Trial · NCT02048072
Evaluation of the Autonomic Nervous System During First-dosing With 0.5mg of Fingolimod (Gilenya) in Patients With Relapsing-remitting MS
NCT02048072, Phase 4, Completed, Jochen Vehoff; results first posted 2016-04-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of the Autonomic Nervous System During First-dosing With 0.5mg of Fingolimod (Gilenya) in Patients With Relapsing-remitting MS. Trials, record NCT02048072. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02048072
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of the Autonomic Nervous System During First-dosing With 0.5mg of Fingolimod (Gilenya) in Patients With Relapsing-remitting MS
- NCT number
- NCT02048072
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 33 participants, actual
- Lead sponsor
- Jochen Vehoff
- Conditions
- Multiple Sclerosis, Autonomic Nervous System Dysfunction
- Interventions
- Gilenya
- First posted
- 2014-01-29
- Last updated
- 2016-04-29
- Results first posted
- 2016-04-29
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | RMSSD Normal Breathing | 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. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | RMSSD Normal Breathing | t-4,5 hours | milliseconds | MEAN |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| RMSSD Normal Breathing | Gilenya | 14.10 | 95% Confidence Interval 2.56 to 25.65 | milliseconds |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Gilenya | 33 | |
| Overall Study | COMPLETED | Gilenya | 29 | |
| Overall Study | NOT COMPLETED | Gilenya | 4 |
Source ClinicalTrials.gov
Adverse events3
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | exacerbation of migraines | Nervous system disorders | Gilenya | 1 | 33 | 1 |
| serious | AV-Block Mobitz II / AV-Block III° | Cardiac disorders | Gilenya | 1 | 33 | 1 |
| serious | worsening of neuropsychological symptoms | Nervous system disorders | Gilenya | 1 | 33 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gilenya | ||
| Total, other adverse events | Gilenya | 1 | 33 |
| Total, serious adverse events | Gilenya | 2 | 33 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02048072
GET https://conductscience.org/api/trials/v1/NCT02048072/registered