Bipolar I DisorderPhase 3NCT00238485
An Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine 750-2000 mg/d in the Treatment of Manic Episodes of Bipolar I Disorder
A Phase 3 study testing Licarbazepine in people with Bipolar I Disorder, run by Novartis.
Trial summary
This extension study is designed to investigate the long-term safety and tolerability of licarbazepine 750-2000 mg/d over 52 weeks in patients who completed the 6-week double-blind study CLIC477D2302. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bipolar I Disorder
- What is being tested?
- Licarbazepine
- How many people
- 251 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to Jul 2007
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- written informed consent provided prior to participation in the extension study.
- successful completion of the study CLIC477D2302
- willingness and ability to comply with all study requirements
Who cannot join
- premature discontinuation from the study CLIC477D2302
- failure to comply with the study CLIC477D2302 protocol
About this study
Official title: A 52-week, Open Label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine 750 - 2000 mg/d in the Treatment of Manic Episodes of Bipolar I Disorder.
This extension study is designed to investigate the long-term safety and tolerability of licarbazepine 750-2000 mg/d over 52 weeks in patients who completed the 6-week double-blind study CLIC477D2302.
- Conditions
- Bipolar I Disorder
- Being tested
- Licarbazepine
- Keywords
- Bipolar I Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LicarbazepineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of licarbazepine with respect to adverse events, serious adverse events, changes in laboratory values, ECGs and vital signs.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2005 (estimated)
- Study startJan 2005
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar I DisorderStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Customer Care information, Study chair, 862-778-8300
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00238485
- Sponsor's protocol ID
- CLIC477D2302E1
- Status last verified
- Mar 2017
- First submitted
- 12 Oct 2005
- Last updated
- 28 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 52-week, Open Label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine 750 - 2000 mg/d in the Treatment of Manic Episodes of Bipolar I Disorder.
- ClinicalTrials.gov ID
- NCT00238485
- Acronym / sponsor ID
- CLIC477D2302E1
- Conditions
- Bipolar I Disorder
- Keywords
- Bipolar I Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 13 Oct 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.
This extension study is designed to investigate the long-term safety and tolerability of licarbazepine 750-2000 mg/d over 52 weeks in patients who completed the 6-week double-blind study CLIC477D2302.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- written informed consent provided prior to participation in the extension study.
- successful completion of the study CLIC477D2302
- willingness and ability to comply with all study requirements
Key exclusion criteria (2 listed)
- premature discontinuation from the study CLIC477D2302
- failure to comply with the study CLIC477D2302 protocol
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 |
|---|---|---|
| Licarbazepine | Drug | – |
Primary outcome
Safety and tolerability of licarbazepine with respect to adverse events, serious adverse events, changes in laboratory values, ECGs and vital signs.
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 28 Mar 2017.
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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 Customer Care information study chair
862-778-8300
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Licarbazepine in people with Bipolar I Disorder, 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 2 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 28 Mar 2017. 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 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?
Safety and tolerability of licarbazepine with respect to adverse events, serious adverse events, changes in laboratory values, ECGs and vital signs.. 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 28 Mar 2017.