Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
TERMINATED
Clinical Phase
PHASE3
Total Enrollment
331 participants
Study Classification
INTERVENTIONAL
Study Start Date
2013-09-30
Study Completion Date
2016-03-31
Brief Summary
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The main purpose of this study is to determine if tadalafil can slow the decline in walking ability of boys who have Duchenne muscular dystrophy (DMD). The study will also assess the safety of tadalafil and any side effects that might be associated with it in boys who have DMD. Participants will receive study treatment (tadalafil or placebo) for the first 48 weeks of the study, and can then continue into an open label extension (OLE) that consists of two periods during which all participants will receive tadalafil. In OLE period 1, all participants will receive tadalafil for 48 weeks. Participants completing OLE period 1 will continue into OLE period 2 and will receive tadalafil for at least another 48 weeks.
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Detailed Description
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Conditions
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Muscular Dystrophy, Duchenne
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Placebo
Placebo taken orally once daily.
Group Type
EXPERIMENTAL
Placebo
Intervention Type
DRUG
0.3 mg/kg Tadalafil
0.3 milligram per kilogram (mg/kg) tadalafil taken orally once daily.
Group Type
EXPERIMENTAL
Tadalafil
Intervention Type
DRUG
Administered orally
0.6 mg/kg Tadalafil
0.6 mg/kg tadalafil taken orally once daily.
Group Type
EXPERIMENTAL
Tadalafil
Intervention Type
DRUG
Administered orally
Interventions
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Tadalafil
Administered orally
Intervention Type
DRUG
Placebo
Intervention Type
DRUG
Other Intervention Names
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LY450190
Cialis
Administered orally
Eligibility Criteria
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Inclusion Criteria
* Ambulant males with Duchenne muscular dystrophy (DMD) confirmed by typical clinical presentation (onset of clinical signs or symptoms before 6 years of age supported by an elevated serum creatinine kinase level, and ongoing difficulty with walking) together with either a record of a genetic confirmation of the DMD diagnosis, or a record of muscle biopsy showing near-complete dystrophin deficiency (excluding revertant fibers)
* Receiving systemic corticosteroids for a minimum of 6 months immediately prior to screening, with no significant change in total daily dosage or dosing regimen (except those adjusting for weight changes) for a minimum of 3 months immediately prior to screening and a reasonable expectation that total daily dosage and dosing regimen will not change significantly (except for adjustments for weight) for the duration of the study
* Able to complete the six minute walk distance (6MWD) test with results within 20% of each other at a minimum of 2 pre-randomization assessments
* Left ventricular ejection fraction (LVEF) ≥50% as determined by echocardiogram
* Written informed consent from parents/legal guardian will be obtained prior to any study procedure being performed. In addition, the child may be required to give documented assent, if capable.
* Receiving systemic corticosteroids for a minimum of 6 months immediately prior to screening, with no significant change in total daily dosage or dosing regimen (except those adjusting for weight changes) for a minimum of 3 months immediately prior to screening and a reasonable expectation that total daily dosage and dosing regimen will not change significantly (except for adjustments for weight) for the duration of the study
* Able to complete the six minute walk distance (6MWD) test with results within 20% of each other at a minimum of 2 pre-randomization assessments
* Left ventricular ejection fraction (LVEF) ≥50% as determined by echocardiogram
* Written informed consent from parents/legal guardian will be obtained prior to any study procedure being performed. In addition, the child may be required to give documented assent, if capable.
Exclusion Criteria
* Symptomatic cardiomyopathy or heart failure
* Change in prophylactic treatment for heart failure within 3 months prior to start of study treatment
* Cardiac rhythm disorder
* History of participation in gene or cell-based therapy , or antisense oligonucleotide or stop codon read-through therapy
* Unable to take orally administered tablets
* Use of any pharmacologic treatment, other than corticosteroids, that might have an effect on muscle strength within 3 months prior to the start of study treatment (for example, growth hormone, anabolic steroids including testosterone)
* New or changed treatment with herbal or dietary supplements being taken with an expectation of an effect on muscle strength or function during 1 month prior to first dose of study drug
* Surgery that might have an effect on muscle strength or function within 3 months before study entry or planned surgery at any time during the study
* Evidence of a lower limb injury that may affect performance on the 6MWD
* Severe behavioral problems, including severe autism or attention deficit disorders, that may interfere with completion of the 6MWD
* Any contraindication to tadalafil (use of any form of organic nitrate, either regularly and/or intermittently, or known serious hypersensitivity to tadalafil)
* History of significant renal insufficiency or clinical evidence of cirrhosis
* Have known allergy to any of the excipients in tadalafil tablets, notably lactose
* Current Phosphodiesterase Type 5 (PDE5) inhibitor therapy or treatment within the past 6 months
* Change in prophylactic treatment for heart failure within 3 months prior to start of study treatment
* Cardiac rhythm disorder
* History of participation in gene or cell-based therapy , or antisense oligonucleotide or stop codon read-through therapy
* Unable to take orally administered tablets
* Use of any pharmacologic treatment, other than corticosteroids, that might have an effect on muscle strength within 3 months prior to the start of study treatment (for example, growth hormone, anabolic steroids including testosterone)
* New or changed treatment with herbal or dietary supplements being taken with an expectation of an effect on muscle strength or function during 1 month prior to first dose of study drug
* Surgery that might have an effect on muscle strength or function within 3 months before study entry or planned surgery at any time during the study
* Evidence of a lower limb injury that may affect performance on the 6MWD
* Severe behavioral problems, including severe autism or attention deficit disorders, that may interfere with completion of the 6MWD
* Any contraindication to tadalafil (use of any form of organic nitrate, either regularly and/or intermittently, or known serious hypersensitivity to tadalafil)
* History of significant renal insufficiency or clinical evidence of cirrhosis
