Pilot Study of Growth Hormon to Treat SMA Typ II and III

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether Growth hormon can increase strength in spinal muscular atrophy type II and III.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Freiburg
• Collaborator: Novo Nordisk A/S

Criteria

Inclusion Criteria:

• genetically confirmed diagnosis of Spinal Muscular Disease

• 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:

• pregnancy or lactation

• 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