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Completed

NCT Number: NCT01797185

Safety Study of SPARC1104

Open-label, safety study of SPARC1104 in subjects with spasticity due to multiple sclerosis

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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–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

SPARC site 4, Gilbert, Arizona, United States

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About this study

Safety study of SPARC1104

Who can participate

Healthy volunteers accepted: No

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

  • Willingness to participate and give written informed consent
  • Men and women ≥ 18 years of age
  • Sexually active women who are of child bearing potential will practice an acceptable method of birth control for the duration of the trial as judged by the investigator. Examples of acceptable contraception are: condoms, foams, jellies, diaphragm, intrauterine device, oral or long-acting injected contraceptives, bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or having a partner who is incapable of initiating conception. The practice of contraception must have started at least 3 months prior to trial entry.
  • If female, negative pregnancy test result at Screening
  • Diagnosed with MS and a known history of spasticity
  • Meet one of the following criteria o Subjects who completed the double-blind randomized withdrawal phase (Part 3) of trial CLR_09_21 with no major protocol violation

Treatment and study plan

SPARC1104 modified dose regimen I

Drug

Subjects who exited study CLR_09_21

SPARC1104 modified dose regimen II

Drug

Subjects who received prior treatment regimen I

SPARC1104 modified dose regimen III

Drug

Subjects who received no prior treatment regimen

Primary outcomes

  1. Number of Subjects With Adverse Events

    Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

Sun Pharma Advanced Research Company Limited

Industry

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Feb 22, 2013
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.

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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