Safety Study of SPARC1104

• Status: Completed
• Trial end date: 2017-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Open-label, safety study of SPARC1104 in subjects with spasticity due to multiple sclerosis

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Pharma Advanced Research Company Limited

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