Trial record 1 of 8 for:    ASUBIO
Previous Study | Return to List | Next Study

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Asubio Pharmaceuticals, Inc.
Sponsor:
Collaborator:
INC Research
Information provided by (Responsible Party):
Asubio Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT02258880
First received: September 29, 2014
Last updated: October 7, 2014
Last verified: October 2014
  Purpose

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 Intervention Phase
Stroke
Drug: SUN13837
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Asubio Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Mean change from baseline in the Physical Performance Assessment in Stroke (PPAS) [ Time Frame: 84 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The proportion of responders as measured by the PPAS [ Time Frame: 84 days ] [ Designated as safety issue: No ]
  • Mean change from baseline in PPAS Patient Reported Outcome Subscale [ Time Frame: 84 days ] [ Designated as safety issue: No ]
  • Mean change from baseline in Short Form-36 Physical Functioning Scale (SF-36 PF) [ Time Frame: 84 days ] [ Designated as safety issue: No ]
  • Mean change from baseline in Gait Speed [ Time Frame: 84 days ] [ Designated as safety issue: No ]
  • Proportion of responders as measured by the Modified Rankin Scale (mRS) [ Time Frame: 84 days ] [ Designated as safety issue: No ]
  • Safety/Tolerability - Number of Participants with Adverse Events [ Time Frame: 84 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 256
Study Start Date: September 2014
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SUN13837
Drug: SUN13837 daily for 28 days.
Drug: SUN13837
Placebo Comparator: Placebo
Placebo: Matching Placebo daily for 28 days

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02258880

Contacts
Contact: Tova Rothschild, PhD, MSc (201) 368-5038 trothschild@asubio.com

  Show 53 Study Locations
Sponsors and Collaborators
Asubio Pharmaceuticals, Inc.
INC Research
Investigators
Study Director: Ger Rikken, MD Asubio Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Asubio Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02258880     History of Changes
Other Study ID Numbers: ASBI 802
Study First Received: September 29, 2014
Last Updated: October 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Asubio Pharmaceuticals, Inc.:
Acute Stroke
Outcome Measures
Physical Performance

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014