Phase 2 Completed N=142 Randomized Double-blind Treatment

Study of SPARC1103 in Subjects With Spasticity

Spasticity

Source: ClinicalTrials.gov NCT02027025 ↗

Enrolled (actual)

142

Serious AEs

0.7%

Results posted

Jan 2019

Primary outcomePrimary: 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

Summary

Study of SPARC1103 in subjects with spasticity

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

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.