Efficacy and Safety of SPARC0921 in Subjects With Spasticity

Completed · Phase 3 · Has a placebo group

Conditions studied: Spasticity

In brief

The purpose of this study is to assess whether SPARC0921 demonstrate efficacy and safety in the treatment of spasticity.

Key facts

Study ID

NCT01457352

Run by

Sun Pharma Advanced Research Company Limited

People needed

392

Starts

2012-11-14

Expected to finish

2017-08-25

Last updated by the study team

2019-06-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• SPARC Site 40 — Phoenix, Arizona, United States
• SPARC Site 36 — Costa Mesa, California, United States
• SPARC Site 20 — Newport Beach, California, United States
• SPARC Site 38 — Basalt, Colorado, United States
• SPARC Site 21 — Denver, Colorado, United States
• SPARC Site 9 — Derby, Connecticut, United States
• SPARC Site 57 — Hartford, Connecticut, United States
• SPARC Site 10 — New London, Connecticut, United States
• SPARC Site 60 — Washington D.C., District of Columbia, United States
• SPARC Site 15 — Bradenton, Florida, United States
• SPARC Site 54 — Jacksonville, Florida, United States
• SPARC Site 41 — Maitland, Florida, United States
• SPARC Site 70 — Miami, Florida, United States
• SPARC Site 8 — Ormond Beach, Florida, United States
• SPARC Site 17 — Port Charlotte, Florida, United States
• SPARC Site 19 — Sarasota, Florida, United States
• SPARC Site 31 — Sunrise, Florida, United States
• SPARC Site 39 — Tampa, Florida, United States
• SPARC Site 65 — Tampa, Florida, United States
• SPARC Site 51 — Lenexa, Kansas, United States
• SPARC Site 30 — Overland Park, Kansas, United States
• SPARC Site 50 — Louisville, Kentucky, United States
• SPARC Site 42 — Alexandria, Louisiana, United States
• SPARC Site 27 — Baton Rouge, Louisiana, United States
• SPARC site 6 — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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