NCT01329757

Efficacy and Safety of Growth Hormone Treatment in Spinal Cord Injury

Efficacy and Safety of Growth Hormone (GH) Treatment in Spinal Cord Injury(SCI): A Triple-blinded, Randomised, Placebo-controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Hospital Nacional de Parapléjicos de Toledo · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Spinal Cord Injury

Interventions

Type	Name	Description
DRUG	GH	Administration of a subcutaneously injected daily dose of GH (0.4mg)for 1 year
DRUG	Placebo	Administration of a subcutaneously injected daily dose of placebo for 1 year

Timeline

• Start date: 2011-04-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2011-04-06
• Last updated: 2022-05-31

Locations

1 site across 1 country: Spain