Study of SPARC1103 in Subjects With Spasticity

Sun Pharma Advanced Research (SPARC)

Status and phase: Completed; Phase 2

Conditions: Spasticity

Treatments: Drug: SPARC Placebo; Drug: SPARC1103 low dose; Drug: SPARC1103 high dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT02027025

CLR_11_03

Details and patient eligibility

About

Study of SPARC1103 in subjects with spasticity

Enrollment: 142 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women greater than or equal to 18 years of age
• Willing to sign the informed consent form
• Women of child bearing potential willing to practice an acceptable method of birth control
• Known history of spasticity due to MS

Exclusion criteria

• Administration of an investigational drug or device within 30 days prior to Screening Visit 1
• Unable to comply with trial procedures in the opinion of the Investigator
• Concomitant neurologic conditions causing spasticity
• Any medical condition, including psychiatric disease or epilepsy, which would interfere with the interpretation of the trial results

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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142 participants in 3 patient groups, including a placebo group

SPARC 1103 low dose

Active Comparator group

Description:

The subjects will receive SPARC 1103 low dose

Treatment:

Drug: SPARC1103 low dose

SPARC1103 high dose

Active Comparator group

Description:

The subjects will receive SPARC1103 high dose

Treatment:

Drug: SPARC1103 high dose

SPARC Placebo

Placebo Comparator group

Description:

The subjects will receive SPARC Placebo

Treatment:

Drug: SPARC Placebo