Study of SPARC1103 in Subjects With Spasticity

Spasticity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02027025
• Other study ID #: CLR_11_03
• Status: Completed
• Phase: Phase 2
• Start date: April 21, 2014
• Est. completion date: April 28, 2017

Study information

• Verified date: May 2019
• Source: Sun Pharma Advanced Research Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study of SPARC1103 in subjects with spasticity

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: April 28, 2017
• Est. primary completion date: April 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men and women greater than or equal to 18 years of age

• Willing to sign the informed consent form

• Women of child bearing potential willing to practice an acceptable method of birth control

• Known history of spasticity due to MS

Exclusion Criteria:

• Administration of an investigational drug or device within 30 days prior to Screening Visit 1

• Unable to comply with trial procedures in the opinion of the Investigator

• Concomitant neurologic conditions causing spasticity

• Any medical condition, including psychiatric disease or epilepsy, which would interfere with the interpretation of the trial results

Related Conditions & MeSH terms

• Muscle Spasticity
• Spasticity

Intervention

Drug:
• SPARC1103 low dose
once daily
• SPARC1103 high dose
once daily
• SPARC Placebo

Locations

Country	Name	City	State
Russian Federation	SPARC Site 18	Moscow
Russian Federation	SPARC Site 17	Nizhniy Novgorod
Russian Federation	SPARC Site 20	Samara
Russian Federation	SPARC Site 19	Smolensk
Russian Federation	SPARC Site 16	Ufa
Ukraine	SPARC Site 22	Dnepropetrovsk
Ukraine	SPARC Site 21	Ivano-Frankivs'k
Ukraine	SPARC Site 23	L'viv
United States	SPARC Site 14	Albuquerque	New Mexico
United States	SPARC Site 10	Aurora	Colorado
United States	SPARC Site 1	Bingham Farms	Michigan
United States	SPARC Site 9	Charlotte	North Carolina
United States	SPARC Site 8	Cleveland	Ohio
United States	SPARC Site 2	Jacksonville	Florida
United States	SPARC Site 11	Kansas City	Kansas
United States	SPARC Site 3	Lenexa	Kansas
United States	SPARC Site 4	Long Beach	California
United States	SPARC Site 15	Miami	Florida
United States	SPARC Site 7	Miami Springs	Florida
United States	SPARC Site 5	Orlando	Florida
United States	SPARC Site 12	Richland	Washington
United States	SPARC Site 6	San Diego	California
United States	SPARC Site 13	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Sun Pharma Advanced Research Company Limited

Countries where clinical trial is conducted

United States,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Modified Ashworth Score	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 in flexion or extension; For calculation of modified Ashworth Score, the following scores were assigned to each category of modified Ashworth scale: not testable=NA, 0=0 units, 1=1 unit, 1+ = 2 units, 2 = 3 units, and 4 = 5 units. The total score was the sum of the scores of the 6 lower extremity muscle groups on both left and right sides (range = o0 to 60).	Baseline, Day 24
Secondary	Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Night Time Awakening Score	Nighttime awakening score was assessed as follows: The subject was asked the following question on the morning of Day 24: How many times did you wake up last night due to spasticity? Score range from "0" (better score) to "infinity" (worse score)	Baseline, Day 24
Secondary	Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Spasm Frequency	Spasm frequency was assessed using following 4-point scale as follows: Minimum score of 0 (better outcome))=no spasm Maximum score of 4 (worst outcome)=Spasms occurring more than 10 times per hour	Baseline, Day 24
Secondary	Clinical Global Impression of Change Results at 24 Hours Post Dose on Day 24	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	Baseline, Day 24
Secondary	Subject Global Impression of Severity of Spasticity	The subject was asked "Overall, how would you rate the severity of your spasticity over the past 24 hours?"; The 7-point scale for Subject's global impression of severity assessment is as follows: minimum score of 1 = normal, no spasticity maximum score of 7 (worst outcome)= worst spasticity imaginable	Baseline, Day 24