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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.

Primary Purpose

Multiple Sclerosis, Muscle Spasticity, Spinal Cord Injury

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
tizanidine hydrochloride capsule
Sponsored by
Elan Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Spasticity, spasticity secondary to Multiple Sclerosis, Spinal Cord Injury, Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Radiant Research
  • The Neurology Center
  • Northridge Neurological Center
  • The Neurology Center
  • Neurology Medical Group of Diablo Valley
  • Colorado Neurology Movement Disorders Center
  • Yale Center for MS Treatment and Research
  • Neurology Clinic Research Institution
  • Axiom Clinical Research
  • Comprehensive Neurology Specialists, PC
  • Neurotrials Research, Inc.
  • Springfield Clinic Neuroscience Institute
  • The Minneapolis Clinic of Neurology, Ltd.
  • Neurological Associates of Tulsa, Inc.
  • Medford Neurological and Spine Clinic
  • Sargent Rehabilitation Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 8, 2002
Last Updated
December 10, 2015
Sponsor
Elan Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00047580
Brief Title
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.
Official Title
A Multicenter, Open-Label, Randomized, 4-Way Crossover Trial of the Safety and Efficacy of Tizanidine Hydrochloride Capsules Versus Zanaflex (Tizanidine Hydrochloride) Tablets Taken Under Fed and Fasted Conditions in Patients With Moderate to Severe Spasticity
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Elan Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Muscle Spasticity, Spinal Cord Injury, Stroke
Keywords
Spasticity, spasticity secondary to Multiple Sclerosis, Spinal Cord Injury, Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
tizanidine hydrochloride capsule

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Radiant Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
The Neurology Center
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Northridge Neurological Center
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
The Neurology Center
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Neurology Medical Group of Diablo Valley
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Colorado Neurology Movement Disorders Center
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80110
Country
United States
Facility Name
Yale Center for MS Treatment and Research
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Neurology Clinic Research Institution
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Axiom Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Comprehensive Neurology Specialists, PC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Facility Name
Neurotrials Research, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Springfield Clinic Neuroscience Institute
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
The Minneapolis Clinic of Neurology, Ltd.
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Neurological Associates of Tulsa, Inc.
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136-8327
Country
United States
Facility Name
Medford Neurological and Spine Clinic
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504-8456
Country
United States
Facility Name
Sargent Rehabilitation Center
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02818
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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.

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