Trial · NCT01128959
Study to Assess the Safety and Tolerability of Intravenous Carbamazepine in Adults With Epilepsy
NCT01128959, Phase 3, Completed, Lundbeck LLC; results first posted 2016-12-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Assess the Safety and Tolerability of Intravenous Carbamazepine in Adults With Epilepsy. Trials, record NCT01128959. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01128959
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess the Safety and Tolerability of Intravenous Carbamazepine in Adults With Epilepsy
- NCT number
- NCT01128959
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 108 participants, actual
- Lead sponsor
- Lundbeck LLC
- Conditions
- Epilepsy
- Interventions
- Intravenous Carbamazepine (IV CBZ)
- First posted
- 2010-05-24
- Last updated
- 2018-01-16
- Results first posted
- 2016-12-05
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adverse Events | Baseline to after last iv dose on day 4 |
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 | Adverse Events | Baseline to after last iv dose on day 4 | All Patients Treated Set | Number of adverse events | NUMBER |
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 |
|---|---|---|---|---|---|
| Adverse Events | Intravenous Carbamazepine (IV CBZ) 15 Minutes Infusion | 126 | Number of adverse events | ||
| Adverse Events | Intravenous Carbamazepine (IV CBZ) 5 Minutes Infusion | 26 | Number of adverse events |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Lead in Period | STARTED | Intravenous Carbamazepine (IV CBZ) | 108 | |
| Lead in Period | COMPLETED | Intravenous Carbamazepine (IV CBZ) | 105 | |
| Lead in Period | NOT COMPLETED | Intravenous Carbamazepine (IV CBZ) | 3 | |
| Treatment Period | STARTED | Intravenous Carbamazepine (IV CBZ) | 105 | |
| Treatment Period | COMPLETED | Intravenous Carbamazepine (IV CBZ) | 101 | |
| Treatment Period | NOT COMPLETED | Intravenous Carbamazepine (IV CBZ) | 4 |
Source ClinicalTrials.gov
Adverse events10
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 | Dizziness | Nervous system disorders | Intravenous Carbamazepine (IV CBZ) 15 Minutes Infusion | 20 | 105 | |
| other | Dizziness | Nervous system disorders | Intravenous Carbamazepine (IV CBZ) 5 Minutes Infusion | 11 | 101 | |
| other | Headache | Nervous system disorders | Intravenous Carbamazepine (IV CBZ) 15 Minutes Infusion | 9 | 105 | |
| other | Headache | Nervous system disorders | Intravenous Carbamazepine (IV CBZ) 5 Minutes Infusion | 0 | 101 | |
| other | Somnolence | Nervous system disorders | Intravenous Carbamazepine (IV CBZ) 15 Minutes Infusion | 7 | 105 | |
| other | Somnolence | Nervous system disorders | Intravenous Carbamazepine (IV CBZ) 5 Minutes Infusion | 1 | 101 | |
| serious | Cerebral Haemorrhage | Nervous system disorders | Intravenous Carbamazepine (IV CBZ) 15 Minutes Infusion | 1 | 105 | 1 |
| serious | Cerebral Haemorrhage | Nervous system disorders | Intravenous Carbamazepine (IV CBZ) 5 Minutes Infusion | 0 | 101 | 0 |
| serious | Convulsion | Nervous system disorders | Intravenous Carbamazepine (IV CBZ) 15 Minutes Infusion | 1 | 105 | 1 |
| serious | Convulsion | Nervous system disorders | Intravenous Carbamazepine (IV CBZ) 5 Minutes Infusion | 0 | 101 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intravenous Carbamazepine (IV CBZ) 15 Minutes Infusion | ||
| Total, all-cause mortality | Intravenous Carbamazepine (IV CBZ) 5 Minutes Infusion | ||
| Total, other adverse events | Intravenous Carbamazepine (IV CBZ) 15 Minutes Infusion | 29 | 105 |
| Total, other adverse events | Intravenous Carbamazepine (IV CBZ) 5 Minutes Infusion | 11 | 101 |
| Total, serious adverse events | Intravenous Carbamazepine (IV CBZ) 15 Minutes Infusion | 2 | 105 |
| Total, serious adverse events | Intravenous Carbamazepine (IV CBZ) 5 Minutes Infusion | 0 | 101 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25912051 | DERIVED |
Source PubMed
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 |
|---|
| Intravenous Carbamazepine (IV CBZ) 15 Minutes Infusion vs Intravenous Carbamazepine (IV CBZ) 5 Minutes Infusion: 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/NCT01128959
GET https://conductscience.org/api/trials/v1/NCT01128959/registered