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Study of VSN16R for the Treatment of Spasticity in Multiple Sclerosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by Canbex Therapeutics Ltd
Sponsor:
Information provided by (Responsible Party):
Canbex Therapeutics Ltd
ClinicalTrials.gov Identifier:
NCT02542787
First received: September 4, 2015
Last updated: January 30, 2017
Last verified: January 2017
  Purpose
Phase II a Proof of concept study in Multiple Sclerosis (MS) patients with spasticity.

Condition Intervention Phase
Spasticity in People With Multiple Sclerosis
Drug: VSN16R
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Canbex Therapeutics Ltd:

Primary Outcome Measures:
  • Numerical Rating Scale [ Time Frame: 26 days ]

Secondary Outcome Measures:
  • Modified Ashworth Scale [ Time Frame: 26 days ]

Estimated Enrollment: 160
Study Start Date: August 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active
VSN16R (Canbex name for molecule) oral capsules, 50mg-400mg daily or twice daily, total exposure 26 days
Drug: VSN16R
Small molecule
Other Name: Not yet available
Placebo Comparator: Placebo
Placebo capsules, 50mg-400mg daily or twice daily, total exposure 26 days
Other: Placebo
dummy tablet

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

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02542787

Contacts
Contact: Dr Rachel Farrell 020 3448 3561 rachel.farrell@ucl.ac.uk

Locations
United Kingdom
The Neuroscience Research Centre, The Walton Centre NHS Foundation Trust Recruiting
Liverpool, United Kingdom, L9 7LJ
Contact: Susan Whittam    0151 529 5666    susan.whittam@thewaltoncentre.nhs.uk   
Principal Investigator: Dr Wojciech Pietkiewicz         
The Royal London Hospital Recruiting
London, United Kingdom, E1 1BB
Contact: Maria Espasandin    02035940637/8    Maria.Espasandin@bartshealth.nhs.uk   
Contact: Kimberley Allen-Philbey    02035941765    Kimberley.Allen-Philbey@bartshealth.nhs.uk   
Principal Investigator: Dr Clarence Liu         
The National Hospital for Neurology and Neurosurgery Recruiting
London, United Kingdom, WC1N 3BG
Contact: Dr Rachel Farrell         
Contact: Michelle Liddicut       Michelle.Liddicut@uclh.nhs.uk   
Principal Investigator: Dr Rachel Farrell         
Royal Hallamshire Hospital, Sheffield Teaching Hospital NHS Foundation Trust Recruiting
Sheffield, United Kingdom, S10 2JFS
Contact: Kamel Bouakline    0114 271 3339    kamel.bouakline@sth.nhs.uk   
Principal Investigator: Dr Siva Nair         
Sponsors and Collaborators
Canbex Therapeutics Ltd
Investigators
Principal Investigator: Dr Rachel Farrell University College London Hospitals
  More Information

Responsible Party: Canbex Therapeutics Ltd
ClinicalTrials.gov Identifier: NCT02542787     History of Changes
Other Study ID Numbers: CBX-001
Study First Received: September 4, 2015
Last Updated: January 30, 2017

Keywords provided by Canbex Therapeutics Ltd:
MS
Spasticity
VSN16R

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Muscle Spasticity
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms
3-(5-dimethylcarbamoylpent-1-enyl)-N-(2-hydroxy-1-methylethyl)benzamide
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2017