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Trial record 1 of 1 for:    ascend tysabri
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A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Participants With Secondary Progressive Multiple Sclerosis (ASCEND in SPMS)

This study has been terminated.
(The ASCEND Study did not achieve statistical significance on the primary or secondary endpoints.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01416181
First Posted: August 12, 2011
Last Update Posted: September 11, 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):
Biogen
Results First Submitted: April 13, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Secondary Progressive Multiple Sclerosis
Interventions: Drug: natalizumab
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
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Reporting Groups
  Description
Placebo Part 1: participants were randomized to receive placebo intravenously (IV) every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
Natalizumab 300 mg Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.

Participant Flow for 2 periods

Period 1:   Part 1
    Placebo   Natalizumab 300 mg
STARTED   449   440 
Withdrew Prior to Dosing   0   1 
COMPLETED   312 [1]   326 [1] 
NOT COMPLETED   137   114 
Not Specified                10                24 
Death                0                1 
Investigator Decision                7                6 
Withdrawal by Subject                74                48 
Lack of Efficacy                16                8 
Lost to Follow-up                1                1 
Adverse Event                15                18 
Ongoing in Follow-Up                14                8 
[1] Completed Study through Week 108

Period 2:   Part 2
    Placebo   Natalizumab 300 mg
STARTED   274   292 
Completed Treatment for 48 Weeks   98 [1]   111 [1] 
Completed Treatment for 96 Weeks   1 [2]   0 [2] 
Completed Treatment for > 96 Weeks   1   0 
COMPLETED   3   6 
NOT COMPLETED   271   286 
Adverse Event                11                4 
Not Specified                234                267 
Investigator Decision                6                7 
Withdrawal by Subject                14                5 
Lack of Efficacy                4                1 
Lost to Follow-up                2                2 
[1] completed study treatment for 48 weeks in Part 2
[2] completed study treatment for 96 weeks in Part 2



  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.
Safety population: all participants who were randomized and received at least 1 infusion of study treatment in Part 1.

Reporting Groups
  Description
Placebo Part 1: participants were randomized to receive placebo IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
Natalizumab 300 mg Part 1: participants were randomized to receive 300 mg of natalizumab IV every 4 weeks for 96 weeks. Part 2: participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks.
Total Total of all reporting groups

Baseline Measures
   Placebo   Natalizumab 300 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 449   439   888 
Age, Customized 
[Units: Participants]
     
20 - 29 years   10   10   20 
30 - 39 years   73   50   123 
40 - 49 years   162   194   356 
≥ 50 years   204   185   389 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      280  62.4%      270  61.5%      550  61.9% 
Male      169  37.6%      169  38.5%      338  38.1% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Part 1: Percentage of Participants With Confirmed Progression of Disability in One or More of the Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), or 9-Hole Peg Test (9HPT)   [ Time Frame: Up to 96 weeks (2 years) ]

2.  Primary:   Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: 218 weeks ]

3.  Secondary:   Part 1: Percentage of Participants With a T25FW Response   [ Time Frame: Up to 96 weeks ]

4.  Secondary:   Part 1: Change From Baseline in the 12-Item MS Walking Scale (MSWS-12)   [ Time Frame: Baseline and Week 96 ]

5.  Secondary:   Part 1: Change From Baseline in Manual Ability Score Based on the ABILHAND Questionnaire   [ Time Frame: Baseline and Week 96 ]

6.  Secondary:   Part 1: Change From Baseline in the Multiple Sclerosis Impact Scale-29 Physical (MSIS-29 Physical) Score   [ Time Frame: Baseline and Week 96 ]

7.  Secondary:   Part 1: Percentage Change From Week 24 in Whole Brain Volume at Week 96   [ Time Frame: Week 24 and Week 96 ]

8.  Secondary:   Part 1: Percentage of Participants Defined as Confirmed Progressors on EDSS Functional System Scores   [ Time Frame: Up to 96 weeks ]

9.  Secondary:   Part 2: Percentage of Participants With Disability Worsening at 156 Weeks   [ Time Frame: Week 156 ]

10.  Secondary:   Part 2: Absolute Change From Baseline (Part 1) in T25FW   [ Time Frame: Baseline (Part 1) and Weeks 156, 204 ]

