Spasticity Clinical Trial
| Verified date | June 2019 |
| Source | Sun Pharma Advanced Research Company Limited |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to assess whether SPARC0921 demonstrate efficacy and safety in the treatment of spasticity.
| Status | Completed |
| Enrollment | 392 |
| Est. completion date | August 25, 2017 |
| Est. primary completion date | August 25, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Men and women age 18 years and older - Able and willing to comply with the protocol, including availability for a scheduled clinic visits - Willingness and giving of written informed consent Exclusion Criteria: - In relapse or history of unstable course over the prior 30 days prior to the Screening Visit - Concomitant neurologic conditions causing spasticity - Has received an investigational drug or device within 30 days that would interfere with the study goals prior to the Screening Visit - Unable to comply with study procedures in the opinion of the investigator |
| Country | Name | City | State |
|---|---|---|---|
| Germany | SPARC Site 77 | Dresden | |
| Germany | SPARC Site 76 | Erbach | |
| Germany | SPARC Site 79 | Teupitz | |
| Germany | SPARC Site 78 | Westerstede | |
| Hungary | SPARC Site 82 | Budapest | |
| Hungary | SPARC site 83 | Budapest | |
| Hungary | SPARC Site 81 | Eger | |
| Hungary | SPARC Site 80 | Esztergom | |
| Russian Federation | SPARC Site 87 | Moscow | |
| Russian Federation | SPARC Site 86 | Novosibirsk | |
| Russian Federation | SPARC Site 85 | Saint Petersburg | |
| Russian Federation | SPARC Site 84 | Sestroretsk | |
| Russian Federation | SPARC Site 88 | Stavropol' | |
| Ukraine | SPARC Site 90 | Dnipropetrovsk | |
| Ukraine | SPARC Site 92 | L'viv | |
| Ukraine | SPARC Site 91 | Poltava | |
| Ukraine | SPARC Site 89 | Zaporozh'ye | |
| United States | SPARC Site 68 | Abington | Pennsylvania |
| United States | SPARC Site 16 | Akron | Ohio |
| United States | SPARC Site 22 | Albuquerque | New Mexico |
| United States | SPARC Site 42 | Alexandria | Louisiana |
| United States | SPARC Site 7 | Austin | Texas |
| United States | SPARC Site 38 | Basalt | Colorado |
| United States | SPARC Site 27 | Baton Rouge | Louisiana |
| United States | SPARC Site 15 | Bradenton | Florida |
| United States | SPARC Site 33 | Centerville | Ohio |
| United States | SPARC Site 4 | Charlotte | North Carolina |
| United States | SPARC Site 45 | Charlotte | North Carolina |
| United States | SPARC Site 32 | Clinton Township | Michigan |
| United States | SPARC Site 56 | Columbus | Ohio |
| United States | SPARC Site 36 | Costa Mesa | California |
| United States | SPARC Site 71 | Dallas | Texas |
| United States | SPARC Site 21 | Denver | Colorado |
| United States | SPARC Site 9 | Derby | Connecticut |
| United States | SPARC Site 64 | Detroit | Michigan |
| United States | SPARC Site 12 | Eugene | Oregon |
| United States | SPARC site 34 | Flemington | New Jersey |
| United States | SPARC Site 35 | Foxboro | Massachusetts |
| United States | SPARC site 6 | Gilbert | Arizona |
| United States | SPARC Site 25 | Golden Valley | Minnesota |
| United States | SPARC Site 24 | Greensboro | North Carolina |
| United States | SPARC Site 57 | Hartford | Connecticut |
| United States | SPARC Site 5 | Henderson | Nevada |
| United States | SPARC Site 43 | Houston | Texas |
| United States | SPARC Site 74 | Huntington | West Virginia |
| United States | SPARC Site 29 | Indian Land | South Carolina |
| United States | SPARC Site 54 | Jacksonville | Florida |
| United States | SPARC Site 51 | Lenexa | Kansas |
| United States | SPARC Site 50 | Louisville | Kentucky |
| United States | SPARC Site 41 | Maitland | Florida |
| United States | SPARC Site 70 | Miami | Florida |
| United States | SPARC Site 69 | Milwaukee | Wisconsin |
| United States | SPARC Site 10 | New London | Connecticut |
| United States | SPARC Site 73 | New Orleans | Louisiana |
| United States | SPARC Site 20 | Newport Beach | California |
| United States | SPARC Site 8 | Ormond Beach | Florida |
| United States | SPARC Site 30 | Overland Park | Kansas |
| United States | SPARC Site 40 | Phoenix | Arizona |
| United States | SPARC Site 17 | Port Charlotte | Florida |
| United States | SPARC Site 49 | Rochester | New York |
| United States | SPARC Site 13 | Salt Lake City | Utah |
| United States | SPARC Site 19 | Sarasota | Florida |
| United States | SPARC Site 23 | Springfield | Massachusetts |
| United States | SPARC Site 44 | Springfield | Oregon |
| United States | SPARC Site 55 | Stratford | New Jersey |
| United States | SPARC Site 31 | Sunrise | Florida |
| United States | SPARC Site 26 | Tacoma | Washington |
| United States | SPARC Site 39 | Tampa | Florida |
| United States | SPARC Site 65 | Tampa | Florida |
| United States | SPARC Site 60 | Washington | District of Columbia |
| United States | SPARC Site 67 | Waukesha | Wisconsin |
| United States | SPARC Site 2 | Winston-Salem | North Carolina |
| United States | SPARC Site 75 | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Sun Pharma Advanced Research Company Limited |
United States, Germany, Hungary, Russian Federation, Ukraine,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Treatment Failure Rate | Percentage of subjects who had treatment failure Clinical Global Impression of Change of = 5 and at least one movement with = 1 unit increase in modified Ashworth score from baseline. The modified Ashworth scale is a 6-point scale as follows: Minimum score of 0 (better outcome) = no increase in tone Maximum score of 4 (worst outcome) = affected part(s) rigid inflexion or extension. The clinician (other than the one performing the Modified Ashworth Scale assessment) rated his/her overall (global) impression of change in spasticity using the 7-point scale shown below: Minimum score of 1 (better outcome) = very much improved Maximum score of 7 (very much worse) = very much worse |
Week 22 | |
| Secondary | Severity of Spasticity Assessed by Subject Global Impression Severity Scale | The subject was asked "Overall, how would you rate the severity of your spasticity over the past 24 hours?" The 7-point scale for Subject's global impression of severity assessment is as follows: minimum score of 1 = normal, no spasticity maximum score of 7 (worst outcome)= worst spasticity imaginable | Week 22 |
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