Safety Study of SPARC1104

Sun Pharma Advanced Research (SPARC)

Status and phase: Completed; Phase 3

Conditions: Spasticity

Treatments: Drug: SPARC1104 modified dose regimen III; Drug: SPARC1104 modified dose regimen II; Drug: SPARC1104 modified dose regimen I

Study type: Interventional

Funder types: Industry

Identifiers

NCT01797185

CLR_11_04

Details and patient eligibility

About

Open-label, safety study of SPARC1104 in subjects with spasticity due to multiple sclerosis

Full description

Safety study of SPARC1104

Enrollment: 375 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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375 participants in 3 patient groups

SPARC1104 group 1

Experimental group

Treatment:

Drug: SPARC1104 modified dose regimen I

SPARC1104 group 2

Experimental group

Treatment:

Drug: SPARC1104 modified dose regimen II

SPARC1104 group 3

Experimental group

Treatment:

Drug: SPARC1104 modified dose regimen III