Study of VSN16R for the Treatment of Spasticity in Multiple Sclerosis

• Status: Completed
• Trial end date: 2017-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase II a Proof of concept study in Multiple Sclerosis (MS) patients with spasticity.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Canbex Therapeutics Ltd
• Treatments: 3-(5-dimethylcarbamoylpent-1-enyl)-N-(2-hydroxy-1-methylethyl)benzamide

Criteria

Inclusion Criteria:

• Have a confirmed diagnosis of MS

• Have an Expanded Disability Status Scale (EDSS) ≤ than 6.5 at screening.

• Spasticity due to MS of at least 3 months duration with minimum mean score of >/=2 mASH

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

• Significant renal and hepatic abnormalities

• Previous history of other significant medical disorders