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Efficacy and Safety of Growth Hormone Treatment in Spinal Cord Injury

NCT01329757 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2022-05-31

No results posted yet for this study

Summary

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)

Conditions

  • Spinal Cord Injury

Interventions

DRUG

GH

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

DRUG

Placebo

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

Sponsors & Collaborators

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

    collaborator UNKNOWN

  • Hospital Nacional de Parapléjicos de Toledo

    lead OTHER

Principal Investigators

  • Antonio Oliviero, MD, PhD · Hospital Nacional de Paraplejicos

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • Spain

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01329757 on ClinicalTrials.gov