SpasticityPhase 3NCT01457352
Efficacy and Safety of SPARC0921 in Subjects With Spasticity
A Phase 3 study testing SPARC0921 in people with Spasticity, run by Sun Pharma Advanced Research Company Limited at 73 sites in 5 countries.
Trial summary
The purpose of this study is to assess whether SPARC0921 demonstrate efficacy and safety in the treatment of spasticity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spasticity
- What is being tested?
- SPARC0921
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 392 participants
- Where
- 73 sitesin 5 countries
- Study dates
- 14 Nov 2012to 25 Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
73 sites in 5 countries.
73 sites in 5 countries
United States56 sites
SPARC Site 68
Abington, Pennsylvania
SPARC Site 16
Akron, Ohio
SPARC Site 22
Albuquerque, New Mexico
SPARC Site 42
Alexandria, Louisiana
SPARC Site 7
Austin, Texas
SPARC Site 38
Basalt, Colorado
SPARC Site 27
Baton Rouge, Louisiana
SPARC Site 15
Bradenton, Florida
SPARC Site 33
Centerville, Ohio
SPARC Site 45
Charlotte, North Carolina
SPARC Site 4
Charlotte, North Carolina
SPARC Site 32
Clinton Township, Michigan
SPARC Site 56
Columbus, Ohio
SPARC Site 36
Costa Mesa, California
SPARC Site 71
Dallas, Texas
SPARC Site 21
Denver, Colorado
SPARC Site 9
Derby, Connecticut
SPARC Site 64
Detroit, Michigan
SPARC Site 12
Eugene, Oregon
SPARC site 34
Flemington, New Jersey
SPARC Site 35
Foxborough, Massachusetts
SPARC site 6
Gilbert, Arizona
SPARC Site 25
Golden Valley, Minnesota
SPARC Site 24
Greensboro, North Carolina
SPARC Site 57
Hartford, Connecticut
SPARC Site 5
Henderson, Nevada
SPARC Site 43
Houston, Texas
SPARC Site 74
Huntington, West Virginia
SPARC Site 54
Jacksonville, Florida
SPARC Site 51
Lenexa, Kansas
SPARC Site 50
Louisville, Kentucky
SPARC Site 41
Maitland, Florida
SPARC Site 70
Miami, Florida
SPARC Site 69
Milwaukee, Wisconsin
SPARC Site 10
New London, Connecticut
SPARC Site 73
New Orleans, Louisiana
SPARC Site 20
Newport Beach, California
SPARC Site 29
Old Point Station, South Carolina
SPARC Site 8
Ormond Beach, Florida
SPARC Site 30
Overland Park, Kansas
SPARC Site 40
Phoenix, Arizona
SPARC Site 17
Port Charlotte, Florida
SPARC Site 49
Rochester, New York
SPARC Site 13
Salt Lake City, Utah
SPARC Site 19
Sarasota, Florida
SPARC Site 23
Springfield, Massachusetts
SPARC Site 44
Springfield, Oregon
SPARC Site 55
Stratford, New Jersey
SPARC Site 31
Sunrise, Florida
SPARC Site 26
Tacoma, Washington
SPARC Site 39
Tampa, Florida
SPARC Site 65
Tampa, Florida
SPARC Site 60
Washington D.C., District of Columbia
SPARC Site 67
Waukesha, Wisconsin
SPARC Site 2
Winston-Salem, North Carolina
SPARC Site 75
Winston-Salem, North Carolina
Russia5 sites
SPARC Site 87
Moscow
SPARC Site 86
Novosibirsk
SPARC Site 85
Saint Petersburg
SPARC Site 84
Sestroretsk
SPARC Site 88
Stavropol
Germany4 sites
SPARC Site 77
Dresden
SPARC Site 76
Erbach im Odenwald
SPARC Site 79
Teupitz
SPARC Site 78
Westerstede
Hungary4 sites
SPARC Site 82
Budapest
SPARC site 83
Budapest
SPARC Site 81
Eger
SPARC Site 80
Esztergom
Ukraine4 sites
SPARC Site 90
Dnipropetrovsk
SPARC Site 92
Lviv
SPARC Site 91
Poltava
SPARC Site 89
Zaporozh’ye
About this study
The purpose of this study is to assess whether SPARC0921 demonstrate efficacy and safety in the treatment of spasticity.
- Conditions
- Spasticity
- Being tested
- SPARC0921, Placebo0921
- 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.
SPARC0921Drug
Placebo0921Drug
| Study group | Role | What they receive |
|---|---|---|
| SPARC0921 | Experimental | Not described Receives: Drug: SPARC0921 |
| Placebo0921 | Placebo comparator | Not described Receives: Drug: Placebo0921 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Failure Rate
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
Measured: Week 22
Secondary outcomes (1)
Severity of Spasticity Assessed by Subject Global Impression Severity Scale
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
Measured: Week 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2011 (estimated)
- Study start14 Nov 2012
- Primary completion25 Aug 2017
- Study completion25 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SpasticityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 392 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharma Advanced Research Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01457352
- Sponsor's protocol ID
- CLR_09_21
- Status last verified
- Jun 2019
- First submitted
- 17 Oct 2011
- Last updated
- 18 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of SPARC0921 in Subjects With Spasticity
- ClinicalTrials.gov ID
- NCT01457352
- Acronym / sponsor ID
- CLR_09_21
- Conditions
- Spasticity
- Keywords
- spasticity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- Sun Pharma Advanced Research Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2012 (actual)
- Primary completion
- 25 Aug 2017 (actual)
- Study completion
- 25 Aug 2017 (actual)
- First posted
- 21 Oct 2011 (estimated)
- Results
- Posted 18 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess whether SPARC0921 demonstrate efficacy and safety in the treatment of spasticity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPARC0921 | Experimental | Drug: SPARC0921 |
| Placebo0921 | Placebo comparator | Drug: Placebo0921 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPARC0921 | Drug | SPARC0921 |
| Placebo0921 | Drug | Placebo0921 |
Primary outcome
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
1 secondary outcome
Severity of Spasticity Assessed by Subject Global Impression Severity Scale
Time frame: Week 22
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
73 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SPARC0921 in people with Spasticity, run by Sun Pharma Advanced Research Company Limited at 73 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. 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 18 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 73 sites in United States, Russia, Germany, Hungary, Ukraine. 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. Some participants in this study may receive a placebo. 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 18 Jun 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?
Treatment Failure Rate (time frame: Week 22). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2019.