The purpose of this study is to examine the safety and efficacy of VSN16R and the performance in treating spasticity (tightness, stiffness or pull of muscles) in patients with Multiple Sclerosis (MS).

Phase 1

• Conditions: Multiple Sclerosis; MedDRA version: 19.0Level: LLTClassification code 10041416Term: SpasticitySystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2014-004412-11-GB
• Lead Sponsor: Canbex Therapeutics Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-19
• Last Update Posted: 23 May 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Be between 18 and 70 years of age, inclusive and having given written informed consent.
•Have a confirmed diagnosis of MS: either, relapsing remitting MS (RRMS), secondary progressive MS (SPMS) or primary progressive MS (PPMS) as per McDonald’s 2010 revised criteria (Polman, 2011).
•Have an Expanded Disability Status Scale (EDSS) = than 6.5 at screening.
•Spasticity due to MS of at least 3 months duration, which is not wholly relieved with current anti-spasticity therapy, and which is expected to remain stable for the duration of the study.
•A minimum score = 4 in the NRS for spasticity as rated by the subject at screening.
•A minimum mean score of =2 on the Ashworth spasticity scale in at least 2 lower extremity muscle groups and a total mASH score of, at least, 4 in the lower extremity muscles tested at screening.
•Normal renal function (estimated CrCl > 60ml/min). Normal hepatic function.
•Women of childbearing potential (i.e., those not postmenopausal or surgically sterile) may participate provided that they are using adequate birth control methods (including barrier methods, intrauterine device [IUD], and oral contraceptives) for the duration of the study. Women who are of child-bearing potential must continue to use contraception for at least 1 month after their last dose of study medication.
•Men must use barrier contraception for the duration of the study and continue to use it for at least 1 month after their last dose of study medication.
•Willing and able to perform all procedures related to the clinical trial and to provide informed consent.

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 138
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

•Acute MS relapse requiring treatment with steroids within 30 days of screening.
•Initiation or discontinuation of MS disease modifying treatment (DMT) within 30 days of screening.
•Receiving medications that would potentially interfere with the actions of the study medication or outcome variables, including antispastic medications like baclofen, tizanidine, botulinum toxin, cannabinoids, benzodiazepines, gabapentin, pregabalin, smoked cannabis etc.
•Any concomitant disease or disorder that has spasticity-like symptoms or that may influence the subject's level of spasticity.
•Changes in chronic oral medications within 4 weeks of baseline and during study
•Significant abnormalities in screening lab parameters (e.g., alanine aminotransferase [ALT], aspartate aminotransferase [AST], bilirubin > 2 ×upper limit of normal [ULN]; creatinine > 2mg/dl; white blood cell [WBC] < 2,300; platelets < 80,000).
•Previous history of dementia, unstable psychiatric disease, or current signs and symptoms of significant medical disorders such as severe, progressive, or uncontrolled renal, hepatic, haematological, endocrine, pulmonary, cardiac, neurological, or cerebral disease.
•Women who are pregnant or breastfeeding.
•History of substance abuse within the past 12 months.
•Participation in another clinical trial within 30 days of V1.
•Subjects who are uncooperative or unwilling to sign consent form.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified