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

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.

Study Overview

• Status: Withdrawn
• Conditions: Stroke
• Intervention / Treatment: Drug: placebo; Drug: SUN13837

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
  • British Columbia
    • Victoria, British Columbia, Canada, V8R 1J8
  • Quebec
    • St-Jerome, Quebec, Canada, J7Z 5T3
• Israel
  • Haifa, Israel, 3109601
  • Haifa, Israel, 3339419
  • Holon, Israel, 5822012
  • Kfar-Saba, Israel, 4428164
  • Naharyia, Israel, 2210001
  • Ramat Gan, Israel, 5262100
  • Tel-Aviv, Israel, 6423906
• South Africa
  • Free State
    • Bloemfontein, Free State, South Africa, 9301
  • Gauteng
    • Alberton, Gauteng, South Africa, 1449
    • Krugersdorp, Gauteng, South Africa, 1739
  • Western Cape
    • Bellville, Western Cape, South Africa, 7350
    • Somerset West, Western Cape, South Africa, 7130
    • Worcester, Western Cape, South Africa, 6850
• United States
  • Alabama
    • Mobile, Alabama, United States, 36693
  • California
    • Encinita, California, United States, 92024
    • Oceanside, California, United States, 92056
  • Florida
    • Sarasota, Florida, United States, 34239
    • Tampa, Florida, United States, 33606
  • Georgia
    • Atlanta, Georgia, United States, 30322
    • Savannah, Georgia, United States, 31405
  • Kentucky
    • Lexington, Kentucky, United States, 40536
  • Louisiana
    • Marrero, Louisiana, United States, 70072
    • New Orleans, Louisiana, United States, 70112
    • New Orleans, Louisiana, United States, 70121
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
  • Michigan
    • Detroit, Michigan, United States, 48201
    • Detroit, Michigan, United States, 48236
    • Novi, Michigan, United States, 48374
    • Southfield, Michigan, United States, 48705
  • Montana
    • Kalispell, Montana, United States, 59901
  • Nevada
    • Reno, Nevada, United States, 89502
  • New Jersey
    • Edison, New Jersey, United States, 08818
    • Summit, New Jersey, United States, 07901
  • New York
    • Brooklyn, New York, United States, 11220
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
  • Ohio
    • Columbus, Ohio, United States, 43210
  • Oregon
    • Portland, Oregon, United States, 97225
    • Portland, Oregon, United States, 97213
    • Portland, Oregon, United States, 97201
  • Pennsylvania
    • Bryn Mawr, Pennsylvania, United States, 19010
    • Hershey, Pennsylvania, United States, 17033
    • Paoli, Pennsylvania, United States, 19301
    • Philadelphia, Pennsylvania, United States, 19102
  • South Carolina
    • Columbia, South Carolina, United States, 29203
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
  • Texas
    • Houston, Texas, United States, 77030
  • Virginia
    • Mechanicsville, Virginia, United States, 23116
    • Midlothian, Virginia, United States, 23114
    • Richmond, Virginia, United States, 23298
    • Richmond, Virginia, United States, 23226

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean change from baseline in the Physical Performance Assessment in Stroke (PPAS)	84 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Safety/Tolerability - Number of Participants with Adverse Events	84 days

Collaborators and Investigators

• Sponsor: Daiichi Sankyo, Inc.
• Collaborators: Syneos Health
• Investigators: Study Director: Ger Rikken, MD, Asubio Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Anticipated): May 1, 2016
• Study Completion (Anticipated): May 1, 2016

Study Registration Dates

• First Submitted: September 29, 2014
• First Submitted That Met QC Criteria: October 7, 2014
• First Posted (Estimate): October 8, 2014

Study Record Updates

• Last Update Posted (Estimate): October 20, 2015
• Last Update Submitted That Met QC Criteria: October 19, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Outcome Measures; Acute Stroke; Physical Performance
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: ASBI 802