Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis
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|ClinicalTrials.gov Identifier: NCT01892722|
Recruitment Status : Active, not recruiting
First Posted : July 4, 2013
Last Update Posted : April 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Drug: Interferon beta-1a i.m. injections Drug: Fingolimod oral capsules Drug: Placebo oral capsule Drug: Placebo i.m. injection||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||215 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A 2 Year, Double-blind, Randomized, Multicenter, Active-controlled Core Phase to Evaluate Safety & Efficacy of Daily Fingolimod vs Weekly Interferon β-1a im in Pediatric Patients With Multiple Sclerosis and 5 Year Fingolimod Extension Phase|
|Actual Study Start Date :||July 26, 2013|
|Actual Primary Completion Date :||July 14, 2017|
|Estimated Study Completion Date :||March 15, 2023|
Active Comparator: Interferon beta-1a i.m.
Interferon beta-1a once-weekly i.m.
Drug: Interferon beta-1a i.m. injections
Administration once weekly via i.m. injections. Double-dummy masking is required to blind formulations: Patients in the interferon beta-1a i.m. arm will also take daily placebo capsules matched in appearance to the fingolimod active capsules.Drug: Placebo oral capsule
Placebo capsule required for double-dummy masking to blind formulations: Patients in interferon beta-1a i.m. arm will also receive daily oral placebo capsules matched in appearance to the fingolimod active capsules.
Fingolimod will be 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.
Drug: Fingolimod oral capsules
Administration orally once daily. Double-dummy masking is required to blind formulations: Patients in the fingolimod arm will also take weekly placebo i.m. injections (syringes matched in appearance to the active interferon beta-1a i.m. syringes).Drug: Placebo i.m. injection
Placebo i.m. injection required for double-dummy masking to blind formulations: Patients in the fingolimod arm will also take weekly placebo i.m. injections (syringes matched in appearance to the active interferon beta-1a i.m. syringes).
- Frequency of relapses" in patients treated for up to 24 months [ Time Frame: 24 months ]Frequency of relapses assessed by the annualized relapse rate (ARR). The ARR is defined as the average number of confirmed relapses per year (total number of confirmed relapses divided by the total days in the study multiplied by 365.25).
- New/newly enlarged T2 lesions [ Time Frame: 24 months ]Annualized rate of the number of new/newly enlarged T2 lesions up to Month 24
- Time to first relapse [ Time Frame: 24 months ]Time to first relapse was determined.
- Proportion of patients relapse-free [ Time Frame: 24 months ]Proportion of patients relapse-free was determined
- T1 Gd- enhancing lesions [ Time Frame: 24 months ]Number of T1 Gd-enhancing lesions per scan up to Month 24
- Pharmacokinetics (Cavg) of fingolimod-P [ Time Frame: 24 months ]Cavg (average drug concentration over the dose interval) will be evaluated.
- Pharmacokinetic/Pharmacodynamic relationship for fingolimod-P to lymphocyte levels [ Time Frame: 24 months ]Population PK/PD modeling approaches were used to relate the individual fingolimod-P concentrations to lymphocyte counts.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01892722
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|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|