Study of VSN16R for the Treatment of Spasticity in Multiple Sclerosis

February 28, 2018 updated by: Canbex Therapeutics Ltd

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Single dose escalation followed by multiple fixed dose administrations to assess short term safety and to determine whether spasticity improves.

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Liverpool, United Kingdom, L9 7LJ
        • The Neuroscience Research Centre, The Walton Centre NHS Foundation Trust
      • London, United Kingdom, E1 1BB
        • The Royal London Hospital
      • London, United Kingdom, WC1N 3BG
        • The National Hospital for Neurology and Neurosurgery
      • Sheffield, United Kingdom, S10 2JFS
        • Royal Hallamshire Hospital, Sheffield Teaching Hospital NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active
VSN16R (Canbex name for molecule) oral capsules, 50mg-400mg daily or twice daily, total exposure 26 days
Drug: VSN16R
Small molecule
Other Names:
  • Not yet available
Placebo Comparator: Placebo
Placebo capsules, 50mg-400mg daily or twice daily, total exposure 26 days
Other: Placebo
dummy tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Numerical Rating Scale
Time Frame: 26 days
26 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Modified Ashworth Scale
Time Frame: 26 days
26 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Canbex Therapeutics Ltd

Investigators

  • Principal Investigator: Dr Rachel Farrell, University College London Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

September 4, 2015

First Submitted That Met QC Criteria

September 4, 2015

First Posted (Estimate)

September 7, 2015

Study Record Updates

Last Update Posted (Actual)

March 2, 2018

Last Update Submitted That Met QC Criteria

February 28, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBX-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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