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

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

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)

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Drug: GH; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Toledo, Spain, 45004
    • Hospital Nacional de Parapléjicos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: GH; Administration of a daily dose of GH (0.4mg)for 1 year	Drug: GH; Administration of a subcutaneously injected daily dose of GH (0.4mg)for 1 year; Other Names: Genotonorm
PLACEBO_COMPARATOR: Placebo; Administration of a daily dose of placebo for 1 year	Drug: Placebo; Administration of a subcutaneously injected daily dose of placebo for 1 year; Other Names: Provided by the Genotonorm producer (Pfizer)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital Nacional de Parapléjicos de Toledo
• Collaborators: Ministerio de Salud y Politicas Sociales (Ministry of Health)

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2011
• Primary Completion (ACTUAL): November 1, 2015
• Study Completion (ACTUAL): November 1, 2015

Study Registration Dates

• First Submitted: April 4, 2011
• First Submitted That Met QC Criteria: April 5, 2011
• First Posted (ESTIMATE): April 6, 2011

Study Record Updates

• Last Update Posted (ACTUAL): May 31, 2022
• Last Update Submitted That Met QC Criteria: May 27, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Growth Hormone; Spinal Cord Injury; Trauma; Incomplete; ASIA
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: FHNP-CT001