safety and preliminary effectiveness of av650 in patients with spasticity associated with multiple sclerosis

Conditions: Muscle Spasticity

Summary: a drug called av650 (tolperisone hcl) will be given to patients who have spasticity associated with multiple sclerosis. this study has three purposes: 1. to determine whether av650 is safe for patients with multiple sclerosis; 2. to gather some early evidence as to whether av650 is effective in treating spasticity in patients with multiple sclerosis; and, 3. to assess what the body does with av650 once it is ingested (germany and czech republic sites only).


Eligibility criteria:
inclusion criteria: * male or female subjects between 18 and 70 years of age (inclusive) * signed and dated informed consent * definite ms as per poser or macdonald criteria (either relapsing remitting or secondary progressive course) * expanded disability status score (edss) from 3.0 to 6.5 (inclusive) at screening * stable ms for at least 30 days before screening * female of child bearing potential and male subjects whose partner is of child bearing potential who are willing to ensure that they or their partner use effective double-barrier contraception during the study and for 90 days thereafter * if female, be neither pregnant nor nursing (confirmation that the subject is not pregnant must be established by a negative serum hcg pregnancy test at baseline.) * significant spasticity in at least two muscle groups defined as a score of 2 or more on the ashworth scale for each muscle group * if a subject is on anti-spastic treatments, the dosage, frequency, and route of administration must be stable for at least 30 days before screening * if a subject is on ms treatments, the dosage, frequency, and route of administration must be stable for at least 30 days before screening exclusion criteria: * subjects who have participated in another research study within 90 days of screening * significant changes in anti-spasticity medications (dosage, frequency, or route of administration) within 30 days of screening * known hypersensitivity to tolperisone hcl, its components, or other lidocaine/lidocaine-like products * use of tolperisone hcl within 30 days of screening * significant changes in ms treatments (dosage, frequency, or route of administration) within 30 days of screening * spasticity due to neurological disorders other than ms * any psychiatric disorder or cognitive impairment that precludes fully informed consent or safe participation in the study * subjects who have suffered an acute relapse of ms or who continue to suffer from an acute relapse of ms within 90 days of baseline * history of alcohol or substance abuse within one year of screening * concurrent clinically significant immunologic, pulmonary, renal, hepatic, or endocrine disease and/or other unstable or major disease other than ms * clinically significant cardiovascular disorders, such as ischemic heart disease, arrhythmias, poorly controlled hypertension, or acute myocardial infarction * qt prolongation greater than 480 msec or greater than 450 msec if accompanied by a partial bundle branch block, or other ecg abnormality in the judgment of the investigator * diastolic blood pressure \ 105mmhg; heart rate \ 110bpm, after 3 minutes in a sitting position; heart rate by ecg \ 110bpm * history of epilepsy (except childhood febrile seizures) * current malignancy or history of malignancy that has not been in remission for more than five years, except basal cell skin carcinoma and cervical cancer (with treatment) * female subject who is pregnant, nursing, or planning pregnancy during the course of the study * scheduled elective surgery or other procedures requiring general anesthesia during the study * subject who is terminally ill in the judgment of the investigator * subject who is inappropriate for placebo medication in the judgment of the investigator * systemic corticosteroid therapy within 28 days of randomization, with the exception of inhaled medications for asthma * exacerbation of ms within 30 days of baseline * regular levo-dopa therapy within 7 days of randomization * subjects taking antiarrhythmic medications * donation of blood during the study

Keywords: multiple sclerosis