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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Hospital Nacional de Parapléjicos de Toledo
Sponsor:
Collaborator:
Ministerio de Salud y Politicas Sociales (Ministry of Health)
Information provided by (Responsible Party):
Antonio Oliviero, Hospital Nacional de Parapléjicos de Toledo
ClinicalTrials.gov Identifier:
NCT01329757
First received: April 4, 2011
Last updated: November 19, 2012
Last verified: November 2012

April 4, 2011
November 19, 2012
April 2011
December 2014   (final data collection date for primary outcome measure)
Motor Score of the American Spinal Injury Association (ASIA) scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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).
Same as current
Complete list of historical versions of study NCT01329757 on ClinicalTrials.gov Archive Site
  • ASIA [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    ASIA grades
  • ASIA sensory score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    ASIA sensory score
  • Spasticity [ Time Frame: Baseline, 15 days, 6 months, 12 months ] [ Designated as safety issue: Yes ]
    Penn scale and Ashworth scale
  • Pain [ Time Frame: Baseline, 15 days, 6 months, 12 months ] [ Designated as safety issue: Yes ]
    Visual analogic scale (VAS)
  • Independence Measures and Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Spinal Cord Indipendence Measures (SCIM) and the Quality of Life Questionnaire (EQ 5D)
  • Neurophysiological Measures [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
    Motor Evoked Potentials, Somatosensory Evoked Potentials, Motor Neurography
  • Safety [ Time Frame: 15, 30, 60, 90, 120, 150, 180, 360 days ] [ Designated as safety issue: Yes ]
    Recording of any adverse event, full blood and urine examination
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Growth Hormone Treatment in Spinal Cord Injury
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)

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Spinal Cord Injury
  • Drug: GH
    Administration of a subcutaneously injected daily dose of GH (0.4mg)for 1 year
    Other Name: Genotonorm
  • Drug: Placebo
    Administration of a subcutaneously injected daily dose of placebo for 1 year
    Other Name: Provided by the Genotonorm producer (Pfizer)
  • Active Comparator: GH
    Administration of a daily dose of GH (0.4mg)for 1 year
    Intervention: Drug: GH
  • Placebo Comparator: Placebo
    Administration of a daily dose of placebo for 1 year
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
76
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Antonio Oliviero, MD, PhD +34925247700 ext 47831 antonioo@sescam.jccm.es
Spain
 
NCT01329757
FHNP-CT001
Yes
Antonio Oliviero, Hospital Nacional de Parapléjicos de Toledo
Hospital Nacional de Parapléjicos de Toledo
Ministerio de Salud y Politicas Sociales (Ministry of Health)
Principal Investigator: Antonio Oliviero, MD, PhD Hospital Nacional de Paraplejicos
Hospital Nacional de Parapléjicos de Toledo
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP