Head InjuryPhase 2NCT00329758
Effect of Rosuvastatin on Amnesia and Orientation Through Galveston Outcome Amnesia Test in Moderate Head Injury
A Phase 2 study testing rosuvastatin in people with Head Injury, run by Universidad Autonoma de San Luis Potosí at 1 site in Mexico.
Trial summary
The purpose of this study is to determine whether rosuvastatin is effective in the management of moderate head injury by improving amnesia and orientation. Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Head Injury
- What is being tested?
- rosuvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteMexico
- Study dates
- Jul 2006to Oct 2007
- Phase
- Phase 2
- 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 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Man or woman >16 and <50 years with HI less 24 hours in progression and Glasgow between 9 y 12.
- Man or woman >16 and <50 years with HI and Glasgow l3, with lesions in TC scan.
- Acceptance of family to participate (first grade).
Who cannot join
- History of HI with disability
- History of neurological or psychiatric disease with disability.
- Administration 24 hrs previous of: fibrates, niacin, ciclosporin, azoles, macrolides, inhibitors of protease, nefazodone, verapamil, diltiazem,amiodarone.
- Existence of systemic injury with life in compromise (massive bleeding, exposition of bone in fracture, hepatic or splenic laceration or in great vessels and shock).
- Administration of THAM, mannitol, barbiturates, corticosteroids, scavengers of free radicals, inhibitors of lipidic peroxidation, indometacin, calcium antagonist, antagonists of neurotransmitters
- Existence of intracranial lesion which needs surgery.
Show all 11Show fewer
- Lesions not classifiable or in brainstem.
- Allergy to the drug.
- Hepatopathy or myopathy (or) history of this, or clinical data of hepatic disease.
- Management previous in other Hospital.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Central "Dr. Ignacio Morones Prieto"
San Luis Potosí City, San Luis Potosí, 78240
About this study
Official title: Phase II Study of Rosuvastatin´s Effect on Amnesia and Orientation Through Galveston Outcome Amnesia Test in Humans With Moderate Head Injury
The purpose of this study is to determine whether rosuvastatin is effective in the management of moderate head injury by improving amnesia and orientation.
Read the detailed description
The head injury is a frequent problem of health, which produces high morbid-mortality. Today is the main cause of death and disability between 18 and 40 years. In addition it originates expensive expenses in health care systems.
Head injury produces damage by primary mechanisms related to impact, then by biochemical ways which are activated and they carry to secondary damage. Many studies have been conducted for explaining secondary injury, the majority conclude there is a kind of ischemic lesion related maybe with changes in cerebral flow and metabolism. The management today is trying to avoid progression in secondary damage without good outcome. Many drugs and measures has been ineffective.
In the last years has been demonstrated in head injury microvascular damage like stroke. Statins o inhibitors of HMG CoA reductase are drugs used in dyslipidemia, frequently for reduction in LDL. Experimental and clinical studies in stroke have shown improvement in outcome. The toxicity related to statin is myopathy and hepatopathy, both with low incidence without fatal cases. Rosuvastatin has been postulated be the most powerful with longest life and toxicity similar to another statins.
We have designed this study for demonstrate if the administration of rosuvastatin in the first 24 hours and by 10 days has improvement in amnesia and orientation, furthermore outcome.
- Conditions
- Head Injury
- Being tested
- rosuvastatin, Placebo
- Keywords
- moderate head injury, rosuvastatin, statin, amnesia, orientation
- Medical subject headings
- Craniocerebral Trauma, Amnesia, Orientation, Spatial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rosuvastatinDrug
Also called Crestor
20 mg oral, during 10 days
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: rosuvastatin |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Galveston Orientation and Amnesia Test
Measured: Days in be positive
Secondary outcomes (4)
Functional outcome by Disability Rating Scale
Measured: at 0 (release) and 3 months
Cytosines (Il-1B, IL-6, TNF-alfa)
Measured: Basal and day 3
acute renal Insuficience
Measured: Periode of medication (10 days)
Lesion on CT scan
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2006 (estimated)
- Study startJul 2006
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Head 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de San Luis Potosí
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Central "Dr. Ignacio Morones Prieto", AstraZeneca
- Investigators
- Jaime Torres-Corzo, Neurosurgeon, Study director, Hospital Central "Dr. Ignacio Morones Prieto"Humberto Tapia-Perez, MD, Principal investigator, Facultad de Medicina UASLP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00329758
- Sponsor's protocol ID
- 26-06ROHI
- Status last verified
- Mar 2009
- First submitted
- 23 May 2006
- Last updated
- 24 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tapia-Perez H, Sanchez-Aguilar M, Torres-Corzo J, Rodriguez-Leyva I, Herrera-Gonzalez LB. [Statins and brain protection mechanisms]. Rev Neurol. 2007 Sep 16-30;45(6):359-64. Spanish.
PubMed 17899518Tapia-Perez J, Sanchez-Aguilar M, Torres-Corzo JG, Gordillo-Moscoso A, Martinez-Perez P, Madeville P, de la Cruz-Mendoza E, Chalita-Williams J. Effect of rosuvastatin on amnesia and disorientation after traumatic brain injury (NCT003229758). J Neurotrauma. 2008 Aug;25(8):1011-7. doi: 10.1089/neu.2008.0554.
