Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis
|
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01892722 |
|
Recruitment Status :
Recruiting
First Posted : July 4, 2013
Results First Posted : September 19, 2018
Last Update Posted : March 9, 2021
|
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
| Condition |
Multiple Sclerosis |
| Interventions |
Drug: Interferon beta-1a Drug: Fingolimod Drug: Placebo capsule Drug: Placebo i.m. injection |
| Enrollment | 220 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details | This study is divided into a core phase and extension phase. In the core phase, patients were randomized to Fingolimod or Interferon beta-1a in a 1:1 ratio. The core phase disposition is reported for interim results disclosure. Upon completion of the extension phase, the extension disposition will be reported. |
| Arm/Group Title | Fingolimod | Interferon Beta-1a |
|---|---|---|
 Arm/Group Description |
Fingolimod was administered orally once daily at a dose of either 0.5 mg or 0.25 mg (depending on patient's body weight) with the aim to achieve systemic exposure in range of that in adults at the licensed 0.5 mg dose. | An intramuscular (IM) injection of Interferon beta-1a was administered once weekly. |
| Period Title: Overall Study | ||
| Started | 107 | 108 |
| Full Analysis Set | 107 | 107 |
| Completed | 100 | 88 |
| Not Completed | 7 | 20 |
| Reason Not Completed | ||
| Protocol deviation | 0 | 1 |
| Administrative problems | 0 | 1 |
| Patient/guardian decision | 0 | 2 |
| Physician Decision | 1 | 2 |
| Adverse Event | 3 | 2 |
| Lack of Efficacy | 0 | 7 |
| Withdrawal by Subject | 3 | 5 |
Baseline Characteristics
| Arm/Group Title | Fingolimod | Interferon Beta-1a | Total | |
|---|---|---|---|---|
|
Arm/Group Description |
Fingolimod was administered orally once daily at a dose of either 0.5 mg or 0.25 mg (depending on patient's body weight) with the aim to achieve systemic exposure in range of that in adults at the licensed 0.5 mg dose. | An intramuscular (IM) injection of Interferon beta-1a was administered once weekly. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 107 | 108 | 215 | |
|
Baseline Analysis Population Description |
[Not Specified]
|
|||
|
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||
| Number Analyzed | 107 participants | 108 participants | 215 participants | |
| 15.2 (2.0) | 15.4 (1.60) | 15.3 (1.81) | ||
|
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
| Number Analyzed | 107 participants | 108 participants | 215 participants | |
| Female |
70 65.4%
|
64 59.3%
|
134 62.3%
|
|
| Male |
37 34.6%
|
44 40.7%
|
81 37.7%
|
|
|
Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||||
| Number Analyzed | 107 participants | 108 participants | 215 participants | |
| American Indian or Alaska Native |
3 2.8%
|
2 1.9%
|
5 2.3%
|
|
| Asian |
1 0.9%
|
0 0.0%
|
1 0.5%
|
|
| Native Hawaiian or Other Pacific Islander |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
| Black or African American |
1 0.9%
|
4 3.7%
|
5 2.3%
|
|
| White |
100 93.5%
|
97 89.8%
|
197 91.6%
|
|
| More than one race |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
| Unknown or Not Reported |
2 1.9%
|
5 4.6%
|
7 3.3%
|
|
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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 terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
| Name/Title: | Study Director |
| Organization: | Novartis Pharmaceuticals |
| Phone: | 862-778-8300 |
| EMail: | novartis.email@novartis.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01892722 |
| Other Study ID Numbers: |
CFTY720D2311 2011-005677-23 ( EudraCT Number ) |
| First Submitted: | May 8, 2013 |
| First Posted: | July 4, 2013 |
| Results First Submitted: | June 8, 2018 |
| Results First Posted: | September 19, 2018 |
| Last Update Posted: | March 9, 2021 |