Phase 3
N=375
Safety Study of SPARC1104
Spasticity
Bottom Line
View on ClinicalTrials.gov: NCT01797185 ↗Enrolled (actual)
375
Serious AEs
20.3%
Results posted
Mar 2019
Primary outcome: Primary: Number of Subjects With Adverse Events — 129; 150; 44 Count of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- SPARC1104 modified dose regimen I (Drug); SPARC1104 modified dose regimen II (Drug); SPARC1104 modified dose regimen III (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sun Pharma Advanced Research Company Limited
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Adverse Events |
129; 150; 44 | — |
Summary
Open-label, safety study of SPARC1104 in subjects with spasticity due to multiple sclerosis
Eligibility Criteria
- Willingness to participate and give written informed consent
- Men and women ≥ 18 years of age
- Sexually active women who are of child bearing potential will practice an acceptable method of birth control for the duration of the trial as judged by the investigator. Examples of acceptable contraception are: condoms, foams, jellies, diaphragm, intrauterine device, oral or long-acting injected contraceptives, bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or having a partner who is incapable of initiating conception. The practice of contraception must have started at least 3 months prior to trial entry.
- If female, negative pregnancy test result at Screening
- Diagnosed with MS and a known history of spasticity
- Meet one of the following criteria o Subjects who completed the double-blind randomized withdrawal phase (Part 3) of trial CLR\_09\_21 with no major protocol violation
Data sourced from ClinicalTrials.gov (NCT01797185). 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.