We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Proof of Concept (POC) in Patients With Ischaemic Stroke

This study has been terminated.
(This study was terminated for futility.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01808261
First Posted: March 11, 2013
Last Update Posted: November 17, 2017
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.
Information provided by (Responsible Party):
GlaxoSmithKline
Results First Submitted: June 9, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Cerebrovascular Accident
Interventions: Drug: GSK249320 100/mg
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 134 participants with Stroke, were randomized to the study. The study was conducted from 18 May 2013 to 28 July 2014 at 30 centers; with 5 in United States, 5 in Canada, 8 in United Kingdom, and 12 in Germany. The ITT population consisted of total 120 participants and the Per Protocol consisted of 104 participants.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Screening details: This study consisted of a 6 month Core study period and an Extended follow Up period, if required. The study was terminated early at the time of Interim Analysis for reasons of futility. At that time, a total of 134 participants were randomized, of which 133 participants had received at least one dose of study medication.

Reporting Groups
  Description
Placebo Participants received placebo administered as two intravenous (IV) infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 milliliters (mL) IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).
GSK249320 15 mg/kg Participants received GSK249320 15 milligrams (mg)/kilogram (kg) administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).

Participant Flow:   Overall Study
    Placebo   GSK249320 15 mg/kg
STARTED   68   65 
COMPLETED   32   32 
NOT COMPLETED   36   33 
Physician Decision                0                2 
Study Closed/Terminated                25                23 
Adverse event, non-fatal                2                0 
Consent withdrawn by subject                6                7 
Lost to Follow-up                3                1 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Participants were administered placebo as two IV infusions, the first on Study Day 1 which was 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL, IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).
GSK249320 15 mg/kg Participants received GSK249320 15 mg/kg administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).
Total Total of all reporting groups

Baseline Measures
   Placebo   GSK249320 15 mg/kg   Total 
Overall Participants Analyzed 
[Units: Participants]
 68   65   133 
Age 
[Units: Years]
Mean (Standard Deviation)
 67.1  (11.2)   68.2  (11.92)   67.6  (11.53) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      29  42.6%      31  47.7%      60  45.1% 
Male      39  57.4%      34  52.3%      73  54.9% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      1   1.5%      0   0.0%      1   0.8% 
Asian      1   1.5%      1   1.5%      2   1.5% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      4   5.9%      2   3.1%      6   4.5% 
White      62  91.2%      62  95.4%      124  93.2% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Change From Baseline (BL) to Month 3/ Day 90 in Gait Velocity   [ Time Frame: BL (Day 1) and Month 3/Day 90 ]

2.  Secondary:   Mean Change From BL to Month 6/ Day 180 in Gait Velocity   [ Time Frame: BL (Day 1) and Month 6/Day 180 ]

3.  Secondary:   Number of Participants With Indicated Transition From One Gait Velocity Category to Another Category at the Indicated Time Points   [ Time Frame: BL (Day 1), Month 1/Day 30, Month 2/Day 60, Month 3/Day 90 and Month 6/Day 180. ]

4.  Secondary:   Change From BL in Dexterity as Measured by Box and Blocks Test   [ Time Frame: BL (Day 1), Month 1/Day 30, Month 2/Day 60, Month 3/Day 90 and Month 6/Day 180 ]

5.  Secondary:   Number of Participants Experiencing Falls   [ Time Frame: BL (Day 1) Day 90 and Day 180 ]

6.  Secondary:   Number of Falls Over Time   [ Time Frame: BL (Day 1), Day 90 and Day 180 ]

7.  Secondary:   Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs)   [ Time Frame: Up to 14 months ]

8.  Secondary:   Number of Participants With Events Common to Stroke   [ Time Frame: From Day 1 until early withdrawal, death, Month 6/Day 180 ]

9.  Secondary:   Change From BL in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)   [ Time Frame: BL (Day 1) , Day 6, Day 180 and early withdrawal (EW) visit ]

