A Phase 2 interventional study of Growth Hormone (Somatropin) and Placebo in Amyotrophic Lateral Sclerosis, sponsored by Federico II University. Completed at 2 sites in Italy. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2010-05-27.
Sponsored by Federico II University · Phase 2, Interventional, and Treatment
Several drugs have been proposed for ALS. These drugs included: Topiramate, Lamotrigine, creatine, Vit. E, Pentoxifylline, etc. Although most of the trials showed a positive trend, none of them reached a statistically significant result. The only exception is the Riluzole trial, that demonstrated a small but significant reduction in mortality between treated and untreated patients. Aim of our study is to determine if the add-on of GH to treatment with Riluzole is able to reduce neuronal loss in the motor cortex of ALS patients.
Several drugs have been proposed for ALS. These drugs included: Topiramate, Lamotrigine, creatine, Vit. E, Pentoxifylline. Although most of the trials showed a positive trend, none of them reached a statistically significant result. The only exception is the Riluzole trial, that demonstrated a small but significant reduction in mortality between treated and untreated patients. When administered to SOD-1 transgenic mice, IGF-I prolongs survival, ameliorates muscular strength, and reduces weight and motor neuron loss, astrocyte gliosis, and ubiquitin positive protein inclusions.
Two clinical trials have been performed in ALS patients with s.c. administration of IGF-I indicating a possible beneficial effect, and a third clinical trial is in progress. Methionyl growth hormone (mGH) showed no effect on survival, disease progression and muscular strength. MGH was administered at a fixed dose and peripheral production of IGF-I appeared to be normal. We propose a double-blind trial of Growth Hormone (GH) as add-on therapy to Riluzole, with an individually regulated dose based on the peripheral response of IGF-I. Aim of our study is to determine if the add-on of GH to treatment with Riluzole is able to reduce neuronal loss in the motor cortex of ALS patients. As secondary objectives, effect of GH on mortality, QoL, and motor function will be assessed.
717 studies on the registry are indexed under Motor Neuron Disease; 137 are open to participants now.
This study's planned enrollment of 40 is above the median of 35 across 461 interventional studies indexed under Motor Neuron Disease.
Browse Motor Neuron Disease studies →Federico II University is the lead sponsor of 356 studies on the registry; 60 are open to participants now.
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Exclusion Criteria:
Patients randomly assigned to treatment
Drug: Growth Hormone (Somatropin)
Patients randomly assigned to placebo
Drug: Placebo
The initial dose will be 2U s.c. every other day. The dose will be progressively increased to reach 1.5-2x the normal levels of IGF-I.
Also known as: Saizen 8mg
Same as for Growth hormone group
Also known as: Saizen 8mg placebo
Primary endpoint is the N-acetylaspartate/Creatine ratio in the motor cortex assessed with magnetic resonance spectroscopy.
Time frame: 0, 6 and 12 months after treatment start
Difference in mortality between groups
Time frame: 12 months
Difference in the ALS-FRS score (motor function scale)
Time frame: 0, 6, and 12 months after treatment start
Difference in the SF-36 score (quality of life )
Time frame: 0, 6, and 12 monthst after treatmetn start
Safety and tolerability
Time frame: 12 months
This study is completed, as verified in May 2010. You cannot join it, but the record below documents what was studied.
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Federico II University