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LX6171 High Dose

Phase 2

Age-Related Memory Disorders | Small molecule | Other |Lexicon Pharmaceuticals, Inc.|Last Updated: Mar 3, 2010

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment103
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00691808Study of LX6171 in Elderly Volunteers With Age Associated Memory ImpairmentPHASE2 COMPLETED 103Feb 1, 2008 -Mar 3, 20102 Netherlands
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Study Endpoints
Primary Endpoints
Number of Participants Who Were Exposed to LX6171
≥28 days
Number of Subjects Reporting at Least One Adverse Event (AE)
28 days

An adverse event includes any noxious, pathological, or unintended change in anatomical, physiological, or metabolic functions as indicated by physical signs or symptoms occurring in any phase of the clinical study whether or not associated with the study medication and whether or not considered related to study medication.

Number of Subjects Reporting Adverse Events Leading to Withdrawal
28 days
Treatment Compliance
End of study

Subjects were considered compliant if they had taken \>70% of possible doses of the study drug.

Secondary Endpoints
Plasma Concentration
Day 28
Change From Baseline (Day -1) in 15-Words Test: Acquisition Score at Day 28
Day 28
Change From Baseline in 15-Word Test: Short-Term Delayed Recall Score at Day 28
Day 28
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
High DoseEXPERIMENTAL -
Low DoseEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
LX6171 High DoseDRUGA high dose of LX6171, using an oral suspension; daily oral intake for 28 days in the morning at approximately the same time.
LX6171 Low DoseDRUGA low dose of LX6171, using an oral suspension; daily oral intake for 28 days in the morning at approximately the same time.
PlaceboDRUGMatching placebo dosing with daily oral intake for 28 days in the morning at approximately the same time.
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Eligibility Criteria
Age Range60 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Males and females aged 60-80 years old. * Complaints of memory loss in everyday life * Non-smokers or very light smokers (no more than 10 cigarettes/day) * Negative urine screen for drugs of abuse * Ability to provide written informed consent Exclusion Criteria: * History or...

Countries:Netherlands
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