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Completed

NCT Number: NCT01457352

Efficacy and Safety of SPARC0921 in Subjects With Spasticity

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

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Key information

Conditions

Spasticity 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 3

Primary location

SPARC Site 77, Dresden, Germany

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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 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

Exclusion criteria

  • 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

Treatment and study plan

SPARC0921

Drug

Placebo0921

Drug

Primary outcomes

  1. Treatment Failure Rate

    Time frame: Week 22

    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

Secondary outcomes

  1. Severity of Spasticity Assessed by Subject Global Impression Severity Scale

    Time frame: Week 22

    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
2012
Primary completion
2017
Study completion
2017
First posted
Oct 21, 2011
Registry last updated
Jun 18, 2019

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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