Efficacy, Safety, Tolerability and Pharmacokinetics of SUN13837 to Treat Acute Stroke

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and tolerability of SUN13837 and to determine whether SUN13837 improves the physical performance, relative to placebo, following an acute stroke in adult subjects.

Official Title
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A Phase 2, Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SUN13837 Administered 28 Doses (27/28 Days) to Adult Subjects With an Acute Ischemic Stroke

Conditions
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Stroke

Intervention / Treatment
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* Drug: SUN13837
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Each subject must meet all of the following criteria to participate in the study: Male or female subjects between 18 and 85 years, inclusive Subjects with no prior history of stroke (unless the stroke was not associated with a motor deficit) Subjects must score at least 16 points on the standard MMSE during baseline assessments Subjects must have a total score between 7 and 30, inclusive, out of 35 on the S-STREAM administered between 24 and 48 hours after the onset of acute stroke Subjects must have an estimated pre-stroke mRS of 0 or 1 Male subjects agree to be heterosexually abstinent or use appropriate contraception Female subjects must have undergone menopause or, if premenopausal, must have a negative pregnancy test at baseline. Female subjects of childbearing potential agree to be sexually abstinent or must be willing to utilize adequate contraception Subjects must be willing to provide verbal/nonverbal informed consent indicating voluntary consent to participate in the study (if a subject is unable to provide informed consent, but able to comply with other study procedures, the subject's LAR may provide consent) Exclusion Criteria: Subjects who meet any of the following criteria will be excluded from the study: Prior exposure to SUN13837 History of severe allergic reaction, whether explained or not, requiring a visit to the ER and/or medical intervention with epinephrine Development of hemodynamic instability following the acute stroke History of dementia, advanced Parkinson's disease, other significant movement disorders, or other clinically significant diseases which would jeopardize the safety of the subject or impact the validity of the study results Presence of significant global or receptive aphasia Presence of clinically significant abnormal laboratory values at the time of presentation in the ER History of malabsorption or any gastrointestinal abnormality that could impair oral absorption Finding of Grade 3 or 4 proliferative retinopathy on routine fundoscopic examination or history of proliferative retinopathy (Grade 3 or 4) in subjects with diabetes mellitus Unable, as determined by the investigator, or unwilling to discontinue use of potent cytochrome (CYP) P450 3A4/5 inhibitors, potent CYP2D6 inhibitors, CYP3A inducers, or potent P glycoprotein (P gp) inhibitors Current participation in another clinical study involving administration of an investigational product or history of such participation within 30 days of acute stroke onset

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SUN13837<br>Drug: SUN13837 daily for 28 days. | Drug: SUN13837<br> <br> |
| Placebo Comparator: Placebo<br>Placebo: Matching Placebo daily for 28 days | Drug: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in the Physical Performance Assessment in Stroke (PPAS) |  | 84 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of responders as measured by the PPAS |  | 84 days | 
| Mean change from baseline in PPAS Patient Reported Outcome Subscale |  | 84 days | 
| Mean change from baseline in Short Form-36 Physical Functioning Scale (SF-36 PF) |  | 84 days | 
| Mean change from baseline in Gait Speed |  | 84 days | 
| Proportion of responders as measured by the Modified Rankin Scale (mRS) |  | 84 days | 
| Safety/Tolerability - Number of Participants with Adverse Events |  | 84 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical Performance, Acute Stroke, Outcome Measures