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Study of Ozanezumab (GSK1223249) Versus Placebo in the Treatment of Amyotrophic Lateral Sclerosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01753076
First received: December 17, 2012
Last updated: April 18, 2017
Last verified: February 2017
Results First Received: December 1, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Investigator, Outcomes Assessor;   Primary Purpose: Treatment
Condition: Amyotrophic Lateral Sclerosis
Interventions: Drug: Ozanezumab
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 304 participants were randomized (151 to placebo; 153 to ozanezumab 15 milligrams [mg]/kilogram [kg]), and 303 participants (151 placebo; 152 ozanezumab 15 mg /kg ) received at least one dose of investigational product (one of the participants who did not receive any study drug was re-randomized to ozanezumab).

Reporting Groups
  Description
Placebo Participants (par) received placebo once every 2 weeks by intravenous infusion up to Week 46.
Ozanezumab 15 mg/kg Participants received ozanezumab 15 milligrams per kilogram (mg/kg) once every 2 weeks by intravenous infusion up to Week 46.

Participant Flow:   Overall Study
    Placebo   Ozanezumab 15 mg/kg
STARTED   151   152 
COMPLETED   110   106 
NOT COMPLETED   41   46 
Adverse Event                17                18 
Lack of Efficacy                3                1 
Lost to Follow-up                2                1 
Physician Decision                4                2 
Withdrawal by Subject                14                24 
Other-Reached Protocol-defined Stopping                1                0 



  Baseline Characteristics
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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.
One participant who did not receive any study drug was excluded from the intent-to-treat (ITT) population.

Reporting Groups
  Description
Placebo Participants received placebo once every 2 weeks by intravenous infusion up to Week 46.
Ozanezumab 15 mg/kg Participants received ozanezumab 15 milligrams per kilogram (mg/kg) once every 2 weeks by intravenous infusion up to Week 46.
Total Total of all reporting groups

Baseline Measures
   Placebo   Ozanezumab 15 mg/kg   Total 
Overall Participants Analyzed 
[Units: Participants]
 151   152   303 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.5  (11.04)   55.7  (10.40)   55.6  (10.70) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      54  35.8%      49  32.2%      103  34.0% 
Male      97  64.2%      103  67.8%      200  66.0% 
Race/Ethnicity, Customized 
[Units: Participants]
     
African American/African Heritage   1   2   3 
Asian - Central/South Asian Heritage   2   3   5 
Asian - East Asian Heritage   3   8   11 
Asian - Japanese Heritage   5   10   15 
Asian - South East Asian Heritage   13   5   18 
White - Arabic/North African Heritage   3   2   5 
White - White/Caucasian/European Heritage   124   121   245 
Mixed Race   0   1   1 


  Outcome Measures
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1.  Primary:   Joint Rank Scores for Combined Analysis of Function (Amyotrophic Lateral Sclerosis Functional Rating Scale Revised [ALSFRS-R] Score) and 48 Week Overall Survival   [ Time Frame: Week 48 ]

2.  Secondary:   Change From Baseline in the ALSFRS-R Total Score at Week 48   [ Time Frame: Baseline and Week 48 ]

3.  Secondary:   Rate of Decline Over Week 48 in the ALSFRS-R Total Score   [ Time Frame: Baseline to Week 48 ]

4.  Secondary:   Change From Baseline in Slow Vital Capacity (SVC) at Week 48   [ Time Frame: Baseline and Week 48 ]

5.  Secondary:   Change From Baseline in Muscle Strength as Measured by Hand Held Dynamometry (HHD) Score at Week 48   [ Time Frame: Baseline and Week 48 ]

6.  Secondary:   Number of Clinical Global Impression-improvement Scale (CGI-I) Responders at Week 48   [ Time Frame: Week 48 ]

7.  Secondary:   Overall Survival at Week 48 and Week 60   [ Time Frame: Week 48 and Week 60 ]

8.  Secondary:   Progression-free Survival at Week 48   [ Time Frame: Week 48 ]

9.  Secondary:   Change From Baseline in the EuroQol 5 Dimensions-5 Level Short Form (EQ-5D-5L) Utility Score at Week 48   [ Time Frame: Baseline and Week 48 ]

10.  Secondary:   Change From Baseline in the Amyotrophic Lateral Sclerosis Assessment Questionnaire-40 (ALSAQ-40) Total Score at Week 48   [ Time Frame: Baseline and Week 48 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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: NCT01753076     History of Changes
Other Study ID Numbers: 112264
Study First Received: December 17, 2012
Results First Received: December 1, 2016
Last Updated: April 18, 2017