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Completed

NCT Number: NCT02542787

Study of VSN16R for the Treatment of Spasticity in Multiple Sclerosis

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

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Key information

Conditions

Spasticity in People With Multiple Sclerosis Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Neuroscience Research Centre, The Walton Centre NHS Foundation Trust, Liverpool, United Kingdom

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VSN16R

Drug

Small molecule

Other names: Not yet available

Placebo

Other

dummy tablet

Primary outcomes

  1. Numerical Rating Scale

    Time frame: 26 days

Secondary outcomes

  1. Modified Ashworth Scale

    Time frame: 26 days

Sponsors and collaborators

Lead sponsor

Canbex Therapeutics Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 7, 2015
Registry last updated
Mar 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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