N/A
Completed N=63
Adherence in Pediatric Multiple Sclerosis
Source: ClinicalTrials.gov NCT02234713 ↗Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcomePrimary: Change in Level of Adherence in Subjects (Objective Measure) — 0.95; 0.86; 0.85; 0.81 Proportion of doses (actual vs expected)
Summary
Disease modifying therapies (DMT) are widely used for children and adolescents with MS. Nonetheless, many pediatric patients continue to relapse and therefore require changes in therapy. We designed this research study to learn more about medication use in children and adolescents with MS. We are also interested in learning what a behavioral feedback intervention can tell us about adherence to medicine. Finally, we hope this research project will inform the way we provide clinical care for children and adolescents with MS.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Level of Adherence in Subjects (Objective Measure) |
0.95; 0.86; 0.85; 0.81; 0.82; 0.66 | — |
| PRIMARY Change in Level of Adherence in Subjects (Parent- and Patient-Reported): MSTAQ |
0.06; 0.07; 0.07; 49.64; 49.24; 49.33 | — |
| PRIMARY Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Morisky |
6.28; 6.40; 6.20; 5.93; 6.00; 5.94 | — |
| PRIMARY Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Parental Involvement |
44.61; 37.50; 33.16; 65.20; 55.21; 57.14 | — |
| SECONDARY Quality of Life and Psychosocial Outcomes (Parent- and Patient-Reported): PedsQL |
80.39; 76.69; 80.93; 73.04; 73.23; 72.30 | — |
| SECONDARY Quality of Life and Psychosocial Outcomes (Parent- and Patient-Reported): MSNQ |
17.90; 17.55; 20.24 | — |
Eligibility Criteria
Inclusion Criteria
- Adolescent boys/girls who are 10 to 17 years 11 months old;
- Have a diagnosis of MS, as per revised McDonald diagnostic criteria and International Pediatric MS Study Group criteria;
- Prescribed with an oral or injectable disease-modifying therapy for MS for at least six months.
Exclusion Criteria
- Have non-specific white matter abnormalities and metabolic or infectious etiologies for white matter abnormalities. This is indicative of not having a true diagnosis of MS.
- Patients on IV DMT will not be included in the study.
- Non-English speaking patients
Data sourced from ClinicalTrials.gov (NCT02234713). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.