Spasticity
Conditions
Keywords
spasticity
Brief summary
Open-label, safety study of SPARC1104 in subjects with spasticity due to multiple sclerosis
Detailed description
Safety study of SPARC1104
Interventions
DRUGSPARC1104 modified dose regimen I
Subjects who exited study CLR\_09\_21
DRUGSPARC1104 modified dose regimen II
Subjects who received prior treatment regimen I
DRUGSPARC1104 modified dose regimen III
Subjects who received no prior treatment regimen
Sponsors
Sun Pharma Advanced Research Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Subjects With Adverse Events | 52 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SPARC1104 Group 1 Subjects who completed Study CLR\_09\_21 | 162 |
| SPARC1104 Group 2 Subjects who are on Dose regimen I of SPARC0921 at entry | 163 |
| SPARC1104 Group 3 Subjects Entering the Trial with no Prior Treatment with SPARC0921 | 50 |
| Total | 375 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 5 | 15 | 6 |
| Overall Study | Lost to Follow-up | 2 | 6 | 1 |
| Overall Study | Physician Decision | 1 | 3 | 0 |
| Overall Study | Protocol Violation | 1 | 1 | 0 |
| Overall Study | Site terminated | 8 | 4 | 0 |
| Overall Study | Withdrawal by Subject | 6 | 9 | 5 |
| Overall Study | Withdrawn per sponsor | 5 | 0 | 0 |
Baseline characteristics
| Characteristic | SPARC1104 Group 1 | SPARC1104 Group 2 | SPARC1104 Group 3 | Total |
|---|---|---|---|---|
| Age, Continuous | 51.7 years STANDARD_DEVIATION 9.56 | 52.9 years STANDARD_DEVIATION 9.77 | 51.3 years STANDARD_DEVIATION 11.55 | 52.2 years STANDARD_DEVIATION 9.93 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 5 Participants | 3 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 155 Participants | 158 Participants | 47 Participants | 360 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 28 Participants | 19 Participants | 5 Participants | 52 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 4 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 132 Participants | 139 Participants | 44 Participants | 315 Participants |
| Sex: Female, Male Female | 119 Participants | 116 Participants | 29 Participants | 264 Participants |
| Sex: Female, Male Male | 43 Participants | 47 Participants | 21 Participants | 111 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 162 | 0 / 163 | 0 / 50 |
| other Total, other adverse events | 129 / 162 | 150 / 163 | 44 / 50 |
| serious Total, serious adverse events | 30 / 162 | 40 / 163 | 6 / 50 |
Outcome results
Primary
Number of Subjects With Adverse Events
Time frame: 52 weeks
Population: Safety population: Subject who received at least one dose of study treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SPARC1104 Group 1 | Number of Subjects With Adverse Events | 129 Count of participants |
| SPARC1104 Group 2 | Number of Subjects With Adverse Events | 150 Count of participants |
| SPARC1104 Group 3 | Number of Subjects With Adverse Events | 44 Count of participants |