PubMed 18690806Tapia-Perez JH, Sanchez-Aguilar M, Schneider T. The role of statins in neurosurgery. Neurosurg Rev. 2010 Jul;33(3):259-70; discussion 270. doi: 10.1007/s10143-010-0259-4. Epub 2010 Apr 29.
PubMed 20429022
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Rosuvastatin´s Effect on Amnesia and Orientation Through Galveston Outcome Amnesia Test in Humans With Moderate Head Injury
- ClinicalTrials.gov ID
- NCT00329758
- Acronym / sponsor ID
- 26-06ROHI
- Conditions
- Head Injury
- Keywords
- moderate head injury, rosuvastatin, statin, amnesia, orientation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidad Autonoma de San Luis PotosíUniversity, hospital or other
- Collaborators
- Hospital Central "Dr. Ignacio Morones Prieto", AstraZeneca
- Study start
- Jul 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 25 May 2006 (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.
The purpose of this study is to determine whether rosuvastatin is effective in the management of moderate head injury by improving amnesia and orientation.
Detailed description
The head injury is a frequent problem of health, which produces high morbid-mortality. Today is the main cause of death and disability between 18 and 40 years. In addition it originates expensive expenses in health care systems.
Head injury produces damage by primary mechanisms related to impact, then by biochemical ways which are activated and they carry to secondary damage. Many studies have been conducted for explaining secondary injury, the majority conclude there is a kind of ischemic lesion related maybe with changes in cerebral flow and metabolism. The management today is trying to avoid progression in secondary damage without good outcome. Many drugs and measures has been ineffective.
In the last years has been demonstrated in head injury microvascular damage like stroke. Statins o inhibitors of HMG CoA reductase are drugs used in dyslipidemia, frequently for reduction in LDL. Experimental and clinical studies in stroke have shown improvement in outcome. The toxicity related to statin is myopathy and hepatopathy, both with low incidence without fatal cases. Rosuvastatin has been postulated be the most powerful with longest life and toxicity similar to another statins.
We have designed this study for demonstrate if the administration of rosuvastatin in the first 24 hours and by 10 days has improvement in amnesia and orientation, furthermore outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: rosuvastatin |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Man or woman >16 and <50 years with HI less 24 hours in progression and Glasgow between 9 y 12.
- Man or woman >16 and <50 years with HI and Glasgow l3, with lesions in TC scan.
- Acceptance of family to participate (first grade).
Key exclusion criteria (11 listed)
- History of HI with disability
- History of neurological or psychiatric disease with disability.
- Administration 24 hrs previous of: fibrates, niacin, ciclosporin, azoles, macrolides, inhibitors of protease, nefazodone, verapamil, diltiazem,amiodarone.
- Existence of systemic injury with life in compromise (massive bleeding, exposition of bone in fracture, hepatic or splenic laceration or in great vessels and shock).
- Administration of THAM, mannitol, barbiturates, corticosteroids, scavengers of free radicals, inhibitors of lipidic peroxidation, indometacin, calcium antagonist, antagonists of neurotransmitters
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 |
|---|---|---|
| rosuvastatinAlso: Crestor20 mg oral, during 10 days | Drug | 1 |
| Placebo | Drug | 2 |
Primary outcome
Galveston Orientation and Amnesia Test
Time frame: Days in be positive
4 secondary outcomes
Functional outcome by Disability Rating Scale
Time frame: at 0 (release) and 3 months
Cytosines (Il-1B, IL-6, TNF-alfa)
Time frame: Basal and day 3
acute renal Insuficience
Time frame: Periode of medication (10 days)
Lesion on CT scan
Time frame: 72 hours
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 24 Jun 2010.
- Background: PubMed 17899518Tapia-Perez H, Sanchez-Aguilar M, Torres-Corzo J, Rodriguez-Leyva I, Herrera-Gonzalez LB. [Statins and brain protection mechanisms]. Rev Neurol. 2007 Sep 16-30;45(6):359-64. Spanish.
- Background: PubMed 18690806Tapia-Perez J, Sanchez-Aguilar M, Torres-Corzo JG, Gordillo-Moscoso A, Martinez-Perez P, Madeville P, de la Cruz-Mendoza E, Chalita-Williams J. Effect of rosuvastatin on amnesia and disorientation after traumatic brain injury (NCT003229758). J Neurotrauma. 2008 Aug;25(8):1011-7. doi: 10.1089/neu.2008.0554.
- Background: PubMed 20429022Tapia-Perez JH, Sanchez-Aguilar M, Schneider T. The role of statins in neurosurgery. Neurosurg Rev. 2010 Jul;33(3):259-70; discussion 270. doi: 10.1007/s10143-010-0259-4. Epub 2010 Apr 29.
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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.
Jaime Torres-Corzo, Neurosurgeon study director
Hospital Central "Dr. Ignacio Morones Prieto"
Humberto Tapia-Perez, MD principal investigator
Facultad de Medicina UASLP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rosuvastatin in people with Head Injury, run by Universidad Autonoma de San Luis Potosí at 1 site in Mexico.
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 3 inclusion and 11 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 24 Jun 2010. 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 Mexico. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Galveston Orientation and Amnesia Test (time frame: Days in be positive). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00329758, which also lists 3 linked publications.
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 24 Jun 2010.