Efficacy and Safety of Growth Hormone Treatment in Spinal Cord Injury (GHSCI)
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)
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Efficacy and Safety of Growth Hormone (GH) Treatment in Spinal Cord Injury(SCI): A Triple-blinded, Randomised, Placebo-controlled Trial|
- Motor Score of the American Spinal Injury Association (ASIA) scale [ Time Frame: 12 months ]Motor score of the ASIA scale reports the strenght of 10 key muscles in each body side (5 key muscles in upper limb and 5 key muscles in lower limb). The strenght is rated between 0 and 5 (Medical Research Council-MRC scale). The ASIA motor score range is between 0 and 100 (normal).
- ASIA [ Time Frame: 12 months ]ASIA grades
- ASIA sensory score [ Time Frame: 12 months ]ASIA sensory score
- Spasticity [ Time Frame: Baseline, 15 days, 6 months, 12 months ]Penn scale and Ashworth scale
- Pain [ Time Frame: Baseline, 15 days, 6 months, 12 months ]Visual analogic scale (VAS)
- Independence Measures and Quality of life [ Time Frame: 12 months ]Spinal Cord Indipendence Measures (SCIM) and the Quality of Life Questionnaire (EQ 5D)
- Neurophysiological Measures [ Time Frame: 6 months and 12 months ]Motor Evoked Potentials, Somatosensory Evoked Potentials, Motor Neurography
- Safety [ Time Frame: 15, 30, 60, 90, 120, 150, 180, 360 days ]Recording of any adverse event, full blood and urine examination
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||November 2015|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
Active Comparator: GH
Administration of a daily dose of GH (0.4mg)for 1 year
Administration of a subcutaneously injected daily dose of GH (0.4mg)for 1 year
Other Name: Genotonorm
Placebo Comparator: Placebo
Administration of a daily dose of placebo for 1 year
Administration of a subcutaneously injected daily dose of placebo for 1 year
Other Name: Provided by the Genotonorm producer (Pfizer)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01329757
|Hospital Nacional de Paraplejicos|
|Toledo, Spain, 45004|
|Principal Investigator:||Antonio Oliviero, MD, PhD||Hospital Nacional de Paraplejicos|