Trial | NCT02542787  Report issue

Title

Study of VSN16R for the Treatment of Spasticity in Multiple Sclerosis
A Phase II Proof of Concept (PoC), Double-Blind, Randomised, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VSN16R for the Treatment of Spasticity in Subjects With Multiple Sclerosis

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    vsn16r ...

  • Study Participants

    160
Phase II a Proof of concept study in Multiple Sclerosis (MS) patients with spasticity.
Single dose escalation followed by multiple fixed dose administrations to assess short term safety and to determine whether spasticity improves.
Study Started
Aug 31
2015
Primary Completion
Oct 31
2017
Study Completion
Oct 31
2017
Last Update
Mar 02
2018

Drug VSN16R

Small molecule

  • Other names: Not yet available

Other Placebo

dummy tablet

Active Experimental

VSN16R (Canbex name for molecule) oral capsules, 50mg-400mg daily or twice daily, total exposure 26 days

Placebo Placebo Comparator

Placebo capsules, 50mg-400mg daily or twice daily, total exposure 26 days

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
No Results Posted