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

May 27, 2022 updated by: Antonio Oliviero, Hospital Nacional de Parapléjicos de Toledo

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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).
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Nacional de Parapléjicos de Toledo

Collaborators

Ministerio de Salud y Politicas Sociales (Ministry of Health)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FHNP-CT001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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