drugset / Trial / NCT00635960
Growth Hormone in Amyotrophic Lateral Sclerosis
Phase 2
Completed
40 enrolled
Federico II University
Agenzia Italiana del Farmaco · collabIstituto Biostrutture e Immagini, CNR Naples · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2007-03
- Primary completion
- 2009-07
- Completion
- 2010-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Somatropin | Protein / enzyme biologic | 2 iu | Subcutaneous |