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Completed

NCT Number: NCT02027025

Study of SPARC1103 in Subjects With Spasticity

Study of SPARC1103 in subjects with spasticity

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Key information

Conditions

Spasticity Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

SPARC Site 18, Moscow, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SPARC1103 low dose

Drug

once daily

SPARC1103 high dose

Drug

once daily

SPARC Placebo

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sun Pharma Advanced Research Company Limited

Industry

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jan 3, 2014
Registry last updated
May 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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