Muscle Spasticity
Conditions
Keywords
Multiple sclerosis
Brief 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).
Interventions
DRUGtolperisone HCl
Low dose AV650 three times a day orally for 5 weeks; followed by optional continuation on either low dose or high dose AV650, as tolerated, for 24 weeks
Sponsors
Avigen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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 \<50mmHg or \>105mmHg; heart rate \<50 beats per minute (bpm) or \>110bpm, after 3 minutes in a sitting position; heart rate by ECG \<50bpm or \>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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the long-term safety and tolerability of AV650 (tolperisone HCl) in subjects with spasticity associated with MS | 38 weeks |
Secondary
| Measure | Time frame |
|---|---|
| To determine preliminary efficacy of AV650 as compared to placebo in subjects with spasticity associated with MS; and to determine the pharmacokinetic (PK) profile of AV650 at two dose levels | 38 weeks |
Countries
Czechia, Germany, Russia, Serbia, Ukraine
Outcome results
None listed