Safety Study of SPARC1104

May 2, 2019 updated by: Sun Pharma Advanced Research Company Limited
Open-label, safety study of SPARC1104 in subjects with spasticity due to multiple sclerosis

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Safety study of SPARC1104

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
375

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • SPARC Site 4
      • Phoenix, Arizona, United States, 85004
        • SPARC Site 34
      • Tucson, Arizona, United States, 85704
        • SPARC Site 1
    • California
      • Costa Mesa, California, United States, 92626
        • SPARC Site 30
      • Newport Beach, California, United States, 92663
        • SPARC Site 14
    • Colorado
      • Basalt, Colorado, United States, 81621
        • SPARC Site 32
      • Denver, Colorado, United States, 80209
        • SPARC Site 5
    • Connecticut
      • Derby, Connecticut, United States, 06418
        • SPARC Site 7
      • Hartford, Connecticut, United States, 06112
        • SPARC site 47
      • New London, Connecticut, United States, 06320
        • SPARC Site 8
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • SPARC Site 50
    • Florida
      • Maitland, Florida, United States, 32751
        • SPARC Site 35
      • Miami, Florida, United States, 33136
        • SPARC Site 59
      • Ormond Beach, Florida, United States, 32174
        • SPARC Site 6
      • Port Charlotte, Florida, United States, 33952
        • SPARC Site 11
      • Sarasota, Florida, United States, 34233
        • SPARC Site 13
      • Sunrise, Florida, United States, 33351
        • SPARC Site 25
      • Tampa, Florida, United States, 33612
        • SPARC Site 55
      • Tampa, Florida, United States, 33634
        • SPARC Site 33
    • Kansas
      • Lenexa, Kansas, United States, 66214
        • SPARC site 45
      • Overland Park, Kansas, United States, 66212
        • SPARC Site 24
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • SPARC Site 44
    • Louisiana
      • Alexandria, Louisiana, United States, 73101
        • SPARC site 36
      • Baton Rouge, Louisiana, United States, 70810
        • SPARC Site 21
      • New Orleans, Louisiana, United States, 70121
        • SPARC Site 61
    • Maryland
      • Baltimore, Maryland, United States, 21287-6985
        • SPARC Site 49
      • Fulton, Maryland, United States, 20759
        • SPARC Site 22
    • Massachusetts
      • Foxboro, Massachusetts, United States, 02035
        • SPARC Site 29
      • Springfield, Massachusetts, United States, 01104
        • SPARC Site 17
    • Michigan
      • Clinton Township, Michigan, United States, 48035
        • SPARC Site 26
      • Detroit, Michigan, United States, 48202
        • SPARC Site 54
    • Minnesota
      • Golden Valley, Minnesota, United States, 55422
        • SPARC Site 19
    • New Jersey
      • Flemington, New Jersey, United States, 08822
        • SPARC Site 28
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • SPARC Site 16
    • New York
      • Rochester, New York, United States, 14642
        • SPARC Site 43
      • White Plains, New York, United States, 10605
        • SPARC Site 52
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • SPARC site 39
      • Greensboro, North Carolina, United States, 27405
        • SPARC Site 18
      • Winston-Salem, North Carolina, United States, 27103
        • SPARC Site 2
    • Ohio
      • Centerville, Ohio, United States, 45459
        • SPARC Site 27
    • Oregon
      • Eugene, Oregon, United States, 97041
        • SPARC Site 10
      • Springfield, Oregon, United States, 97477
        • SPARC site 38
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19090
        • SPARC Site 57
    • South Carolina
      • Indian Land, South Carolina, United States, 29707
        • SPARC Site 23
    • Texas
      • Austin, Texas, United States, 78731
        • SPARC Site 5
      • Dallas, Texas, United States, 75246
        • SPARC Site 60
      • Houston, Texas, United States, 77025
        • SPARC Site 37
    • Washington
      • Tacoma, Washington, United States, 98405
        • SPARC Site 20
    • West Virginia
      • Huntington, West Virginia, United States, 25701
        • SPARC Site 62
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • SPARC Site 58
      • Waukesha, Wisconsin, United States, 53188
        • SPARC Site 56

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SPARC1104 group 1
Drug: SPARC1104 modified dose regimen I
Subjects who exited study CLR_09_21
Experimental: SPARC1104 group 2
Drug: SPARC1104 modified dose regimen II
Subjects who received prior treatment regimen I
Experimental: SPARC1104 group 3
Drug: SPARC1104 modified dose regimen III
Subjects who received no prior treatment regimen

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of Subjects With Adverse Events
Time Frame: 52 weeks
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Pharma Advanced Research Company Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 9, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 22, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLR_11_04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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