Traumatic Brain Injury With Persistent Cognitive DeficitsPhase 4NCT00219245
An Extension Study Evaluating the Efficacy and Safety of Rivastigmine in Patients With Traumatic Brain Injury (TBI) With Persistent Cognitive Deficits
A Phase 4 study testing Rivastigmine in people with Traumatic Brain Injury With Persistent Cognitive Deficits, run by Novartis.
Trial summary
Patients who completed the 12-week double blind protocol may enter this 26-week, open-label extension. This extension will give patients who complete the study an opportunity to receive treatment with open-label rivastigmine 3-12 mg/day and further evaluation for the cognitive deficits related to traumatic brain… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Traumatic Brain Injury With Persistent Cognitive Deficits
- What is being tested?
- Rivastigmine
- How many people
- 157 participants
- Where
- No sites listed yet
- Study dates
- Nov 2002to Jan 2005
- Phase
- Phase 4
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Have a deficit in the areas of attention and/or memory.
- Have current cognitive deficits which were present from the time of the injury, are persistent, and are deemed to be the result of the brain injury;
- Be at least 12 months post brain injury;
Who cannot join
- A history of a major brain surgery;
- A penetrating brain injury (e.g., gun shot wound);
- A current diagnosis of epilepsy;
- Had more than one seizure in the past year (patients who have had a single seizure within a year post-injury will be considered on a case by case basis);
- Previous exposure to rivastigmine.
About this study
Official title: A 26-Week Open-Label Extension to Protocol No. CENA713BUS11: A 12-Week, Prospective, Double-blind, Placebo-controlled, Multi-center Study Evaluating the Efficacy and Safety of Rivastigmine 3 to 6 mg/Day in Patients With Traumatic Brain Injury (TBI) With Persistent Cognitive Deficits
Patients who completed the 12-week double blind protocol may enter this 26-week, open-label extension. This extension will give patients who complete the study an opportunity to receive treatment with open-label rivastigmine 3-12 mg/day and further evaluation for the cognitive deficits related to traumatic brain injury. This extension will enable further evaluation of patients, as well as analyses to be conducted examining response to treatments in the original drug and placebo groups.
- Being tested
- Rivastigmine
- Keywords
- Traumatic brain injury, head trauma, rivastigmine, cognitive deficits
- Medical subject headings
- Brain Injuries, Traumatic, Craniocerebral Trauma, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivastigmineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in cognitive functioning in the areas of attention or verbal memory from baseline to week 26
Safety and tolerability of 26 week's of treatment with rivastigmine in patients with traumatic brain injury with persistent cognitive impairment
Secondary outcomes (5)
Changes in cognitive functioning from baseline to week 26
Changes in behavior from baseline to week 26
Changes in depression from baseline to week 26
Changes in quality of life from baseline to week 26
Changes in overall functioning from baseline to week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startNov 2002
- Primary completionJan 2005
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain Injury With Persistent Cognitive DeficitsStudies 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 4
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00219245
- Sponsor's protocol ID
- CENA713BUS11E1
- Status last verified
- Nov 2011
- First submitted
- 14 Sep 2005
- Last updated
- 17 Nov 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 26-Week Open-Label Extension to Protocol No. CENA713BUS11: A 12-Week, Prospective, Double-blind, Placebo-controlled, Multi-center Study Evaluating the Efficacy and Safety of Rivastigmine 3 to 6 mg/Day in Patients With Traumatic Brain Injury (TBI) With Persistent Cognitive Deficits
- ClinicalTrials.gov ID
- NCT00219245
- Acronym / sponsor ID
- CENA713BUS11E1
- Keywords
- Traumatic brain injury, head trauma, rivastigmine, cognitive deficits
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 22 Sep 2005 (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.
Patients who completed the 12-week double blind protocol may enter this 26-week, open-label extension. This extension will give patients who complete the study an opportunity to receive treatment with open-label rivastigmine 3-12 mg/day and further evaluation for the cognitive deficits related to traumatic brain injury. This extension will enable further evaluation of patients, as well as analyses to be conducted examining response to treatments in the original drug and placebo groups.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Have a deficit in the areas of attention and/or memory.
- Have current cognitive deficits which were present from the time of the injury, are persistent, and are deemed to be the result of the brain injury;
- Be at least 12 months post brain injury;
Key exclusion criteria (5 listed)
- A history of a major brain surgery;
- A penetrating brain injury (e.g., gun shot wound);
- A current diagnosis of epilepsy;
- Had more than one seizure in the past year (patients who have had a single seizure within a year post-injury will be considered on a case by case basis);
- Previous exposure to rivastigmine.
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 |
|---|---|---|
| Rivastigmine | Drug | – |
Primary outcome
Improvement in cognitive functioning in the areas of attention or verbal memory from baseline to week 26
Safety and tolerability of 26 week's of treatment with rivastigmine in patients with traumatic brain injury with persistent cognitive impairment
5 secondary outcomes
Changes in cognitive functioning from baseline to week 26
Changes in behavior from baseline to week 26
Changes in depression from baseline to week 26
Changes in quality of life from baseline to week 26
Changes in overall functioning from baseline to week 26
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 17 Nov 2011.
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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.
Novartis Pharmaceuticals study director
Sponsor GmbH
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rivastigmine in people with Traumatic Brain Injury With Persistent Cognitive Deficits, run by Novartis.
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 5 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 17 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Improvement in cognitive functioning in the areas of attention or verbal memory from baseline to week 26. The study lists 2 primary outcomes in all. 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 17 Nov 2011.