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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2015 by Antonio Oliviero, Hospital Nacional de Parapléjicos de Toledo.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01329757
First Posted: April 6, 2011
Last Update Posted: January 12, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ministerio de Salud y Politicas Sociales (Ministry of Health)
Information provided by (Responsible Party):
Antonio Oliviero, Hospital Nacional de Parapléjicos de Toledo
  Purpose

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)


Condition Intervention Phase
Spinal Cord Injury Drug: GH Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Growth Hormone (GH) Treatment in Spinal Cord Injury(SCI): A Triple-blinded, Randomised, Placebo-controlled Trial

Resource links provided by NLM:


Further study details as provided by Antonio Oliviero, Hospital Nacional de Parapléjicos de Toledo:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • ASIA [ Time Frame: 12 months ]
    ASIA grades

  • ASIA sensory score [ Time Frame: 12 months ]
    ASIA sensory score

  • Spasticity [ Time Frame: Baseline, 15 days, 6 months, 12 months ]
    Penn scale and Ashworth scale

  • Pain [ Time Frame: Baseline, 15 days, 6 months, 12 months ]
    Visual analogic scale (VAS)

  • Independence Measures and Quality of life [ Time Frame: 12 months ]
    Spinal Cord Indipendence Measures (SCIM) and the Quality of Life Questionnaire (EQ 5D)

  • Neurophysiological Measures [ Time Frame: 6 months and 12 months ]
    Motor Evoked Potentials, Somatosensory Evoked Potentials, Motor Neurography

  • Safety [ Time Frame: 15, 30, 60, 90, 120, 150, 180, 360 days ]
    Recording of any adverse event, full blood and urine examination


Estimated Enrollment: 76
Study Start Date: April 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Provided by the Genotonorm producer (Pfizer)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01329757


Locations
Spain
Hospital Nacional de Paraplejicos
Toledo, Spain, 45004
Sponsors and Collaborators
Hospital Nacional de Parapléjicos de Toledo
Ministerio de Salud y Politicas Sociales (Ministry of Health)
Investigators
Principal Investigator: Antonio Oliviero, MD, PhD Hospital Nacional de Paraplejicos
  More Information

Responsible Party: Antonio Oliviero, MD, PhD, Neurologist, Hospital Nacional de Parapléjicos de Toledo
ClinicalTrials.gov Identifier: NCT01329757     History of Changes
Other Study ID Numbers: FHNP-CT001
First Submitted: April 4, 2011
First Posted: April 6, 2011
Last Update Posted: January 12, 2015
Last Verified: January 2015

Keywords provided by Antonio Oliviero, Hospital Nacional de Parapléjicos de Toledo:
Spinal Cord Injury
Growth Hormone
Trauma
Incomplete
ASIA

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs