Spasticity in People With Multiple SclerosisPhase 2NCT02542787
Study of VSN16R for the Treatment of Spasticity in Multiple Sclerosis
A Phase 2 study testing VSN16R in people with Spasticity in People With Multiple Sclerosis, run by Canbex Therapeutics Ltd at 4 sites in United Kingdom.
Trial summary
Phase II a Proof of concept study in Multiple Sclerosis (MS) patients with spasticity. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spasticity in People With Multiple Sclerosis
- What is being tested?
- VSN16R
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- Aug 2015to Oct 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
The Neuroscience Research Centre, The Walton Centre NHS Foundation Trust
Liverpool, L9 7LJ
The Royal London Hospital
London, E1 1BB
The National Hospital for Neurology and Neurosurgery
London, WC1N 3BG
Royal Hallamshire Hospital, Sheffield Teaching Hospital NHS Foundation Trust
Sheffield, S10 2JFS
About this study
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
Phase II a Proof of concept study in Multiple Sclerosis (MS) patients with spasticity.
Read the detailed description
Single dose escalation followed by multiple fixed dose administrations to assess short term safety and to determine whether spasticity improves.
- Being tested
- VSN16R, Placebo
- Keywords
- MS, Spasticity, VSN16R
- Medical subject headings
- Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VSN16RDrug
Also called Not yet available
Small molecule
PlaceboOther
dummy tablet
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | VSN16R (Canbex name for molecule) oral capsules, 50mg-400mg daily or twice daily, total exposure 26 days Receives: Drug: VSN16R |
| Placebo | Placebo comparator | Placebo capsules, 50mg-400mg daily or twice daily, total exposure 26 days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale
Measured: 26 days
Secondary outcomes (1)
Modified Ashworth Scale
Measured: 26 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spasticity in People With Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canbex Therapeutics Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Rachel Farrell, Principal investigator, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02542787
- Sponsor's protocol ID
- CBX-001
- Status last verified
- Feb 2018
- First submitted
- 4 Sep 2015
- Last updated
- 2 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02542787
- Acronym / sponsor ID
- CBX-001
- Keywords
- MS, Spasticity, VSN16R
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Canbex Therapeutics LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 7 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: VSN16RVSN16R (Canbex name for molecule) oral capsules, 50mg-400mg daily or twice daily, total exposure 26 days |
| Placebo | Placebo comparator | Other: PlaceboPlacebo capsules, 50mg-400mg daily or twice daily, total exposure 26 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VSN16RAlso: Not yet availableSmall molecule | Drug | Active |
| Placebodummy tablet | Other | Placebo |
Primary outcome
Numerical Rating Scale
Time frame: 26 days
1 secondary outcome
Modified Ashworth Scale
Time frame: 26 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Rachel Farrell principal investigator
University College London Hospitals
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VSN16R in people with Spasticity in People With Multiple Sclerosis, run by Canbex Therapeutics Ltd at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale (time frame: 26 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2018; AzTrials last refreshed its copy on 8 Nov 2026.