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
1 other identifier
interventional
160
1 country
4
Brief Summary
Phase II a Proof of concept study in Multiple Sclerosis (MS) patients with spasticity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2015
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 4, 2015
CompletedFirst Posted
Study publicly available on registry
September 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedMarch 2, 2018
February 1, 2018
2.2 years
September 4, 2015
February 28, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Numerical Rating Scale
26 days
Secondary Outcomes (1)
Modified Ashworth Scale
26 days
Study Arms (2)
Active
EXPERIMENTALVSN16R (Canbex name for molecule) oral capsules, 50mg-400mg daily or twice daily, total exposure 26 days
Placebo
PLACEBO COMPARATORPlacebo capsules, 50mg-400mg daily or twice daily, total exposure 26 days
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
The Neuroscience Research Centre, The Walton Centre NHS Foundation Trust
Liverpool, L9 7LJ, United Kingdom
The Royal London Hospital
London, E1 1BB, United Kingdom
The National Hospital for Neurology and Neurosurgery
London, WC1N 3BG, United Kingdom
Royal Hallamshire Hospital, Sheffield Teaching Hospital NHS Foundation Trust
Sheffield, S10 2JFS, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr Rachel Farrell
University College London Hospitals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2015
First Posted
September 7, 2015
Study Start
August 1, 2015
Primary Completion
October 1, 2017
Study Completion
October 1, 2017
Last Updated
March 2, 2018
Record last verified: 2018-02