Duchenne Muscular DystrophyNCT03372655
Prognostic Factors Affecting Duchenne Muscular Dystrophy
An observational study of Duchenne Muscular Dystrophy, run by Assiut University.
Trial summary
Determination of prognostic factors affecting ambulation of duchenne muscular dystrophy Read more about this study
- Who is it for?
- Ages 10 to 18 years, men only
- Conditions the study is for
- Duchenne Muscular Dystrophy
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2018to 1 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- Men only
- Child, Adult
Study population: Male patient diagnosed as duchenne muscular dystrophy by typical clinical picture\&shooting serum CPK level \& EMG study or biopsy
Who may be able to join
- any male pt diagnosed as duchenne muscular dystrophy by typical clinical picture \&shooting serum CPK level \&EMG study or biopsy \& age 10 to 18yrs old
Who cannot join
- female patient ' age below 10 yrs old or above 18 yrs old .patient with autoimmune disease or malignancy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prognstic Factors Affecting Duchenne Muscular Dystrophy
Determination of prognostic factors affecting ambulation of duchenne muscular dystrophy
Read the detailed description
Duchenne muscular dystrophy is the most common herditary muscular disease , it lead to loss of ambulation in early teenageers . It lead to early death at the mean age of 19 years
- Conditions
- Duchenne Muscular Dystrophy
- Medical subject headings
- Muscular Dystrophy, Duchenne
What is being measured
The primary outcome is the main question the study is designed to answer.
Ten meter walking test
Questionnaire
Measured: 2018 - 2019
Secondary outcomes (1)
Muscle strenght
Questionnaire
Measured: 2018- 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start1 Jan 2018 (estimated)
- Primary completion1 Jan 2019 (estimated)
- Study completion1 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duchenne Muscular DystrophyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nehal Refaat Mohammed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03372655
- Sponsor's protocol ID
- PFADMD
- Status last verified
- Dec 2017
- First submitted
- 6 Dec 2017
- Last updated
- 14 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognstic Factors Affecting Duchenne Muscular Dystrophy
- ClinicalTrials.gov ID
- NCT03372655
- Acronym / sponsor ID
- PFADMD
- Conditions
- Duchenne Muscular Dystrophy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 Mar 2019 (estimated)
- First posted
- 14 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determination of prognostic factors affecting ambulation of duchenne muscular dystrophy
Detailed description
Duchenne muscular dystrophy is the most common herditary muscular disease , it lead to loss of ambulation in early teenageers . It lead to early death at the mean age of 19 years
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 18 years
- Sex
- Male only
- Age groups
- Child, Adult
- Study population
- Male patient diagnosed as duchenne muscular dystrophy by typical clinical picture\&shooting serum CPK level \& EMG study or biopsy
Key inclusion criteria (1 listed)
- any male pt diagnosed as duchenne muscular dystrophy by typical clinical picture \&shooting serum CPK level \&EMG study or biopsy \& age 10 to 18yrs old
Key exclusion criteria (1 listed)
- female patient ' age below 10 yrs old or above 18 yrs old .patient with autoimmune disease or malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ten meter walking test
Time frame: 2018 - 2019
Questionnaire
1 secondary outcome
Muscle strenght
Time frame: 2018- 2019
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Duchenne Muscular Dystrophy, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nehal Refaat, Residant (01000242438, nehalrefaatmohammed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ten meter walking test (time frame: 2018 - 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2017.