Bipolar I DisorderPhase 3NCT00228059
An Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine 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 at 1 site in United States.
Trial summary
This extension study is designed to investigate the long-term safety and tolerability of licarbazepine 750-2000 mg/day over 52 weeks in patients who completed the 3-week double-blind study CLIC477D2301. 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
- 132 participants
- Where
- 1 siteUnited States
- 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 study CLIC477D2301
- willingness and ability to comply with all study requirements
Who cannot join
- premature discontinuation from study CLIC477D2301
- failure to comply with the study CLIC477D2301 protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 52-week, Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine 750- 2000 mg/Day 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/day over 52 weeks in patients who completed the 3-week double-blind study CLIC477D2301.
Read the detailed description
A 52-week, open-label extension study to evaluate the safety and tolerability of licarbazepine 750- 2000 mg/day in the treatment of manic episodes of bipolar I disorder
- Conditions
- Bipolar I Disorder
- Being tested
- Licarbazepine
- Keywords
- Bipolar disorder, manic episode/treatment/licarbazepine
- Medical subject headings
- Bipolar Disorder, Mania
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 posted28 Sep 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmcuticals, Study chair, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00228059
- Sponsor's protocol ID
- CLIC477D2301E1
- Status last verified
- Feb 2017
- First submitted
- 26 Sep 2005
- Last updated
- 23 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 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/Day in the Treatment of Manic Episodes of Bipolar I Disorder
- ClinicalTrials.gov ID
- NCT00228059
- Acronym / sponsor ID
- CLIC477D2301E1
- Conditions
- Bipolar I Disorder
- Keywords
- Bipolar disorder, manic episode/treatment/licarbazepine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 28 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.
This extension study is designed to investigate the long-term safety and tolerability of licarbazepine 750-2000 mg/day over 52 weeks in patients who completed the 3-week double-blind study CLIC477D2301.
Detailed description
A 52-week, open-label extension study to evaluate the safety and tolerability of licarbazepine 750- 2000 mg/day in the treatment of manic episodes of bipolar I disorder
Study design
- Primary purpose
- Treatment
- 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 study CLIC477D2301
- willingness and ability to comply with all study requirements
Key exclusion criteria (2 listed)
- premature discontinuation from study CLIC477D2301
- failure to comply with the study CLIC477D2301 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 23 Feb 2017.
- (Click here for further information and to find an investigational site near you)Link provided by the sponsor.
Related trials for Bipolar I Disorder
Enrolling by invitationObservational study
Digital Phenotypes for Predicting Depression_Validation
Major Depressive Disorder, Bipolar I Disorder
RecruitingPhase 3
A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)
Bipolar Disorder Type I With Mania
RecruitingPhase 2
NMDA Receptor Modulation for the Treatment of Bipolar I Disorder
Bipolar I Disorder
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder
Bipolar-I Disorder With Mania or Mania With Mixed Features
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)
Bipolar Disorder Type I With Mania or Mania With Mixed Features
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 Pharmcuticals study chair
Novartis
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 Licarbazepine in people with Bipolar I Disorder, run by Novartis at 1 site in United States.
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 23 Feb 2017. 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 United States. 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. 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 23 Feb 2017.