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TCH346

Phase 2

Amyotrophic Lateral Sclerosis | Small molecule | Neurology |Novartis AG|Last Updated: Nov 24, 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-BlindUNCONTROLLED
Total Trials3
Total Enrollment945
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00230074A Long-term Extension Study of TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis(ALS)PHASE2 COMPLETED 350Nov 1, 2004Feb 1, 2005Nov 23, 20111 United States
NCT00072709Study Evaluating TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis (ALS)PHASE2 COMPLETED 551Sep 1, 2003Dec 1, 2004Nov 24, 20119 United States, Belgium +7
NCT00036413A 12-week, Multicenter, Safety and Dose-ranging Study of 3 Oral Doses of TCH346 in Patients With Amyotrophic Lateral SclerosisPHASE2 COMPLETED 44Jan 1, 2002Oct 1, 2002Nov 24, 20111 United States
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Study Endpoints
Primary Endpoints
Rate of functional decline as defined by the ALS Functional Rating Scale-Revised
Safety of three oral doses of TCH346 versus placebo administered for up to 12 weeks to patients with ALS
Secondary Endpoints
Survival time
Functional outcome measures including pulmonary function and manual muscle strength assessments (every visit)
Functional outcome measures including pulmonary function and manual muscle strength assessments (every visit except screening)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
TCH346DRUG -
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Eligibility Criteria
Age Range21 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Completed original protocol, Study No. CTCH346A2211 * Be capable of satisfying the requirements of the extension protocol and must sign informed consent after the nature of the extension protocol has been fully explained Exclusion Criteria: * Exclusion criteria as described ...

Countries:United StatesBelgiumCanadaFranceGermanyItalyNetherlandsSwitzerlandUnited Kingdom
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