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| Name | Class |
|---|---|
| Ministerio de Salud y Politicas Sociales (Ministry of Health) | UNKNOWN |
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GH | Active Comparator | Administration of a daily dose of GH (0.4mg)for 1 year |
|
| Placebo | Placebo Comparator | Administration of a daily dose of placebo for 1 year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GH | Drug | Administration of a subcutaneously injected daily dose of GH (0.4mg)for 1 year |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| ASIA | ASIA grades | 12 months |
| ASIA sensory score | ASIA sensory score | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Oliviero, MD, PhD | Hospital Nacional de Paraplejicos | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Nacional de Paraplejicos | Toledo | 45004 | Spain |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D019382 | Human Growth Hormone |
| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
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| Placebo | Drug | Administration of a subcutaneously injected daily dose of placebo for 1 year |
|
|
| 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 |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |