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Safety Study of SPARC1104

Primary Purpose

Spasticity

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
SPARC1104 modified dose regimen I
SPARC1104 modified dose regimen II
SPARC1104 modified dose regimen III
Sponsored by
Sun Pharma Advanced Research Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Spasticity focused on measuring spasticity

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • 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

Sites / Locations

  • SPARC site 4
  • SPARC Site 34
  • SPARC Site 1
  • SPARC Site 30
  • SPARC Site 14
  • SPARC Site 32
  • SPARC Site 5
  • SPARC Site 7
  • SPARC site 47
  • SPARC Site 8
  • SPARC Site 50
  • SPARC Site 35
  • SPARC Site 59
  • SPARC Site 6
  • SPARC Site 11
  • SPARC Site 13
  • SPARC Site 25
  • SPARC Site 55
  • SPARC Site 33
  • SPARC site 45
  • SPARC Site 24
  • SPARC Site 44
  • SPARC site 36
  • SPARC Site 21
  • SPARC Site 61
  • SPARC Site 49
  • SPARC Site 22
  • SPARC Site 29
  • SPARC Site 17
  • SPARC Site 26
  • SPARC Site 54
  • SPARC Site 19
  • SPARC Site 28
  • SPARC Site 16
  • SPARC Site 43
  • SPARC Site 52
  • SPARC site 39
  • SPARC Site 18
  • SPARC Site 2
  • SPARC Site 27
  • SPARC site 10
  • SPARC site 38
  • SPARC Site 57
  • SPARC Site 23
  • SPARC Site 5
  • SPARC Site 60
  • SPARC Site 37
  • SPARC Site 20
  • SPARC Site 62
  • SPARC Site 58
  • SPARC Site 56

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

SPARC1104 group 1

SPARC1104 group 2

SPARC1104 group 3

Arm Description

Outcomes

Primary Outcome Measures

Number of Subjects With Adverse Events

Secondary Outcome Measures

Full Information

First Posted
February 16, 2013
Last Updated
May 2, 2019
Sponsor
Sun Pharma Advanced Research Company Limited
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1. Study Identification

Unique Protocol Identification Number
NCT01797185
Brief Title
Safety Study of SPARC1104
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
April 9, 2013 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Pharma Advanced Research Company Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Open-label, safety study of SPARC1104 in subjects with spasticity due to multiple sclerosis
Detailed Description
Safety study of SPARC1104

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spasticity
Keywords
spasticity

7. Study Design

Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
375 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SPARC1104 group 1
Arm Type
Experimental
Arm Title
SPARC1104 group 2
Arm Type
Experimental
Arm Title
SPARC1104 group 3
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SPARC1104 modified dose regimen I
Intervention Description
Subjects who exited study CLR_09_21
Intervention Type
Drug
Intervention Name(s)
SPARC1104 modified dose regimen II
Intervention Description
Subjects who received prior treatment regimen I
Intervention Type
Drug
Intervention Name(s)
SPARC1104 modified dose regimen III
Intervention Description
Subjects who received no prior treatment regimen
Primary Outcome Measure Information:
Title
Number of Subjects With Adverse Events
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
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
Facility Information:
Facility Name
SPARC site 4
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
SPARC Site 34
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
SPARC Site 1
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
SPARC Site 30
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
SPARC Site 14
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
SPARC Site 32
City
Basalt
State/Province
Colorado
ZIP/Postal Code
81621
Country
United States
Facility Name
SPARC Site 5
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
SPARC Site 7
City
Derby
State/Province
Connecticut
ZIP/Postal Code
06418
Country
United States
Facility Name
SPARC site 47
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06112
Country
United States
Facility Name
SPARC Site 8
City
New London
State/Province
Connecticut
ZIP/Postal Code
06320
Country
United States
Facility Name
SPARC Site 50
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
SPARC Site 35
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
SPARC Site 59
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
SPARC Site 6
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
SPARC Site 11
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
SPARC Site 13
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34233
Country
United States
Facility Name
SPARC Site 25
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Facility Name
SPARC Site 55
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
SPARC Site 33
City
Tampa
State/Province
Florida
ZIP/Postal Code
33634
Country
United States
Facility Name
SPARC site 45
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66214
Country
United States
Facility Name
SPARC Site 24
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Facility Name
SPARC Site 44
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
SPARC site 36
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
73101
Country
United States
Facility Name
SPARC Site 21
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70810
Country
United States
Facility Name
SPARC Site 61
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
SPARC Site 49
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287-6985
Country
United States
Facility Name
SPARC Site 22
City
Fulton
State/Province
Maryland
ZIP/Postal Code
20759
Country
United States
Facility Name
SPARC Site 29
City
Foxboro
State/Province
Massachusetts
ZIP/Postal Code
02035
Country
United States
Facility Name
SPARC Site 17
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01104
Country
United States
Facility Name
SPARC Site 26
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48035
Country
United States
Facility Name
SPARC Site 54
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
SPARC Site 19
City
Golden Valley
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
SPARC Site 28
City
Flemington
State/Province
New Jersey
ZIP/Postal Code
08822
Country
United States
Facility Name
SPARC Site 16
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
SPARC Site 43
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
SPARC Site 52
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States
Facility Name
SPARC site 39
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
SPARC Site 18
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405
Country
United States
Facility Name
SPARC Site 2
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
SPARC Site 27
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
SPARC site 10
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97041
Country
United States
Facility Name
SPARC site 38
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
Facility Name
SPARC Site 57
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
Facility Name
SPARC Site 23
City
Indian Land
State/Province
South Carolina
ZIP/Postal Code
29707
Country
United States
Facility Name
SPARC Site 5
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
SPARC Site 60
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
SPARC Site 37
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Facility Name
SPARC Site 20
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
SPARC Site 62
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Facility Name
SPARC Site 58
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
SPARC Site 56
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States

12. IPD Sharing Statement

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Safety Study of SPARC1104

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