Study of VSN16R for the Treatment of Spasticity in Multip... | NCT02542787

Studies
Study of VSN16R for the Treatment of Spasticity in Multiple Sclerosis

NCT02542787

Sponsor

Canbex Therapeutics Ltd

Status

Completed

Last Update Posted

Mar 2, 2018Actual

Enrollment

160Estimated

Phase

Phase 2

Conditions

Spasticity in People With Multiple Sclerosis

Interventions

VSN16R
Placebo

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2015

Primary Completion Date

Oct 2017Actual

Completion Date

Oct 2017Actual

First Submitted Date

Sep 4, 2015

First Submission Date that Met QC Criteria

Sep 4, 2015

First Posted Date

Sep 7, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2018

Last Update Posted Date

Mar 2, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active	Experimental	VSN16R (Canbex name for molecule) oral capsules, 50mg-400mg daily or twice daily, total exposure 26 days	Drug: VSN16R
Placebo	Placebo Comparator	Placebo capsules, 50mg-400mg daily or twice daily, total exposure 26 days	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VSN16R	Drug	Small molecule	Active	Not yet available

Measure	Description	Time Frame
Numerical Rating Scale		26 days

Measure	Description	Time Frame
Modified Ashworth Scale		26 days

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dr Rachel Farrell	University College London Hospitals	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Neuroscience Research Centre, The Walton Centre NHS Foundation Trust		Liverpool		L9 7LJ	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D009128	Muscle Spasticity

Ancestor Terms

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D009122	Muscle Hypertonia
D020879	Neuromuscular Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided