Pilot Study of Growth Hormon to Treat SMA Typ II and III
NCT ID: NCT00533221
Last Updated: 2013-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2007-10-31
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Somatotropin
subcutaneous application of somatotropin over 12 weeks followed by 8 weeks wash out period followed by 12 weeks subcutaneous placebo application
somatotropin
0,015 mg/kg/d as one dose s.c. in the evening over one week followed by a 11 week period with 0,03 mg/kg/d s.c. as one dose in the evening
Placebo
12 weeks placebo subcutaneous application followed by 8 weeks wash out and 12 weeks subcutaneous application of somatotropin
Placebo
0,015 mg/kg/d as one dose s.c. in the evening over one week followed by a 11 week period with 0,03 mg/kg/d s.c. as one dose in the evening
Interventions
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somatotropin
0,015 mg/kg/d as one dose s.c. in the evening over one week followed by a 11 week period with 0,03 mg/kg/d s.c. as one dose in the evening
Placebo
0,015 mg/kg/d as one dose s.c. in the evening over one week followed by a 11 week period with 0,03 mg/kg/d s.c. as one dose in the evening
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Spinal muscular atrophy type II or III
* age between 6 years and 35 years
* ability to perform the tests for measurement of muscle strength (handheld myometry)
* informed consent of the patient and/or parents
Exclusion Criteria
* woman with child bearing potential without contraception
* overweight or BMI over 30 kg/m²
* Treatment with other drugs, that can influence strength 8 weeks before participation in the study or during participation
* medical history or evidence of a malignant or cerebral tumor
* cardiovascular, intestinal, endocrinologically or airway disease
* Hypertension
* growth hormone deficiency
* hypersensitivity to one component part of the study medication
* participation on a clinical trial during the study or 3 month before
* abuse to drugs or alcohol
* patient incapable of contracting or not able to understand the character, meaning and consequences of the clinical trial
6 Years
35 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
University Hospital Freiburg
OTHER
Responsible Party
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Janbernd Kirschner
MD
Principal Investigators
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Rudolf Korinthenberg, Professor
Role: PRINCIPAL_INVESTIGATOR
University medical centre Freiburg, children's hospital
Locations
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von Haunersches Kinderspital
Munich, Bavaria, Germany
University Children'S Hospital
Göttingen, Lower Saxony, Germany
University Children'S Hospital
Essen, North Rhine-Westphalia, Germany
University Children'S Hospital
Mainz, Rhineland-Palatinate, Germany
University Children'S Hospital
Kiel, Schleswig-Holstein, Germany
Charité, Department of Neurpaediatrics
Berlin, State of Berlin, Germany
Countries
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References
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Kirschner J, Schorling D, Hauschke D, Rensing-Zimmermann C, Wein U, Grieben U, Schottmann G, Schara U, Konrad K, Muller-Felber W, Thiele S, Wilichowski E, Hobbiebrunken E, Stettner GM, Korinthenberg R. Somatropin treatment of spinal muscular atrophy: a placebo-controlled, double-blind crossover pilot study. Neuromuscul Disord. 2014 Feb;24(2):134-42. doi: 10.1016/j.nmd.2013.10.011. Epub 2013 Nov 13.
Related Links
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University Children's Hospital Freiburg, Germany
Other Identifiers
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2005-002822-78
Identifier Type: -
Identifier Source: secondary_id
SMA-GH
Identifier Type: -
Identifier Source: org_study_id