search
Back to results

Study of VSN16R for the Treatment of Spasticity in Multiple Sclerosis

Primary Purpose

Spasticity in People With Multiple Sclerosis

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
VSN16R
Placebo
Sponsored by
Canbex Therapeutics Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spasticity in People With Multiple Sclerosis focused on measuring MS, Spasticity, VSN16R

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Neuroscience Research Centre, The Walton Centre NHS Foundation Trust
  • The Royal London Hospital
  • The National Hospital for Neurology and Neurosurgery
  • Royal Hallamshire Hospital, Sheffield Teaching Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Numerical Rating Scale

Secondary Outcome Measures

Modified Ashworth Scale

Full Information

First Posted
September 4, 2015
Last Updated
February 28, 2018
Sponsor
Canbex Therapeutics Ltd
search

1. Study Identification

Unique Protocol Identification Number
NCT02542787
Brief Title
Study of VSN16R for the Treatment of Spasticity in Multiple Sclerosis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Canbex Therapeutics Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Phase II a Proof of concept study in Multiple Sclerosis (MS) patients with spasticity.
Detailed Description
Single dose escalation followed by multiple fixed dose administrations to assess short term safety and to determine whether spasticity improves.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spasticity in People With Multiple Sclerosis
Keywords
MS, Spasticity, VSN16R

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Description
VSN16R (Canbex name for molecule) oral capsules, 50mg-400mg daily or twice daily, total exposure 26 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsules, 50mg-400mg daily or twice daily, total exposure 26 days
Intervention Type
Drug
Intervention Name(s)
VSN16R
Other Intervention Name(s)
Not yet available
Intervention Description
Small molecule
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
dummy tablet
Primary Outcome Measure Information:
Title
Numerical Rating Scale
Time Frame
26 days
Secondary Outcome Measure Information:
Title
Modified Ashworth Scale
Time Frame
26 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Rachel Farrell
Organizational Affiliation
University College London Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Neuroscience Research Centre, The Walton Centre NHS Foundation Trust
City
Liverpool
ZIP/Postal Code
L9 7LJ
Country
United Kingdom
Facility Name
The Royal London Hospital
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
The National Hospital for Neurology and Neurosurgery
City
London
ZIP/Postal Code
WC1N 3BG
Country
United Kingdom
Facility Name
Royal Hallamshire Hospital, Sheffield Teaching Hospital NHS Foundation Trust
City
Sheffield
ZIP/Postal Code
S10 2JFS
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Study of VSN16R for the Treatment of Spasticity in Multiple Sclerosis

We'll reach out to this number within 24 hrs