Growth Hormone in Amyotrophic Lateral Sclerosis

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Federico II University
• Collaborators: Agenzia Italiana del Farmaco; Istituto Biostrutture e Immagini, CNR Naples
• Treatments: Hormones

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