Efficacy and Safety of SPARC0921 in Subjects With Spasticity | NCT01457352

Status Module

Label	Type	Description	Intervention Names
SPARC0921	Experimental		Drug: SPARC0921
Placebo0921	Placebo Comparator		Drug: Placebo0921

Name	Type	Description	Arm Group Labels	Other Names
SPARC0921	Drug		SPARC0921
Placebo0921

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	Week 22

Secondary Outcomes

Measure	Description	Time Frame
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	Week 22

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
SPARC site 6		Gilbert	Arizona		United States
SPARC Site 40

Results Section

Participant Flow Module

ID	Title	Description
FG000	SPARC0921	once, twice, thrice, or four times daily for one week
FG001	Placebo	Placebo formulation

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 24, 2012	Feb 18, 2019

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00048.8± 10.39 BG00151.0± 9.39 BG00249.9± 9.95

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000105 BG00199 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00010 BG00110 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0011 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

Intent to treat population: SPARC0921, N=147 and and Placebo, N=146

Posted

Number

percentage of subjects

Week 22

ID	Title	Description
OG000	SPARC0921	SPARC0921
OG001	Placebo0921	Placebo0921

Units	Counts
Participants	OG000147 OG001146

Title

Denominators

Categories

Title	Measurements
	OG00036.1 OG00143.2

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Cochran-Mantel-Haenszel		0.2062														Superiority

Secondary

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

Intent to treat population: SPARC0921, N=147 and Placebo0921, N=146

Posted

Number

percentage of subjects

Week 22

ID	Title	Description
OG000	SPARC0921	Subject Global Impression of Severity of Spasticity in SPARC0921 group
OG001	Placebo0921	Subject Global Impression of Severity of Spasticity in Placebo0921 group

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	SPARC0921- Part 3	SPARC0921 in randomized phase	0	147	3	147	23	147
EG001	Placebo0921 - Part 3	Placebo0921 in randomized phase	0	149	0	149	25	149
EG002	SPARC 0921 - Part 2	Open label	1	376	12	376	226	376
EG003	Run-in Part 1	Open label run-in period	0	392	0	392	6	392

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Hip fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected147 at risk EG0010 events0 affected149 at risk EG0020 affected376 at risk EG0030 affected392 at risk
Hypokalaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected147 at risk EG0010 events0 affected149 at risk EG0020 affected376 at risk EG003
Syncope	Nervous system disorders	Systematic Assessment	EG0001 events1 affected147 at risk EG0010 events0 affected149 at risk EG0020 affected376 at risk EG003
Acute myocardial infarction	Cardiac disorders	Systematic Assessment	EG0000 affected147 at risk EG0010 affected149 at risk EG0021 affected376 at risk EG003
death	General disorders	Systematic Assessment	EG0000 affected147 at risk EG0010 affected149 at risk EG0021 affected376 at risk EG003
Urinary tract infection	Infections and infestations	Systematic Assessment	EG0000 affected147 at risk EG0010 affected149 at risk EG0021 affected376 at risk EG003
Accidental overdose	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected147 at risk EG0010 affected149 at risk EG0021 affected376 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected147 at risk EG0010 affected149 at risk EG0021 affected376 at risk EG003
Multiple sclerosis relapse	Nervous system disorders	Systematic Assessment	EG0000 affected147 at risk EG0010 affected149 at risk EG0022 affected376 at risk EG003
Encephalopathy	Nervous system disorders	Systematic Assessment	EG0000 affected147 at risk EG0010 affected149 at risk EG0021 affected376 at risk EG003
Delirium	Psychiatric disorders	Systematic Assessment	EG0000 affected147 at risk EG0010 affected149 at risk EG0021 affected376 at risk EG003
Psychotic disorder	Psychiatric disorders	Systematic Assessment	EG0000 affected147 at risk EG0010 affected149 at risk EG0021 affected376 at risk EG003
Deep vein thrombosis	Vascular disorders	Systematic Assessment	EG0000 affected147 at risk EG0010 affected149 at risk EG0021 affected376 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected147 at risk EG0010 affected149 at risk EG0021 affected376 at risk EG003

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Muscle spasticity	Nervous system disorders	Systematic Assessment	EG00014 affected147 at risk EG00115 affected149 at risk EG00227 affected376 at risk EG0030 affected392 at risk
Headache	Nervous system disorders	Systematic Assessment	EG0006 affected147 at risk EG0014 affected149 at risk EG00214 affected376 at risk EG003
Urinary tract infection	Infections and infestations	Systematic Assessment	EG0003 affected147 at risk EG0016 affected149 at risk EG00212 affected376 at risk EG003
Muscle spasm	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 affected147 at risk EG0014 affected149 at risk EG00212 affected376 at risk EG003
Blood pressure increased	Investigations	Systematic Assessment	EG0001 affected147 at risk EG0014 affected149 at risk EG0025 affected376 at risk EG003
Fatigue	General disorders	Systematic Assessment	EG0004 affected147 at risk EG0010 affected149 at risk EG00224 affected376 at risk EG003
Nasopharyngitis	Infections and infestations	Systematic Assessment	EG0000 affected147 at risk EG0014 affected149 at risk EG00213 affected376 at risk EG003
Insomnia	Psychiatric disorders	Systematic Assessment	EG0000 affected147 at risk EG0010 affected149 at risk EG0029 affected376 at risk EG003
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0000 affected147 at risk EG0010 affected149 at risk EG00222 affected376 at risk EG003
somnolence	Nervous system disorders	Systematic Assessment	EG0000 affected147 at risk EG0010 affected149 at risk EG00221 affected376 at risk EG003
multiple sclerosis relapse	Nervous system disorders	Systematic Assessment	EG0000 affected147 at risk EG0010 affected149 at risk EG00212 affected376 at risk EG003
dizziness	Nervous system disorders	Systematic Assessment	EG0000 affected147 at risk EG0010 affected149 at risk EG00210 affected376 at risk EG003
Tremor	Nervous system disorders	Systematic Assessment	EG0000 affected147 at risk EG0010 affected149 at risk EG0026 affected376 at risk EG003
vomitting	Gastrointestinal disorders	Systematic Assessment	EG0000 affected147 at risk EG0010 affected149 at risk EG0029 affected376 at risk EG003
sinusitis	Infections and infestations	Systematic Assessment	EG0000 affected147 at risk EG0010 affected149 at risk EG00212 affected376 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected147 at risk EG0010 affected149 at risk EG00211 affected376 at risk EG003
Oedema peripheral	General disorders	Systematic Assessment	EG0000 affected147 at risk EG0010 affected149 at risk EG00210 affected376 at risk EG003
Insomnia	Psychiatric disorders	Systematic Assessment	EG0001 affected147 at risk EG0013 affected149 at risk EG0029 affected376 at risk EG003
Asthenia	General disorders	Systematic Assessment	EG0000 affected147 at risk EG0010 affected149 at risk EG0026 affected376 at risk EG003
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG0002 affected147 at risk EG0012 affected149 at risk EG0026 affected376 at risk EG003

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D009122	Muscle Hypertonia
D020879	Neuromuscular Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description
BG000	SPARC0921	SPARC0921 Subjects who received SPARC0921 Dose Regimen I at Visit 1: 392 Received SPARC0921 Dose Regimen II at Visit 2 (Safety Population): 376 Randomized at Visit 7 to receive Dose Regimen III: 147
BG001	Placebo0921	Placebo0921 Randomized at Visit 7: 149
BG002	Total	Total of all reporting groups