Trial · NCT02642315
The Effect of Horizant (Gabapentin Enacarbil) on Augmentation
NCT02642315, Not applicable, Completed, University of Missouri-Columbia; results first posted 2022-02-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Effect of Horizant (Gabapentin Enacarbil) on Augmentation. Trials, record NCT02642315. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02642315
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Effect of Horizant (Gabapentin Enacarbil) on Augmentation
- NCT number
- NCT02642315
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 10 participants, actual
- Lead sponsor
- University of Missouri-Columbia
- Conditions
- Restless Legs Syndrome
- Interventions
- Horizant
- First posted
- 2015-12-30
- Last updated
- 2022-02-24
- Results first posted
- 2022-02-24
- Limitations and caveats
- Limited (small numbers) open label study
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Augmentation Severity From Day 0 to Day 90 | From Day 0 (Baseline) to Day 90 | Augmentation severity rating scale; 0-24, 0 is better, 24 is worst |
| Secondary | Change in Augmentation Severity Rating Scale Form Day 0 to Day 360 (270 Days After Discontinuation pf Dopaminergic Medication) | Day 0 to day 360 (270 days after discontinuing dopaminergic medication) | Numeric Scale to assess degree of augmentation; Range 0-24; 0 is better, 24 is worst. We compared the Augmentation severity scale on day 0 to day 360 (which is 270 days after this decrease of dopaminergic medication) |
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 | Change in Augmentation Severity From Day 0 to Day 90 | From Day 0 (Baseline) to Day 90 | 10 patients enrolled - 2 dropped out - 8 completed the study | score on a scale | MEDIAN |
| SECONDARY | Change in Augmentation Severity Rating Scale Form Day 0 to Day 360 (270 Days After Discontinuation pf Dopaminergic Medication) | Day 0 to day 360 (270 days after discontinuing dopaminergic medication) | Only 8 subjects completed the study to its final point | score on a scale | MEDIAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Augmentation Severity From Day 0 to Day 90 | Open-label | Baseline | 6.5 | Full Range 5 to 13 | score on a scale |
| Change in Augmentation Severity From Day 0 to Day 90 | Open-label | 90 days | 0 | Full Range 0 to 2 | score on a scale |
| Change in Augmentation Severity Rating Scale Form Day 0 to Day 360 (270 Days After Discontinuation pf Dopaminergic Medication) | Open-label | Day 0 augmentation scale score | 6.5 | Full Range 5 to 13 | score on a scale |
| Change in Augmentation Severity Rating Scale Form Day 0 to Day 360 (270 Days After Discontinuation pf Dopaminergic Medication) | Open-label | Day 360 Augmentation scale score | 0 | Full Range 0 to 1 | score on a scale |
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 | Open-label | 10 | |
| Overall Study | COMPLETED | Open-label | 8 | |
| Overall Study | NOT COMPLETED | Open-label | 2 |
Source ClinicalTrials.gov
Adverse events6
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 | Meralgia paraesthetica | Nervous system disorders | Open-label | 1 | 10 | 1 |
| other | Hypertension | Cardiac disorders | Open-label | 1 | 10 | 1 |
| other | Plantar fasciitis | Musculoskeletal and connective tissue disorders | Open-label | 1 | 10 | 1 |
| other | Rheumatoid arthritis - exacerbation | Musculoskeletal and connective tissue disorders | Open-label | 1 | 10 | 1 |
| other | Sleep apnea | Nervous system disorders | Open-label | 1 | 10 | 1 |
| other | Calcification on right thyroid gland | Endocrine disorders | Open-label | 1 | 10 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Open-label | 0 | 10 |
| Total, other adverse events | Open-label | 6 | 10 |
| Total, serious adverse events | Open-label | 0 | 10 |
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/NCT02642315
GET https://conductscience.org/api/trials/v1/NCT02642315/registered