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Study of VSN16R for the Treatment of Spasticity in Multiple Sclerosis

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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

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

Condition or disease Intervention/treatment Phase
Spasticity in People With Multiple Sclerosis Drug: VSN16R Other: Placebo Phase 2

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  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : August 2015
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


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 Name: Not yet available

Placebo Comparator: Placebo
Placebo capsules, 50mg-400mg daily or twice daily, total exposure 26 days
Other: Placebo
dummy tablet




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

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


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02542787


Locations
United Kingdom
The Neuroscience Research Centre, The Walton Centre NHS Foundation Trust
Liverpool, United Kingdom, L9 7LJ
The Royal London Hospital
London, United Kingdom, E1 1BB
The National Hospital for Neurology and Neurosurgery
London, United Kingdom, WC1N 3BG
Royal Hallamshire Hospital, Sheffield Teaching Hospital NHS Foundation Trust
Sheffield, United Kingdom, S10 2JFS
Sponsors and Collaborators
Canbex Therapeutics Ltd
Investigators
Principal Investigator: Dr Rachel Farrell University College London Hospitals

Responsible Party: Canbex Therapeutics Ltd
ClinicalTrials.gov Identifier: NCT02542787     History of Changes
Other Study ID Numbers: CBX-001
First Posted: September 7, 2015    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: February 2018

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