NCT02027025

Brief Summary

Study of SPARC1103 in subjects with spasticity

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2014

Typical duration for phase_2

Geographic Reach
3 countries

23 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 3, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

April 21, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2017

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

January 15, 2019

Completed
Last Updated

May 3, 2019

Status Verified

May 1, 2019

Enrollment Period

3 years

First QC Date

January 1, 2014

Results QC Date

October 16, 2018

Last Update Submit

May 2, 2019

Conditions

Spasticity

Keywords

Spasticity, Multiple sclerosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Night Time Awakening Score

    Baseline, Day 24

  • Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Spasm Frequency

    Baseline, Day 24

  • Clinical Global Impression of Change Results at 24 Hours Post Dose on Day 24

    Baseline, Day 24

  • Subject Global Impression of Severity of Spasticity

    Baseline, Day 24

Study Arms (3)

SPARC 1103 low dose

ACTIVE COMPARATOR

The subjects will receive SPARC 1103 low dose

Drug: SPARC1103 low dose

SPARC1103 high dose

ACTIVE COMPARATOR

The subjects will receive SPARC1103 high dose

Drug: SPARC1103 high dose

SPARC Placebo

PLACEBO COMPARATOR

The subjects will receive SPARC Placebo

Drug: SPARC Placebo

Interventions

SPARC1103 low doseDRUG

once daily

SPARC 1103 low dose
SPARC1103 high doseDRUG

once daily

SPARC1103 high dose
SPARC PlaceboDRUG
SPARC Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

SPARC Site 4

Long Beach, California, United States

Location

SPARC Site 6

San Diego, California, United States

Location

SPARC Site 10

Aurora, Colorado, United States

Location

SPARC Site 2

Jacksonville, Florida, United States

Location

SPARC Site 15

Miami, Florida, United States

Location

SPARC Site 7

Miami Springs, Florida, United States

Location

SPARC Site 5

Orlando, Florida, United States

Location

SPARC Site 13

Tampa, Florida, United States

Location

SPARC Site 11

Kansas City, Kansas, United States

Location

SPARC Site 3

Lenexa, Kansas, United States

Location

SPARC Site 1

Bingham Farms, Michigan, United States

Location

SPARC Site 14

Albuquerque, New Mexico, United States

Location

SPARC Site 9

Charlotte, North Carolina, United States

Location

SPARC Site 8

Cleveland, Ohio, United States

Location

SPARC Site 12

Richland, Washington, United States

Location

SPARC Site 18

Moscow, Russia

Location

SPARC Site 17

Nizhny Novgorod, Russia

Location

SPARC Site 20

Samara, Russia

Location

SPARC Site 19

Smolensk, Russia

Location

SPARC Site 16

Ufa, Russia

Location

SPARC Site 22

Dnipro, Ukraine

Location

SPARC Site 21

Ivano-Frankivsk, Ukraine

Location

SPARC Site 23

Lviv, Ukraine

Location

MeSH Terms

Conditions

Muscle SpasticityMultiple Sclerosis

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Mudgal Kothekar
Organization
Sun Pharma Advanced Research Company Limited
mudgal.kothekar@sparcmail.com
912266455645

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 1, 2014

First Posted

January 3, 2014

Study Start

April 21, 2014

Primary Completion

April 28, 2017

Study Completion

April 28, 2017

Last Updated

May 3, 2019

Results First Posted

January 15, 2019

Record last verified: 2019-05

Locations

UA(3)US(15)RU(5)