Spinal Cord InjuryPhase 3GHSCINCT01329757
Efficacy and Safety of Growth Hormone Treatment in Spinal Cord Injury
A Phase 3 study testing GH in people with Spinal Cord Injury, run by Hospital Nacional de Parapléjicos de Toledo at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- GH
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2011to Nov 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Growth Hormone (GH) Treatment in Spinal Cord Injury(SCI): A Triple-blinded, Randomised, Placebo-controlled Trial
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.
Read more
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
- Being tested
- GH, Placebo
- Keywords
- Spinal Cord Injury, Growth Hormone, Trauma, Incomplete, ASIA
- Medical subject headings
- Spinal Cord Injuries, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GHDrug
Also called Genotonorm
Administration of a subcutaneously injected daily dose of GH (0.4mg)for 1 year
PlaceboDrug
Also called Provided by the Genotonorm producer (Pfizer)
Administration of a subcutaneously injected daily dose of placebo for 1 year
| Study group | Role | What they receive |
|---|---|---|
| GH | Active comparator | Administration of a daily dose of GH (0.4mg)for 1 year Receives: Drug: GH |
| Placebo | Placebo comparator | Administration of a daily dose of placebo for 1 year Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Secondary outcomes (7)
ASIA
ASIA grades
Measured: 12 months
ASIA sensory score
ASIA sensory score
Measured: 12 months
Spasticity
Penn scale and Ashworth scale
Measured: Baseline, 15 days, 6 months, 12 months
Pain
Visual analogic scale (VAS)
Measured: Baseline, 15 days, 6 months, 12 months
Independence Measures and Quality of life
Spinal Cord Indipendence Measures (SCIM) and the Quality of Life Questionnaire (EQ 5D)
Measured: 12 months
Neurophysiological Measures
Motor Evoked Potentials, Somatosensory Evoked Potentials, Motor Neurography
Measured: 6 months and 12 months
Safety
Recording of any adverse event, full blood and urine examination
Measured: 15, 30, 60, 90, 120, 150, 180, 360 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Nacional de Parapléjicos de Toledo
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Salud y Politicas Sociales (Ministry of Health)
- Responsible party
- Principal investigator, Antonio Oliviero, Hospital Nacional de Parapléjicos de Toledo
- Investigators
- Antonio Oliviero, MD, PhD, Principal investigator, Hospital Nacional de Paraplejicos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01329757
- Sponsor's protocol ID
- FHNP-CT001
- Acronym
- GHSCI
- Status last verified
- May 2022
- First submitted
- 4 Apr 2011
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Growth Hormone (GH) Treatment in Spinal Cord Injury(SCI): A Triple-blinded, Randomised, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT01329757
- Acronym / sponsor ID
- GHSCI / FHNP-CT001
- Conditions
- Spinal Cord Injury
- Keywords
- Spinal Cord Injury, Growth Hormone, Trauma, Incomplete, ASIA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Hospital Nacional de Parapléjicos de ToledoUniversity, hospital or other
- Collaborators
- Ministerio de Salud y Politicas Sociales (Ministry of Health)
- Study start
- Apr 2011 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 6 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GH | Active comparator | Drug: GHAdministration of a daily dose of GH (0.4mg)for 1 year |
| Placebo | Placebo comparator | Drug: PlaceboAdministration of a daily dose of placebo for 1 year |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GHAlso: GenotonormAdministration of a subcutaneously injected daily dose of GH (0.4mg)for 1 year | Drug | GH |
| PlaceboAlso: Provided by the Genotonorm producer (Pfizer)Administration of a subcutaneously injected daily dose of placebo for 1 year | Drug | Placebo |
Primary outcome
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).
7 secondary outcomes
ASIA
Time frame: 12 months
ASIA sensory score
Time frame: 12 months
Spasticity
Time frame: Baseline, 15 days, 6 months, 12 months
Pain
Time frame: Baseline, 15 days, 6 months, 12 months
Independence Measures and Quality of life
Time frame: 12 months
Neurophysiological Measures
Time frame: 6 months and 12 months
Safety
Time frame: 15, 30, 60, 90, 120, 150, 180, 360 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Oliviero, MD, PhD principal investigator
Hospital Nacional de Paraplejicos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GH in people with Spinal Cord Injury, run by Hospital Nacional de Parapléjicos de Toledo at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Score of the American Spinal Injury Association (ASIA) scale (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.