Primary objective:- To assess the effect of teriflunomide in comparison to placebo on disease activity measured by time to first clinical relapse after randomization in children and adolescents 10 to 17 years of age with relapsing forms of multiple…
ID
Source
Brief title
Condition
- Demyelinating disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Time to first clinical relapse after randomization.
Secondary outcome
- Proportion of relapse free patients.
- Number of of new/newly enlarged T2 lesions.
- Number of T1 Gd-enhancing T1 lesions.
- Change in volume of T2 lesions.
- Change in volume of T1 hypointense lesions.
- Number of new T1 hypointense lesions.
- Proportion of patients free of new or enlarged MRI T2-lesions.
- Brain atrophy.
- Change in performance on symbol digit modalities test (SDMT) and Cognitive
Battery Test.
- Safety, as assessed by clinical, laboratory, ECG, and vital signs events.
- Assessment of PK parameter - lowest concentration of drug in the blood
measured after dosing (Ctrough).
Background summary
Multiple sclerosis (MS) is a demyelinating disease of the central nervous
system (CNS) that affects approximately 2.5 million people worldwide. MS
represents the leading cause of neurologic disability in young and middle-aged
adults. Multiple sclerosis is typically considered to be a disease of young
adults. However, pediatric MS, defined as onset of MS before the age of 16, is
increasingly recognized and accounts for approximately 5 percent of cases.
Study objective
Primary objective:
- To assess the effect of teriflunomide in comparison to placebo on disease
activity measured by time to first clinical relapse after randomization in
children and adolescents 10 to 17 years of age with relapsing forms of multiple
sclerosis.
Secondary objectives:
* To assess the effect of teriflunomide in comparison to placebo on disease
activity/progression measured by brain MRI and on cognitive function.
* To evaluate the safety and tolerability of teriflunomide in comparison to
placebo.
Study design
Phase 3, randomized, parallel, double blind study.
Intervention
Teriflunomide 3,5 ; 7 or 14 mg, or placebo.
Study burden and risks
Risks and burdens related to blood collection, study procedures and possible
adverse events of study medication.
Paasheuvelweg 25
Amsterdam 1105 BP
NL
Paasheuvelweg 25
Amsterdam 1105 BP
NL
Listed location countries
Age
Inclusion criteria
-Patients with relapsing multiple sclerosis are eligible. Patients should meet
the criteria of MS based on McDonald criteria 2010 and International Pediatric
Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric MS, version of
2012 (5) and have:
- At least one relapse (or attack) in the 12 months preceding randomization or
- At least two relapses (or attack) in the 24 months preceding randomization
- Less than or equal to 17 years of age and 10 years or older of age at
randomization
- Signed informed consent/assent obtained from patient and patient*s legal
representative (parents or guardians) according to local regulations.
Exclusion criteria
- EDSS score greater than 5.5 at screening or randomization visits
- Relapse within 30 days prior to randomization
- Treated with glatiramer acetate, interferons, or dimethyl fumarate within 1
month prior to randomization
- Treated with fingolimod, or intravenous immunoglobulins within 3 months prior
to randomization
- Treated with natalizumab, other immunosuppressant or immunomodulatory agents
such as cyclophosphamide, azathioprine, cyclosporine, methotrexate,
mycophenolate, within 6 months prior to randomization
- Treated with cladribine or mitoxantrone within 2 years prior to randomization
- Treated with alemtuzumab at any time
- History of HIV infection
- Contraindication for MRI
- Pregnant or breast-feeding females or those who plan to become pregnant
during the study
- Female patients of child-bearing potential not using highly effective
contraceptive method (contraception in both female and male is required).
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2011-005249-12-NL |
| CCMO | NL58357.078.16 |
| Other | U1111-1124-0983 |