Trial Outcomes & Findings for Evaluation of the Autonomic Nervous System During First-dosing With 0.5mg of Fingolimod (Gilenya) in Patients With Relapsing-remitting MS (NCT NCT02048072)

NCT ID: NCT02048072

Last Updated: 2016-04-29

Results Overview

Root Mean Square of the Successive Differences (RMSSD) is one of a few time-domain tools used to assess heart rate variability, the successive differences being neighboring RR or pulse intervals. It is calculated as the square root of the mean of the squares of the successive differences between adjacent RR intervals or pulse intervals. In this study pulse intervals were measured non-invasively during five minutes, while subjects were supine, breathing regularly. Measurements were done at two timepoints t=0 and t=4,5hours. RMSSD was compared between these two timepoints.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 33 participants
• Primary outcome timeframe: t-4,5 hours
• Results posted on: 2016-04-29

Participant Flow

First patient in: 21.08.2013 Last patient out: 16.06.2015

Participant milestones

Measure	Gilenya Gilenya 0.5mg p.o. once daily
Overall Study STARTED	33
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Gilenya Gilenya 0.5mg p.o. once daily
Overall Study Adverse Event	3
Overall Study Lost to Follow-up	1

Baseline Characteristics

Evaluation of the Autonomic Nervous System During First-dosing With 0.5mg of Fingolimod (Gilenya) in Patients With Relapsing-remitting MS

Baseline characteristics by cohort

Measure	Gilenya n=33 Participants Gilenya 0.5mg p.o. once daily
Age, Continuous	37.57 years STANDARD_DEVIATION 12.44 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment Switzerland	33 participants n=5 Participants
EDSS	1.75 units on a scale STANDARD_DEVIATION 1.16 • n=5 Participants
Weight	71.18 kg STANDARD_DEVIATION 13.18 • n=5 Participants
Height	168.72 cm STANDARD_DEVIATION 7.98 • n=5 Participants
Body temperature	36.58 °C STANDARD_DEVIATION 0.45 • n=5 Participants

PRIMARY outcome

Timeframe: t-4,5 hours

Root Mean Square of the Successive Differences (RMSSD) is one of a few time-domain tools used to assess heart rate variability, the successive differences being neighboring RR or pulse intervals.

It is calculated as the square root of the mean of the squares of the successive differences between adjacent RR intervals or pulse intervals.

In this study pulse intervals were measured non-invasively during five minutes, while subjects were supine, breathing regularly.

Measurements were done at two timepoints t=0 and t=4,5hours. RMSSD was compared between these two timepoints.

Outcome measures

Measure	Gilenya n=32 Participants Gilenya 0.5mg p.o. once daily
RMSSD Normal Breathing	14.10 milliseconds Interval 2.56 to 25.65

Adverse Events

Gilenya

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Gilenya n=33 participants at risk Gilenya 0.5mg p.o. once daily
Cardiac disorders AV-Block Mobitz II / AV-Block III°	3.0% 1/33 • Number of events 1
Nervous system disorders worsening of neuropsychological symptoms	3.0% 1/33 • Number of events 1

Other adverse events

Measure	Gilenya n=33 participants at risk Gilenya 0.5mg p.o. once daily
Nervous system disorders exacerbation of migraines	3.0% 1/33 • Number of events 1

Additional Information

Jochen Vehoff

Cantonal Hospital of St. Gallen

Phone: 0041714941111

Email: jochen.vehoff@kssg.ch

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place