Study Stopped
study was stopped for business/administrative reasons and not for patient safety concerns
Efficacy, Safety, Tolerability and Pharmacokinetics of SUN13837 to Treat Acute Stroke
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
1 other identifier
interventional
N/A
4 countries
53
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2014
Shorter than P25 for phase_2 stroke
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 29, 2014
CompletedFirst Posted
Study publicly available on registry
October 8, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedOctober 20, 2015
October 1, 2015
1.7 years
September 29, 2014
October 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean change from baseline in the Physical Performance Assessment in Stroke (PPAS)
84 days
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (2)
SUN13837
EXPERIMENTALDrug: SUN13837 daily for 28 days.
Placebo
PLACEBO COMPARATORPlacebo: Matching Placebo daily for 28 days
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
- Syneos Healthcollaborator
Study Sites (53)
Unknown Facility
Mobile, Alabama, 36693, United States
Unknown Facility
Encinita, California, 92024, United States
Unknown Facility
Oceanside, California, 92056, United States
Unknown Facility
Sarasota, Florida, 34239, United States
Unknown Facility
Tampa, Florida, 33606, United States
Unknown Facility
Atlanta, Georgia, 30322, United States
Unknown Facility
Savannah, Georgia, 31405, United States
Unknown Facility
Lexington, Kentucky, 40536, United States
Unknown Facility
Marrero, Louisiana, 70072, United States
Unknown Facility
New Orleans, Louisiana, 70112, United States
Unknown Facility
New Orleans, Louisiana, 70121, United States
Unknown Facility
Worcester, Massachusetts, 01655, United States
Unknown Facility
Detroit, Michigan, 48201, United States
Unknown Facility
Detroit, Michigan, 48236, United States
Unknown Facility
Novi, Michigan, 48374, United States
Unknown Facility
Southfield, Michigan, 48705, United States
Unknown Facility
Kalispell, Montana, 59901, United States
Unknown Facility
Reno, Nevada, 89502, United States
Unknown Facility
Edison, New Jersey, 08818, United States
Unknown Facility
Summit, New Jersey, 07901, United States
Unknown Facility
Brooklyn, New York, 11220, United States
Unknown Facility
Chapel Hill, North Carolina, 27599, United States
Unknown Facility
Columbus, Ohio, 43210, United States
Unknown Facility
Portland, Oregon, 97201, United States
Unknown Facility
Portland, Oregon, 97213, United States
Unknown Facility
Portland, Oregon, 97225, United States
Unknown Facility
Bryn Mawr, Pennsylvania, 19010, United States
Unknown Facility
Hershey, Pennsylvania, 17033, United States
Unknown Facility
Paoli, Pennsylvania, 19301, United States
Unknown Facility
Philadelphia, Pennsylvania, 19102, United States
Unknown Facility
Columbia, South Carolina, 29203, United States
Unknown Facility
Chattanooga, Tennessee, 37404, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
Mechanicsville, Virginia, 23116, United States
Unknown Facility
Midlothian, Virginia, 23114, United States
Unknown Facility
Richmond, Virginia, 23226, United States
Unknown Facility
Richmond, Virginia, 23298, United States
Unknown Facility
Edmonton, Alberta, T6G 2B7, Canada
Unknown Facility
Victoria, British Columbia, V8R 1J8, Canada
Unknown Facility
Saint-Jérôme, Quebec, J7Z 5T3, Canada
Unknown Facility
Haifa, 3109601, Israel
Unknown Facility
Haifa, 3339419, Israel
Unknown Facility
Holon, 5822012, Israel
Unknown Facility
Kfar Saba, 4428164, Israel
Unknown Facility
Naharyia, 2210001, Israel
Unknown Facility
Ramat Gan, 5262100, Israel
Unknown Facility
Tel Aviv, 6423906, Israel
Unknown Facility
Bloemfontein, Free State, 9301, South Africa
Unknown Facility
Alberton, Gauteng, 1449, South Africa
Unknown Facility
Krugersdorp, Gauteng, 1739, South Africa
Unknown Facility
Bellville, Western Cape, 7350, South Africa
Unknown Facility
Somerset West, Western Cape, 7130, South Africa
Unknown Facility
Worcester, Western Cape, 6850, South Africa
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ger Rikken, MD
Asubio Pharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2014
First Posted
October 8, 2014
Study Start
September 1, 2014
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
October 20, 2015
Record last verified: 2015-10