|
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: |
NCT02027025 |
|
Date of registration:
|
01/01/2014 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Study of SPARC1103 in Subjects With Spasticity
|
|
Scientific title:
|
|
|
Date of first enrolment:
|
April 21, 2014 |
|
Target sample size:
|
142 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02027025 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
Russian Federation
|
Ukraine
|
United States
| | | | | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Men and women greater than or equal to 18 years of age
- Willing to sign the informed consent form
- Women of child bearing potential willing to practice an acceptable method of birth
control
- Known history of spasticity due to MS
Exclusion Criteria:
- Administration of an investigational drug or device within 30 days prior to Screening
Visit 1
- Unable to comply with trial procedures in the opinion of the Investigator
- Concomitant neurologic conditions causing spasticity
- Any medical condition, including psychiatric disease or epilepsy, which would
interfere with the interpretation of the trial results
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Spasticity
|
|
Intervention(s)
|
|
Drug: SPARC Placebo
|
|
Drug: SPARC1103 low dose
|
|
Drug: SPARC1103 high dose
|
|
Primary Outcome(s)
|
|
Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Modified Ashworth Score
[Time Frame: Baseline, Day 24]
|
|
Secondary Outcome(s)
|
|
Subject Global Impression of Severity of Spasticity
[Time Frame: Baseline, Day 24]
|
|
Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Night Time Awakening Score
[Time Frame: Baseline, Day 24]
|
|
Clinical Global Impression of Change Results at 24 Hours Post Dose on Day 24
[Time Frame: Baseline, Day 24]
|
|
Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Spasm Frequency
[Time Frame: Baseline, Day 24]
|
|
Secondary ID(s)
|
|
CLR_11_03
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|