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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.

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of TAS-205 in patients with Duchenne muscular dystrophy

Condition or disease Intervention/treatment Phase
Duchenne Muscular Dystrophy Drug: TAS-205 Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Placebo-controlled, Double-blind and Open-label, Extension Study of TAS-205 in Patients With Duchenne Muscular Dystrophy
Actual Study Start Date : November 1, 2020
Estimated Primary Completion Date : May 2027
Estimated Study Completion Date : May 2027


Arm Intervention/treatment
Experimental: TAS-205 Drug: TAS-205
・Treatment period:oral administration for 52 weeks, BID after meal

Placebo Comparator: Placebo Drug: Placebo
  • Observation period:oral administration for 2 weeks, BID after meal
  • Treatment period:oral administration for 52 weeks, BID after meal




Primary Outcome Measures :
  1. Mean change from baseline to Week 52 in the time to rise from the floor [ Time Frame: Baseline to Week 52 of treatment ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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.

  3. Change from baseline in North Star Ambulatory Assessment (NSAA) [ Time Frame: Baseline to 52 weeks of treatment ]
  4. Change from baseline in Six-minutes Walk Test (6MWT) [ Time Frame: Baseline to 52 weeks of treatment ]
  5. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT04587908


Contacts
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Contact: Drug Information Center +81-3-3294-4527 toiawase@taiho.co.jp

Locations
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Japan
A site selected by Taiho Pharmaceutical Co., Ltd. Recruiting
Aichi, Japan
A site selected by Taiho Pharmaceutical Co., Ltd. Recruiting
Fukuoka, Japan
A site selected by Taiho Pharmaceutical Co., Ltd. Recruiting
Hokkaido, Japan
A site selected by Taiho Pharmaceutical Co., Ltd. Recruiting
Osaka, Japan
A site selected by Taiho Pharmaceutical Co., Ltd. Recruiting
Tokyo, Japan
Sponsors and Collaborators
Taiho Pharmaceutical Co., Ltd.
Investigators
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Study Director: Taiho Pharmaceutical Co., Ltd. Taiho Pharmaceutical Co., Ltd.
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Responsible Party: Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT04587908    
Other Study ID Numbers: 10053050
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Muscular Dystrophies
Muscular Dystrophy, Duchenne
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked