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SpasticityPhase 3NCT01797185

Safety Study of SPARC1104

A Phase 3 study testing SPARC1104 modified dose regimen I, SPARC1104 modified dose regimen II and SPARC1104 modified dose regimen III in people with Spasticity, run by Sun Pharma Advanced Research Company Limited at 51 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Spasticity
What is being tested?
SPARC1104 modified dose regimen I, SPARC1104 modified dose regimen II and SPARC1104 modified dose regimen III
Could I receive a placebo?
No, everyone receives an active treatment
How many people
375 participants
Where
51 sitesUnited States
Study dates
9 Apr 2013to Oct 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult
  • 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

Trial locations and contacts

51 sites in 1 country.

51 sites in 1 country

United States51 sites

  • SPARC Site 57

    Abington, Pennsylvania, 19090

  • SPARC Site 16

    Albuquerque, New Mexico, 87108

  • SPARC site 36

    Alexandria, Louisiana, 73101

  • SPARC Site 5

    Austin, Texas, 78731

  • SPARC Site 49

    Baltimore, Maryland, 21287-6985

  • SPARC Site 32

    Basalt, Colorado, 81621

  • SPARC Site 21

    Baton Rouge, Louisiana, 70810

  • SPARC Site 27

    Centerville, Ohio, 45459

  • SPARC site 39

    Charlotte, North Carolina, 28203

  • SPARC Site 26

    Clinton Township, Michigan, 48035

  • SPARC Site 30

    Costa Mesa, California, 92626

  • SPARC Site 60

    Dallas, Texas, 75246

  • SPARC Site 5

    Denver, Colorado, 80209

  • SPARC Site 7

    Derby, Connecticut, 06418

  • SPARC Site 54

    Detroit, Michigan, 48202

  • SPARC site 10

    Eugene, Oregon, 97041

  • SPARC Site 28

    Flemington, New Jersey, 08822

  • SPARC Site 29

    Foxborough, Massachusetts, 02035

  • SPARC Site 22

    Fulton, Maryland, 20759

  • SPARC site 4

    Gilbert, Arizona, 85234

  • SPARC Site 19

    Golden Valley, Minnesota, 55422

  • SPARC Site 18

    Greensboro, North Carolina, 27405

  • SPARC site 47

    Hartford, Connecticut, 06112

  • SPARC Site 37

    Houston, Texas, 77025

  • SPARC Site 62

    Huntington, West Virginia, 25701

  • SPARC site 45

    Lenexa, Kansas, 66214

  • SPARC Site 44

    Louisville, Kentucky, 40207

  • SPARC Site 35

    Maitland, Florida, 32751

  • SPARC Site 59

    Miami, Florida, 33136

  • SPARC Site 58

    Milwaukee, Wisconsin, 53215

  • SPARC Site 8

    New London, Connecticut, 06320

  • SPARC Site 61

    New Orleans, Louisiana, 70121

  • SPARC Site 14

    Newport Beach, California, 92663

  • SPARC Site 23

    Old Point Station, South Carolina, 29707

  • SPARC Site 6

    Ormond Beach, Florida, 32174

  • SPARC Site 24

    Overland Park, Kansas, 66212

  • SPARC Site 34

    Phoenix, Arizona, 85004

  • SPARC Site 11

    Port Charlotte, Florida, 33952

  • SPARC Site 43

    Rochester, New York, 14642

  • SPARC Site 13

    Sarasota, Florida, 34233

  • SPARC Site 17

    Springfield, Massachusetts, 01104

  • SPARC site 38

    Springfield, Oregon, 97477

  • SPARC Site 25

    Sunrise, Florida, 33351

  • SPARC Site 20

    Tacoma, Washington, 98405

  • SPARC Site 55

    Tampa, Florida, 33612

  • SPARC Site 33

    Tampa, Florida, 33634

  • SPARC Site 1

    Tucson, Arizona, 85704

  • SPARC Site 50

    Washington D.C., District of Columbia, 20007

  • SPARC Site 56

    Waukesha, Wisconsin, 53188

  • SPARC Site 52

    White Plains, New York, 10605

  • SPARC Site 2

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

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

Read the detailed description

Safety study of SPARC1104

Conditions
Spasticity
Being tested
SPARC1104 modified dose regimen I, SPARC1104 modified dose regimen II, SPARC1104 modified dose regimen III
Keywords
spasticity
Medical subject headings
Muscle Spasticity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SPARC1104 modified dose regimen IDrug

    Subjects who exited study CLR_09_21

  • SPARC1104 modified dose regimen IIDrug

    Subjects who received prior treatment regimen I

  • SPARC1104 modified dose regimen IIIDrug

    Subjects who received no prior treatment regimen

Study groups in NCT01797185
Study groupRoleWhat they receive
SPARC1104 group 1ExperimentalNot described
Receives: Drug: SPARC1104 modified dose regimen I
SPARC1104 group 2ExperimentalNot described
Receives: Drug: SPARC1104 modified dose regimen II
SPARC1104 group 3ExperimentalNot described
Receives: Drug: SPARC1104 modified dose regimen III

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Subjects With Adverse Events

    Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2013 (estimated)
  2. Study start9 Apr 2013
  3. Primary completionJul 2017
  4. Study completionOct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
375 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01797185
Sponsor's protocol ID
CLR_11_04
Status last verified
May 2019
First submitted
16 Feb 2013
Last updated
3 May 2019
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SPARC1104 modified dose regimen I, SPARC1104 modified dose regimen II and SPARC1104 modified dose regimen III in people with Spasticity, run by Sun Pharma Advanced Research Company Limited at 51 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With Adverse Events (time frame: 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01797185.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2019.

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