Efficacy and Safety of SPARC0921 in Subjects With Spasticity

NCT01457352 | Completed Phase 3 Results

• 1 other identifier: CLR_09_21
• Study Type: interventional
• Target: 392
• Locations: 5 countries
• Sites: 73

Brief Summary

The purpose of this study is to assess whether SPARC0921 demonstrate efficacy and safety in the treatment of spasticity.

Conditions

Spasticity

Keywords

spasticity

Outcome Measures

Primary Outcomes (1)

• Treatment Failure Rate

  Percentage of subjects who had treatment failure Clinical Global Impression of Change of ≥ 5 and at least one movement with ≥ 1 unit increase in modified Ashworth score from baseline. The modified Ashworth scale is a 6-point scale as follows: Minimum score of 0 (better outcome) = no increase in tone Maximum score of 4 (worst outcome) = affected part(s) rigid inflexion or extension. The clinician (other than the one performing the Modified Ashworth Scale assessment) rated his/her overall (global) impression of change in spasticity using the 7-point scale shown below: Minimum score of 1 (better outcome) = very much improved Maximum score of 7 (very much worse) = very much worse

  Week 22

Secondary Outcomes (1)

• Severity of Spasticity Assessed by Subject Global Impression Severity Scale

  Week 22

Study Arms (2)

SPARC0921

EXPERIMENTAL

Drug: SPARC0921

Placebo0921

PLACEBO COMPARATOR

Drug: Placebo0921

Interventions

SPARC0921 DRUG

SPARC0921

Placebo0921 DRUG

Placebo0921

Eligibility Criteria

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

You may qualify if:

• Men and women age 18 years and older
• Able and willing to comply with the protocol, including availability for a scheduled clinic visits
• Willingness and giving of written informed consent

You may not qualify if:

• In relapse or history of unstable course over the prior 30 days prior to the Screening Visit
• Concomitant neurologic conditions causing spasticity
• Has received an investigational drug or device within 30 days that would interfere with the study goals prior to the Screening Visit
• Unable to comply with study procedures in the opinion of the investigator

Sponsors & Collaborators

• Sun Pharma Advanced Research Company Limited: lead

Study Sites (73)

SPARC site 6

Gilbert, Arizona, United States

Location

SPARC Site 40

Phoenix, Arizona, United States

Location

SPARC Site 36

Costa Mesa, California, United States

Location

SPARC Site 20

Newport Beach, California, United States

Location

SPARC Site 38

Basalt, Colorado, United States

Location

SPARC Site 21

Denver, Colorado, United States

Location

SPARC Site 9

Derby, Connecticut, United States

Location

SPARC Site 57

Hartford, Connecticut, United States

Location

SPARC Site 10

New London, Connecticut, United States

Location

SPARC Site 60

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

Location

SPARC Site 15

Bradenton, Florida, United States

Location

SPARC Site 54

Jacksonville, Florida, United States

Location

SPARC Site 41

Maitland, Florida, United States

Location

SPARC Site 70

Miami, Florida, United States

Location

SPARC Site 8

Ormond Beach, Florida, United States

Location

SPARC Site 17

Port Charlotte, Florida, United States

Location

SPARC Site 19

Sarasota, Florida, United States

Location

SPARC Site 31

Sunrise, Florida, United States

Location

SPARC Site 39

Tampa, Florida, United States

Location

SPARC Site 65

Tampa, Florida, United States

Location

SPARC Site 51

Lenexa, Kansas, United States

Location

SPARC Site 30

Overland Park, Kansas, United States

Location

SPARC Site 50

Louisville, Kentucky, United States

Location

SPARC Site 42

Alexandria, Louisiana, United States

Location

SPARC Site 27

Baton Rouge, Louisiana, United States

Location

SPARC Site 73

New Orleans, Louisiana, United States

Location

SPARC Site 35

Foxborough, Massachusetts, United States

Location

SPARC Site 23

Springfield, Massachusetts, United States

Location

SPARC Site 32

Clinton Township, Michigan, United States

Location

SPARC Site 64

Detroit, Michigan, United States

Location

SPARC Site 25

Golden Valley, Minnesota, United States

Location

SPARC Site 5

Henderson, Nevada, United States

Location

SPARC site 34

Flemington, New Jersey, United States

Location

SPARC Site 55

Stratford, New Jersey, United States

Location

SPARC Site 22

Albuquerque, New Mexico, United States

Location

SPARC Site 49

Rochester, New York, United States

Location

SPARC Site 45

Charlotte, North Carolina, United States

Location

SPARC Site 4

Charlotte, North Carolina, United States

Location

SPARC Site 24

Greensboro, North Carolina, United States

Location

SPARC Site 2

Winston-Salem, North Carolina, United States

Location

SPARC Site 75

Winston-Salem, North Carolina, United States

Location

SPARC Site 16

Akron, Ohio, United States

Location

SPARC Site 33

Centerville, Ohio, United States

Location

SPARC Site 56

Columbus, Ohio, United States

Location

SPARC Site 12

Eugene, Oregon, United States

Location

SPARC Site 44

Springfield, Oregon, United States

Location

SPARC Site 68

Abington, Pennsylvania, United States

Location

SPARC Site 29

Old Point Station, South Carolina, United States

Location

SPARC Site 7

Austin, Texas, United States

Location

SPARC Site 71

Dallas, Texas, United States

Location

SPARC Site 43

Houston, Texas, United States

Location

SPARC Site 13

Salt Lake City, Utah, United States

Location

SPARC Site 26

Tacoma, Washington, United States

Location

SPARC Site 74

Huntington, West Virginia, United States

Location

SPARC Site 69

Milwaukee, Wisconsin, United States

Location

SPARC Site 67

Waukesha, Wisconsin, United States

Location

SPARC Site 77

Dresden, Germany

Location

SPARC Site 76

Erbach im Odenwald, Germany

Location

SPARC Site 79

Teupitz, Germany

Location

SPARC Site 78

Westerstede, Germany

Location

SPARC Site 82

Budapest, Hungary

Location

SPARC site 83

Budapest, Hungary

Location

SPARC Site 81

Eger, Hungary

Location

SPARC Site 80

Esztergom, Hungary

Location

SPARC Site 87

Moscow, Russia

Location

SPARC Site 86

Novosibirsk, Russia

Location

SPARC Site 85

Saint Petersburg, Russia

Location

SPARC Site 84

Sestroretsk, Russia

Location

SPARC Site 88

Stavropol, Russia

Location

SPARC Site 90

Dnipropetrovsk, Ukraine

Location

SPARC Site 92

Lviv, Ukraine

Location

SPARC Site 91

Poltava, Ukraine

Location

SPARC Site 89

Zaporozh’ye, Ukraine

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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2011
• First Posted: October 21, 2011
• Study Start: November 14, 2012
• Primary Completion: August 25, 2017
• Study Completion: August 25, 2017
• Last Updated: June 18, 2019
• Results First Posted: June 18, 2019

Record last verified: 2019-06

Locations

HU (4); DE (4); US (56); RU (5); UA (4)