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Tizanidine

Phase 1

Muscle Spasticity | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: Jan 21, 2009

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-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00358293Study of Nighttime Dosing of Sublingual Tizanidine (12 mg) in Multiple Sclerosis (MS) Patients With Significant SpasticityPHASE1 COMPLETED 20 — — Dec 1, 2006Feb 1, 2007Jan 21, 20091 Israel
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Study Endpoints
Primary Endpoints
Clinical efficacy - improvement in next-day spasticity (Ashworth scores)
Safety - no increase in next-day somnolence (measured objectively using PVT psychomotor vigilance task monitoring) and subjectively, using Epworth Sleepiness Scale (ESS) and Fatigue Severity Scale (FSS) questionnaires
Secondary Endpoints
Secondary clinical efficacy - objective measure of sleep (actigraphy measures)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Interventions
NameTypeDescription
Tizanidine (sublingual or oral)DRUG -
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Eligibility Criteria
Age Range20 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male and female patients between the ages of 20-65 * Definitive diagnosis of MS, with Expanded Disability Status Scale (EDSS) less than 6.5 at screening * Has significant spasticity (total Ashworth =\> 6) at screening * Can maintain sleep regimens of at least 5 hours nightly f...

Countries:Israel
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