Trial · NCT02582866
A Clinical Study to Investigate the Long-term Use of Lacosamide as Monotherapy in Subjects Who Completed Study SP0994
NCT02582866, Phase 3, Completed, UCB Biopharma S.P.R.L.; results first posted 2021-01-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Clinical Study to Investigate the Long-term Use of Lacosamide as Monotherapy in Subjects Who Completed Study SP0994. Trials, record NCT02582866. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02582866
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Study to Investigate the Long-term Use of Lacosamide as Monotherapy in Subjects Who Completed Study SP0994
- NCT number
- NCT02582866
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 106 participants, actual
- Lead sponsor
- UCB Biopharma S.P.R.L.
- Conditions
- Epilepsy
- Interventions
- Lacosamide
- First posted
- 2015-10-21
- Last updated
- 2023-06-06
- Other registries' IDs
- eudract:2015-001549-96
- Results first posted
- 2021-01-22
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Experiencing Any Adverse Events (AEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator | From Visit 1 (Week 0) to Final Visit (up to Week 158) | An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication. |
| Primary | Percentage of Participants That Withdrew Due to Adverse Events (AEs) | From Visit 1 (Week 0) to Final Visit (up to Week 158) | An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication. |
| Primary | Percentage of Participants Experiencing Any Serious Adverse Events (SAEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator | From Visit 1 (Week 0) to Final Visit (up to Week 158) | A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalization or prolongation of existing hospitalization * Is a congenital anomaly or birth defect * Is an infection that requires treatment parenteral antibiotics * Other important medical events which based on medical or scientific judgement may jeopardize the study participants, or may require medical or surgical intervention to prevent any of the above. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Experiencing Any Adverse Events (AEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator | From Visit 1 (Week 0) to Final Visit (up to Week 158) | The SS consisted of all study participants in the ES who received at least 1 dose of study medication in SP1042. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants That Withdrew Due to Adverse Events (AEs) | From Visit 1 (Week 0) to Final Visit (up to Week 158) | The SS consisted of all study participants in the ES who received at least 1 dose of study medication in SP1042. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Experiencing Any Serious Adverse Events (SAEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator | From Visit 1 (Week 0) to Final Visit (up to Week 158) | The SS consisted of all study participants in the ES who received at least 1 dose of study medication in SP1042. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Experiencing Any Adverse Events (AEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator | Lacosamide (SS) | 59.4 | percentage of participants | ||
| Percentage of Participants That Withdrew Due to Adverse Events (AEs) | Lacosamide (SS) | 0.9 | percentage of participants | ||
| Percentage of Participants Experiencing Any Serious Adverse Events (SAEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator | Lacosamide (SS) | 14.2 | percentage of participants |
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 | Lacosamide | 106 | |
| Overall Study | COMPLETED | Lacosamide | 84 | |
| Overall Study | NOT COMPLETED | Lacosamide | 22 |
Source ClinicalTrials.gov
Adverse events24
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 | Nasopharyngitis | Infections and infestations | Lacosamide (SS) | 8 | 106 | 17 |
| other | Headache | Nervous system disorders | Lacosamide (SS) | 11 | 106 | 11 |
| serious | Atrial Flutter | Cardiac disorders | Lacosamide (SS) | 1 | 106 | 1 |
| serious | Cardiac Failure | Cardiac disorders | Lacosamide (SS) | 1 | 106 | 1 |
| serious | Myocardial Infarction | Cardiac disorders | Lacosamide (SS) | 1 | 106 | 1 |
| serious | Ventricular Tachycardia | Cardiac disorders | Lacosamide (SS) | 1 | 106 | 1 |
| serious | Diarrhoea | Gastrointestinal disorders | Lacosamide (SS) | 1 | 106 | 1 |
| serious | Gastrooesophageal Reflux Disease | Gastrointestinal disorders | Lacosamide (SS) | 1 | 106 | 1 |
| serious | Umbilical Hernia | Gastrointestinal disorders | Lacosamide (SS) | 1 | 106 | 1 |
| serious | Device Dislocation | General disorders | Lacosamide (SS) | 1 | 106 | 1 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lacosamide (SS) | 1 | 106 |
| Total, other adverse events | Lacosamide (SS) | 19 | 106 |
| Total, serious adverse events | Lacosamide (SS) | 15 | 106 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT02582866
GET https://conductscience.org/api/trials/v1/NCT02582866/events?page=2