Safety Study of SPARC1104

NCT01797185 | Completed Phase 3 Results

• 1 other identifier: CLR_11_04
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 51

Brief Summary

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

Conditions

Spasticity

Keywords

spasticity

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Adverse Events

  52 weeks

Study Arms (3)

SPARC1104 group 1

EXPERIMENTAL

Drug: SPARC1104 modified dose regimen I

SPARC1104 group 2

EXPERIMENTAL

Drug: SPARC1104 modified dose regimen II

SPARC1104 group 3

EXPERIMENTAL

Drug: SPARC1104 modified dose regimen III

Interventions

SPARC1104 modified dose regimen I DRUG

Subjects who exited study CLR\_09\_21

SPARC1104 group 1

SPARC1104 modified dose regimen II DRUG

Subjects who received prior treatment regimen I

SPARC1104 group 2

SPARC1104 modified dose regimen III DRUG

Subjects who received no prior treatment regimen

SPARC1104 group 3

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Sun Pharma Advanced Research Company Limited: lead

Study Sites (51)

SPARC site 4

Gilbert, Arizona, 85234, United States

Location

SPARC Site 34

Phoenix, Arizona, 85004, United States

Location

SPARC Site 1

Tucson, Arizona, 85704, United States

Location

SPARC Site 30

Costa Mesa, California, 92626, United States

Location

SPARC Site 14

Newport Beach, California, 92663, United States

Location

SPARC Site 32

Basalt, Colorado, 81621, United States

Location

SPARC Site 5

Denver, Colorado, 80209, United States

Location

SPARC Site 7

Derby, Connecticut, 06418, United States

Location

SPARC site 47

Hartford, Connecticut, 06112, United States

Location

SPARC Site 8

New London, Connecticut, 06320, United States

Location

SPARC Site 50

Washington D.C., District of Columbia, 20007, United States

Location

SPARC Site 35

Maitland, Florida, 32751, United States

Location

SPARC Site 59

Miami, Florida, 33136, United States

Location

SPARC Site 6

Ormond Beach, Florida, 32174, United States

Location

SPARC Site 11

Port Charlotte, Florida, 33952, United States

Location

SPARC Site 13

Sarasota, Florida, 34233, United States

Location

SPARC Site 25

Sunrise, Florida, 33351, United States

Location

SPARC Site 55

Tampa, Florida, 33612, United States

Location

SPARC Site 33

Tampa, Florida, 33634, United States

Location

SPARC site 45

Lenexa, Kansas, 66214, United States

Location

SPARC Site 24

Overland Park, Kansas, 66212, United States

Location

SPARC Site 44

Louisville, Kentucky, 40207, United States

Location

SPARC site 36

Alexandria, Louisiana, 73101, United States

Location

SPARC Site 21

Baton Rouge, Louisiana, 70810, United States

Location

SPARC Site 61

New Orleans, Louisiana, 70121, United States

Location

SPARC Site 49

Baltimore, Maryland, 21287-6985, United States

Location

SPARC Site 22

Fulton, Maryland, 20759, United States

Location

SPARC Site 29

Foxborough, Massachusetts, 02035, United States

Location

SPARC Site 17

Springfield, Massachusetts, 01104, United States

Location

SPARC Site 26

Clinton Township, Michigan, 48035, United States

Location

SPARC Site 54

Detroit, Michigan, 48202, United States

Location

SPARC Site 19

Golden Valley, Minnesota, 55422, United States

Location

SPARC Site 28

Flemington, New Jersey, 08822, United States

Location

SPARC Site 16

Albuquerque, New Mexico, 87108, United States

Location

SPARC Site 43

Rochester, New York, 14642, United States

Location

SPARC Site 52

White Plains, New York, 10605, United States

Location

SPARC site 39

Charlotte, North Carolina, 28203, United States

Location

SPARC Site 18

Greensboro, North Carolina, 27405, United States

Location

SPARC Site 2

Winston-Salem, North Carolina, 27103, United States

Location

SPARC Site 27

Centerville, Ohio, 45459, United States

Location

SPARC site 10

Eugene, Oregon, 97041, United States

Location

SPARC site 38

Springfield, Oregon, 97477, United States

Location

SPARC Site 57

Abington, Pennsylvania, 19090, United States

Location

SPARC Site 23

Old Point Station, South Carolina, 29707, United States

Location

SPARC Site 5

Austin, Texas, 78731, United States

Location

SPARC Site 60

Dallas, Texas, 75246, United States

Location

SPARC Site 37

Houston, Texas, 77025, United States

Location

SPARC Site 20

Tacoma, Washington, 98405, United States

Location

SPARC Site 62

Huntington, West Virginia, 25701, United States

Location

SPARC Site 58

Milwaukee, Wisconsin, 53215, United States

Location

SPARC Site 56

Waukesha, Wisconsin, 53188, United States

Location

MeSH Terms

Conditions

Muscle Spasticity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: SPARC
• Organization: Sun Pharma Advanced Research Company Limited

Clinical.Trials@Sparcmail.com

+912266455645

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2013
• First Posted: February 22, 2013
• Study Start: April 9, 2013
• Primary Completion: July 1, 2017
• Study Completion: October 1, 2017
• Last Updated: May 3, 2019
• Results First Posted: March 12, 2019

Record last verified: 2019-05

Locations

US (51)