NCT01329757

Brief 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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2011

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 6, 2011

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

May 31, 2022

Status Verified

May 1, 2022

Enrollment Period

4.6 years

First QC Date

April 4, 2011

Last Update Submit

May 27, 2022

Conditions

Spinal Cord Injury

Keywords

Spinal Cord InjuryGrowth HormoneTraumaIncompleteASIA

Outcome Measures

Primary Outcomes (1)

  • Motor Score of the American Spinal Injury Association (ASIA) scale

    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).

    12 months

Secondary Outcomes (7)

  • ASIA

    12 months

  • ASIA sensory score

    12 months

  • Spasticity

    Baseline, 15 days, 6 months, 12 months

  • Pain

    Baseline, 15 days, 6 months, 12 months

  • Independence Measures and Quality of life

    12 months

  • +2 more secondary outcomes

Study Arms (2)

GH

ACTIVE COMPARATOR

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

Drug: GH

Placebo

PLACEBO COMPARATOR

Administration of a daily dose of placebo for 1 year

Drug: Placebo

Interventions

GHDRUG

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

Also known as: Genotonorm
GH
PlaceboDRUG

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

Also known as: Provided by the Genotonorm producer (Pfizer)
Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Nacional de Paraplejicos

Toledo, 45004, Spain

Location

MeSH Terms

Conditions

Spinal Cord InjuriesWounds and Injuries

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous System

Intervention Hierarchy (Ancestors)

Growth HormonePituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Antonio Oliviero, MD, PhD

    Hospital Nacional de Paraplejicos

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Neurologist

Study Record Dates

First Submitted

April 4, 2011

First Posted

April 6, 2011

Study Start

April 1, 2011

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

May 31, 2022

Record last verified: 2022-05

Locations

ES(1)