Study of SPARC1103 in Subjects With Spasticity
Study of SPARC1103 in Subjects With Spasticity
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- SPARC1103 low dose
- SPARC1103 high dose
Placebo
- SPARC Placebo
Results by group
Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Modified Ashworth Score
Baseline, Day 24
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| SPARC1103 Low Dose | 0.33 score on a scale | 1.47 (Standard Error) | 47 |
| SPARC1103 High Dose | 0.03 score on a scale | 1.53 (Standard Error) | 42 |
SPARC1103 Low Dose
SPARC1103 High Dose
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| SPARC1103 Low Dose | 48 | 0 (0.0%) | 0 |
| SPARC1103 High Dose | 47 | 1 (2.1%) | 0 |
| SPARC Placebo | 47 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Modified Ashworth Score
Baseline, Day 24
Spasticity
Other measures (4)
Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Night Time Awakening Score
Baseline, Day 24
SpasticityLeast Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Spasm Frequency
Baseline, Day 24
SpasticityClinical Global Impression of Change Results at 24 Hours Post Dose on Day 24
Baseline, Day 24
SpasticitySubject Global Impression of Severity of Spasticity
Baseline, Day 24
Spasticity
Who could take part
MS (type not specified) · 18 and over
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Study of SPARC1103 in subjects with spasticity
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History
Started
Apr 2014
Main results due
Apr 2017
Finished
Apr 2017
Results posted
Jan 2019