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Study of VSN16R for the Treatment of Spasticity in Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02542787
Recruitment Status : Completed
First Posted : September 7, 2015
Last Update Posted : March 2, 2018
Sponsor:
Information provided by (Responsible Party):
Canbex Therapeutics Ltd

Tracking Information
First Submitted Date  ICMJE September 4, 2015
First Posted Date  ICMJE September 7, 2015
Last Update Posted Date March 2, 2018
Study Start Date  ICMJE August 2015
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2015)
Numerical Rating Scale [ Time Frame: 26 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2015)
Modified Ashworth Scale [ Time Frame: 26 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of VSN16R for the Treatment of Spasticity in Multiple Sclerosis
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Spasticity in People With Multiple Sclerosis
Intervention  ICMJE
  • Drug: VSN16R
    Small molecule
    Other Name: Not yet available
  • Other: Placebo
    dummy tablet
Study Arms  ICMJE
  • Experimental: Active
    VSN16R (Canbex name for molecule) oral capsules, 50mg-400mg daily or twice daily, total exposure 26 days
    Intervention: Drug: VSN16R
  • Placebo Comparator: Placebo
    Placebo capsules, 50mg-400mg daily or twice daily, total exposure 26 days
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 4, 2015)
160
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2017
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02542787
Other Study ID Numbers  ICMJE CBX-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Canbex Therapeutics Ltd
Study Sponsor  ICMJE Canbex Therapeutics Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dr Rachel Farrell University College London Hospitals
PRS Account Canbex Therapeutics Ltd
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP