NEWS HIGHLIGHTS
Published Studies Related to Zanaflex (Tizanidine)
Nightly sublingual tizanidine HCl in multiple sclerosis: clinical efficacy and
safety. [2010]
spasticity requiring treatment... CONCLUSIONS: Overnight sublingual tizanidine provides improvement in next-day
Aceclofenac-tizanidine in the treatment of acute low back pain: a double-blind,
double-dummy, randomized, multicentric, comparative study against aceclofenac
alone. [2009]
Tizanidine and aceclofenac individually have shown efficacy in the treatment of
low back pain... In this study, aceclofenac-tizanidine combination was more effective
than aceclofenac alone and had a favourable safety profile in the treatment of
acute low back pain.
Botulinum neurotoxin versus tizanidine in upper limb spasticity: a
placebo-controlled study. [2009]
compared... CONCLUSIONS: BoNT is safer and more effective than TZD in reducing tone and
Botulinum Neurotoxin vs Tizanidine in Upper Limb Spasticity: A Placebo-Controlled Study. [2008.10.31]
BACKGROUND: While spasticity is commonly treated with oral agents or botulinum neurotoxin (BoNT) injection, these treatments have not been systematically compared... CONCLUSIONS: BoNT is safer and more effective than TZD in reducing tone and disfigurement in upper extremity spasticity, and may be considered as first line therapy for this disorder.
Effects of daily ingestion of cranberry juice on the pharmacokinetics of warfarin, tizanidine, and midazolam--probes of CYP2C9, CYP1A2, and CYP3A4. [2007.06]
Case reports suggest that cranberry juice can increase the anticoagulant effect of warfarin. We investigated the effects of cranberry juice on R-S-warfarin, tizanidine, and midazolam; probes of CYP2C9, CYP1A2, and CYP3A4.A pharmacokinetic mechanism for the cranberry juice-warfarin interaction seems unlikely.
Clinical Trials Related to Zanaflex (Tizanidine)
One Year Extension Study To Protocol C2/5/TZ:MS-05 [Not yet recruiting]
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.
Drug Discrimination in Methadone-Maintained Humans Study 3 [Recruiting]
This study involves giving psychoactive drugs intramuscularly (injected into the muscle of
the upper arm or the hip) and/or orally, and measuring the participant's ability to tell the
difference between one drug and another, as well as measuring the effects of the drugs on
mood, physiology (e. g., heart rate, blood pressure, respiration rate) and behavior. Each
participant will receive 2-4 of the listed interventions.
Monoaminergic Modulation of Motor Function in Subacute Incomplete Spinal Cord Injury (SCI) [Recruiting]
The primary goal of the proposed clinical trial is to investigate the combined effects of
walking training and monoaminergic agents (SSRIs and TIZ) on motor function of individuals
in sub-acute (2-7 mo) human motor incomplete Spinal Cord Injury (SCI), with a primary
emphasis on improvement in locomotor capability. We hypothesize that the use of these drugs
applied early following SCI may facilitate independent stepping ability, and its combination
with intensive stepping training will result in improved locomotor recovery following
incomplete SCI. Loss of descending control via norepinephrine inputs following spinal cord
injury can impair normal sensorimotor function through depressing motor excitability and
impairing walking capacity. Replacing these inputs with drugs can alter the excitability and
assist with reorganization of locomotor circuits. Assessment of single-dose administration
of these agents has been tested in patients with motor incomplete spinal cord injury; only
limited changes in walking performance have been noted. The resultant onset of weakness and
increase in involuntary reflexes following motor incomplete SCI may partly be a result of
damage to descending pathways to the spinal cord that control the release of serotonin. In
models of SCI, for example, application of agents that simulate serotonin has been shown to
change voluntary motor behaviors, including improvement of walking recovery. In humans
following neurological injury, the effects of 5HT agents are unclear. Few previous reports
indicate improved motor function following administration of agents which enhance the
available serotonin in the brain, although some data suggests that increased serotonin may
be beneficial. In this application, we propose to study the effects of clinically used
agents that increase or decrease intrinsic serotonin activity in the brain on strength and
walking ability following human motor incomplete SCI. Using detailed electrophysiological
recordings, and biomechanical and behavioral measures, we will determine the effects of
single or chronic doses of these drugs on voluntary and involuntary motor behaviors during
clinical measures and walking measures. The novelty of this proposed research is the
expectation that agents that increase serotonin activity may increase abnormal reflexes in
SCI, but simultaneously help to facilitate motor and walking recovery. Despite potential
improvements in voluntary function, the use of pharmacological agents that may enhance
spastic motor behaviors following SCI is in marked contrast to the way in which drugs are
typically used in the clinical setting.
Observational Study for Assessment of the Effect of Fampyra on the Manual Function of Persons With Multiple Sclerosis [Not yet recruiting]
Multiple Sclerosis (MS) is the most common chronic neurological disease affecting young
adults, with onset usually at age 20-40 years. Women are affected 3-4 times more than men.
The disease is characterized by 2 main phenotypes: relapsing-remitting or progressive
course.
Several immunotherapies were developed in the last 10-15 years for the long term management
of the relapsing type of disease. Treatment with these drugs decreases disease activity
though cannot cure it.
There are few treatments for targeting specific symptoms of MS, such as Provigil for the
treatment of fatigue.
Regarding problems related to spasticity and related gait problems , which is stated by over
40 % of MS patients as their main complaint - present treatments include:
non-pharmacological treatments such as physiotherapy, occupational therapy, hydrotherapy and
pharmacological treatments such as Baclofen, Tizanidine and Botulinium toxin.
Fampyra (Fampridine) has recently been approved for use in patients with gait problems. This
drug acts by blocking potassium ion channels and has been proven to improve walking in 35%
of the patients after one month of treatment.
The effect of Fampyra on hand function in MS has yet to be studied. The aim of this
research project is to assess the effect of treatment with Fampyra on manual function of
patients with MS. The investigators hypothesize that through the same mechanism by which
Fampyra improves ambulation it can also improve manual function.
MS patients visiting the MS center clinic at the Carmel Medical Center, with walking
disabilities eligible to Fampyra treatment, that have also manual dysfunction, will be
offered to participate in this study. Participants who agree to participate will be asked to
sign a written informed consent. Information regarding their personal and family medical
history will be collected via questionnaires. Medical staff will fill clinical
questionnaires detailing patient clinical status prior to the study.
Patients will be followed up to 4 months after initiation of treatment with Fampyra.
Compliance to treatment will be assessed by collection of the empty vials of the medication.
In each of the follow-up meetings evaluation of manual function, evaluation of ambulation
and evaluation of general neurological function will be performed.
Reports of Suspected Zanaflex (Tizanidine) Side Effects
Asthenia (17),
Drug Ineffective (14),
Blood Pressure Decreased (12),
Fall (11),
Multiple Sclerosis (10),
Pneumonia (10),
Cachexia (10),
Death (5),
Drug Interaction (4),
Muscle Spasms (4), more >>
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