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SpasticityPhase 1/2NCT00464958

One Year Extension Study To Protocol C2/5/TZ:MS-05

A Phase 1/2 study testing sublingual tizanidine 12 mg in people with Spasticity and Multiple Sclerosis, run by Teva GTC at 1 site in Israel.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Open label, one year extension study to evaluate the clinical efficacy and safety of 12 mg sublingual tizanidine administered once nightly in MS patients who successfully completed Phase I/II protocol C2/5/TZ:MS-05 at the Tel Aviv Sourasky Medical Center, Department of Neurology, Dr. Arnon Karni, PI. Read more about this study

Who is it for?
Ages 20 to 65 years
Conditions the study is for
Spasticity, Multiple Sclerosis
What is being tested?
sublingual tizanidine 12 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteIsrael
Study dates
Jan 2008to Dec 2008
Phase
Phase 1/2
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 20 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Successful completion of previous protocol, Study C2/5/TZ:MS-05
  • Have a definitive diagnosis of Multiple Sclerosis
  • Patients may be allowed to take other anti-spasticity medication during the study (other than Baclofen pump)as per their individual daily dosing regimen, with the following qualification: (1) No dose after 18:00 on any study day (2) No dose at all on a clinic evaluation day
  • Females must agree to use a medically accepted form of birth control, be surgically sterile, or be two years post-menopausal. Oral contraception in NOT acceptable as it is contraindicated for tizanidine use.
  • Patients must meet criteria for stable 24 hour BP values based on the screening ABPM monitorings (with and without tizanidine challenge) as determined by the study's BP consultant

Who cannot join

  • Use of CYP1A2 inhibitors [e.g. ciprofloxacin or fluvoxamine as well as zileuton, other fluroquinolones (norfloxacin), antiarrythmics (amiodarone, mexiletine, propafenone), cimetidine, famotidine, oral contraceptives, acyclovir, and ticlopidine] from baseline and for the duration of the study
  • Taking medications from baseline and for the duration of the study that would potentially interfere with the actions of the study medication or outcome variables as determined by the PI
  • Previous history of dementia, unstable psychiatric disease or current signs and symptoms of significant medical disorders such as severe, progressive or uncontrolled renal, hepatic hematological, endocrine, pulmonary, cardiac, neurological or cerebral disease
  • Significant abnormalities in screening laboratory parameters as described below:
  • ALT > 2xULN
  • AST > 2xULN
Show all 13Show fewer
  • Creatinine > 2.0 mg/dL
  • Bilirubin > 2xULN
  • WBC < 2,300/mm3
  • Platelets < 80,000/mm3
  • History of allergy to tizanidine or any inactive component (including lactose intolerance) of the sublingual tizanidine tablet
  • History of substance abuse within past 12 months
  • Patients who are non-cooperative or unwilling to sign consent form

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

About this study

Official title: Long Term Clinical Efficacy and Safety of Novel Sublingual Tizanidine HCl (12 mg) for the Treatment of Spasticity in Patients With Multiple Sclerosis - Open Label Extension Study

Open label, one year extension study to evaluate the clinical efficacy and safety of 12 mg sublingual tizanidine administered once nightly in MS patients who successfully completed Phase I/II protocol C2/5/TZ:MS-05 at the Tel Aviv Sourasky Medical Center, Department of Neurology, Dr. Arnon Karni, PI.

Read the detailed description

The previous study, Protocol C2/5/TZ-MS-05, using 12 mg sublingual tizanidine, confirmed that administration of once nightly sublingual tizanidine before sleep results in a statistically and clinically significant reduction in next-day spasticity, as compared to placebo. The clinical effect following 12 mg sublingual tizanidine was larger (4-5 units on the Ashworth scale) and more sustained (up to 18-20 hours post-dose) than was seen for 8 mg tizanidine (earlier study, Protocol C2/5/TZ:MS-03z). This study also reconfirmed that the increased improvement in next-day reduction of spasticity following overnight sublingual tizanidine dosing is not accompanied by a concomitant increase in next-day somnolence.

This study, a 12 month open label extension, will allow those patients who successfully completed Protocol C2/5/TZ-MS-05 and who found tizanidine to be beneficial, to continue treatment under close medical supervision. The study will provide long-term (12 months) clinical efficacy and safety data re: the use of once daily sublingual tizanidine, administered at night, just before bedtime.

Being tested
sublingual tizanidine 12 mg
Keywords
Fatigue, Spasticity, Sublingual Tizanidine, Epworth Sleepiness Scale, Fatigue Severity Scale
Medical subject headings
Muscle Spasticity, Multiple Sclerosis, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sublingual tizanidine 12 mgDrug

    Single sublingual tizanidine 12 mg tablet, to be administered once nightly, via sublingual administration for 12 months

Study groups in NCT00464958
Study groupRoleWhat they receive
Sublingual tizanidineExperimentalOnce nightly dosing of 12 mg sublingual tizanidine tablet
Receives: Drug: sublingual tizanidine 12 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical Efficacy- reduction in next-day spasticity (Ashworth scores)

    Measured: 12 months

  2. Safety- No increase in next-day somnolence/fatigue, measured via Epworth Sleepiness Scale (ESS) and Fatigue Severity Scale (FSS) questionnaires

    Measured: 12 months

Secondary outcomes (1)

  1. Additional Safety Measures: Clinical Laboratories (hematology and clinical chemistry, with special emphasis on liver function tests); Blood pressure monitoring (standard vital signs: BP and pulse at every monthly visit, + 24 hour Holter ambulatory Blood

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2007 (estimated)
  2. Study startJan 2008
  3. Primary completionDec 2008
  4. Study completionDec 2008

Why it stopped: Study was stopped as the sponsor is no longer funding this project

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00464958
Sponsor's protocol ID
Protocol C2/5/TZ:MS-05 EXT
Status last verified
Jan 2009
First submitted
22 Apr 2007
Last updated
19 Feb 2009
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing sublingual tizanidine 12 mg in people with Spasticity and Multiple Sclerosis, run by Teva GTC at 1 site in Israel.

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 13 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: stopped early, as of the sponsor's last update on 19 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was stopped early (reason given: Study was stopped as the sponsor is no longer funding this project). Results are not available in the source record.

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.

What does the primary outcome measure?

Clinical Efficacy- reduction in next-day spasticity (Ashworth scores) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00464958.

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 19 Feb 2009; AzTrials last refreshed its copy on 28 Oct 2026.

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