Trial · NCT02438137
Dimethyl Fumarate for Obstructive Sleep Apnea
NCT02438137, Phase 2, Completed, University of Michigan; results first posted 2017-05-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dimethyl Fumarate for Obstructive Sleep Apnea. Trials, record NCT02438137. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02438137
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dimethyl Fumarate for Obstructive Sleep Apnea
- NCT number
- NCT02438137
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 65 participants, actual
- Lead sponsor
- University of Michigan
- Conditions
- Obstructive Sleep Apnea, OSA, Sleep Apnea
- Interventions
- Dimethyl fumarate, Placebo
- First posted
- 2015-05-08
- Last updated
- 2017-05-31
- Results first posted
- 2017-05-31
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change in Apnea Severity as Measured by the Respiratory Disturbance Index (RDI) | Month 0 to Month 4 | For the 50 participants who had interpretable month 4 polysomnography (PSG) data available, mean change in sleep apnea severity, as measured by the mean change in respiratory disturbance index (RDI) between baseline (Month 0) PSG and Month 4 PSG, was calculated. The RDI represents the total number of apneas, hypopneas and respiratory-related arousals per hour of sleep. |
| Secondary | Mean Change in Serum Cytokine Levels (Mean Difference of Log-transformed Values) | Month 0 to Month 4 | Levels of markers in the blood known as cytokines (measured in picograms per milliliter) were measured on a monthly basis from Month 0 (baseline) to Month 4. The outcome is the mean difference in cytokine level from baseline to month 4 (mean level at Month 4 - mean level at Baseline). Values were log-transformed for normality, prior to analysis. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change in Apnea Severity as Measured by the Respiratory Disturbance Index (RDI) | Month 0 to Month 4 | 65 participants were randomized. 14 participants withdrew from the study or were lost to followup. 51 completed study activities. 50 (35 DMF and 15 placebo) both completed the study and had an interpretable Month 4 PSG. One participant's Month 4 PSG was uninterpretable, thus the RDI from this participant could not be included in the final analysis. | respiratory events/hour | MEAN |
| SECONDARY | Mean Change in Serum Cytokine Levels (Mean Difference of Log-transformed Values) | Month 0 to Month 4 | Cytokine analyses were conducted for those participants who completed the study and had interpretable Month 4 PSG results. Among this group, 3 participants did not have usable Month 4 blood specimens for this analysis. Thus, the mean difference in cytokine levels was calculated for 47 participants. | picograms/milliliter (log-transformed) | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change in Apnea Severity as Measured by the Respiratory Disturbance Index (RDI) | Dimethyl Fumarate (Tecfidera®) Capsules | -3.11 | Standard Deviation 12.9 | respiratory events/hour | |
| Mean Change in Apnea Severity as Measured by the Respiratory Disturbance Index (RDI) | Placebo | 10.2 | Standard Deviation 13.1 | respiratory events/hour | |
| Mean Change in Serum Cytokine Levels (Mean Difference of Log-transformed Values) | Dimethyl Fumarate (Tecfidera®) Capsules | Interleukin-6 | 0.038 | Standard Deviation 0.249 | picograms/milliliter (log-transformed) |
| Mean Change in Serum Cytokine Levels (Mean Difference of Log-transformed Values) | Placebo | Interleukin-6 | -0.015 | Standard Deviation 0.096 | picograms/milliliter (log-transformed) |
| Mean Change in Serum Cytokine Levels (Mean Difference of Log-transformed Values) | Dimethyl Fumarate (Tecfidera®) Capsules | Tissue necrosis factor-alpha | -0.002 | Standard Deviation 0.171 | picograms/milliliter (log-transformed) |
| Mean Change in Serum Cytokine Levels (Mean Difference of Log-transformed Values) | Placebo | Tissue necrosis factor-alpha | 0.003 | Standard Deviation 0.257 | picograms/milliliter (log-transformed) |
| Mean Change in Serum Cytokine Levels (Mean Difference of Log-transformed Values) | Dimethyl Fumarate (Tecfidera®) Capsules | Interleukin-10 | 0.084 | Standard Deviation 0.253 | picograms/milliliter (log-transformed) |
| Mean Change in Serum Cytokine Levels (Mean Difference of Log-transformed Values) | Placebo | Interleukin-10 | -0.036 | Standard Deviation 0.170 | picograms/milliliter (log-transformed) |
| Mean Change in Serum Cytokine Levels (Mean Difference of Log-transformed Values) | Dimethyl Fumarate (Tecfidera®) Capsules | Monocyte chemoattractant protein-1 | 0.005 | Standard Deviation 0.136 | picograms/milliliter (log-transformed) |
| Mean Change in Serum Cytokine Levels (Mean Difference of Log-transformed Values) | Placebo | Monocyte chemoattractant protein-1 | 0.057 | Standard Deviation 0.157 | picograms/milliliter (log-transformed) |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dimethyl Fumarate (Tecfidera®) Capsules | 44 | |
| Overall Study | STARTED | Placebo | 21 | |
| Overall Study | COMPLETED | Dimethyl Fumarate (Tecfidera®) Capsules | 36 | |
| Overall Study | COMPLETED | Placebo | 15 | |
| Overall Study | NOT COMPLETED | Dimethyl Fumarate (Tecfidera®) Capsules | 8 | |
| Overall Study | NOT COMPLETED | Placebo | 6 |
Source ClinicalTrials.gov
Adverse events14
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 | Flushing | Skin and subcutaneous tissue disorders | Dimethyl Fumarate (Tecfidera®) Capsules | 23 | 44 | 27 |
| other | Flushing | Skin and subcutaneous tissue disorders | Placebo | 0 | 21 | 0 |
| other | Indigestion | Gastrointestinal disorders | Dimethyl Fumarate (Tecfidera®) Capsules | 2 | 44 | 3 |
| other | Indigestion | Gastrointestinal disorders | Placebo | 3 | 21 | 3 |
| other | Nausea | Gastrointestinal disorders | Dimethyl Fumarate (Tecfidera®) Capsules | 4 | 44 | 5 |
| other | Nausea | Gastrointestinal disorders | Placebo | 0 | 21 | 0 |
| other | Cold | Infections and infestations | Dimethyl Fumarate (Tecfidera®) Capsules | 3 | 44 | 4 |
| other | Cold | Infections and infestations | Placebo | 3 | 21 | 3 |
| other | Sinus Infection | Infections and infestations | Dimethyl Fumarate (Tecfidera®) Capsules | 0 | 44 | 0 |
| other | Sinus Infection | Infections and infestations | Placebo | 2 | 21 | 2 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dimethyl Fumarate (Tecfidera®) Capsules | 0 | 44 |
| Total, all-cause mortality | Placebo | 0 | 21 |
| Total, other adverse events | Dimethyl Fumarate (Tecfidera®) Capsules | 27 | 44 |
| Total, other adverse events | Placebo | 7 | 21 |
| Total, serious adverse events | Dimethyl Fumarate (Tecfidera®) Capsules | 1 | 44 |
| Total, serious adverse events | Placebo | 1 | 21 |
Source ClinicalTrials.gov
Papers19
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dimethyl Fumarate (Tecfidera®) Capsules vs Placebo: deaths from any cause | Trial comparisons |
| Dimethyl Fumarate (Tecfidera®) Capsules vs Placebo: serious adverse events | Trial comparisons |
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/NCT02438137
GET https://conductscience.org/api/trials/v1/NCT02438137/registered