Efficacy and Safety of Growth Hormone Treatment in Spinal Cord Injury

Phase 3

Completed

• Conditions: Spinal Cord Injury
• Interventions: Drug: GH; Drug: Placebo

• Registration Number: NCT01329757
• Lead Sponsor: Hospital Nacional de Parapléjicos de Toledo

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-04
• Study First Submitted QC: 2011-04-05
• Study First Posted: 2011-04-06
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-27
• Last Update Posted: 2022-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GH	GH	Administration of a daily dose of GH (0.4mg)for 1 year
Placebo	Placebo	Administration of a daily dose of placebo for 1 year

Primary Outcome Measures

Name	Time	Method
Motor Score of the American Spinal Injury Association (ASIA) scale	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 Outcome Measures

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

Trial Locations

Locations (1)

Hospital Nacional de Paraplejicos; 🇪🇸 Toledo, Spain