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Licarbazepine

Phase 4

Bipolar Disorder | Small molecule | Psychiatry |Novartis AG|Trials Updated: Mar 28, 2017

Licarbazepine development status

Highest phase Phase 4 (NCT00139594)
Phase scored for NVSPhase 3
Registered trials 8 across 2 sponsors since Dec 2004

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials5
Total Enrollment1,499

FDA Designations

No designations recorded

Licarbazepine clinical trials

Licarbazepine · 5 trials · 2 indications

Phase 3 5
NCT00228059An Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder.Bipolar I Disorder
COMPLETED132 Analytics
NCT00238485An 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 DisorderBipolar I Disorder
COMPLETED251 Analytics
NCT00099229Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar DisorderBipolar Disorder
COMPLETED320 Analytics
NCT00107939Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar DisorderBipolar Disorder
COMPLETED453 Analytics
NCT00107926Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar DisorderBipolar Disorder
COMPLETED343 Analytics
PHASE3COMPLETED
An Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder.
Bipolar I DisorderUnlock trial analytics
PHASE3COMPLETED
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
Bipolar I DisorderUnlock trial analytics
PHASE3COMPLETED
Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar Disorder
Bipolar DisorderUnlock trial analytics
PHASE3COMPLETED
Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar Disorder
Bipolar DisorderUnlock trial analytics
PHASE3COMPLETED
Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar Disorder
Bipolar DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability of licarbazepine with respect to adverse events, serious adverse events, changes in laboratory values, ECGs and vital signs.
Mean reduction in manic episodes and major depressive episodes from baseline to endpoint (Week 3).
Mean reduction in manic episodes and major depressive episodes from baseline to endpoint (week 6)
Mean reduction in manic episodes and major depressive episodes from baseline to endpoint (week 6).

Secondary Endpoints

Major improvement in anxiety and depression from baseline to endpoint (Week 3)
Safety and tolerability of treatment with licarbazepine over 6 weeks, with respect to adverse events and SAEs, laboratory values, ECGs and vital signs.
Major improvement in anxiety and depression from baseline to endpoint (week 6)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
licarbazepineEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
LicarbazepineDRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. written informed consent provided prior to participation in the extension study 2. successful completion of study CLIC477D2301 3. willingness and ability to comply with all study requirements Exclusion Criteria: 1. premature discontinuation from study CLIC477D2301 2. failur...

Countries:United StatesFranceRussiaAustriaCanadaColombiaCzechiaGermanyGuatemalaPeruSlovakiaSouth AfricaUkraineVenezuela
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Frequently asked questions about Licarbazepine

What is Licarbazepine used for?

Licarbazepine is an investigational small molecule developed for the treatment of bipolar disorder, specifically manic episodes of Bipolar I Disorder. It has been studied in Phase 3 clinical trials in adults aged 18 years and older. It is not approved for any indication.

Who is developing Licarbazepine?

Licarbazepine is being developed by Novartis AG, which trades under the ticker NVS. Novartis sponsored the Phase 3 clinical program evaluating the drug in bipolar disorder.

What phase is Licarbazepine in?

Licarbazepine is in Phase 3 clinical development. All four trials identified are Phase 3 studies, and all have been completed. The drug remains investigational and has not been approved by the FDA for any indication.

What clinical trials is Licarbazepine in?

Licarbazepine has been evaluated in four completed Phase 3 trials: NCT00238485, NCT00228059, NCT00107939, and NCT00107926. These studies enrolled a total of 1,179 participants and assessed Licarbazepine in manic episodes of Bipolar I Disorder or Bipolar Disorder.

How does Licarbazepine work?

Licarbazepine is a small molecule. No molecular target or target class is specified for Licarbazepine in the available information, so its precise mechanism of action cannot be described here.