Trial · NCT02607254
Efficacy and Safety of Pregabalin in Treatment of Neuropathic Pain in Patients With Idiopathic Small Fiber Neuropathy
NCT02607254, Phase 2, Completed, Johns Hopkins University; results first posted 2018-10-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Pregabalin in Treatment of Neuropathic Pain in Patients With Idiopathic Small Fiber Neuropathy. Trials, record NCT02607254. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02607254
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Pregabalin in Treatment of Neuropathic Pain in Patients With Idiopathic Small Fiber Neuropathy
- NCT number
- NCT02607254
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 11 participants, actual
- Lead sponsor
- Johns Hopkins University
- Conditions
- Idiopathic Small Fiber Neuropathy
- Interventions
- Pregabalin, Placebo
- First posted
- 2015-11-18
- Last updated
- 2018-10-04
- Results first posted
- 2018-10-04
- Limitations and caveats
- There were low number of participants due to requirements of the study.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Visual Analogue Score for Pain Intensity. | Baseline, at 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase | The primary outcome is change in visual analogue score for pain, with 0 being no pain at all and 10 being the most severe pain and a higher score meaning more pain, after 8 weeks of treatment phase and 4 weeks of randomized withdrawal phase. |
| Secondary | Brief Pain Inventory (BPI sf); | Baseline, at 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase | Brief pain inventory is a scoring system for average pain intensity on scale of 0-10 with higher number meaning more pain. |
| Secondary | Sleep Quality as Assessed by Daily Sleep Interference Rating Scale (SIRS); | Baseline, at 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase | a scoring system describing sleep quality between 0-10 with 0 having no problem with sleep and 10 not being to sleep at all. |
| Secondary | Patient Global Impression of Change (PGIC); | At 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase | patient assign a number between 1-7 to the level of improvement, 1 showing substantial improvement and 7 showing no improvement at all. |
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 | Visual Analogue Score for Pain Intensity. | Baseline, at 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase | Patient with idiopathic small fiber neuropathy. | score on visual analogue score | MEAN |
| SECONDARY | Brief Pain Inventory (BPI sf); | Baseline, at 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase | Patients with idiopathic small fiber neuropathy. | score in brief pain inventory scale | MEAN |
| SECONDARY | Sleep Quality as Assessed by Daily Sleep Interference Rating Scale (SIRS); | Baseline, at 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase | Patients with idiopathic small fiber neuropathy | score on Sleep Interference Rating scale | MEAN |
| SECONDARY | Patient Global Impression of Change (PGIC); | At 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase | Patients with idiopathic small fiber neuropathy | score on PGIC scale | MEAN |
Source ClinicalTrials.gov
Results by group33
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Visual Analogue Score for Pain Intensity. | Pregabalin Treatment/Pregabalin Withdrawal | Basline | 7.1 | Standard Deviation 1.4 | score on visual analogue score |
| Visual Analogue Score for Pain Intensity. | Pregabalin Treatment/ Placebo Withdrawal | Basline | 6.9 | Standard Deviation 1.7 | score on visual analogue score |
| Visual Analogue Score for Pain Intensity. | Pregabalin Treatment/No Withdrwal | Basline | 7.3 | Standard Deviation 2.3 | score on visual analogue score |
| Visual Analogue Score for Pain Intensity. | Pregabalin Treatment/Pregabalin Withdrawal | After 8 weeks of Pregabalin | 5.4 | Standard Deviation 0.8 | score on visual analogue score |
| Visual Analogue Score for Pain Intensity. | Pregabalin Treatment/ Placebo Withdrawal | After 8 weeks of Pregabalin | 5.1 | Standard Deviation 1.1 | score on visual analogue score |
| Visual Analogue Score for Pain Intensity. | Pregabalin Treatment/No Withdrwal | After 8 weeks of Pregabalin | 7.6 | Standard Deviation 2.9 | score on visual analogue score |
| Visual Analogue Score for Pain Intensity. | Pregabalin Treatment/Pregabalin Withdrawal | After 4 weeks of Withdrawal phase | 6.1 | Standard Deviation 1.2 | score on visual analogue score |
| Visual Analogue Score for Pain Intensity. | Pregabalin Treatment/ Placebo Withdrawal | After 4 weeks of Withdrawal phase | 7.4 | Standard Deviation 1.8 | score on visual analogue score |
| Visual Analogue Score for Pain Intensity. | Pregabalin Treatment/No Withdrwal | After 4 weeks of Withdrawal phase | NA | Standard Deviation NA | score on visual analogue score |
| Brief Pain Inventory (BPI sf); | Pregabalin Treatment/Pregabalin Withdrawal | Basline | 6.7 | Standard Deviation 0.9 | score in brief pain inventory scale |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pregabalin Treatment/Pregabalin Withdrawal | 3 | |
| Overall Study | STARTED | Pregabalin Treatment/ Placebo Withdrawal | 3 | |
| Overall Study | STARTED | Pregabalin Treatment/No Withdrwal | 5 | |
| Overall Study | COMPLETED | Pregabalin Treatment/Pregabalin Withdrawal | 3 | |
| Overall Study | COMPLETED | Pregabalin Treatment/ Placebo Withdrawal | 3 | |
| Overall Study | COMPLETED | Pregabalin Treatment/No Withdrwal | 5 | |
| Overall Study | NOT COMPLETED | Pregabalin Treatment/Pregabalin Withdrawal | 0 | |
| Overall Study | NOT COMPLETED | Pregabalin Treatment/ Placebo Withdrawal | 0 | |
| Overall Study | NOT COMPLETED | Pregabalin Treatment/No Withdrwal | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pregabalin Treatment/Pregabalin Withdrawal | 0 | 3 |
| Total, all-cause mortality | Pregabalin Treatment/ Placebo Withdrawal | 0 | 3 |
| Total, all-cause mortality | Pregabalin Treatment/No Withdrawal | 0 | 5 |
| Total, other adverse events | Pregabalin Treatment/Pregabalin Withdrawal | 0 | 3 |
| Total, other adverse events | Pregabalin Treatment/ Placebo Withdrawal | 0 | 3 |
| Total, other adverse events | Pregabalin Treatment/No Withdrawal | 0 | 5 |
| Total, serious adverse events | Pregabalin Treatment/Pregabalin Withdrawal | 0 | 3 |
| Total, serious adverse events | Pregabalin Treatment/ Placebo Withdrawal | 0 | 3 |
| Total, serious adverse events | Pregabalin Treatment/No Withdrawal | 0 | 5 |
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/NCT02607254
GET https://conductscience.org/api/trials/v1/NCT02607254/results?page=2