11.  Secondary:   Part 2: Percentage Change From Baseline (Part 1) in T25FW   [ Time Frame: Baseline (Part 1) and Weeks 156, 204 ]

12.  Secondary:   Part 2: Absolute Change From Baseline (Part 1) in 9HPT (Dominant Hand)   [ Time Frame: Baseline (Part 1) and Weeks 156, 204 ]

13.  Secondary:   Part 2: Percentage Change From Baseline (Part 1) in 9HPT (Dominant Hand)   [ Time Frame: Baseline (Part 1) and Weeks 156, 204 ]

14.  Secondary:   Part 2: Absolute Change From Baseline (Part 1) in 9HPT (Non-Dominant Hand)   [ Time Frame: Baseline (Part 1) and Weeks 156, 204 ]

15.  Secondary:   Part 2: Percentage Change From Baseline (Part 1) in 9HPT (Non-Dominant Hand)   [ Time Frame: Baseline (Part 1) and Weeks 156, 204 ]

16.  Secondary:   Part 2: Absolute Change From Baseline (Part 1) in EDSS   [ Time Frame: Baseline (Part 1) and Weeks 156, 204 ]

17.  Secondary:   Part 2: Percentage Change From Baseline (Part 1) in EDSS   [ Time Frame: Baseline (Part 1) and Weeks 156, 204 ]

18.  Secondary:   Part 2: Absolute Change From Baseline (Part 1) in the 6-Minute Walk Test (6MWT)   [ Time Frame: Baseline (Part 1) and Weeks 156 and 204 ]

19.  Secondary:   Part 2: Percentage Change From Baseline (Part 1) in the 6MWT   [ Time Frame: Baseline (Part 1) and Weeks 156, 204 ]

20.  Secondary:   Part 2: Absolute Change From Baseline (Part 1) in the MSIS-29 Physical Score   [ Time Frame: Baseline (Part 1) and Weeks 156 and 204 ]

21.  Secondary:   Part 2: Percentage Change From Baseline (Part 1) in the MSIS-29 Physical Score   [ Time Frame: Baseline (Part 1) and Weeks 156, 204 ]

22.  Secondary:   Part 2: Absolute Change From Baseline (Part 1) in the Symbol Digit Modalities Test (SDMT)   [ Time Frame: Baseline (Part 1) and every 4 weeks from Week 108 to Week 204 ]

23.  Secondary:   Part 2: Percentage Change From Baseline (Part 1) in the SDMT   [ Time Frame: Baseline (Part 1) and every 4 weeks from Week 108 to Week 204 ]

24.  Secondary:   Part 2: Absolute Change From Baseline (Part 2) in the Work Productivity and Activity Impairment – Multiple Sclerosis (WPAI-MS) Questionnaire   [ Time Frame: Part 2 Baseline (Week 108) and Weeks 156 and 204 ]

25.  Secondary:   Part 2: Percentage Change From Baseline (Part 2) in the WPAI-MS Questionnaire   [ Time Frame: Part 2 Baseline (Week 108) and Weeks 156 and 204 ]

26.  Secondary:   Part 2: Percentage Change From Week 24 (Part 1) in Whole Brain Volume   [ Time Frame: Week 24 (Part 1) and Weeks 156 and 204 ]

27.  Secondary:   Part 2: Percentage Change From Baseline (Part 1) in Whole Gray Matter Brain Volume   [ Time Frame: Baseline (Part 1) and Weeks 156 and 204 ]

28.  Secondary:   Part 2: Summary of New/Enlarging T2 Lesion Counts   [ Time Frame: Baseline (Part 1) up to Week 204 ]

29.  Secondary:   Part 2: Percentage Change From Baseline (Part 1) in Number of New/Enlarging T2 Lesions   [ Time Frame: Baseline (Part 1) and Weeks 156 and 204 ]


  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: Biogen Study Medical Director
Organization: Biogen
e-mail: clinicaltrials@biogen.com



Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01416181     History of Changes
Other Study ID Numbers: 101MS326
2010-021978-11 ( EudraCT Number )
First Submitted: July 21, 2011
First Posted: August 12, 2011
Results First Submitted: April 13, 2017
Results First Posted: June 27, 2017
Last Update Posted: September 11, 2017