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talampanel

Phase 1

Dyskinesias | Small molecule | Neurology |Teva Pharmaceutical Industries Limited|Last Updated: Apr 13, 2011

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 Enrollment22
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00036296Effects of Talampanel on Patients With Advanced Parkinson's DiseasePHASE1 COMPLETED 22Dec 1, 2006Feb 1, 2007Apr 13, 2011 -
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL75mg per day (in 3 doses) Talampanel for 22 days
2PLACEBO_COMPARATOR3 doses a day for 22 days
Interventions
NameTypeDescription
talampanelDRUG75mg per day divided into 3 doses for 22 days
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Eligibility Criteria
Age Range40 Years — 85 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Troublesome on-period dyskinesias as defined by a Unified Parkinson's Disease Rating Scale (UPDRS) dyskinesia sub-score \>25% of Duration of dyskinesia during waking hours and 33 must have moderate disability * Lang-Fahn dyskinesia rating score more than 2 for at least two of ...

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