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Clinical Trials/CTRI/2022/03/041060
CTRI/2022/03/041060
Not yet recruiting
Phase 1

SAFETY, TOLERABILITY AND EFFICACY OF 2â??-O-METHYL-PHOSPHOROTHIOATE ANTI SENSE OLIGORIBONUCLEOTIDES FOR THE TREATMENT OF CONFIRMED DUCHENNE MUSCULAR DYSTROPHY OF INDIAN PEDIATRIC PATIENTS: PHASE 1 -OPEN LABELED STUDY

Muscular Dystrophy Patients Welfare Society0 sites0 target enrollmentTBD
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Muscular Dystrophy Patients Welfare Society
Status
Not yet recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Muscular Dystrophy Patients Welfare Society

Eligibility Criteria

Inclusion Criteria

  • •1 Written informed to be sign
  • •2 Should of out frame deletion
  • •3 Not ventilator dependent
  • •4 Life expectancy of at least 6 months
  • •6 Within 6 months no treatment with investigational medicine

Exclusion Criteria

  • •1 Max presence of dystrophin 5 percentage
  • •2 If FVC less than 60 percentage
  • •3 If Creatinine clearance less than 70 percentage
  • •4 If EF less than 30 percentage
  • •5 If history of respiratory insufficiency
  • •6 Severe Cognitive dysfunction
  • •7 If any immune deficiency
  • •8 If any known bleeding disorder
  • •9 Receipt of Pharmacologic treatment apart from corticosteroids
  • •10 Surgery within 6 months

Outcomes

Primary Outcomes

Not specified

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