|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02542787 |
|
Date of registration:
|
04/09/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Study of VSN16R for the Treatment of Spasticity in Multiple Sclerosis
|
|
Scientific 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 |
|
Date of first enrolment:
|
August 2015 |
|
Target sample size:
|
160 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02542787 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
United Kingdom
| | | | | | | |
|
Contacts
|
|
Name:
|
Dr Rachel Farrell |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University College London Hospitals |
| | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Spasticity in People With Multiple Sclerosis
|
|
Intervention(s)
|
|
Other: Placebo
|
|
Drug: VSN16R
|
|
Primary Outcome(s)
|
|
Numerical Rating Scale
[Time Frame: 26 days]
|
|
Secondary Outcome(s)
|
|
Modified Ashworth Scale
[Time Frame: 26 days]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|