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NCT Number: NCT01329757

Efficacy and Safety of Growth Hormone Treatment in Spinal Cord Injury

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)

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Nacional de Paraplejicos

Toledo, 45004, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GH

Drug

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

Other names: Genotonorm

Placebo

Drug

Administration of a subcutaneously injected daily dose of placebo for 1 year

Other names: Provided by the Genotonorm producer (Pfizer)

Primary outcomes

  1. 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 outcomes

  1. ASIA

    Time frame: 12 months

    ASIA grades

  2. ASIA sensory score

    Time frame: 12 months

    ASIA sensory score

  3. Spasticity

    Time frame: Baseline, 15 days, 6 months, 12 months

    Penn scale and Ashworth scale

  4. Pain

    Time frame: Baseline, 15 days, 6 months, 12 months

    Visual analogic scale (VAS)

  5. Independence Measures and Quality of life

    Time frame: 12 months

    Spinal Cord Indipendence Measures (SCIM) and the Quality of Life Questionnaire (EQ 5D)

  6. Neurophysiological Measures

    Time frame: 6 months and 12 months

    Motor Evoked Potentials, Somatosensory Evoked Potentials, Motor Neurography

  7. Safety

    Time frame: 15, 30, 60, 90, 120, 150, 180, 360 days

    Recording of any adverse event, full blood and urine examination

Sponsors and collaborators

Lead sponsor

Hospital Nacional de Parapléjicos de Toledo

Other

Collaborators

  • Ministerio de Salud y Politicas Sociales (Ministry of Health)

Registry information

Official study title

Efficacy and Safety of Growth Hormone (GH) Treatment in Spinal Cord Injury(SCI): A Triple-blinded, Randomised, Placebo-controlled Trial

Acronym: GHSCI

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Apr 6, 2011
Registry last updated
May 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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