Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Avigen
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Safety and Preliminary Effectiveness of AV650 in Patients With Spasticity Associated With Multiple Sclerosis
