Trial Outcomes & Findings for Safety and Tolerability of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis (NCT NCT01497262)
NCT ID: NCT01497262
Last Updated: 2015-03-19
Results Overview
Any Adverse Event was defined as occurrence of any symptom regardless of intensity grade, Serious Adverse Event (SAEs) assessed as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in persistent or significant disability/incapacity
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
162 participants
Primary outcome timeframe
28 weeks
Results posted on
2015-03-19
Participant Flow
Participant milestones
| Measure |
Fingolimod 0.5 mg
Open-label fingolimod 0.5 mg, taken orally once daily for 4 months
|
|---|---|
|
Overall Study
STARTED
|
162
|
|
Overall Study
COMPLETED
|
151
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Fingolimod 0.5 mg
Open-label fingolimod 0.5 mg, taken orally once daily for 4 months
|
|---|---|
|
Overall Study
Abnormal Lab Values
|
4
|
|
Overall Study
Abnormal Test Procedure Result
|
1
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
Safety and Tolerability of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Fingolimod 0.5 mg
n=162 Participants
Open-label fingolimod 0.5 mg, taken orally once daily for 4 months
|
|---|---|
|
Age, Continuous
|
37.3 Years
STANDARD_DEVIATION 9.67 • n=93 Participants
|
|
Age, Customized
<18 years
|
0 Participants
n=93 Participants
|
|
Age, Customized
18-30 years
|
47 Participants
n=93 Participants
|
|
Age, Customized
31-40 years
|
60 Participants
n=93 Participants
|
|
Age, Customized
41-55 years
|
47 Participants
n=93 Participants
|
|
Age, Customized
56-65 years
|
8 Participants
n=93 Participants
|
|
Age, Customized
>65 years
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
114 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 28 weeksPopulation: Safety set includes all patients who received at least one dose of study drug
Any Adverse Event was defined as occurrence of any symptom regardless of intensity grade, Serious Adverse Event (SAEs) assessed as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in persistent or significant disability/incapacity
Outcome measures
| Measure |
Fingolimod 0.5 mg
n=162 Participants
Open-label fingolimod 0.5 mg, taken orally once daily for 4 months
|
|---|---|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Adverse Events (AE)
|
100 Participants
|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Serious Adverse Event (SAE)
|
12 Participants
|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Deaths
|
0 Participants
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: Safety set includes all patients who received at least one dose of study drug
The incidence of events in special areas of safety interest (including bradyarrhythmias, BP increase, liver function, infections and macular oedema) were assessed by the nature and frequency of AE reporting. These areas of special interest have been identified and potential risks of fingolimod based on knowledge from clinical trials and post-marketing reporting.
Outcome measures
| Measure |
Fingolimod 0.5 mg
n=162 Participants
Open-label fingolimod 0.5 mg, taken orally once daily for 4 months
|
|---|---|
|
Number (%) of Patients With AE of Special Interest Including Bradyarrhythmia, BP Increase, Liver Transaminase Elevations, Infections , Macula Oedema.
Bradyarrhythmias
|
8.6 Percent of Participants
|
|
Number (%) of Patients With AE of Special Interest Including Bradyarrhythmia, BP Increase, Liver Transaminase Elevations, Infections , Macula Oedema.
Blood pressure increase
|
0.6 Percent of Participants
|
|
Number (%) of Patients With AE of Special Interest Including Bradyarrhythmia, BP Increase, Liver Transaminase Elevations, Infections , Macula Oedema.
Hypertension
|
2.5 Percent of Participants
|
|
Number (%) of Patients With AE of Special Interest Including Bradyarrhythmia, BP Increase, Liver Transaminase Elevations, Infections , Macula Oedema.
Liver Transaminase evaluations
|
3.7 Percent of Participants
|
|
Number (%) of Patients With AE of Special Interest Including Bradyarrhythmia, BP Increase, Liver Transaminase Elevations, Infections , Macula Oedema.
Infections
|
28.4 Percent of Participants
|
|
Number (%) of Patients With AE of Special Interest Including Bradyarrhythmia, BP Increase, Liver Transaminase Elevations, Infections , Macula Oedema.
Macula Oedema
|
0 Percent of Participants
|
Adverse Events
Fingolimod 0.5 mg
Serious events: 12 serious events
Other events: 63 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fingolimod 0.5 mg
n=162 participants at risk
Open-label fingolimod 0.5 mg, taken orally once daily for 4 months
|
|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.62%
1/162 • Weeks 2,8, 16 and end of study visit
Safety set includes all patients who took at least one dose of study drug
|
|
Infections and infestations
Gastroenteritis
|
1.2%
2/162 • Weeks 2,8, 16 and end of study visit
Safety set includes all patients who took at least one dose of study drug
|
|
Infections and infestations
Gastroenteritis viral
|
0.62%
1/162 • Weeks 2,8, 16 and end of study visit
Safety set includes all patients who took at least one dose of study drug
|
|
Infections and infestations
Urinary tract infection
|
0.62%
1/162 • Weeks 2,8, 16 and end of study visit
Safety set includes all patients who took at least one dose of study drug
|
|
Investigations
Fibrin D dimer increased
|
0.62%
1/162 • Weeks 2,8, 16 and end of study visit
Safety set includes all patients who took at least one dose of study drug
|
|
Investigations
White blood cell count decreased
|
0.62%
1/162 • Weeks 2,8, 16 and end of study visit
Safety set includes all patients who took at least one dose of study drug
|
|
Nervous system disorders
Multiple sclerosis relapse
|
1.9%
3/162 • Weeks 2,8, 16 and end of study visit
Safety set includes all patients who took at least one dose of study drug
|
|
Nervous system disorders
Optic neuritis
|
0.62%
1/162 • Weeks 2,8, 16 and end of study visit
Safety set includes all patients who took at least one dose of study drug
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.62%
1/162 • Weeks 2,8, 16 and end of study visit
Safety set includes all patients who took at least one dose of study drug
|
|
Vascular disorders
Hypertension
|
0.62%
1/162 • Weeks 2,8, 16 and end of study visit
Safety set includes all patients who took at least one dose of study drug
|
Other adverse events
| Measure |
Fingolimod 0.5 mg
n=162 participants at risk
Open-label fingolimod 0.5 mg, taken orally once daily for 4 months
|
|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
10.5%
17/162 • Weeks 2,8, 16 and end of study visit
Safety set includes all patients who took at least one dose of study drug
|
|
Cardiac disorders
Bradycardia
|
3.7%
6/162 • Weeks 2,8, 16 and end of study visit
Safety set includes all patients who took at least one dose of study drug
|
|
Eye disorders
Vision blurred
|
2.5%
4/162 • Weeks 2,8, 16 and end of study visit
Safety set includes all patients who took at least one dose of study drug
|
|
Gastrointestinal disorders
Diarrhoea
|
4.9%
8/162 • Weeks 2,8, 16 and end of study visit
Safety set includes all patients who took at least one dose of study drug
|
|
Gastrointestinal disorders
Nausea
|
3.1%
5/162 • Weeks 2,8, 16 and end of study visit
Safety set includes all patients who took at least one dose of study drug
|
|
General disorders
Fatigue
|
6.2%
10/162 • Weeks 2,8, 16 and end of study visit
Safety set includes all patients who took at least one dose of study drug
|
|
Infections and infestations
Influenza
|
2.5%
4/162 • Weeks 2,8, 16 and end of study visit
Safety set includes all patients who took at least one dose of study drug
|
|
Infections and infestations
Upper respiratory tract infection
|
4.9%
8/162 • Weeks 2,8, 16 and end of study visit
Safety set includes all patients who took at least one dose of study drug
|
|
Infections and infestations
Urinary tract infection
|
2.5%
4/162 • Weeks 2,8, 16 and end of study visit
Safety set includes all patients who took at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.1%
5/162 • Weeks 2,8, 16 and end of study visit
Safety set includes all patients who took at least one dose of study drug
|
|
Nervous system disorders
Dizziness
|
3.1%
5/162 • Weeks 2,8, 16 and end of study visit
Safety set includes all patients who took at least one dose of study drug
|
|
Nervous system disorders
Headache
|
13.6%
22/162 • Weeks 2,8, 16 and end of study visit
Safety set includes all patients who took at least one dose of study drug
|
|
Psychiatric disorders
Anxiety
|
3.1%
5/162 • Weeks 2,8, 16 and end of study visit
Safety set includes all patients who took at least one dose of study drug
|
|
Psychiatric disorders
Depression
|
2.5%
4/162 • Weeks 2,8, 16 and end of study visit
Safety set includes all patients who took at least one dose of study drug
|
Additional Information
Study director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER