Skip to main content
MedPathMedPath Home
Clinical Trials/NCT00167609
NCT00167609
Completed
Phase 2

Phase 3 Study of Oral Dehydroepiandrosterone (DHEA) in Adults With Myotonic Dystrophy

University of Versailles4 sites in 1 country75 target enrollmentNovember 2004
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsMyotonic Dystrophy
Drugsdehydroepiandrosterone 100 and 400 mg

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Myotonic Dystrophy
Sponsor
University of Versailles
Enrollment
75
Locations
4
Primary Endpoint
Variation in a Muscle Strength Score between randomization and study week 12
Status
Completed
Last Updated
16 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

To test the efficacy and safety of two doses of dehydroepiandrosterone (DHEA) in adults with myotonic dystrophy

Detailed Description

Myotonic dystrophy is an inherited disorder that affects 1 per 8000 adults. The disease is characterize by muscular dystrophy, myotonia, cardiac disorders, cognitive function impairment, hypersomnia, hair loss, endocrine disorders. Recent small studies suggested that DHEA treatment may improve muscle strength in adults with myotonic dystrophy. Thus, the current study aims at investigating the safety and efficacy of a prolonged treatment with DHEA in adults with myotonic dystrophy.

Registry
clinicaltrials.gov
Start Date
November 2004
End Date
December 2006
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Versailles

Eligibility Criteria

Inclusion Criteria

  • •Myotonic dystrophy (genetically proven)
  • •MDRS score of 3 or 4

Exclusion Criteria

  • •Age \<18 years or \>70 years
  • •Pregnancy or breastfeeding
  • •Poor compliance to treatment and follow up
  • •Inclusion in any other clinical trial
  • •Severe cardiac disease: acute myocardial infarction in the preceding 6 months, unstable heart failure, uncontrolled hypertension (systolic blood pressure \>180 mmHg or diastolic blood pressure \>100 mmHg after 10 minutes of rest in the lying position), severe arteritis, any past history of thrombose or embolic event, any past history of symptomatic arrhythmia)
  • •Chronic renal failure
  • •Chronic liver disease
  • •Long term mechanical ventilation
  • •Any ongoing cancer
  • •Any underlying endocrine disorders

Outcomes

Primary Outcomes

Variation in a Muscle Strength Score between randomization and study week 12

Time Frame: 3 months

Secondary Outcomes

  • evaluation of myotonia(3 months)
  • Appeal score(3 months)
  • Epworth score(3 months)
  • Forced vital capacity(3 months)
  • arterial blood gas(3 months)
  • changes in EKG and echocardiography(3 months)
  • tolerance(3 months)

Study Sites (4)

Loading locations...

Similar Trials

Completed
Phase 3
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone Replacement for Primary Adrenal InsufficiencyAddison's Disease
NCT00004313National Center for Research Resources (NCRR)40
Completed
Phase 3
Efficacy and Safety of Oral DHEA Therapy for Postmenopausal Women on Sexual Function, Wellbeing and Vasomotor SymptomsQuality of LifeMenopausal SyndromeLibido Disorder
NCT00289926Monash University240
Completed
Not Applicable
The effect of dehydroepiandrosterone on quality of liferheumatoid arthritis.Seropositive rheumatoid arthritis
IRCT2017052134062N1Vice chancellor for research, Zahedan University of Medical Sciences46
Terminated
Not Applicable
The Effect of a Higher Dose of Dehydroepiandrosterone (DHEA) Supplementation in Poor RespondersInfertility
NCT02357472ShangHai Ji Ai Genetics & IVF Institute60
Completed
Phase 3
DHEA Against Vaginal Atrophy - 3-Month Efficacy StudyVaginal Atrophy
NCT01256684EndoCeutics Inc.255