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Study of SPARC1103 in Subjects With Spasticity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02027025
Recruitment Status : Completed
First Posted : January 3, 2014
Results First Posted : January 15, 2019
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited

Brief Summary:
Study of SPARC1103 in subjects with spasticity

Condition or disease Intervention/treatment Phase
Spasticity Drug: SPARC1103 low dose Drug: SPARC1103 high dose Drug: SPARC Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Actual Study Start Date : April 21, 2014
Actual Primary Completion Date : April 28, 2017
Actual Study Completion Date : April 28, 2017

Arm Intervention/treatment
Active Comparator: SPARC 1103 low dose
The subjects will receive SPARC 1103 low dose
Drug: SPARC1103 low dose
once daily

Active Comparator: SPARC1103 high dose
The subjects will receive SPARC1103 high dose
Drug: SPARC1103 high dose
once daily

Placebo Comparator: SPARC Placebo
The subjects will receive SPARC Placebo
Drug: SPARC Placebo



Primary Outcome Measures :
  1. Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Modified Ashworth Score [ Time Frame: Baseline, Day 24 ]

    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).



Secondary Outcome Measures :
  1. Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Night Time Awakening Score [ Time Frame: Baseline, Day 24 ]

    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)


  2. Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Spasm Frequency [ Time Frame: Baseline, Day 24 ]

    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


  3. Clinical Global Impression of Change Results at 24 Hours Post Dose on Day 24 [ Time Frame: Baseline, 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


  4. Subject Global Impression of Severity of Spasticity [ Time Frame: Baseline, Day 24 ]

    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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02027025


Locations
Show Show 23 study locations
Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited
  Study Documents (Full-Text)

Documents provided by Sun Pharma Advanced Research Company Limited:
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Responsible Party: Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier: NCT02027025    
Other Study ID Numbers: CLR_11_03
First Posted: January 3, 2014    Key Record Dates
Results First Posted: January 15, 2019
Last Update Posted: May 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Sun Pharma Advanced Research Company Limited:
Spasticity, Multiple sclerosis
Additional relevant MeSH terms:
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Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms