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

NCT00464958 | Terminated Phase 1

• 1 other identifier: Protocol C2/5/TZ:MS-05 EXT
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 C2/5/TZ:MS-05 at the Tel Aviv Sourasky Medical Center, Department of Neurology, Dr. Arnon Karni, PI.

Conditions

Spasticity; Multiple Sclerosis

Keywords

Fatigue; Spasticity; Sublingual Tizanidine; Epworth Sleepiness Scale; Fatigue Severity Scale

Outcome Measures

Primary Outcomes (2)

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

  12 months

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

  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

  12 months

Study Arms (1)

Sublingual tizanidine

EXPERIMENTAL

Once nightly dosing of 12 mg sublingual tizanidine tablet

Drug: sublingual tizanidine 12 mg

Interventions

sublingual tizanidine 12 mg DRUG

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

Sublingual tizanidine

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Teva GTC: lead

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Related Links

• ClinicalTrials.gov Identifier: NCT00358293

MeSH Terms

Conditions

Muscle Spasticity; Multiple Sclerosis; Fatigue

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Arnon Karni, MD

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 22, 2007
• First Posted: April 24, 2007
• Study Start: January 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 19, 2009

Record last verified: 2009-01

Locations

IL (1)