Phase 3
Completed N=392
Efficacy and Safety of SPARC0921 in Subjects With Spasticity
Source: ClinicalTrials.gov NCT01457352 ↗Enrolled (actual)
392
Serious AEs
1.4%
Results posted
Jun 2019
Primary outcomePrimary: Treatment Failure Rate — 36.1; 43.2 percentage of subjects — p=0.2062
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to assess whether SPARC0921 demonstrate efficacy and safety in the treatment of spasticity.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Failure Rate |
36.1; 43.2 | 0.2062 |
| SECONDARY Severity of Spasticity Assessed by Subject Global Impression Severity Scale |
19.7; 10.3; 6.8; 13; 26.5; 20.5 | 0.0485 sig |
Eligibility Criteria
Inclusion Criteria
- Men and women age 18 years and older
- Able and willing to comply with the protocol, including availability for a scheduled clinic visits
- Willingness and giving of written informed consent
Exclusion Criteria
- In relapse or history of unstable course over the prior 30 days prior to the Screening Visit
- Concomitant neurologic conditions causing spasticity
- Has received an investigational drug or device within 30 days that would interfere with the study goals prior to the Screening Visit
- Unable to comply with study procedures in the opinion of the investigator
Data sourced from ClinicalTrials.gov (NCT01457352). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.