Status:
COMPLETED
Low Protein Diet in Patients With Collagen VI Related Myopathies
Lead Sponsor:
Istituto Ortopedico Rizzoli
Conditions:
Bethlem Myopathy
Ullrich Congenital Muscular Dystrophy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
* This is a 2 stage exploratory study with a 3-month observational phase on the natural course, followed by a 12-month, open-label, non-comparative, single-arm, phase II pilot study on the efficacy, s...
Eligibility Criteria
Inclusion
- Males or females aged ≥18 years.
- Women of childbearing age must have a negative pregnancy test and must use adequate contraception during the study.
- Clinical and molecular diagnosis of Bethlem myopathy or Ullrich congenital muscular dystrophy.
- No previous treatment with CsA within 6 months prior to the start of the study.
- Willing and able to adhere to the study visit schedule and other protocol requirements.
- Written informed consent signed.
Exclusion
- Current or history of liver or renal disease.
- Pregnant or breast-feeding women.
- Any serious internal medicine condition interfering with the study.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01438788
Start Date
October 1 2011
End Date
September 1 2013
Last Update
October 31 2016
Active Locations (1)
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1
Istituto Ortopedico Rizzoli
Bologna, Italy, 40136