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Prospective Follow-up of Patients With Glycogen Storage Disease Type III (PRO GSDIII)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2012 by Institut de Myologie, France.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01563705
First Posted: March 27, 2012
Last Update Posted: December 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Institut de Myologie, France
March 21, 2012
March 27, 2012
December 20, 2012
February 2011
August 2016   (Final data collection date for primary outcome measure)
  • Knee flexion and extension strength [ Time Frame: at baseline ]
  • Knee flexion and extension strength [ Time Frame: 2 years after baseline ]
  • Knee flexion and extension strength [ Time Frame: 4 years after baseline ]
  • Time to perform each motor function test [ Time Frame: at baseline ]
  • Time to perform each motor function test [ Time Frame: 2 years after baseline ]
  • Time to perform each motor function test [ Time Frame: 4 years after baseline ]
  • Gait speed measured during the 6 minutes walk test [ Time Frame: at baseline ]
  • Gait speed measured during the 6 minutes walk test [ Time Frame: 2 years after baseline ]
  • Gait speed measured during the 6 minutes walk test [ Time Frame: 4 years after baseline ]
Same as current
Complete list of historical versions of study NCT01563705 on ClinicalTrials.gov Archive Site
  • Accelerometric variables measured for the 6 minutes walk test [ Time Frame: At baseline ]
  • Accelerometric variables measured for the 6 minutes walk test [ Time Frame: 2 years after baseline ]
  • Accelerometric variables measured for the 6 minutes walk test [ Time Frame: 4 years after baseline ]
  • NMR variables measured during each specific NMR sequence [ Time Frame: at baseline ]
  • NMR variables measured during each specific NMR sequence [ Time Frame: 2 years after baseline ]
  • NMR variables measured during each specific NMR sequence [ Time Frame: 4 years after baseline ]
Same as current
Not Provided
Not Provided
 
Prospective Follow-up of Patients With Glycogen Storage Disease Type III
Prospective Follow-up of Patients With Glycogen Storage Disease Type III
The aim of this study is to improve knowledge of natural history and methods of monitoring the evolution of Glycogen storage disease type III regarding the muscle and to study the prospective approach of large series of patients, and using the same protocol for the follow up of the children and adults.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Neuromuscular Disorders
  • Procedure: Different motor function tests
    Time to rise from a chair, time to go from lying to sitting, time to go from lying to standing, time to cover 10 meters, time to climb 4 steps
  • Procedure: Manual dexterity assessment
    Purdue pegboard test
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
30
August 2016
August 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients with a debranching enzyme deficiency confirmed by enzymatic analysis (debranching enzyme deficiency).
  • Written consent
  • Age: at least 10 years
  • Affiliated with a social security system

Exclusion Criteria:

  • Pregnant and lactating women
Sexes Eligible for Study: All
10 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01563705
2010-A00615-34
No
Not Provided
Not Provided
Institut de Myologie, France
Institut de Myologie, France
Not Provided
Not Provided
Institut de Myologie, France
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP