Efficacy and Safety of Growth Hormone Treatment in Spinal Cord Injury

Spinal Cord Injury Clinical Trial

— GHSCI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01329757
• Other study ID #: FHNP-CT001
• Status: Completed
• Phase: Phase 3
• Start date: April 2011
• Est. completion date: November 2015

Study information

• Verified date: May 2022
• Source: Hospital Nacional de Parapléjicos de Toledo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

Drug:
• GH
Administration of a subcutaneously injected daily dose of GH (0.4mg)for 1 year
• Placebo
Administration of a subcutaneously injected daily dose of placebo for 1 year

Locations

Country	Name	City	State
Spain	Hospital Nacional de Paraplejicos	Toledo

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Nacional de Parapléjicos de Toledo	Ministerio de Salud y Politicas Sociales (Ministry of Health)

Country where clinical trial is conducted

Spain, 

Outcome

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