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Study to Assess the Efficacy and Safety of Eutropin in Prader-Willi Syndrome

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ClinicalTrials.gov Identifier: NCT02204163
Recruitment Status : Completed
First Posted : July 30, 2014
Last Update Posted : July 6, 2018
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences

Brief Summary:
Evaluate the efficacy and safety after treatment of Eutropin® inj. compared to Genotropin® in infants/toddlers with Prader-Willi syndrome

Condition or disease Intervention/treatment Phase
Prader-Willi Syndrome Drug: Eutropin Drug: Genotropin Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, Multi-center, Randomized, Comparative, Parallel, Open Study to Assess the Efficacy and Safety After Treatment of Eutropin® Inj. Compared to Genotropin® in Infants/Toddlers With Prader-Willi Syndrome
Study Start Date : June 2014
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017


Arm Intervention/treatment
Experimental: Eutropin
Eutropin 0.24mg/kg/week
Drug: Eutropin
Active Comparator: Genotropin
Genotropin 0.24mg/kg/week
Drug: Genotropin



Primary Outcome Measures :
  1. Change from baseline in height SDS (Standard Deviation Score) [ Time Frame: baseline and 52 weeks ]
  2. Change from baseline in Lean body mass [ Time Frame: baseline and 52 weeks ]
  3. Change from baseline in Percent body fat [ Time Frame: baseline and 52 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in height velocity [ Time Frame: baseline, 16, 28 and 52 weeks ]
  2. Change from baseline in head circumference [ Time Frame: baseline, 16, 28 and 52 weeks ]
  3. Change from baseline in mental development by Bayley Scale [ Time Frame: baseline, 28 and 52 weeks ]
  4. Change from baseline in motor development by Bayley Scale [ Time Frame: baseline, 28 and 52 weeks ]
  5. Change from baseline in weight SDS [ Time Frame: baseline 16, 28 and 52 weeks ]
  6. Change from baseline in BMI (Body Mass Index) [ Time Frame: baseline, 16, 28 and 52 weeks ]
  7. Change from baseline in Bone age [ Time Frame: baseline and 52 weeks ]
  8. Change from baseline in Bone mineral density [ Time Frame: baseline and 52 weeks ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Genetically diagnosed Prader-Willi Syndrome
  • Pre-pubertal at start of treatment; assessed by Tanner stage 1

Exclusion Criteria:

  • Known presence or history of malignancy
  • Impaired Fasting Glucose or Diabetes mellitus

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02204163


Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
LG Life Sciences

Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT02204163     History of Changes
Other Study ID Numbers: LG-HGCL007
First Posted: July 30, 2014    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
Prader-Willi Syndrome
Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Obesity
Overnutrition
Nutrition Disorders