Efficacy and Safety of SPARC0921 in Subjects With Spasticity

Sun Pharma Advanced Research (SPARC)

Status and phase: Completed; Phase 3

Conditions: Spasticity

Treatments: Drug: SPARC0921; Drug: Placebo0921

Study type: Interventional

Funder types: Industry

Identifiers

NCT01457352

CLR_09_21

Details and patient eligibility

About

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

Enrollment: 392 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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392 participants in 2 patient groups, including a placebo group

SPARC0921

Experimental group

Treatment:

Drug: SPARC0921

Placebo0921

Placebo Comparator group

Treatment:

Drug: Placebo0921