Trial · NCT01190098
Randomized Controlled Trial to Assess Effects of Lacosamide on Sleep and Wake in Adults With Focal Epilepsy
NCT01190098, Phase 4, Completed, The Cleveland Clinic; results first posted 2016-12-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Randomized Controlled Trial to Assess Effects of Lacosamide on Sleep and Wake in Adults With Focal Epilepsy. Trials, record NCT01190098. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01190098
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized Controlled Trial to Assess Effects of Lacosamide on Sleep and Wake in Adults With Focal Epilepsy
- NCT number
- NCT01190098
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 59 participants, actual
- Lead sponsor
- The Cleveland Clinic
- Conditions
- Partial Epilepsy
- Interventions
- Lacosamide, Placebo
- First posted
- 2010-08-27
- Last updated
- 2016-12-05
- Results first posted
- 2016-12-05
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Epworth Sleepiness Scale Score From Baseline to Visit 4 | Baseline and Visit 4 (approximately 1 - 2 months) | Scale 0 - 24 Higher scores indicate more severe symptoms |
| Secondary | Change in the Fatigue Severity Scale From Baseline to Visit 4. | Baseline to Visit 4 (approximately 1 - 2 months) | Fatigue Severity Scale (FSS): Range 7- 63 where higher scores indicate more severe fatigue. |
| Secondary | Change in Pittsburgh Sleep Quality Inventory (PSQI) From Baseline to Visit 4 | Baseline to Visit 4 (approximately 1 - 2 months) | Range 0-21, where higher scores more impairment (in terms of sleep quality). |
| Secondary | Change in Functional Outcomes of Sleep Questionnaire (FOSQ) From Baseline to Visit 4. | Baseline to visit 4 (approximately 1 - 2 months) | Range 0-20 where lower scores indicate more impairment (sleep related QOL). |
| Secondary | Change in Adverse Event Profile (AEP) From Baseline to Visit 4. | Baseline to visit 4 (approximately 1 - 2 months) | Range 19-76, where higher scores indicate more severe impairment (in terms of 19 common antiepileptic drug side effects. |
| Secondary | Change in Patient Health Questionnaire-9 (PHQ-9) From Baseline to Visit 4. | Baseline to visit 4 (approximately 1 - 2 months) | Range 0-27, where higher scores indicate more impairment (depressive symptoms) |
| Secondary | Change in Daily Seizure Frequency From Baseline to Visit 4 | Baseline to visit 4 (approximately 1 - 2 months) | Number of seizures per day. |
| Secondary | Change in Quality of Life in Epilepsy (QOLIE-31) From Baseline to Visit 4 | Baseline to visit 4 (approximately 1 - 2 months) | Range 0 -10 where higher scores reflect better quality of life. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Epworth Sleepiness Scale Score From Baseline to Visit 4 | Baseline and Visit 4 (approximately 1 - 2 months) | Units on a scale | MEAN | |
| SECONDARY | Change in the Fatigue Severity Scale From Baseline to Visit 4. | Baseline to Visit 4 (approximately 1 - 2 months) | 6 subjects did not complete enough questions on the tool for the total score to be calculated at both time points. | units on a scale | MEAN |
| SECONDARY | Change in Pittsburgh Sleep Quality Inventory (PSQI) From Baseline to Visit 4 | Baseline to Visit 4 (approximately 1 - 2 months) | 7 subjects did not complete enough questions on the tool for the total score to be calculated at both time points. | units on a scale | MEAN |
| SECONDARY | Change in Functional Outcomes of Sleep Questionnaire (FOSQ) From Baseline to Visit 4. | Baseline to visit 4 (approximately 1 - 2 months) | 5 subjects did not complete enough questions on the tool for the total score to be calculated at both time points. | units on a scale | MEAN |
| SECONDARY | Change in Adverse Event Profile (AEP) From Baseline to Visit 4. | Baseline to visit 4 (approximately 1 - 2 months) | 3 subjects did not complete enough questions on the tool for the total score to be calculated at both time points. | units on a scale | MEAN |
