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.

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00047580

Enrollment

120

Registered

2002-10-10

Start date

2002-06-30

Completion date

2002-09-30

Last updated

2015-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis, Muscle Spasticity, Spinal Cord Injury, Stroke

Keywords

Spasticity, spasticity secondary to Multiple Sclerosis, Spinal Cord Injury, Stroke

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.

Interventions

DRUGtizanidine hydrochloride capsule

Study design

Allocation

RANDOMIZED

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026