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Cherry lamotrigine ODT

Phase 1

Mental Disorders | Small molecule | Psychiatry |GSK plc|Last Updated: Aug 3, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

Cherry lamotrigine ODT · 1 trial · 1 indication

Phase 1 1
NCT01607086Compare the Properties and Characteristics of an Investigational Formulation of Lamotrigine With PlaceboMental Disorders
COMPLETED24 Analytics
PHASE1COMPLETED
Compare the Properties and Characteristics of an Investigational Formulation of Lamotrigine With Placebo
Mental DisordersUnlock trial analytics

Study Endpoints

Primary Endpoints

Comparison score of flavor and aftertaste between the active and placebo tablets.
1 day

Secondary Endpoints

Comparison score of mouth feel between the active and placebo tablets
1 day
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group 1EXPERIMENTALTo receive the sequence of investigational products in the order of AB where A is cherry lamotrigine ODT and B is cherry placebo.
Group 2EXPERIMENTALTo receive the sequence of investigational products in the order of BA where A is cherry lamotrigine ODT and B is cherry placebo.

Interventions

NameTypeDescription
Cherry lamotrigine ODTDRUG25mg, taken orally on one study visit
Cherry PlaceboDRUGTaken orally on one study visit
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: A subject will be eligible for inclusion in this study only if all of the following criteria apply: * Healthy as judged by the responsible physician or designee. No clinically significant abnormality identified on the medical or laboratory evaluation. A subject with a clinical ...

Countries:United Kingdom
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Competitive Landscape -Mental Health Disorders 10 trials (matched to "Mental Disorders")

No competing companies are currently tracked in active development for Mental Health Disorders.
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Frequently asked questions about Cherry lamotrigine ODT

What is Cherry lamotrigine ODT used for?

Cherry lamotrigine ODT is an investigational small molecule being developed by GSK plc for the treatment of Mental Disorders. It is an orally disintegrating tablet formulation of lamotrigine, a drug used in psychiatry. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes Cherry lamotrigine ODT?

Cherry lamotrigine ODT is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The drug is currently in Phase 1 clinical trials and is not yet approved for commercial use.

What phase is Cherry lamotrigine ODT in?

Cherry lamotrigine ODT is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and properties. One Phase 1 trial has been completed.

What clinical trials is Cherry lamotrigine ODT in?

Cherry lamotrigine ODT has one completed Phase 1 clinical trial, identified as NCT01607086. This study compared the properties and characteristics of an investigational formulation of lamotrigine with placebo in 24 participants with Mental Disorders. The trial was conducted in the United Kingdom and enrolled healthy volunteers aged 18 years and older.

Is Cherry lamotrigine ODT the same as lamotrigine?

Cherry lamotrigine ODT is a specific oral disintegrating tablet formulation of lamotrigine, developed by GSK plc. It is being studied for use in Mental Disorders. The drug is in Phase 1 clinical development and is not yet approved.