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Safety Study of SPARC1104

NCT01797185 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 375

Last updated 2019-05-03

Study results available
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Summary

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

Conditions

  • Spasticity

Interventions

DRUG

SPARC1104 modified dose regimen I

Subjects who exited study CLR\_09\_21

DRUG

SPARC1104 modified dose regimen II

Subjects who received prior treatment regimen I

DRUG

SPARC1104 modified dose regimen III

Subjects who received no prior treatment regimen

Sponsors & Collaborators

  • Sun Pharma Advanced Research Company Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-09
Primary Completion
2017-07-31
Completion
2017-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01797185 on ClinicalTrials.gov