Trial · NCT01673282
Study Evaluating Changes in Total Drug Load and Seizure Frequency Using Vimpat® (Lacosamide) in Combination Therapy
NCT01673282, Completed, UCB Pharma GmbH; results first posted 2016-11-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study Evaluating Changes in Total Drug Load and Seizure Frequency Using Vimpat® (Lacosamide) in Combination Therapy. Trials, record NCT01673282. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01673282
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Evaluating Changes in Total Drug Load and Seizure Frequency Using Vimpat® (Lacosamide) in Combination Therapy
- NCT number
- NCT01673282
- Status
- Completed
- Enrollment
- 315 participants, actual
- Lead sponsor
- UCB Pharma GmbH
- Conditions
- Focal Epilepsy With and Without Secondary Generalization
- Interventions
- Lacosamide
- First posted
- 2012-08-27
- Last updated
- 2016-11-15
- Results first posted
- 2016-11-15
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Percent Change in Ratio of Dose and Defined Daily Dose (DDD) for the Drug Load of Concomitant Anti-Epileptic Drugs (AEDs) From Baseline to the End of Observation Period (Day 0 to 6 Months) | From Baseline (Day 0) to 6 months | Drug load is defined as the sum of the ratios of the actual doses divided by the defined daily dose for all concomitant AEDs. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Percent Change in Ratio of Dose and Defined Daily Dose (DDD) for the Drug Load of Concomitant Anti-Epileptic Drugs (AEDs) From Baseline to the End of Observation Period (Day 0 to 6 Months) | From Baseline (Day 0) to 6 months | The analysis group for the outcome measure is the Full Analysis Set (FAS). The FAS included all patients who received at least 1 dose of Lacosamide and for whom at least 1 valid ratio of dose and DDD at Baseline and post-Baseline could be calculated. | percent change of ratio in dose | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Percent Change in Ratio of Dose and Defined Daily Dose (DDD) for the Drug Load of Concomitant Anti-Epileptic Drugs (AEDs) From Baseline to the End of Observation Period (Day 0 to 6 Months) | Vimpat + Na Channel Blocking AED | -15.0 | Standard Deviation 64.8 | percent change of ratio in dose | |
| The Percent Change in Ratio of Dose and Defined Daily Dose (DDD) for the Drug Load of Concomitant Anti-Epileptic Drugs (AEDs) From Baseline to the End of Observation Period (Day 0 to 6 Months) | Vimpat + Non-Na Channel Blocking AED | -4.4 | Standard Deviation 31.9 | percent change of ratio in dose |
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 | Vimpat + Na Channel Blocking AED | 153 | |
| Overall Study | STARTED | Vimpat + Non-Na Channel Blocking AED | 158 | |
| Overall Study | COMPLETED | Vimpat + Na Channel Blocking AED | 120 | |
| Overall Study | COMPLETED | Vimpat + Non-Na Channel Blocking AED | 132 | |
| Overall Study | NOT COMPLETED | Vimpat + Na Channel Blocking AED | 33 | |
| Overall Study | NOT COMPLETED | Vimpat + Non-Na Channel Blocking AED | 26 |
Source ClinicalTrials.gov
Adverse events28
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 | Drug ineffective | General disorders | Vimpat + Na Channel Blocking AED | 9 | 153 | 9 |
| other | Drug ineffective | General disorders | Vimpat + Non-Na Channel Blocking AED | 2 | 158 | 2 |
| other | Off label use | Injury, poisoning and procedural complications | Vimpat + Na Channel Blocking AED | 15 | 153 | 16 |
| other | Off label use | Injury, poisoning and procedural complications | Vimpat + Non-Na Channel Blocking AED | 7 | 158 | 7 |
| other | Overdose | Injury, poisoning and procedural complications | Vimpat + Na Channel Blocking AED | 15 | 153 | 16 |
| other | Overdose | Injury, poisoning and procedural complications | Vimpat + Non-Na Channel Blocking AED | 7 | 158 | 7 |
| serious | Cardiac arrest | Cardiac disorders | Vimpat + Na Channel Blocking AED | 0 | 153 | 0 |
| serious | Cardiac arrest | Cardiac disorders | Vimpat + Non-Na Channel Blocking AED | 1 | 158 | 1 |
| serious | Palpitations | Cardiac disorders | Vimpat + Na Channel Blocking AED | 0 | 153 | 0 |
| serious | Palpitations | Cardiac disorders | Vimpat + Non-Na Channel Blocking AED | 1 | 158 | 1 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vimpat + Na Channel Blocking AED | ||
| Total, all-cause mortality | Vimpat + Non-Na Channel Blocking AED | ||
| Total, other adverse events | Vimpat + Na Channel Blocking AED | 22 | 153 |
| Total, other adverse events | Vimpat + Non-Na Channel Blocking AED | 9 | 158 |
| Total, serious adverse events | Vimpat + Na Channel Blocking AED | 1 | 153 |
| Total, serious adverse events | Vimpat + Non-Na Channel Blocking AED | 6 | 158 |
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 |
|---|
| Vimpat + Na Channel Blocking AED vs Vimpat + Non-Na Channel Blocking AED: 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/NCT01673282
GET https://conductscience.org/api/trials/v1/NCT01673282/events?page=2