* Have known allergy to any of the excipients in tadalafil tablets, notably lactose
* Current Phosphodiesterase Type 5 (PDE5) inhibitor therapy or treatment within the past 6 months
Minimum Eligible Age
7 Years
Maximum Eligible Age
14 Years
Eligible Sex
MALE
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Cedars Sinai Medical Center
Los Angeles, California, United States
Site Status
University of California, Davis - Health Systems
Sacramento, California, United States
Site Status
Children's Hospital
Aurora, Colorado, United States
Site Status
University of Florida Health Science Center
Gainesville, Florida, United States
Site Status
NW Florida Clinical Research Group
Gulf Breeze, Florida, United States
Site Status
Nemours Children's Hospital
Orlando, Florida, United States
Site Status
Ann and Robert Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Site Status
University of Iowa
Iowa City, Iowa, United States
Site Status
University of Kansas Medical Center
Kansas City, Kansas, United States
Site Status
Washington University Medical Center
St Louis, Missouri, United States
Site Status
Carolinas Healthcare System
Charlotte, North Carolina, United States
Site Status
Duke University Medical Center
Durham, North Carolina, United States
Site Status
Childrens Hospital Medical Center
Cincinnati, Ohio, United States
Site Status
Oregon Health and Science University
Portland, Oregon, United States
Site Status
Pennsylvania State University College of Medicine
Hershey, Pennsylvania, United States
Site Status
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Site Status
Childrens Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Site Status
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Site Status
Children's Medical Center Dallas
Dallas, Texas, United States
Site Status
Univ of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Site Status
University of Utah School of Medicine
Salt Lake City, Utah, United States
Site Status
Children of the King's Daughters
Norfolk, Virginia, United States
Site Status
Seattle Children's Hospital Research Foundation
Seattle, Washington, United States
Site Status
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Caba, , Argentina
Site Status
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Ghent, , Belgium
Site Status
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Leuven, , Belgium
Site Status
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Liège, , Belgium
Site Status
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Calgary, Alberta, Canada
Site Status
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Vancouver, British Columbia, Canada
Site Status
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Winnipeg, Manitoba, Canada
Site Status
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Halifax, Nova Scotia, Canada
Site Status
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London, Ontario, Canada
Site Status
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Ottawa, Ontario, Canada
Site Status
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Angers, , France
Site Status
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Nantes, , France
Site Status
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Dresden, , Germany
Site Status
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Essen, , Germany
Site Status
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Freiburg im Breisgau, , Germany
Site Status
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Göttingen, , Germany
Site Status
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Munich, , Germany
Site Status
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Genova, , Italy
Site Status
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Milan, , Italy
Site Status
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Padua, , Italy
Site Status
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Rome, , Italy
Site Status
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Aichi, , Japan
Site Status
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Nagano, , Japan
Site Status
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Saitama, , Japan
Site Status
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Tokyo, , Japan
Site Status
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Leiden, , Netherlands
Site Status
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Nijmegen, , Netherlands
Site Status
University of Puerto Rico, Medical Sciences Campus
San Juan, , Puerto Rico
Site Status
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Moscow, , Russia
Site Status
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Seoul, , South Korea
Site Status
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Barcelona, , Spain
Site Status
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Donostia / San Sebastian, , Spain
Site Status
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Madrid, , Spain
Site Status
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Valencia, , Spain
Site Status
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Kaohsiung City, , Taiwan
Site Status
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Taipei, , Taiwan
Site Status
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Adana, , Turkey (Türkiye)
Site Status
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Ankara, , Turkey (Türkiye)
Site Status
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Oxford, Oxfordshire, United Kingdom
Site Status
Countries
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United States
Argentina
Belgium
Canada
France
Germany
Italy
Japan
Netherlands
Puerto Rico
Russia
South Korea
Spain
Taiwan
Turkey (Türkiye)
United Kingdom
References
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McDonald CM, Henricson EK, Han JJ, Abresch RT, Nicorici A, Elfring GL, Atkinson L, Reha A, Hirawat S, Miller LL. The 6-minute walk test as a new outcome measure in Duchenne muscular dystrophy. Muscle Nerve. 2010 Apr;41(4):500-10. doi: 10.1002/mus.21544.
Reference Type
BACKGROUND
Cox D, Byrne B, Hammers DW, Landry J, Sweeney HL. Effect of Tadalafil on cardiac function and left ventricular dimensions in Duchenne muscular dystrophy: safety and cardiac MRI substudy results from a randomized, placebo-controlled trial. BMC Cardiovasc Disord. 2025 Apr 11;25(1):276. doi: 10.1186/s12872-025-04727-3.
Reference Type
DERIVED
Victor RG, Sweeney HL, Finkel R, McDonald CM, Byrne B, Eagle M, Goemans N, Vandenborne K, Dubrovsky AL, Topaloglu H, Miceli MC, Furlong P, Landry J, Elashoff R, Cox D; Tadalafil DMD Study Group. A phase 3 randomized placebo-controlled trial of tadalafil for Duchenne muscular dystrophy. Neurology. 2017 Oct 24;89(17):1811-1820. doi: 10.1212/WNL.0000000000004570. Epub 2017 Sep 29.
Reference Type
DERIVED
Other Identifiers
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H6D-MC-LVJJ
Identifier Type: OTHER
Identifier Source: secondary_id
15122
Identifier Type: -
Identifier Source: org_study_id
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