Safety Study of SPARC1104 | NCT01797185 | Trialant
CompletedInterventionalPhase 3Updated May 3, 2019
Safety Study of SPARC1104
ClinicalTrials.gov ID
NCT01797185
Lead Sponsor
Sun Pharma Advanced Research Company LimitedINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 3
Enrollment
375Actual
Last Update Posted
May 3, 2019Actual
Start Date
Apr 9, 2013Actual
Primary Completion Date
Jul 2017Actual
Completion Date
Oct 2017Actual
Brief Summary
Open-label, safety study of SPARC1104 in subjects with spasticity due to multiple sclerosis
Detailed Description
Safety study of SPARC1104
Spasticity
SPARC1104 modified dose regimen I
SPARC1104 modified dose regimen II
SPARC1104 modified dose regimen III
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility 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
Primary Purpose
Other
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
None (Open Label)
No central contacts
There are no central contacts for this study.
SPARC site 4
Gilbert, Arizona 85234, United States
SPARC Site 34
Phoenix, Arizona 85004, United States
SPARC Site 1
Tucson, Arizona 85704, United States
SPARC Site 30
Costa Mesa, California 92626, United States
SPARC Site 14
Newport Beach, California 92663, United States
SPARC Site 32
Basalt, Colorado 81621, United States
SPARC Site 5
Denver, Colorado 80209, United States
SPARC Site 7
Derby, Connecticut 06418, United States
SPARC site 47
Hartford, Connecticut 06112, United States
SPARC Site 8
New London, Connecticut 06320, United States
SPARC Site 50
Washington D.C., District of Columbia 20007, United States
SPARC Site 35
Maitland, Florida 32751, United States
SPARC Site 59
Miami, Florida 33136, United States
SPARC Site 6
Ormond Beach, Florida 32174, United States
SPARC Site 11
Port Charlotte, Florida 33952, United States
SPARC Site 13
Sarasota, Florida 34233, United States
SPARC Site 25
Sunrise, Florida 33351, United States
SPARC Site 55
Tampa, Florida 33612, United States
SPARC Site 33
Tampa, Florida 33634, United States
SPARC site 45
Lenexa, Kansas 66214, United States
SPARC Site 24
Overland Park, Kansas 66212, United States
SPARC Site 44
Louisville, Kentucky 40207, United States
SPARC site 36
Alexandria, Louisiana 73101, United States
SPARC Site 21
Baton Rouge, Louisiana 70810, United States
SPARC Site 61
New Orleans, Louisiana 70121, United States
SPARC Site 49
Baltimore, Maryland 21287-6985, United States
SPARC Site 22
Fulton, Maryland 20759, United States
SPARC Site 29
Foxborough, Massachusetts 02035, United States
SPARC Site 17
Springfield, Massachusetts 01104, United States
SPARC Site 26
Clinton Township, Michigan 48035, United States
SPARC Site 54
Detroit, Michigan 48202, United States
SPARC Site 19
Golden Valley, Minnesota 55422, United States
SPARC Site 28
Flemington, New Jersey 08822, United States
SPARC Site 16
Albuquerque, New Mexico 87108, United States
SPARC Site 43
Rochester, New York 14642, United States
SPARC Site 52
White Plains, New York 10605, United States
SPARC site 39
Charlotte, North Carolina 28203, United States
SPARC Site 18
Greensboro, North Carolina 27405, United States
SPARC Site 2
Winston-Salem, North Carolina 27103, United States
SPARC Site 27
Centerville, Ohio 45459, United States
SPARC site 10
Eugene, Oregon 97041, United States
SPARC site 38
Springfield, Oregon 97477, United States
SPARC Site 57
Abington, Pennsylvania 19090, United States
SPARC Site 23
Old Point Station, South Carolina 29707, United States
SPARC Site 5
Austin, Texas 78731, United States
SPARC Site 60
Dallas, Texas 75246, United States
SPARC Site 37
Houston, Texas 77025, United States
SPARC Site 20
Tacoma, Washington 98405, United States
SPARC Site 62
Huntington, West Virginia 25701, United States
SPARC Site 58
Milwaukee, Wisconsin 53215, United States
SPARC Site 56
Waukesha, Wisconsin 53188, United States
Lead Sponsor
Sun Pharma Advanced Research Company LimitedINDUSTRY