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Tizanidine

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

Tizanidine · 2 trials · 2 indications

Phase 1 2
NCT00358293Study of Nighttime Dosing of Sublingual Tizanidine (12 mg) in Multiple Sclerosis (MS) Patients With Significant SpasticityMuscle Spasticity
COMPLETED20 Analytics
NCT00287157Pilot, Proof-of-Concept Study of Sublingual Tizanidine in Children With Chronic Traumatic Brain Injury (TBI)Traumatic Brain Injury
COMPLETED5 Analytics
PHASE1COMPLETED
Study of Nighttime Dosing of Sublingual Tizanidine (12 mg) in Multiple Sclerosis (MS) Patients With Significant Spasticity
Muscle SpasticityUnlock trial analytics
PHASE1COMPLETED
Pilot, Proof-of-Concept Study of Sublingual Tizanidine in Children With Chronic Traumatic Brain Injury (TBI)
Traumatic Brain InjuryUnlock trial analytics

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
Improvement in Spasticity, Cognition and Daily Function
4 weeks

Secondary Endpoints

Secondary clinical efficacy - objective measure of sleep (actigraphy measures)
Improvement in nighttime actigraphy sleep parameters
4 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Interventions

NameTypeDescription
Tizanidine (sublingual or oral)DRUG -
Sublingual Tizanidine HClDRUG -
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Eligibility Criteria

Age Range20 Years to 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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Frequently asked questions about Tizanidine

What is Tizanidine used for?

Tizanidine is being studied for use in muscle spasticity and traumatic brain injury. It is a small molecule in development for neurology indications, specifically to address spasticity associated with conditions like multiple sclerosis and chronic traumatic brain injury in pediatric and adult patients.

Who makes Tizanidine?

Tizanidine is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company is conducting clinical trials to evaluate the drug's safety and efficacy for neurological conditions.

What phase is Tizanidine in?

Tizanidine 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 assess its safety and effectiveness.

What clinical trials is Tizanidine in?

Tizanidine has one completed Phase 1 trial, NCT00287157, a pilot proof-of-concept study in children with chronic traumatic brain injury. Another completed trial, NCT00358293, evaluated nighttime dosing in multiple sclerosis patients with significant spasticity. Both were conducted in Israel.

Is Tizanidine the same as sublingual tizanidine?

Yes, Tizanidine is the same as sublingual tizanidine. The clinical trials NCT00287157 and NCT00358293 both investigate the sublingual formulation of tizanidine, which is administered under the tongue for potential therapeutic effects.