Efficacy and Safety of Growth Hormone Treatment in Spinal Cord Injury (GHSCI)

Hospital Nacional de Parapléjicos de Toledo

Status and phase: Completed; Phase 3

Conditions: Spinal Cord Injury

Treatments: Drug: GH; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01329757

FHNP-CT001

Details and patient eligibility

About

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)

Enrollment: 76 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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76 participants in 2 patient groups, including a placebo group

GH

Active Comparator group

Description:

Administration of a daily dose of GH (0.4mg)for 1 year

Treatment:

Drug: GH

Placebo

Placebo Comparator group

Description:

Administration of a daily dose of placebo for 1 year

Treatment:

Drug: Placebo