AV650-018: A two-part (double-blind followed by open-label), placebo-controlled,randomized trial to assess the safety, tolerability, and preliminary efficacy of AV650 (tolperisone HCl) in subjects with spasticity associated with multiple sclerosis.
- Conditions
- Spasticity associated with multiple sclerosisMedDRA version: 9.1Level: LLTClassification code 10028335Term: Muscle spasticity
- Registration Number
- EUCTR2007-001031-63-CZ
- Lead Sponsor
- Avigen Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
1. Male or female subjects between 18 and 70 years of age (inclusive)
2. Signed and dated informed consent
3. Definite MS as per Poser or MacDonald Criteria (either relapsing remitting or secondary progressive course)
4. Expanded Disability Status Score (EDSS) from 3.0 to 6.5 (inclusive) at Screening
5. Stable MS for at least 30 days before screening
6. 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
7. 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.)
8. Significant spasticity in at least two muscle groups defined as a score of 2 or more on the Ashworth scale for each muscle group
9. 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
10. If a subject is on MS treatments, the dosage, frequency, and route of administration must be stable for at least 30 days before Screening
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Subjects who have participated in another research study within 90 days of Screening
2. Significant changes in anti-spasticity medications (dosage, frequency, or route of administration) within 30 days of Screening
3. Known hypersensitivity to tolperisone HCl, its components, or other lidocaine/lidocaine-like products
4. Use of tolperisone within 30 days of Screening
5. Significant changes in MS treatments (dosage, frequency, or route of administration) within 30 days of Screening
6. Spasticity due to neurological disorders other than MS
7. Any psychiatric disorder or cognitive impairment that precludes fully informed consent or safe participation in the study
8. 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
9. History of alcohol or substance abuse within one year of Screening
10. Concurrent clinically significant immunologic, pulmonary, renal, hepatic, or endocrine disease and/or other unstable or major disease other than MS
11. Clinically significant cardiovascular disorders, such as ischemic heart disease, arrhythmias, poorly controlled hypertension, or acute myocardial infarction
12. 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
13. 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
14. History of epilepsy (except childhood febrile seizures)
15. 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 documentation of normal pap smears after definitive treatment)
16. Female subject who is pregnant, nursing, or planning pregnancy during the course of the study
17. Scheduled elective surgery or other procedures requiring general anesthesia during the study
18. Subject who is terminally ill in the judgment of the Investigator
19. Subject who is inappropriate for placebo medication in the judgment of the Investigator
20. Systemic corticosteroid therapy within 28 days of randomization, with the exception of inhaled medications for asthma
21. Exacerbation of MS within 30 days of Baseline.
22. Regular levo-dopa therapy within 7 days of randomization
23. Subjects taking antiarrhythmic medications
24. Donation of blood during the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the long-term safety and tolerability of AV650 in subjects with spasticity associated with MS.;Secondary Objective: To determine preliminary efficacy of AV650 as compared to placebo in subjects with spasticity associated with MS.<br><br>To determine the pharmacokinetic (PK) profile of AV650 administered 150 mg TID or 300mg TID in subjects with<br>spasticity associated with MS.;Primary end point(s):
- Secondary Outcome Measures
Name Time Method