Efficacy and Safety of Growth Hormone Treatment in Spinal Cord Injury
Status:
Unknown status
Trial end date:
2015-11-01
Target enrollment:
Participant gender:
Summary
Objectives: To evaluate the efficacy and safety of one year treatment based on daily doses of
exogenous growth hormone (GH) in patients with traumatic spinal cord injury. The first six
months the pharmacological treatment will be associated to rehabilitation treatment.
The main hypothesis is that GH can improve motor function of patients with traumatic spinal
cord injury below the lesion level. The hypothesis is based on possible effects of GH at
muscle and synaptic level. GH can also promote axonal growth and regeneration.
Design: Clinical trial placebo-controlled, double-blind intervention with blind evaluation by
third parties and blinding in the analysis of data (triple-blind design).
Duration of intervention and monitoring: 364 days.
Primary outcome measures. Changes of the American Spinal Injury Association (ASIA) scale
(motor score)
Phase:
Phase 3
Details
Lead Sponsor:
Hospital Nacional de Parapléjicos de Toledo
Collaborator:
Ministerio de Salud y Politicas Sociales (Ministry of Health)