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Safety Study of Flavocoxid in Duchenne Muscular Dystrophy

NCT01335295 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2014-02-03

No results posted yet for this study

Summary

Objective of this study is to evaluate safety and tolerability of flavocoxid administered at the daily oral dose of 500 or 1000 mg/die for one year in DMD patients, alone or in association with steroids (deflazacort on alternate days) started at least one year before. The investigators will also perform a multidimensional clinical evaluation covering functional and muscle strength and quality of life (QoL)assessments.

Conditions

Interventions

DRUG

Flavocoxid

Flavocoxid capsules TTD 500 mg/die or 1000 mg/die for 1 year

Sponsors & Collaborators

  • University of Messina

    lead OTHER

Principal Investigators

  • Giuseppe Vita, MD · Department of Neuroscience, University of Messina

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
16 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01335295 on ClinicalTrials.gov