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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Hospital Nacional de Parapléjicos de Toledo:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 76
Study Start Date: April 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01329757

Contacts
Contact: Antonio Oliviero, MD, PhD +34925247700 ext 47831 antonioo@sescam.jccm.es

Locations
Spain
Hospital Nacional de Paraplejicos Recruiting
Toledo, Spain, 45004
Contact: Antonio Oliviero, MD, PhD    +34925247700 ext 47831    antonioo@sescam.jccm.es   
Principal Investigator: Antonio Oliviero, MD, PhD         
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

No publications provided

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
Study First Received: April 4, 2011
Last Updated: November 19, 2012
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

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

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

ClinicalTrials.gov processed this record on October 19, 2014