Efficacy and Safety of Growth Hormone Treatment in Spinal Cord Injury

Study Overview
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Brief Summary
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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)

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

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Drug: GH
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 A history of heart disease, diabetes or hypertension Concomitant Neurological Diseases Regular use of substances of abuse Patients with severe kidney and / or liver failure. Patients who can not be included in an intensive rehabilitation program Patients who are pregnant or breast-feeding History of malignancy Impossibility to obtain informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GH<br>Administration of a daily dose of GH (0.4mg)for 1 year | Drug: GH<br>* Administration of a subcutaneously injected daily dose of GH (0.4mg)for 1 year<br>* Other names: Genotonorm;|
| Placebo Comparator: Placebo<br>Administration of a daily dose of placebo for 1 year | Drug: Placebo<br>* Administration of a subcutaneously injected daily dose of placebo for 1 year<br>* Other names: Provided by the Genotonorm producer (Pfizer);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor Score of the American Spinal Injury Association (ASIA) scale | 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). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ASIA | ASIA grades | 12 months | 
| ASIA sensory score | ASIA sensory score | 12 months | 
| Spasticity | Penn scale and Ashworth scale | Baseline, 15 days, 6 months, 12 months | 
| Pain | Visual analogic scale (VAS) | Baseline, 15 days, 6 months, 12 months | 
| Independence Measures and Quality of life | Spinal Cord Indipendence Measures (SCIM) and the Quality of Life Questionnaire (EQ 5D) | 12 months | 
| Neurophysiological Measures | Motor Evoked Potentials, Somatosensory Evoked Potentials, Motor Neurography | 6 months and 12 months | 
| Safety | Recording of any adverse event, full blood and urine examination | 15, 30, 60, 90, 120, 150, 180, 360 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal Cord Injury, Growth Hormone, Trauma, Incomplete, ASIA