Status:
TERMINATED
One Year Extension Study To Protocol C2/5/TZ:MS-05
Lead Sponsor:
Teva GTC
Conditions:
Spasticity
Multiple Sclerosis
Eligibility:
All Genders
20-65 years
Phase:
PHASE1
PHASE2
Brief 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...
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 clinicall...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00464958
Start Date
January 1 2008
End Date
December 1 2008
Last Update
February 19 2009
Active Locations (1)
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1
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239