Multiple SclerosisPhase 3NCT00047580
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 Phase 3 study testing tizanidine hydrochloride capsule in people with Multiple Sclerosis and Muscle Spasticity, run by Elan Pharmaceuticals at 16 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Muscle Spasticity, Spinal Cord Injury
- What is being tested?
- tizanidine hydrochloride capsule
- Type of treatment
- Pill or oral medicine
- How many people
- 120 participants
- Where
- 16 sitesUnited States
- Study dates
- Jun 2002to Sep 2002
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Comprehensive Neurology Specialists, PC
Atlanta, Georgia, 30338
Neurotrials Research, Inc.
Atlanta, Georgia, 30342
The Neurology Center
Encinitas, California, 92024
Colorado Neurology Movement Disorders Center
Englewood, Colorado, 80110
Medford Neurological and Spine Clinic
Medford, Oregon, 97504-8456
The Minneapolis Clinic of Neurology, Ltd.
Minneapolis, Minnesota, 55422
Yale Center for MS Treatment and Research
New Haven, Connecticut, 06510
Northridge Neurological Center
Northridge, California, 91325
The Neurology Center
Oceanside, California, 92056
Neurology Clinic Research Institution
Plantation, Florida, 33324
Springfield Clinic Neuroscience Institute
Springfield, Illinois, 62702
Axiom Clinical Research
Tampa, Florida, 33609
Radiant Research
Tucson, Arizona, 85710
Neurological Associates of Tulsa, Inc.
Tulsa, Oklahoma, 74136-8327
Neurology Medical Group of Diablo Valley
Walnut Creek, California, 94598
Sargent Rehabilitation Center
Warwick, Rhode Island, 02818
About this study
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
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.
- Conditions
- Multiple Sclerosis, Muscle Spasticity, Spinal Cord Injury, Stroke
- Being tested
- tizanidine hydrochloride capsule
- Keywords
- Spasticity, spasticity secondary to Multiple Sclerosis, Spinal Cord Injury, Stroke
- Medical subject headings
- Multiple Sclerosis, Muscle Spasticity, Spinal Cord Injuries, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tizanidine hydrochloride capsuleDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2002 (estimated)
- Study startJun 2002
- Study completionSep 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Elan Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00047580
- Sponsor's protocol ID
- ELN021-502
- Status last verified
- Dec 2015
- First submitted
- 8 Oct 2002
- Last updated
- 14 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00047580
- Acronym / sponsor ID
- ELN021-502
- Conditions
- Multiple Sclerosis, Muscle Spasticity, Spinal Cord Injury, Stroke
- Keywords
- Spasticity, spasticity secondary to Multiple Sclerosis, Spinal Cord Injury, Stroke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- Elan PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2002
- Study completion
- Sep 2002
- First posted
- 10 Oct 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tizanidine hydrochloride capsule | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tizanidine hydrochloride capsule in people with Multiple Sclerosis and Muscle Spasticity, run by Elan Pharmaceuticals at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2015.