Trial | NCT00635960  Report issue

Title

Growth Hormone in Amyotrophic Lateral Sclerosis
Efficacy, Safety and Tolerability of Growth Hormone in Patients With Amyotrophic Lateral Sclerosis as add-on Therapy to Riluzole

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    somatropin ...

  • Study Participants

    40
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.
Study Started
Mar 31
2007
Primary Completion
Jul 31
2009
Study Completion
May 31
2010
Last Update
May 27
2010
Estimate

Drug Growth Hormone (Somatropin)

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.

  • Other names: Saizen 8mg

Drug Placebo

Same as for Growth hormone group

  • Other names: Saizen 8mg placebo

1 Experimental

Patients randomly assigned to treatment

2 Placebo Comparator

Patients randomly assigned to placebo

Criteria 

Inclusion Criteria:

Definite/probable ALS according to El Escorial criteria
Aged > 40, < 85 years
Progression from onset
Disease duration ≤3 years
Treatment with Riluzole

Exclusion Criteria:

Rapid disease progression in the first 6 months after diagnosis
Patients with tracheostomy and/or Gastrostomy
Disease duration > 3 years
Patient with exclusive bulbar or 2° motorneuron involvement
Hepatic/renal failure
Pregnant or breastfeeding
Signs of active neoplasia
Complicated Diabetes
Severe hypertension
Unable to undergo MRI exams
No Results Posted