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

History of Changes

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
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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 ]

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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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 ]

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6. Secondary:

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

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7. Secondary:

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

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8. Secondary:

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

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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 ]

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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 ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

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

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