Study of VSN16R for the Treatment of Spasticity in Multiple Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2017-10-31

Brief Summary

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

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Detailed Description

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

Conditions

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Spasticity in People With Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active

VSN16R (Canbex name for molecule) oral capsules, 50mg-400mg daily or twice daily, total exposure 26 days

Group Type EXPERIMENTAL

VSN16R

Intervention Type DRUG

Small molecule

Placebo

Placebo capsules, 50mg-400mg daily or twice daily, total exposure 26 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

dummy tablet

Interventions

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VSN16R

Small molecule

Intervention Type DRUG

Placebo

dummy tablet

Intervention Type OTHER

Other Intervention Names

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Not yet available

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No