Trial | NCT01329757  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    somatropin ...

  • Study Participants

    76
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)
Study Started
Apr 30
2011
Primary Completion
Nov 30
2015
Study Completion
Nov 30
2015
Last Update
May 31
2022

Drug GH

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

  • Other names: Genotonorm

Drug Placebo

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

  • Other names: Provided by the Genotonorm producer (Pfizer)

GH Active Comparator

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

Placebo Placebo Comparator

Administration of a daily dose of placebo for 1 year

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
No Results Posted