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

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Stroke

In brief

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.

Key facts

Study ID

NCT02258880

Run by

Daiichi Sankyo

People needed

0

Starts

2014-09-01

Expected to finish

2016-05-01

Last updated by the study team

2015-10-20

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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

Where it is running

• Study site — Encinita, California, United States
• Study site — Oceanside, California, United States
• Study site — Sarasota, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Savannah, Georgia, United States
• Study site — Lexington, Kentucky, United States
• Study site — Marrero, Louisiana, United States
• Study site — New Orleans, Louisiana, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Worcester, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — Detroit, Michigan, United States
• Study site — Novi, Michigan, United States
• Study site — Southfield, Michigan, United States
• Study site — Kalispell, Montana, United States
• Study site — Reno, Nevada, United States
• Study site — Edison, New Jersey, United States
• Study site — Summit, New Jersey, United States
• Study site — Brooklyn, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Columbus, Ohio, United States
• Study site — Portland, Oregon, United States
• Study site — Portland, Oregon, United States
• Study site — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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