Efficacy and Safety of Growth Hormone (GH) Treatment in Spinal Cord Injury(SCI): A Triple-blinded, Randomised, Placebo-controlled Trial
Overview
- Phase
- Phase 3
- Intervention
- GH
- Conditions
- Spinal Cord Injury
- Sponsor
- Hospital Nacional de Parapléjicos de Toledo
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- Motor Score of the American Spinal Injury Association (ASIA) scale
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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)
Investigators
Antonio Oliviero
MD, PhD, Neurologist
Hospital Nacional de Parapléjicos de Toledo
Eligibility Criteria
Inclusion Criteria
- •Traumatic Spinal cord injury
- •Incomplete (ASIA scale B or C)
- •Level of injury: Between C4 and D12
- •More than 18 months from the SCI injury.
Exclusion Criteria
- •Non traumatic Spinal cord injury
- •Complete SCI (ASIA A)
- •Incomplete (ASIA D or E)
- •Less than 18 months from the SCI
- •Intensive Care Unit (ICU) staying for a period of 2 months or more
- •More than 3 urological infections in the last year
- •Pneumonia in the 6 months prior to the study
- •Severe respiratory failure
- •History of head trauma
- •Severe psychiatric disorder
Arms & Interventions
GH
Administration of a daily dose of GH (0.4mg)for 1 year
Intervention: GH
Placebo
Administration of a daily dose of placebo for 1 year
Intervention: Placebo
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- ASIA(12 months)
- ASIA sensory score(12 months)
- Spasticity(Baseline, 15 days, 6 months, 12 months)
- Pain(Baseline, 15 days, 6 months, 12 months)
- Independence Measures and Quality of life(12 months)
- Neurophysiological Measures(6 months and 12 months)
- Safety(15, 30, 60, 90, 120, 150, 180, 360 days)