SpasticityPhase 2NCT02027025

Study of SPARC1103 in Subjects With Spasticity

A Phase 2 study testing SPARC1103 low dose and SPARC1103 high dose in people with Spasticity, run by Sun Pharma Advanced Research Company Limited at 23 sites in 3 countries.

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

Study of SPARC1103 in subjects with 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?: SPARC1103 low dose and SPARC1103 high dose
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 142 participants
Where: 23 sitesin 3 countries
Study dates: 21 Apr 2014to 28 Apr 2017
Phase: Phase 2
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 greater than or equal to 18 years of age
Willing to sign the informed consent form
Women of child bearing potential willing to practice an acceptable method of birth control
Known history of spasticity due to MS

Who cannot join

Administration of an investigational drug or device within 30 days prior to Screening Visit 1
Unable to comply with trial procedures in the opinion of the Investigator
Concomitant neurologic conditions causing spasticity
Any medical condition, including psychiatric disease or epilepsy, which would interfere with the interpretation of the trial results

Trial locations and contacts

23 sites in 3 countries.

Country

City, postcode or hospital

23 sites in 3 countries

United States15 sites

SPARC Site 14
Albuquerque, New Mexico
SPARC Site 10
Aurora, Colorado
SPARC Site 1
Bingham Farms, Michigan
SPARC Site 9
Charlotte, North Carolina
SPARC Site 8
Cleveland, Ohio
SPARC Site 2
Jacksonville, Florida
SPARC Site 11
Kansas City, Kansas
SPARC Site 3
Lenexa, Kansas
SPARC Site 4
Long Beach, California
SPARC Site 15
Miami, Florida
SPARC Site 7
Miami Springs, Florida
SPARC Site 5
Orlando, Florida
SPARC Site 12
Richland, Washington
SPARC Site 6
San Diego, California
SPARC Site 13
Tampa, Florida

Other trials in United States

Russia5 sites

SPARC Site 18
Moscow
SPARC Site 17
Nizhny Novgorod
SPARC Site 20
Samara
SPARC Site 19
Smolensk
SPARC Site 16
Ufa

Other trials in Russia

Ukraine3 sites

SPARC Site 22
Dnipro
SPARC Site 21
Ivano-Frankivsk
SPARC Site 23
Lviv

Other trials in Ukraine

About this study

Study of SPARC1103 in subjects with spasticity

Conditions: Spasticity
Being tested: SPARC1103 low dose, SPARC1103 high dose, SPARC Placebo
Keywords: Spasticity, Multiple sclerosis
Medical subject headings: Muscle Spasticity, Multiple Sclerosis

What participants receive

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

SPARC1103 low doseDrug
once daily
SPARC1103 high doseDrug
once daily
SPARC PlaceboDrug

Study groups in NCT02027025
Study group	Role	What they receive
SPARC 1103 low dose	Active comparator	The subjects will receive SPARC 1103 low dose Receives: Drug: SPARC1103 low dose
SPARC1103 high dose	Active comparator	The subjects will receive SPARC1103 high dose Receives: Drug: SPARC1103 high dose
SPARC Placebo	Placebo comparator	The subjects will receive SPARC Placebo Receives: Drug: SPARC Placebo

What is being measured

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

Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Modified Ashworth Score
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 in flexion or extension
For calculation of modified Ashworth Score, the following scores were assigned to each category of modified Ashworth scale: not testable=NA, 0=0 units, 1=1 unit, 1+ = 2 units, 2 = 3 units, and 4 = 5 units. The total score was the sum of the scores of the 6 lower extremity muscle groups on both left and right sides (range = o0 to 60).
Measured: Baseline, Day 24

Secondary outcomes (4)

Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Night Time Awakening Score
Nighttime awakening score was assessed as follows:
The subject was asked the following question on the morning of Day 24: How many times did you wake up last night due to spasticity? Score range from "0" (better score) to "infinity" (worse score)
Measured: Baseline, Day 24
Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Spasm Frequency
Spasm frequency was assessed using following 4-point scale as follows:
Minimum score of 0 (better outcome))=no spasm Maximum score of 4 (worst outcome)=Spasms occurring more than 10 times per hour
Measured: Baseline, Day 24
Clinical Global Impression of Change Results at 24 Hours Post Dose on Day 24
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: Baseline, Day 24
Subject Global Impression of Severity of Spasticity
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: Baseline, Day 24

Timeline

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

21 Apr 201428 Apr 2017

First posted3 Jan 2014 (estimated)
Study start21 Apr 2014
Primary completion28 Apr 2017
Study completion28 Apr 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 142 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02027025
Sponsor's protocol ID: CLR_11_03
Status last verified: May 2019
First submitted: 1 Jan 2014
Last updated: 3 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Spasticity trials

Study at a glance

From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of SPARC1103 in Subjects With Spasticity
ClinicalTrials.gov ID: NCT02027025
Acronym / sponsor ID: CLR_11_03
Conditions: Spasticity
Keywords: Spasticity, Multiple sclerosis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 142 participants (actual)
Lead sponsor: Sun Pharma Advanced Research Company LimitedIndustry (pharma, biotech, devices)
Study start: 21 Apr 2014 (actual)
Primary completion: 28 Apr 2017 (actual)
Study completion: 28 Apr 2017 (actual)
First posted: 3 Jan 2014 (estimated)
Results: Posted 15 Jan 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study of SPARC1103 in subjects with spasticity

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
SPARC 1103 low dose	Active comparator	Drug: SPARC1103 low doseThe subjects will receive SPARC 1103 low dose
SPARC1103 high dose	Active comparator	Drug: SPARC1103 high doseThe subjects will receive SPARC1103 high dose
SPARC Placebo	Placebo comparator	Drug: SPARC PlaceboThe subjects will receive SPARC Placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Men and women greater than or equal to 18 years of age
Willing to sign the informed consent form
Women of child bearing potential willing to practice an acceptable method of birth control
Known history of spasticity due to MS

Key exclusion criteria (4 listed)

Administration of an investigational drug or device within 30 days prior to Screening Visit 1
Unable to comply with trial procedures in the opinion of the Investigator
Concomitant neurologic conditions causing spasticity
Any medical condition, including psychiatric disease or epilepsy, which would interfere with the interpretation of the trial results

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
SPARC1103 low doseonce daily	Drug	SPARC 1103 low dose
SPARC1103 high doseonce daily	Drug	SPARC1103 high dose
SPARC Placebo	Drug	SPARC Placebo

Primary outcome

Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Modified Ashworth Score
Time frame: Baseline, Day 24
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 in flexion or extension For calculation of modified Ashworth Score, the following scores were assigned to each category of modified Ashworth scale: not testable=NA, 0=0 units, 1=1 unit, 1+ = 2 units, 2 = 3 units, and 4 = 5 units. The total score was the sum of the scores of the 6 lower extremity muscle groups on both left and right sides (range = o0 to 60).

4 secondary outcomes

Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Night Time Awakening Score
Time frame: Baseline, Day 24
Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Spasm Frequency
Time frame: Baseline, Day 24
Clinical Global Impression of Change Results at 24 Hours Post Dose on Day 24
Time frame: Baseline, Day 24
Subject Global Impression of Severity of Spasticity
Time frame: Baseline, Day 24

Results and safety

Results posted to the registry on 15 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SPARC1103 Low Dose	48	47
SPARC1103 High Dose	47	42
SPARC Placebo	47	46

Primary outcome: Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Modified Ashworth Score

Time frame: Baseline, Day 24. Least squares mean (Standard Error). Unit: score on a scale

Measure	SPARC1103 Low Dose n = 47	SPARC1103 High Dose n = 42
Value	0.33 (1.47)	0.03 (1.53)

Population analysed: Intent to treat population: SPARC1103 low dose, N=47; SPARC 1103 high hose, N=42; and Placebo, N=46

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Screening through Day 24. Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SPARC1103 Low Dose	0 of 48 (0%)	4 of 48 (8.3%)	0 of 48
SPARC1103 High Dose	1 of 47 (2.1%)	2 of 47 (4.3%)	0 of 47
SPARC Placebo	0 of 47 (0%)	0 of 47 (0%)	0 of 47

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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Video-based Visual Feedback Combined With Task-oriented Physiotherapy Among Cerebral Palsy
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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.

23 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SPARC1103 low dose and SPARC1103 high dose in people with Spasticity, run by Sun Pharma Advanced Research Company Limited at 23 sites in 3 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 4 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 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 23 sites in United States, Russia, 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 15 Jan 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?

Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Modified Ashworth Score (time frame: Baseline, Day 24). 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 NCT02027025.

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.