Spasticity Clinical Trial
| Verified date | May 2019 |
| Source | Sun Pharma Advanced Research Company Limited |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Open-label, safety study of SPARC1104 in subjects with spasticity due to multiple sclerosis
| Status | Completed |
| Enrollment | 375 |
| Est. completion date | October 2017 |
| Est. primary completion date | July 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 90 Years |
| Eligibility |
- 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | SPARC Site 57 | Abington | Pennsylvania |
| United States | SPARC Site 16 | Albuquerque | New Mexico |
| United States | SPARC site 36 | Alexandria | Louisiana |
| United States | SPARC Site 5 | Austin | Texas |
| United States | SPARC Site 49 | Baltimore | Maryland |
| United States | SPARC Site 32 | Basalt | Colorado |
| United States | SPARC Site 21 | Baton Rouge | Louisiana |
| United States | SPARC Site 27 | Centerville | Ohio |
| United States | SPARC site 39 | Charlotte | North Carolina |
| United States | SPARC Site 26 | Clinton Township | Michigan |
| United States | SPARC Site 30 | Costa Mesa | California |
| United States | SPARC Site 60 | Dallas | Texas |
| United States | SPARC Site 5 | Denver | Colorado |
| United States | SPARC Site 7 | Derby | Connecticut |
| United States | SPARC Site 54 | Detroit | Michigan |
| United States | SPARC site 10 | Eugene | Oregon |
| United States | SPARC Site 28 | Flemington | New Jersey |
| United States | SPARC Site 29 | Foxboro | Massachusetts |
| United States | SPARC Site 22 | Fulton | Maryland |
| United States | SPARC site 4 | Gilbert | Arizona |
| United States | SPARC Site 19 | Golden Valley | Minnesota |
| United States | SPARC Site 18 | Greensboro | North Carolina |
| United States | SPARC site 47 | Hartford | Connecticut |
| United States | SPARC Site 37 | Houston | Texas |
| United States | SPARC Site 62 | Huntington | West Virginia |
| United States | SPARC Site 23 | Indian Land | South Carolina |
| United States | SPARC site 45 | Lenexa | Kansas |
| United States | SPARC Site 44 | Louisville | Kentucky |
| United States | SPARC Site 35 | Maitland | Florida |
| United States | SPARC Site 59 | Miami | Florida |
| United States | SPARC Site 58 | Milwaukee | Wisconsin |
| United States | SPARC Site 8 | New London | Connecticut |
| United States | SPARC Site 61 | New Orleans | Louisiana |
| United States | SPARC Site 14 | Newport Beach | California |
| United States | SPARC Site 6 | Ormond Beach | Florida |
| United States | SPARC Site 24 | Overland Park | Kansas |
| United States | SPARC Site 34 | Phoenix | Arizona |
| United States | SPARC Site 11 | Port Charlotte | Florida |
| United States | SPARC Site 43 | Rochester | New York |
| United States | SPARC Site 13 | Sarasota | Florida |
| United States | SPARC Site 17 | Springfield | Massachusetts |
| United States | SPARC site 38 | Springfield | Oregon |
| United States | SPARC Site 25 | Sunrise | Florida |
| United States | SPARC Site 20 | Tacoma | Washington |
| United States | SPARC Site 33 | Tampa | Florida |
| United States | SPARC Site 55 | Tampa | Florida |
| United States | SPARC Site 1 | Tucson | Arizona |
| United States | SPARC Site 50 | Washington | District of Columbia |
| United States | SPARC Site 56 | Waukesha | Wisconsin |
| United States | SPARC Site 52 | White Plains | New York |
| United States | SPARC Site 2 | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Sun Pharma Advanced Research Company Limited |
United States,
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|---|---|---|---|---|
| Primary | Number of Subjects With Adverse Events | 52 weeks |
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