10.  Secondary:   Change From BL in Vitals Signs-Heart Rate   [ Time Frame: Day 1, Day 6, Day 180 and EW visit ]

11.  Secondary:   Change From BL in ECG Parameter-Heart Rate   [ Time Frame: BL (Day 1) Day 6, Day 30 and EW visit ]

12.  Secondary:   Change From BL in ECG Parameters   [ Time Frame: BL (Day 1), Day 6, Day 30 and EW visit ]

13.  Secondary:   Change From BL in Clinical Chemistry- Albumin and Total Protein   [ Time Frame: BL (Day 1), Day 6, Day 30, Day 90 and Day 180 ]

14.  Secondary:   Change From BL in Clinical Chemistry-urea/Blood Urea Nitrogen (BUN), Sodium (Na), Potassium (K), Glucose (Gluc), Chloride (Cl), Calcium (Ca)   [ Time Frame: BL (Day 1), Day 6, Day 30, Day 90 and Day 180 ]

15.  Secondary:   Change From BL in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)   [ Time Frame: BL (Day 1), Day 6, Day 30, Day 90 and Day 180 ]

16.  Secondary:   Change From BL in Clinical Chemistry- Direct Bilirubin, Total Bilirubin, Creatinine   [ Time Frame: BL (Day 1), Day 6, Day 30, Day 90 and Day 180 ]

17.  Secondary:   Change From BL in Eosinophils (EOS), Lymphocytes (LYM), Total Absolute Neutrophil Count (ANC), Platelet (PLT) Count, White Blood Cell (WBC) Count   [ Time Frame: BL (Day 1), Day 6, Day 30, Day 90 and Day 180 ]

18.  Secondary:   Change From BL in Hematology- Hemoglobin   [ Time Frame: BL (Day 1), Day 6, Day 30, Day 90 and Day 180 ]

19.  Secondary:   Change From Baseline in Hematology- Hematocrit   [ Time Frame: BL (Day 1), Day 6, Day 30, Day 90 and Day 180 ]

20.  Secondary:   Change From BL in NIHSS Total Score   [ Time Frame: BL (Day 1), Day 30, Day 90 and Day 180 ]

21.  Secondary:   Number of Participants With Suicidal Ideation Via Columbia Suicide Severity Rating Scale (CSSRS)   [ Time Frame: Da y 1, Da y 6, Day 30, Day 60, Day 90 and Day 180 ]

22.  Secondary:   Maximum Observed Plasma Concentration (Cmax) for GSK249320   [ Time Frame: Pre-dose and post-dose up to Day 180 ]

23.  Secondary:   Time to Reach Maximum Observed Plasma Concentration (Tmax) GSK249320   [ Time Frame: Pre-dose and post-dose up to Day 180 ]

24.  Secondary:   PK as Measured by Plasma Decay Half-life (t1/2) GSK249320   [ Time Frame: Up to Day 180 ]

25.  Secondary:   Area Under the Concentration-time Curve From 0 to 5 Days [AUC(0-5d)] and Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time [AUC(0-inf)] for GSK249320   [ Time Frame: Pre-dose and post-dose up to Day 180 ]

26.  Secondary:   Clearance (CL) for GSK249320   [ Time Frame: Up to Day 180 ]

27.  Secondary:   Volume of Distribution (V1 and V2) and Volume at Steady State (Vss) for GSK249320   [ Time Frame: Up to Day 180 ]

28.  Secondary:   Antibodies Against GSK249320, Assessed Using Electrochemi-luminescent Assay (ECL) Assay   [ Time Frame: Day 1, Day 30, Day 180, EW visit and Follow-up visit ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was terminated early, on 27 May 2014, at the planned interim analysis for futility.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343



Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01808261     History of Changes
Other Study ID Numbers: 104615
First Submitted: February 14, 2013
First Posted: March 11, 2013
Results First Submitted: June 9, 2017
Results First Posted: October 3, 2017
Last Update Posted: November 17, 2017