Phase 4
Completed N=175
Long-term Follow-up of Fingolimod Phase II Study Patients
Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis
Source: ClinicalTrials.gov NCT02307838 ↗
Enrolled (actual)
175
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Change From Baseline (BL) in Expanded Disability Status Scale (EDSS) — 0.58; 1.17 score on a scale — p=0.0155
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study collected follow-up data on approximately 90% of participants who were randomized and received one dose of study drug in FTY720D2201 (D2201). No study drug was given or required. Participants were required to be assessed at one or two visits, preferably at the original study site, but the option to be interviewed via phone or seen at home was provided. Information was gathered also on deceased participants. Assessments were performed only once within an 8 week period and included medical history, Multiple Sclerosis (MS) and Multiple Sclerosis Disease Modifying Therapy (MS DMT) history, Expanded Disability Status Scale (EDSS), Magnetic Resonance Imaging (MRI), and Multiple Sclerosis Functional Composite (MSFC).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline (BL) in Expanded Disability Status Scale (EDSS) |
0.58; 1.17 | 0.0155 sig |
| SECONDARY Number of Participants With Disability Progression |
35; 8; 29 | — |
| SECONDARY Number of Participants With EDSS <4 or <6 |
78; 10; 31; 90; 13; 41 | — |
| SECONDARY Number of Participants Not Using a Wheelchair or Being Bedridden |
99; 13; 46 | — |
| SECONDARY Number of Participants Classified as Secondary Progressive MS (SPMS) |
10; 2; 14 | — |
| SECONDARY Percentage of Participants With First Use of an Ambulatory Device |
12.4; 17.6 | — |
| SECONDARY Percentage of Participants With First Use of a Wheelchair |
4.9; 16.9 | — |
| SECONDARY Change From Baseline in Multiple Sclerosis Fuctional Composite (MSFC) Component: Nine Hole Peg Test (9-HPT) |
2.29; 5.06 | — |
| SECONDARY Change From Baseline in MSFC Component: Paced Auditory Serial Addition Test (PASAT) Score |
0.54; -5.39 | — |
| SECONDARY Change From Baseline in MSFC Component: Timed 25-foot Walk Test Score |
1.32; 3.89 | — |
| SECONDARY Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Z Score |
-0.11; -0.60 | — |
| SECONDARY Total Volume in T2 Lesion |
8685.4; 11279.0 | — |
| SECONDARY Change From Baseline in Total Volume of T2 Lesion |
1031.7; 3636.7 | — |
| SECONDARY Third Ventricle Diameter |
5.28; 5.57 | — |
| SECONDARY Change From Baseline in Third Ventricle Diameter |
0.80; 0.92 | — |
| SECONDARY Percentage Brain Volume Change (PBVC) |
-9.28; -9.87 | — |
| SECONDARY Correlation Coeffcients Between FTY Treatment Duration and Disability Progression Parameters |
-0.12; -0.09; 0.35; 0.11; 0.27; 0.00 | — |
Eligibility Criteria
Inclusion Criteria
- Written informed consent must be obtained before any assessment is performed.
- Randomized in study FTY720D2201 and received at least one dose of study drug.
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT02307838). 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.