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 : August 24, 2017
|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 :||208 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Two-year, Double-blind, Randomzied, Multicenter, Active-controlled Study to Evaluate Safety and Efficacy of Oral Fingolimod Versus Interferon Beta-1a i.m. in Pediatric Patients With Multiple Sclerosis|
|Actual Study Start Date :||July 26, 2013|
|Estimated Primary Completion Date :||March 15, 2023|
|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).
- Number of new/newly enlarged T2 (n/neT2) lesions [ Time Frame: 24 months ]Cumulative number of new/newly enlarged T2 lesions (n/neT2) over 24 months.
- Frequency and nature of adverse events as a measure of Safety and Tolerability [ Time Frame: 24 months ]Based on frequency adverse events (the number and percentage of patients having any AE by primary system organ class and preferred term) and on the incidence of clinically notable laboratory abnormalities.
- Pharmacokinetics (Cavg)of fingolimod and fingolimod-P [ Time Frame: 24 months ]Characterization of pharmacokinetics (PK): Cavg (average drug concentration over the dose interval) will be evaluated. Determine if population covariates affect PK in the pediatric MS population.
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|