search
Back to results

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

Primary Purpose

Spinal Cord Injury

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
GH
Placebo
Sponsored by
Hospital Nacional de Parapléjicos de Toledo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring Spinal Cord Injury, Growth Hormone, Trauma, Incomplete, ASIA

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital Nacional de Paraplejicos

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

GH

Placebo

Arm Description

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

Administration of a daily dose of placebo for 1 year

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

ASIA
ASIA grades
ASIA sensory score
ASIA sensory score
Spasticity
Penn scale and Ashworth scale
Pain
Visual analogic scale (VAS)
Independence Measures and Quality of life
Spinal Cord Indipendence Measures (SCIM) and the Quality of Life Questionnaire (EQ 5D)
Neurophysiological Measures
Motor Evoked Potentials, Somatosensory Evoked Potentials, Motor Neurography
Safety
Recording of any adverse event, full blood and urine examination

Full Information

First Posted
April 4, 2011
Last Updated
May 27, 2022
Sponsor
Hospital Nacional de Parapléjicos de Toledo
Collaborators
Ministerio de Salud y Politicas Sociales (Ministry of Health)
search

1. Study Identification

Unique Protocol Identification Number
NCT01329757
Brief Title
Efficacy and Safety of Growth Hormone Treatment in Spinal Cord Injury
Acronym
GHSCI
Official Title
Efficacy and Safety of Growth Hormone (GH) Treatment in Spinal Cord Injury(SCI): A Triple-blinded, Randomised, Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
April 2011 (Actual)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Nacional de Parapléjicos de Toledo
Collaborators
Ministerio de Salud y Politicas Sociales (Ministry of Health)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
Spinal Cord Injury, Growth Hormone, Trauma, Incomplete, ASIA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GH
Arm Type
Active Comparator
Arm Description
Administration of a daily dose of GH (0.4mg)for 1 year
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Administration of a daily dose of placebo for 1 year
Intervention Type
Drug
Intervention Name(s)
GH
Other Intervention Name(s)
Genotonorm
Intervention Description
Administration of a subcutaneously injected daily dose of GH (0.4mg)for 1 year
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Provided by the Genotonorm producer (Pfizer)
Intervention Description
Administration of a subcutaneously injected daily dose of placebo for 1 year
Primary Outcome Measure Information:
Title
Motor Score of the American Spinal Injury Association (ASIA) scale
Description
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).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
ASIA
Description
ASIA grades
Time Frame
12 months
Title
ASIA sensory score
Description
ASIA sensory score
Time Frame
12 months
Title
Spasticity
Description
Penn scale and Ashworth scale
Time Frame
Baseline, 15 days, 6 months, 12 months
Title
Pain
Description
Visual analogic scale (VAS)
Time Frame
Baseline, 15 days, 6 months, 12 months
Title
Independence Measures and Quality of life
Description
Spinal Cord Indipendence Measures (SCIM) and the Quality of Life Questionnaire (EQ 5D)
Time Frame
12 months
Title
Neurophysiological Measures
Description
Motor Evoked Potentials, Somatosensory Evoked Potentials, Motor Neurography
Time Frame
6 months and 12 months
Title
Safety
Description
Recording of any adverse event, full blood and urine examination
Time Frame
15, 30, 60, 90, 120, 150, 180, 360 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Oliviero, MD, PhD
Organizational Affiliation
Hospital Nacional de Paraplejicos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Nacional de Paraplejicos
City
Toledo
ZIP/Postal Code
45004
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of Growth Hormone Treatment in Spinal Cord Injury

We'll reach out to this number within 24 hrs