Status:
COMPLETED
Safety Study of SPARC1104
Lead Sponsor:
Sun Pharma Advanced Research Company Limited
Conditions:
Spasticity
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
Brief Summary
Open-label, safety study of SPARC1104 in subjects with spasticity due to multiple sclerosis
Detailed Description
Safety study of SPARC1104
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 9 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2017
Estimated Enrollment :
375 Patients enrolled
Trial Details
Trial ID
NCT01797185
Start Date
April 9 2013
End Date
October 1 2017
Last Update
May 3 2019
Active Locations (51)
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1
SPARC site 4
Gilbert, Arizona, United States, 85234
2
SPARC Site 34
Phoenix, Arizona, United States, 85004
3
SPARC Site 1
Tucson, Arizona, United States, 85704
4
SPARC Site 30
Costa Mesa, California, United States, 92626