| SECONDARY | Change in Patient Health Questionnaire-9 (PHQ-9) From Baseline to Visit 4. | Baseline to visit 4 (approximately 1 - 2 months) | 5 subjects did not complete enough questions on the tool for the total score to be calculated at both time points. | units on a scale | MEAN |
| SECONDARY | Change in Daily Seizure Frequency From Baseline to Visit 4 | Baseline to visit 4 (approximately 1 - 2 months) | 2 subjects did not complete seizure diary at both time points. | number of seizures per day | MEDIAN |
| SECONDARY | Change in Quality of Life in Epilepsy (QOLIE-31) From Baseline to Visit 4 | Baseline to visit 4 (approximately 1 - 2 months) | 5 subjects did not complete enough questions on the tool for the total score to be calculated at both time points. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Epworth Sleepiness Scale Score From Baseline to Visit 4 | Lacosamide | -1.2 | 95% Confidence Interval -2.9 to 0.53 | Units on a scale | |
| Change in Epworth Sleepiness Scale Score From Baseline to Visit 4 | Sugar Pill | -1.1 | 95% Confidence Interval -5.2 to 3.0 | Units on a scale | |
| Change in the Fatigue Severity Scale From Baseline to Visit 4. | Lacosamide | 0.30 | 95% Confidence Interval -3.7 to 4.3 | units on a scale | |
| Change in the Fatigue Severity Scale From Baseline to Visit 4. | Sugar Pill | -5.4 | 95% Confidence Interval -17.1 to 6.4 | units on a scale | |
| Change in Pittsburgh Sleep Quality Inventory (PSQI) From Baseline to Visit 4 | Lacosamide | -1.6 | 95% Confidence Interval -2.9 to 0.0 | units on a scale | |
| Change in Pittsburgh Sleep Quality Inventory (PSQI) From Baseline to Visit 4 | Sugar Pill | -1.3 | 95% Confidence Interval -2.9 to 0.3 | units on a scale | |
| Change in Functional Outcomes of Sleep Questionnaire (FOSQ) From Baseline to Visit 4. | Lacosamide | 0.3 | 95% Confidence Interval 0.0 to 1.0 | units on a scale | |
| Change in Functional Outcomes of Sleep Questionnaire (FOSQ) From Baseline to Visit 4. | Sugar Pill | 1.1 | 95% Confidence Interval -1.3 to 3.5 | units on a scale | |
| Change in Adverse Event Profile (AEP) From Baseline to Visit 4. | Lacosamide | -1.2 | 95% Confidence Interval -5.2 to 2.9 | units on a scale | |
| Change in Adverse Event Profile (AEP) From Baseline to Visit 4. | Sugar Pill | -6.0 | 95% Confidence Interval -14.2 to 2.2 | units on a scale |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lacosamide | 42 | |
| Overall Study | STARTED | Sugar Pill | 10 | |
| Overall Study | COMPLETED | Lacosamide | 39 | |
| Overall Study | COMPLETED | Sugar Pill | 8 | |
| Overall Study | NOT COMPLETED | Lacosamide | 3 | |
| Overall Study | NOT COMPLETED | Sugar Pill | 2 |
Source ClinicalTrials.gov
Adverse events40
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 | Heart palpitations | Cardiac disorders | Lacosamide | 1 | 42 | |
| other | Heart palpitations | Cardiac disorders | Sugar Pill | 2 | 10 | |
| other | Common cold/flu | Immune system disorders | Lacosamide | 9 | 42 | |
| other | Common cold/flu | Immune system disorders | Sugar Pill | 1 | 10 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Lacosamide | 1 | 42 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Sugar Pill | 1 | 10 | |
| other | Infection | Infections and infestations | Lacosamide | 1 | 42 | |
| other | Infection | Infections and infestations | Sugar Pill | 1 | 10 | |
| other | Skin burn/abrasion/bruise | Injury, poisoning and procedural complications | Lacosamide | 3 | 42 | |
| other | Skin burn/abrasion/bruise | Injury, poisoning and procedural complications | Sugar Pill | 0 | 10 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lacosamide | ||
| Total, all-cause mortality | Sugar Pill | ||
| Total, other adverse events | Lacosamide | 37 | 42 |
| Total, other adverse events | Sugar Pill | 6 | 10 |
| Total, serious adverse events | Lacosamide | 3 | 42 |
| Total, serious adverse events | Sugar Pill | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Lacosamide vs Sugar Pill: serious adverse events |
Source 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/NCT01190098
GET https://conductscience.org/api/trials/v1/NCT01190098/events?page=2