Trial record 1 of 3 for:    ASUBIO
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02258880
Recruitment Status : Withdrawn (study was stopped for business/administrative reasons and not for patient safety concerns)
First Posted : October 8, 2014
Last Update Posted : October 20, 2015
INC Research
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

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.

Condition or disease Intervention/treatment Phase
Stroke Drug: SUN13837 Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : September 2014
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : May 2016

Arm Intervention/treatment
Experimental: SUN13837
Drug: SUN13837 daily for 28 days.
Drug: SUN13837
Placebo Comparator: Placebo
Placebo: Matching Placebo daily for 28 days
Drug: placebo

Primary Outcome Measures :
  1. Mean change from baseline in the Physical Performance Assessment in Stroke (PPAS) [ Time Frame: 84 days ]

Secondary Outcome Measures :
  1. The proportion of responders as measured by the PPAS [ Time Frame: 84 days ]
  2. Mean change from baseline in PPAS Patient Reported Outcome Subscale [ Time Frame: 84 days ]
  3. Mean change from baseline in Short Form-36 Physical Functioning Scale (SF-36 PF) [ Time Frame: 84 days ]
  4. Mean change from baseline in Gait Speed [ Time Frame: 84 days ]
  5. Proportion of responders as measured by the Modified Rankin Scale (mRS) [ Time Frame: 84 days ]
  6. Safety/Tolerability - Number of Participants with Adverse Events [ Time Frame: 84 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02258880

  Show 53 Study Locations
Sponsors and Collaborators
Daiichi Sankyo, Inc.
INC Research
Study Director: Ger Rikken, MD Asubio Pharmaceuticals, Inc.

Responsible Party: Daiichi Sankyo, Inc. Identifier: NCT02258880     History of Changes
Other Study ID Numbers: ASBI 802
First Posted: October 8, 2014    Key Record Dates
Last Update Posted: October 20, 2015
Last Verified: October 2015

Keywords provided by Daiichi Sankyo, Inc.:
Acute Stroke
Outcome Measures
Physical Performance

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases