Phase 2
N=142
Study of SPARC1103 in Subjects With Spasticity
Spasticity
Bottom Line
View on ClinicalTrials.gov: NCT02027025 ↗Enrolled (actual)
142
Serious AEs
0.7%
Results posted
Jan 2019
Primary outcome: Primary: Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Modified Ashworth Score — 0.33; 0.03 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SPARC1103 low dose (Drug); SPARC1103 high dose (Drug); SPARC Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sun Pharma Advanced Research Company Limited
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Modified Ashworth Score |
0.33; 0.03 | — |
| SECONDARY Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Night Time Awakening Score |
-0.25; -0.24; 0.23 | 0.4532 |
| SECONDARY Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Spasm Frequency |
-0.46; -0.46; -2.6 | 0.3013 |
| SECONDARY Clinical Global Impression of Change Results at 24 Hours Post Dose on Day 24 |
4; 2; 3; 12; 8; 8 | 0.3815 |
| SECONDARY Subject Global Impression of Severity of Spasticity |
5; 4; 4; 4; 5; 6 | 0.8991 |
Summary
Study of SPARC1103 in subjects with spasticity
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02027025). 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.