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Study of SPARC1103 in subjects with spasticity
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPARC 1103 low dose | Active Comparator | The subjects will receive SPARC 1103 low dose |
|
| SPARC1103 high dose | Active Comparator | The subjects will receive SPARC1103 high dose |
|
| SPARC Placebo | Placebo Comparator | The subjects will receive SPARC Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPARC1103 low dose | Drug | once daily |
| |
| SPARC1103 high dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, Day 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline, Day 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SPARC Site 4 | Long Beach | California | United States | |||
| SPARC Site 6 |
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| ID | Title | Description |
|---|---|---|
| FG000 | SPARC1103 Low Dose | SPARC1103 low dose dosing regimen: 1 capsule orally, approximately 30 minutes |
| FG001 | SPARC1103 High Dose | SPARC1103 high dose dosing regimen 1 capsule orally, approximately 30 minutes |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 31, 2017 |
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| Drug |
once daily |
|
| SPARC Placebo | Drug |
|
| 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 | 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 | 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 | Baseline, Day 24 |
| San Diego |
| California |
| United States |
| SPARC Site 10 | Aurora | Colorado | United States |
| SPARC Site 2 | Jacksonville | Florida | United States |
| SPARC Site 15 | Miami | Florida | United States |
| SPARC Site 7 | Miami Springs | Florida | United States |
| SPARC Site 5 | Orlando | Florida | United States |
| SPARC Site 13 | Tampa | Florida | United States |
| SPARC Site 11 | Kansas City | Kansas | United States |
| SPARC Site 3 | Lenexa | Kansas | United States |
| SPARC Site 1 | Bingham Farms | Michigan | United States |
| SPARC Site 14 | Albuquerque | New Mexico | United States |
| SPARC Site 9 | Charlotte | North Carolina | United States |
| SPARC Site 8 | Cleveland | Ohio | United States |
| SPARC Site 12 | Richland | Washington | United States |
| SPARC Site 18 | Moscow | Russia |
| SPARC Site 17 | Nizhny Novgorod | Russia |
| SPARC Site 20 | Samara | Russia |
| SPARC Site 19 | Smolensk | Russia |
| SPARC Site 16 | Ufa | Russia |
| SPARC Site 22 | Dnipro | Ukraine |
| SPARC Site 21 | Ivano-Frankivsk | Ukraine |
| SPARC Site 23 | Lviv | Ukraine |
| FG002 | SPARC Placebo | SPARC Placebo dosing regimen 1 capsule orally, approximately 30 minutes |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | SPARC1103 Low Dose | Age: 50.5 (9.12) |
| BG001 | SPARC1103 High Dose | Age: 52.3 (9.33) |
| BG002 | SPARC Placebo | Age: 50.2 (10.43) |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | 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). | Intent to treat population: SPARC1103 low dose, N=47; SPARC 1103 high hose, N=42; and Placebo, N=46 | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Day 24 |
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| Secondary | 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) | Intent to treat population: SPARC 1103 low dose, N=47; SPARC 1103 high dose, N=42; and Placebo N=46. | Posted | Least Squares Mean | Standard Error | Awakenings | Baseline, Day 24 |
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| Secondary | 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 | Intent to treat population: SPARC 1103 low dose, N= 47; SPARC1103 High dose, N=42; and Placebo, N=46 | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Day 24 |
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| Secondary | 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 | Intent to treat population: SPARC 1103 low dose, N=47; SPARC 1103 high dose, N=42; and Placebo N=46 | Posted | Number | participants | Baseline, Day 24 |
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| Secondary | 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 | Intent to treat population: SPARC1103 low dose, N=47; SPARC1103 high dose, N=42; and Placebo, N=46 | Posted | Count of Participants | Participants | No | Baseline, Day 24 |
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Screening through Day 24
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SPARC1103 Low Dose | Subjects with treatment emergent adverse events | 0 | 48 | 0 | 48 | 4 | 48 |
| EG001 | SPARC1103 High Dose | Subjects with treatment emergent adverse events | 0 | 47 | 1 | 47 | 2 | 47 |
| EG002 | SPARC Placebo | Subjects with treatment emergent adverse events | 0 | 47 | 0 | 47 | 0 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza | Infections and infestations | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mudgal Kothekar | Sun Pharma Advanced Research Company Limited | 912266455645 | mudgal.kothekar@sparcmail.com |
| Dec 17, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D009128 | Muscle Spasticity |
| D009103 | Multiple Sclerosis |
| 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 |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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