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

October 19, 2015 updated by: Daiichi Sankyo, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Mean change from baseline in the Physical Performance Assessment in Stroke (PPAS)
Time Frame: 84 days
84 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
The proportion of responders as measured by the PPAS
Time Frame: 84 days
84 days
Mean change from baseline in PPAS Patient Reported Outcome Subscale
Time Frame: 84 days
84 days
Mean change from baseline in Short Form-36 Physical Functioning Scale (SF-36 PF)
Time Frame: 84 days
84 days
Mean change from baseline in Gait Speed
Time Frame: 84 days
84 days
Proportion of responders as measured by the Modified Rankin Scale (mRS)
Time Frame: 84 days
84 days
Safety/Tolerability - Number of Participants with Adverse Events
Time Frame: 84 days
84 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Daiichi Sankyo, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Syneos Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ger Rikken, MD, Asubio Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 8, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 20, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ASBI 802

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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