling gait, Gower's sign)
  • Patients aged 5 years or more at the time of informed consent
  • Patients who meet all of the following at the time of screening test

    • walk by themselves
    • time to rise from the floor on own is ≥ 3 seconds and <10 seconds
  • Patients who can expect a 6-minute walking test of 350 meters or more
  • If taking oral glucocorticoids no significant change in the total daily or dosing 6 months before enrollment.

Key Exclusion Criteria

  • Patients who have serious concomitant drug hypersensitivity or medical history
  • Patients who have used cyclooxygenase-1 (COX-1) or COX-2 inhibitors, or nonsteroidal anti-inflammatory drugs (NSAIDs) during 7 days before the measurement of time to rise from the floor in the screening period
  • Patients who have incurred an injury (trauma/damage) that may affect muscle strength or motor function within 3 months before enrollment or who have an uncured injury (trauma/damage) that may affect muscle strength or motor function at the enrollment
  • Patients who have received gene-/cell-based therapy or stop-codon readthrough therapy with antisense oligonucleotides
  • Patients who have participated in another clinical trial and received a study drug within 90 days before study drug administration in the present study
  • Patients with a left ventricular ejection fraction (EF) of <40% or left ventricular fractional shortening (FS) of <25% on the cardiac ultrasonography (echocardiography) at observation period
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 5 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Drug Information Center +81-3-3294-4527 toiawase@taiho.co.jp
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04587908
Other Study ID Numbers  ICMJE 10053050
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Data will not be shared according to the Sponsor policy on data sharing. Taiho policy on data sharing may be found at https://www.taiho.co.jp/en/science/policy/clinical_trial_information_disclosure_policy/index.html.
Responsible Party Taiho Pharmaceutical Co., Ltd.
Study Sponsor  ICMJE Taiho Pharmaceutical Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Taiho Pharmaceutical Co., Ltd. Taiho Pharmaceutical Co., Ltd.
PRS Account Taiho Pharmaceutical Co., Ltd.
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP