Safety Study of SPARC1104
Status: | Completed |
---|---|
Conditions: | Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - 90 |
Updated: | 3/14/2019 |
Start Date: | April 9, 2013 |
End Date: | October 2017 |
Open-label, safety study of SPARC1104 in subjects with spasticity due to multiple sclerosis
Safety study of SPARC1104
- 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
We found this trial at
51
sites
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