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TerminatedNCT00464958Updated Feb 19, 2009

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

A Phase 1/2 interventional study of sublingual tizanidine 12 mg in Spasticity and Multiple Sclerosis, sponsored by Teva GTC. Terminated at 1 site in Israel. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2009-02-19.

Sponsored by Teva GTC · Phase 1/2, Interventional, and Treatment

Why this study was terminated
Study was stopped as the sponsor is no longer funding this project
Phase
Phase 1/2
Study type
Interventional
Enrollment
10
Allocation
Non-randomized
Ages
20 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Spasticity
  • Multiple Sclerosis

Keywords

  • Fatigue
  • Spasticity
  • Sublingual Tizanidine
  • Epworth Sleepiness Scale
  • Fatigue Severity Scale
03

In context

Muscle Spasticity

704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.

This study's enrollment of 10 is below the median of 36 across 525 interventional studies indexed under Muscle Spasticity.

Browse Muscle Spasticity studies →

Lead sponsor

Teva GTC is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Sublingual tizanidine

    Once nightly dosing of 12 mg sublingual tizanidine tablet

    Drug: sublingual tizanidine 12 mg

Interventions

  • Drugsublingual tizanidine 12 mg

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

06

What researchers measure

Primary outcomes

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

    Time frame: 12 months

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

    Time frame: 12 months

Secondary outcomes

  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

    Time frame: 12 months

07

Study locations

1 site
  • Tel Aviv Sourasky Medical Center
    Tel Aviv, 64239, Israel
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 19, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00464958
Lead sponsor
Teva GTC
First posted
Apr 24, 2007
Start date
Jan 2008
Primary completion
Dec 2008
Completion
Dec 2008
Last update
Feb 19, 2009

Study contacts

Arnon Karni, MD
principal investigator · Tel-Aviv Sourasky Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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