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

Phase 2

Withdrawn

• Conditions: Stroke
• Interventions: Drug: SUN13837; Drug: placebo

• Registration Number: NCT02258880
• Lead Sponsor: Daiichi Sankyo

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-29
• Study First Submitted QC: 2014-10-07
• Study First Posted: 2014-10-08
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-19
• Last Update Posted: 2015-10-20
• Primary Completion: 2016-05
• Study Completion: 2016-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Subjects who meet any of the following criteria will be excluded from the study:

1. Prior exposure to SUN13837
2. History of severe allergic reaction, whether explained or not, requiring a visit to the ER and/or medical intervention with epinephrine
3. Development of hemodynamic instability following the acute stroke
4. 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
5. Presence of significant global or receptive aphasia
6. Presence of clinically significant abnormal laboratory values at the time of presentation in the ER
7. History of malabsorption or any gastrointestinal abnormality that could impair oral absorption
8. 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
9. 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
10. Current participation in another clinical study involving administration of an investigational product or history of such participation within 30 days of acute stroke onset

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SUN13837	SUN13837	Drug: SUN13837 daily for 28 days.
Placebo	placebo	Placebo: Matching Placebo daily for 28 days

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in the Physical Performance Assessment in Stroke (PPAS)	84 days

Secondary Outcome Measures

Name	Time	Method
Mean change from baseline in Gait Speed	84 days
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
Proportion of responders as measured by the Modified Rankin Scale (mRS)	84 days
Safety/Tolerability - Number of Participants with Adverse Events	84 days