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Safety Study of SPARC1104

NCT ID: NCT01797185

Last Updated: 2019-05-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

375 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-09

Study Completion Date

2017-10-31

Brief Summary

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

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Detailed Description

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Safety study of SPARC1104

Conditions

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Spasticity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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SPARC1104 group 1

Group Type EXPERIMENTAL

SPARC1104 modified dose regimen I

Intervention Type DRUG

Subjects who exited study CLR\_09\_21

SPARC1104 group 2

Group Type EXPERIMENTAL

SPARC1104 modified dose regimen II

Intervention Type DRUG

Subjects who received prior treatment regimen I

SPARC1104 group 3

Group Type EXPERIMENTAL

SPARC1104 modified dose regimen III

Intervention Type DRUG

Subjects who received no prior treatment regimen

Interventions

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SPARC1104 modified dose regimen I

Subjects who exited study CLR\_09\_21

Intervention Type DRUG

SPARC1104 modified dose regimen II

Subjects who received prior treatment regimen I

Intervention Type DRUG

SPARC1104 modified dose regimen III

Subjects who received no prior treatment regimen

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Pharma Advanced Research Company Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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SPARC site 4

Gilbert, Arizona, United States

Site Status

SPARC Site 34

Phoenix, Arizona, United States

Site Status

SPARC Site 1

Tucson, Arizona, United States

Site Status

SPARC Site 30

Costa Mesa, California, United States

Site Status

SPARC Site 14

Newport Beach, California, United States

Site Status

SPARC Site 32

Basalt, Colorado, United States

Site Status

SPARC Site 5

Denver, Colorado, United States

Site Status

SPARC Site 7

Derby, Connecticut, United States

Site Status

SPARC site 47

Hartford, Connecticut, United States

Site Status

SPARC Site 8

New London, Connecticut, United States

Site Status

SPARC Site 50

Washington D.C., District of Columbia, United States

Site Status

SPARC Site 35

Maitland, Florida, United States

Site Status

SPARC Site 59

Miami, Florida, United States

Site Status

SPARC Site 6

Ormond Beach, Florida, United States

Site Status

SPARC Site 11

Port Charlotte, Florida, United States

Site Status

SPARC Site 13

Sarasota, Florida, United States

Site Status

SPARC Site 25

Sunrise, Florida, United States

Site Status

SPARC Site 55

Tampa, Florida, United States

Site Status

SPARC Site 33

Tampa, Florida, United States

Site Status

SPARC site 45

Lenexa, Kansas, United States

Site Status

SPARC Site 24

Overland Park, Kansas, United States

Site Status

SPARC Site 44

Louisville, Kentucky, United States

Site Status

SPARC site 36

Alexandria, Louisiana, United States

Site Status

SPARC Site 21

Baton Rouge, Louisiana, United States

Site Status

SPARC Site 61

New Orleans, Louisiana, United States

Site Status

SPARC Site 49

Baltimore, Maryland, United States

Site Status

SPARC Site 22

Fulton, Maryland, United States

Site Status

SPARC Site 29

Foxborough, Massachusetts, United States

Site Status

SPARC Site 17

Springfield, Massachusetts, United States

Site Status

SPARC Site 26

Clinton Township, Michigan, United States

Site Status

SPARC Site 54

Detroit, Michigan, United States

Site Status

SPARC Site 19

Golden Valley, Minnesota, United States

Site Status

SPARC Site 28

Flemington, New Jersey, United States

Site Status

SPARC Site 16

Albuquerque, New Mexico, United States

Site Status

SPARC Site 43

Rochester, New York, United States

Site Status

SPARC Site 52

White Plains, New York, United States

Site Status

SPARC site 39

Charlotte, North Carolina, United States

Site Status

SPARC Site 18

Greensboro, North Carolina, United States

Site Status

SPARC Site 2

Winston-Salem, North Carolina, United States

Site Status

SPARC Site 27

Centerville, Ohio, United States

Site Status

SPARC site 10

Eugene, Oregon, United States

Site Status

SPARC site 38

Springfield, Oregon, United States

Site Status

SPARC Site 57

Abington, Pennsylvania, United States

Site Status

SPARC Site 23

Old Point Station, South Carolina, United States

Site Status

SPARC Site 5

Austin, Texas, United States

Site Status

SPARC Site 60

Dallas, Texas, United States

Site Status

SPARC Site 37

Houston, Texas, United States

Site Status

SPARC Site 20

Tacoma, Washington, United States

Site Status

SPARC Site 62

Huntington, West Virginia, United States

Site Status

SPARC Site 58

Milwaukee, Wisconsin, United States

Site Status

SPARC Site 56

Waukesha, Wisconsin, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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CLR_11_04

Identifier Type: -

Identifier Source: org_study_id

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