NCT01772043

Brief Summary

We will utilize the Cooperative International Neuromuscular Research Group (CINRG) network to collect and store tissue and blood from patients with Duchenne muscular dystrophy (DMD) with specific genetic mutations within the dystrophin gene that could be treated by antisense oligonucleotide (AO) drugs.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2012

Longer than P75 for all trials

Geographic Reach
2 countries

9 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 21, 2013

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

July 28, 2015

Status Verified

July 1, 2015

Enrollment Period

3.9 years

First QC Date

January 17, 2013

Last Update Submit

July 27, 2015

Conditions

Keywords

muscular dystrophytissue bank

Outcome Measures

Primary Outcomes (1)

  • Tissue Collection

    Collection of blood, skin and optional muscle samples

    1 day

Study Arms (1)

Duchenne muscular dystrophy

Eligibility Criteria

Age4 Years+
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Duchenne muscular dystrophy (DMD) is an X-linked recessive disorder caused by mutations in the dystrophin gene. DMD participants over 4 years of age with known mutations that could be targeted by exon skipping therapies will be recruited for this study.

You may qualify if:

  • Age 4 and above
  • Diagnosis of DMD with a confirmed out-of-frame dystrophin gene deletions that could be corrected by skipping exon 45, 51, or 53 based on past genetic testing.

You may not qualify if:

  • Investigator assessment of inability to comply with blood and skin sample collection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

University of California Davis

Sacramento, California, United States

Location

Stanford University Medical Center

Stanford, California, United States

Location

Children's National Health System

Washington D.C., District of Columbia, United States

Location

Johns Hopkins University School of Medicine, Kennedy Krieger

Baltimore, Maryland, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, United States

Location

Duke Children's Hospital and Health Center

Durham, North Carolina, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Location

University of Tennessee

Memphis, Tennessee, United States

Location

Alberta Children's Hospital

Calgary, Alberta, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples with DNA Skin samples Muscle samples (optional)

MeSH Terms

Conditions

Muscular Dystrophy, DuchenneMuscular Dystrophies

Condition Hierarchy (Ancestors)

Muscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2013

First Posted

January 21, 2013

Study Start

September 1, 2012

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

July 28, 2015

Record last verified: 2015-07

Locations