Clinical trial NCT02258880: Efficacy, Safety, Tolerability and Pharmacokinetics of SUN13837 to Treat Acute Stroke
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Stroke
Keywords: Acute Stroke
Outcome Measures
Physical Performance
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
Collaborators: name: Syneos Health
First posted: 2014-10-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Each subject must meet all of the following criteria to participate in the study:

1. Male or female subjects between 18 and 85 years, inclusive
2. Subjects with no prior history of stroke (unless the stroke was not associated with a motor deficit)
3. Subjects must score at least 16 points on the standard MMSE during baseline assessments
4. 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
5. Subjects must have an estimated pre-stroke mRS of 0 or 1
6. Male subjects agree to be heterosexually abstinent or use appropriate contraception
7. 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
8. 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:

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

Primary outcomes:
measure: Mean change from baseline in the Physical Performance Assessment in Stroke (PPAS)
timeFrame: 84 days
Secondary outcomes:
measure: The proportion of responders as measured by the PPAS
timeFrame: 84 days
measure: Mean change from baseline in PPAS Patient Reported Outcome Subscale
timeFrame: 84 days
measure: Mean change from baseline in Short Form-36 Physical Functioning Scale (SF-36 PF)
timeFrame: 84 days
measure: Mean change from baseline in Gait Speed
timeFrame: 84 days
measure: Proportion of responders as measured by the Modified Rankin Scale (mRS)
timeFrame: 84 days
measure: Safety/Tolerability - Number of Participants with Adverse Events
timeFrame: 84 days
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Encinita
country: United States
state: California
city: Oceanside
country: United States
state: California
city: Sarasota
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Savannah
country: United States
state: Georgia
city: Lexington
country: United States
state: Kentucky
city: Marrero
country: United States
state: Louisiana
city: New Orleans
country: United States
state: Louisiana
city: New Orleans
country: United States
state: Louisiana
city: Worcester
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: Novi
country: United States
state: Michigan
city: Southfield
country: United States
state: Michigan
city: Kalispell
country: United States
state: Montana
city: Reno
country: United States
state: Nevada
city: Edison
country: United States
state: New Jersey
city: Summit
country: United States
state: New Jersey
city: Brooklyn
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Columbus
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Bryn Mawr
country: United States
state: Pennsylvania
city: Hershey
country: United States
state: Pennsylvania
city: Paoli
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Chattanooga
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Mechanicsville
country: United States
state: Virginia
city: Midlothian
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Edmonton
country: Canada
state: Alberta
city: Victoria
country: Canada
state: British Columbia
city: St-Jerome
country: Canada
state: Quebec
city: Haifa
country: Israel
city: Haifa
country: Israel
city: Holon
country: Israel
city: Kfar-Saba
country: Israel
city: Naharyia
country: Israel
city: Ramat Gan
country: Israel
city: Tel-Aviv
country: Israel
city: Bloemfontein
country: South Africa
state: Free State
city: Alberton
country: South Africa
state: Gauteng
city: Krugersdorp
country: South Africa
state: Gauteng
city: Bellville
country: South Africa
state: Western Cape
city: Somerset West
country: South Africa
state: Western Cape
city: Worcester
country: South Africa
state: Western Cape
Study officials:
affiliation: Asubio Pharmaceuticals, Inc.
name: Ger Rikken, MD
role: STUDY_DIRECTOR
References: