Safety Study of SPARC1104

Phase 3

Completed

• Conditions: Spasticity
• Interventions: Drug: SPARC1104 modified dose regimen I; Drug: SPARC1104 modified dose regimen II; Drug: SPARC1104 modified dose regimen III

• Registration Number: NCT01797185
• Lead Sponsor: Sun Pharma Advanced Research Company Limited

Brief Summary

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

Detailed Description

Safety study of SPARC1104

Study Timeline

• Study First Submitted: 2013-02-16
• Study First Submitted QC: 2013-02-20
• Study First Posted: 2013-02-22
• Study Start: 2013-04-09
• Primary Completion: 2017-07
• Study Completion: 2017-10
• Results First Submitted: 2018-11-15
• Results First Submitted QC: 2019-02-18
• Results First Posted: 2019-03-12
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-02
• Last Update Posted: 2019-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 375

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SPARC1104 group 1	SPARC1104 modified dose regimen I	-
SPARC1104 group 2	SPARC1104 modified dose regimen II	-
SPARC1104 group 3	SPARC1104 modified dose regimen III	-

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Adverse Events	52 weeks

Trial Locations

Locations (50)

SPARC site 4; 🇺🇸 Gilbert, Arizona, United States

SPARC Site 34; 🇺🇸 Phoenix, Arizona, United States

SPARC Site 1; 🇺🇸 Tucson, Arizona, United States

SPARC Site 30; 🇺🇸 Costa Mesa, California, United States

SPARC Site 14; 🇺🇸 Newport Beach, California, United States

SPARC Site 32; 🇺🇸 Basalt, Colorado, United States

SPARC Site 5; 🇺🇸 Austin, Texas, United States

SPARC Site 7; 🇺🇸 Derby, Connecticut, United States

SPARC site 47; 🇺🇸 Hartford, Connecticut, United States

SPARC Site 8; 🇺🇸 New London, Connecticut, United States

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