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

NCT00464958 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2009-02-19

No results posted yet for this 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.

Conditions

Interventions

DRUG

sublingual tizanidine 12 mg

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

Sponsors & Collaborators

  • Teva GTC

    lead INDUSTRY

Principal Investigators

  • Arnon Karni, MD · Tel-Aviv Sourasky Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00464958 on ClinicalTrials.gov