Comparison of Safety and Efficacy of Tizanidine Hydrochlo... | NCT00047580

Studies
Comparison of Safety and Efficacy of Tizanidine Hydrochloride Capsules Versus Zanaflex® (Tizanidine Hydrochloride Tablets) Taken While in the Fed State (Just After a Meal) and in the Fasted State (Before a Meal) in Patients With Moderate to Severe Spasticity.

NCT00047580

Sponsor

Elan Pharmaceuticals

Status

Completed

Last Update Posted

Dec 14, 2015Estimated

Enrollment

120

Phase

Phase 3

Conditions

Multiple Sclerosis
Muscle Spasticity
Spinal Cord Injury
Stroke

Interventions

tizanidine hydrochloride capsule

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Jun 2002

Primary Completion Date

Not provided

Completion Date

Sep 2002

First Submitted Date

Oct 8, 2002

First Submission Date that Met QC Criteria

Oct 9, 2002

First Posted Date

Oct 10, 2002Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 10, 2015

Last Update Posted Date

Dec 14, 2015Estimated

Description Module

Brief Summary

This study is being conducted to compare the impact of somnolence (sleepiness) on cognition (awareness) as well as the safety and effectiveness of tizanidine hydrochloride capsules versus Zanaflex® (tizanidine hydrochloride tablets) taken while in the fed state (just after a meal) and in the fasted state (before a meal) in patients with moderate to severe spasticity.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120

Name	Type	Description	Arm Group Labels	Other Names
tizanidine hydrochloride capsule	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

IRB approved ICF must be signed and dated by patient or patient's legal representative
Male or Female 18 years of age or older
Clinical diagnosis of established spasticity (at least 3 months) secondary to multiple sclerosis, stroke, or spinal cord injury
Currently on stable dose of up to 36mg of Zanaflex
Must be able to swallow tablets or capsules whole

Exclusion Criteria:

Patients with dementia, aphasia, or other deficits in cognition
Unwilling or unable to complete cognition test or daily diary
Known sensitivity to Zanaflex
Taking Zanaflex on an as needed ("prn") basis
Currently being treated with drugs having significant effects at the alpha2 receptors whether agonist (i.e., clonidine, methyldopa) or antagonist (i.e., phenothiazines, imipramine)
Currently on any other muscle relaxant or any drugs having muscle relaxant properties (including baclofen, dantrolene, diazepam and other benzodiazepines, tranquilizers, narcotic analgesics, high dose neuroleptics, chlormezanone, meprobamate, methocarbamol, orphenadrine, carisoprodol, gabapentin and clonidine
Taking any over-the-counter or prescription sleep aids within 30 days prior to screening
Use of illegal drugs or legal drugs for recreational purposes or excessive use of alcohol
Patients suffering from disabling, symptomatic hypotension (i.e., syncope)
Patients having any systemic disease such as renal insufficiency, clinically relevant elevations in hepatic transaminase, severe, uncontrolled systemic hypertension
Any clinically significant illnesses, within four weeks of screening
Patients with known sleep disorders
Patients who participated in a clinical trial within thiry days prior to screening
Women of childbearing potential who are pregnant, have a positive serum pregnancy test, lactating, or do not or will not take adequate contraceptive precautions for the duration of trial

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Radiant Research		Tucson	Arizona	85710	United States
The Neurology Center

ID	Term
D009103	Multiple Sclerosis
D009128	Muscle Spasticity
D013119	Spinal Cord Injuries
D020521	Stroke

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D009122	Muscle Hypertonia
D020879	Neuromuscular Manifestations
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D020196	Trauma, Nervous System
D014947	Wounds and Injuries
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases