Trial · NCT01625182
Evaluate Efficacy and Safety of Fingolimod 0.5 mg Orally Once Daily Versus Placebo in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients.
NCT01625182, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2017-09-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluate Efficacy and Safety of Fingolimod 0.5 mg Orally Once Daily Versus Placebo in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients. Trials, record NCT01625182. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01625182
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluate Efficacy and Safety of Fingolimod 0.5 mg Orally Once Daily Versus Placebo in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients.
- NCT number
- NCT01625182
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 106 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Chronic Inflammatory Demyelinating Polyradiculoneuropathy
- Interventions
- Fingolimod, Placebo Comparator
- First posted
- 2012-06-21
- Last updated
- 2017-10-30
- Other registries' IDs
- eudract:2011-005280-24
- Results first posted
- 2017-09-19
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to First Confirmed Worsening on the Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Scale | Month 12 | Confirmed worsening in CIDP was measured by the adjusted INCAT Disability Scale. The adjusted INCAT disability scale measures arm disability and leg disability. For arm disability the scale ranges from 0 (no upper limb problems) to 5 (inability to use either arm for any purposeful movement). The leg disability scale ranges from 0 (walking not affected) to 5 (restricted to wheelchair, unable to stand and walk a few steps with help). The total adjusted INCAT disability score is calculated by the sum of the arm and leg disability scores where the total score ranges from 0 to 10. A confirmed worsening was defined as an increase by 1 or more points on the adjusted INCAT disability scale from the value at baseline. |
| Secondary | Change From Baseline for Grip Strength, Dominant Hand | baseline, Month 6, Month 12 | Grip strength measurements were done using a vigorimeter. With this device, the pressure in the bulb exercised by the participant was registered on a manometer via a rubber junction tube. Both the dominant and non-dominant hands were tested. A negative change from baseline indicates deterioration. |
| Secondary | Change From Baseline for Grip Strength, Non-dominant Hand | baseline, Month 6, Month 12 | Grip strength measurements were done using a vigorimeter. With this device, the pressure in the bulb exercised by the participant was registered on a manometer via a rubber junction tube. Both the dominant and non-dominant hands were tested. A negative change from baseline indicates deterioration. |
| Secondary | Change From Baseline for Rasch-Built Linearly Weighted Overall Disability Scale (R-ODS) | baseline, Month 6, Month 12 | This questionnaire was constructed using the patients' perception of their ability to perform daily and social activities. The questionnaire comprises 24 items ranging from ability to read a book or newspaper (as the easiest item to accomplish) to ability to run (most difficult item to accomplish). The obtained raw summed score was translated subsequently to a convenient centile metric score ranging from 0 (most severe disability) to 100 (no disability at all). A higher score indicated a better health status. A negative change from baseline indicates deterioration. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to First Confirmed Worsening on the Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Scale | Month 12 | The full analysis set, which included all participants who were assigned randomly to receive treatment, was analyzed. | Days | MEDIAN |
| SECONDARY | Change From Baseline for Grip Strength, Dominant Hand | baseline, Month 6, Month 12 | Only participants from the FAS, who had non-missing baseline values and the given post-baseline values, were included in the analysis. The FAS included all participants who were assigned randomly to receive treatment. | kPa | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline for Grip Strength, Non-dominant Hand | baseline, Month 6, Month 12 | Only participants from the FAS, who had non-missing baseline values and the given post-baseline values, were included in the analysis. The FAS included all participants who were assigned randomly to receive treatment. | kPa | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline for Rasch-Built Linearly Weighted Overall Disability Scale (R-ODS) | baseline, Month 6, Month 12 | Only participants from the FAS, who had non-missing baseline values and the given post-baseline values, were included in the analysis. The FAS included all participants who were assigned randomly to receive treatment. | score on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to First Confirmed Worsening on the Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Scale | Fingolimod (FTY720) | 721.0 | 95% Confidence Interval 159.0 to NA | Days | |
| Time to First Confirmed Worsening on the Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Scale | Placebo | 540.0 | 95% Confidence Interval 183.0 to NA | Days | |
| Change From Baseline for Grip Strength, Dominant Hand | Fingolimod (FTY720) | Month 6 | -2.6 | 95% Confidence Interval -8.09 to 2.80 | kPa |
| Change From Baseline for Grip Strength, Dominant Hand | Placebo | Month 6 | -3.8 | 95% Confidence Interval -9.37 to 1.70 | kPa |
| Change From Baseline for Grip Strength, Dominant Hand | Fingolimod (FTY720) | Month 12 | -0.8 | 95% Confidence Interval -6.47 to 4.96 | kPa |
| Change From Baseline for Grip Strength, Dominant Hand | Placebo | Month 12 | -3.9 | 95% Confidence Interval -9.68 to 1.94 | kPa |
| Change From Baseline for Grip Strength, Non-dominant Hand | Fingolimod (FTY720) | Month 6 | -2.7 | 95% Confidence Interval -8.13 to 2.66 | kPa |
| Change From Baseline for Grip Strength, Non-dominant Hand | Placebo | Month 6 | -6.1 | 95% Confidence Interval -11.59 to -0.66 | kPa |
| Change From Baseline for Grip Strength, Non-dominant Hand | Fingolimod (FTY720) | Month 12 | -1.2 | 95% Confidence Interval -6.69 to 4.37 | kPa |
| Change From Baseline for Grip Strength, Non-dominant Hand | Placebo | Month 12 | -5.0 | 95% Confidence Interval -10.57 to 0.64 | kPa |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fingolimod (FTY720) | 54 | |
| Overall Study | STARTED | Placebo | 52 | |
| Overall Study | COMPLETED | Fingolimod (FTY720) | 34 | |
| Overall Study | COMPLETED | Placebo | 41 | |
| Overall Study | NOT COMPLETED | Fingolimod (FTY720) | 20 | |
| Overall Study | NOT COMPLETED | Placebo | 11 |
Source ClinicalTrials.gov
Adverse events741
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 | Anaemia | Blood and lymphatic system disorders | Fingolimod (FTY720) | 0 | 54 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 1 | 52 | |
| other | Anaemia | Blood and lymphatic system disorders | Overall Participants | 1 | 106 | |
| other | Leukopenia | Blood and lymphatic system disorders | Fingolimod (FTY720) | 1 | 54 | |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo | 0 | 52 | |
| other | Leukopenia | Blood and lymphatic system disorders | Overall Participants | 1 | 106 | |
| other | Palpitations | Cardiac disorders | Fingolimod (FTY720) | 1 | 54 | |
| other | Palpitations | Cardiac disorders | Placebo | 1 | 52 | |
| other | Palpitations | Cardiac disorders | Overall Participants | 2 | 106 | |
| other | Tachycardia | Cardiac disorders | Fingolimod (FTY720) | 0 | 54 |
1 to 10 of 741Source ClinicalTrials.gov
See all 741 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fingolimod (FTY720) | ||
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Overall Participants | ||
| Total, other adverse events | Fingolimod (FTY720) | 40 | 54 |
| Total, other adverse events | Placebo | 42 | 52 |
| Total, other adverse events | Overall Participants | 82 | 106 |
| Total, serious adverse events | Fingolimod (FTY720) | 9 | 54 |
| Total, serious adverse events | Placebo | 4 | 52 |
| Total, serious adverse events | Overall Participants | 13 | 106 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30001923 | DERIVED |
Source PubMed
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/NCT01625182
GET https://conductscience.org/api/trials/v1/NCT01625182/events?page=2