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Trial record 1 of 1 for:    FTY 720 2306
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This Was an Open-label, Single-arm Extension Study (CFTY720D2306E1) to a Double-blind, Randomized Multicenter, Placebo-controlled, Parallel-group Core Study (CFTY720D2306) in PPMS. (INFORMS)

This study has been terminated.
(The extension study was terminated early after the results of the core study showed the study did not meet primary endpoint; confirmed disability progression)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00731692
First Posted: August 11, 2008
Last Update Posted: June 14, 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):
Novartis ( Novartis Pharmaceuticals )
Results First Submitted: December 16, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Primary Progressive Multiple Sclerosis
Interventions: Drug: FTY720
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
Patients were randomized equally to receive either fingolimod or placebo. Patients initially randomized to fingolimod 1.25 mg/day or matching placebo groups switched in a blinded manner to fingolimod 0.5 mg/day or continued on placebo after amendment in Nov. 2009. Patients were randomized to receive either fingolimod 0.5 mg/day or placebo..

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Prior to protocol amendment 147 patients received 1.25mg of FTY720; post protocol amendment 5 not all 147 patients switched to 0.5mg FTY720, only 121 switched and their data is presented under the 0.5mg dose.

Reporting Groups
  Description
FTY720 1.25 mg to 0.5 mg Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment
FTY720 0.5 mg to 0.5 mg Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
Placebo to -FTY 0.5 mg Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization

Participant Flow for 2 periods

Period 1:   Core Study (36 Months)
    FTY720 1.25 mg to 0.5 mg   FTY720 0.5 mg to 0.5 mg   Placebo to -FTY 0.5 mg
STARTED   147   336   487 
Safety Set (SAF)   0   336   487 
Full Analysis Set (FAS)   0   336   487 
Pharmacokinetic Analysis Set   102   249   0 
Post Protocol Amendment 5 Switch   0   121 [1]   0 
COMPLETED   79   220   317 
NOT COMPLETED   68   116   170 
Lack of Efficacy                11                23                64 
Physician Decision                1                0                2 
Death                2                1                2 
Lost to Follow-up                1                3                3 
Administrative                2                2                6 
Abnormal Test Procedure Result                4                3                5 
Protocol Violation                4                5                8 
Abnormal Lab values                6                19                5 
Adverse Event                25                28                29 
Withdrawal by Subject                12                32                46 
[1] post protocol amendment 121 patients switch to 0.5 mg dose from 125mg dose

Period 2:   Extension Phase
    FTY720 1.25 mg to 0.5 mg   FTY720 0.5 mg to 0.5 mg   Placebo to -FTY 0.5 mg
STARTED   74   196   301 
COMPLETED   0   0   0 
NOT COMPLETED   74   196   301 
Admin Problems: Terminated # patients                69                189                277 
Abnormal test procedure                0                0                1 
Abnormal lab values                0                0                1 
Lost to Follow-up                0                1                4 
Withdrawal by Subject                4                5                3 
Adverse Event                1                1                15 



  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.
No text entered.

Reporting Groups
  Description
FTY720 1.25 mg to 0.5 mg Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment
FTY720 0.5 mg to 0.5 mg Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
Placebo Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
Total Total of all reporting groups

Baseline Measures
   FTY720 1.25 mg to 0.5 mg   FTY720 0.5 mg to 0.5 mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 147   336   487   970 
Age 
[Units: Years]
Mean (Standard Deviation)
 47.8  (8.47)   48.5  (8.59)   48.5  (8.31)   48.5  (8.42) 
Age, Customized 
[Units: Particpants]
       
<=30   3   6   4   13 
31 to 40   22   60   90   172 
41 to 50   68   127   194   389 
>50   54   143   199   396 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      71  48.3%      163  48.5%      235  48.3%      469  48.4% 
Male      76  51.7%      173  51.5%      252  51.7%      501  51.6% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Kaplan-Meier Estimate of the Risk of 3-month Confirmed Disability Progression Based on Composite Endpoint   [ Time Frame: up to 36 months after the last patient was randomized ]

2.  Secondary:   Kaplan-Meier Estimate of the Risk of 3- Month Confirmed Disability Progression Based on Expanded Disability Status Scale (EDSS)   [ Time Frame: up to 36 months after the last patient was randomized ]

3.  Secondary:   Percent Change From Baseline in Brain Volume at Month 36   [ Time Frame: Baseline to month 36 ]

4.  Secondary:   Kaplan Meier Estimate -Percentage of Participants With 3- Month Confirmed Disability Progression Based on 9-HPT.   [ Time Frame: up to 36 months after the last patient was randomized ]

5.  Secondary:   Kaplan Meier Estimate -Percentage of Participants With 3- Month Confirmed Disability Progression Based on 25' TWT.   [ Time Frame: up to 36 months after the last patient was randomized ]

6.  Secondary:   Number of New/Enlarging T2 Lesions Per Year Measured From Baseline to Month 36   [ Time Frame: Baseline to 36 months ]

7.  Secondary:   Number of Gd-enhancing Lesions at Month 36   [ Time Frame: Baseline to 36 months ]

8.  Secondary:   Percent Change in Total T2 Lesion Volume From Baseline to Month 36   [ Time Frame: Baseline to month 36 ]

9.  Secondary:   Change From Baseline in the Patient Reported Indices in Multiple Sclerosis (PRIMUS-QoL Score)   [ Time Frame: Baseline, 36 months ]

10.  Secondary:   Change From Baseline in PRIMUS-Activities   [ Time Frame: Baseline, 36 months ]

11.  Secondary:   Change From Baseline in Unidimensional Fatigue Impact (U-FIS) Score   [ Time Frame: Baseline, 36 months ]

12.  Secondary:   Change From Baseline in European Quality of Life – 5 Dimensions (EQ-5D Score)   [ Time Frame: Baseline, 36 months ]

13.  Secondary:   Change From Baseline in Multiple Sclerosis Walking Scale (MSWS-12 Score)   [ Time Frame: Baseline, 36 months ]

14.  Secondary:   Blood Concentrations of Fingolimod and Fingolimod-phosphate   [ Time Frame: Month 3 up to 36 months ]

15.  Secondary:   Change in MSFC Z-score and Subscale Scores From Baseline to Month 36   [ Time Frame: Baseline to Month 36 ]


  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: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300
e-mail: trialandresults.registries@novartis.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00731692     History of Changes
Obsolete Identifiers: NCT01779934
Other Study ID Numbers: CFTY720D2306
2007-002627-32 ( EudraCT Number )
First Submitted: August 7, 2008
First Posted: August 11, 2008
Results First Submitted: December 16, 2015
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017