Trial · NCT01431976
Clinical Study of Lamotrigine to Treat Newly Diagnosed Typical Absence Seizure in Children and Adolescents
NCT01431976, Phase 3, Completed, GlaxoSmithKline; results first posted 2014-08-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Clinical Study of Lamotrigine to Treat Newly Diagnosed Typical Absence Seizure in Children and Adolescents. Trials, record NCT01431976. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01431976
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Study of Lamotrigine to Treat Newly Diagnosed Typical Absence Seizure in Children and Adolescents
- NCT number
- NCT01431976
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 20 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Epilepsy
- Interventions
- Lamictal
- First posted
- 2011-09-12
- Last updated
- 2017-03-08
- Results first posted
- 2014-08-27
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Were Seizure Free as Confirmed by Hyperventilation (HV)-Electroencephalography (EEG) at the End of the Maintenance Phase (MP) | Week 12 of the Maintenance Phase (up to Study Week 50) | EEG is a diagnostic test for epilepsy. The EEG machine records the brain's electrical activity as a series of waveforms. HV is an activation technique used to provoke seizures during an EEG recording. An approximately 30-minute EEG with HV was performed on participants in a supine position. In the HV test, participants breathed through their mouths deeply and rapidly (at a rate of approximately 20-25 breaths/minute) for 4 continuous minutes using a pin-wheel provided to them. |
| Secondary | Number of Participants Who Were Seizure Free as Confirmed by HV-EEG at Two Consecutive Visits in the Escalation Phase (EP) | Up to Study Week 49 | EEG is a diagnostic test for epilepsy. The EEG machine records the brain's electrical activity as a series of waveforms. HV is an activation technique used to provoke seizures during an EEG recording. An approximately 30-minute EEG with HV was performed on participants in a supine position. In the HV test, participants breathed through their mouths deeply and rapidly (at a rate of approximately 20-25 breaths/minute ) for 4 continuous minutes using a pin-wheel provided to them. |
| Secondary | Number of Participants Who Were Seizure Free as Confirmed by HV-clinical Signs at Each Dose During the Escalation Phase | Up to Study Week 49 | HV is an activation technique used to provoke seizures. Participants were instructed to breathe through their mouths deeply and rapidly (at a rate of approximately 20-25 breaths/minute) for 4 continuous minutes while sitting using a pin-wheel and were observed for clinical signs of seizures like impairment of consciousness; staring; eye enrollment; eye blinking; chewing movements; hand movement; other automatisms; atonic, tonic, clonic components; autonomic components; or any other signs. During the Escalation Phase, HV-clinical signs were assessed to confirm a status of seizure free. Only participants data available at the analysis time point were analyzed (represented as n=X, X, X in category title). |
| Secondary | Number of Participants Who Were Seizure Free as Confirmed by HV-clinical Signs During Week 4 and Week 8 of the Maintenance Phase | Week 4 and Week 8 of the Maintenance Phase (up to Study Weeks 42 and 46, respectively) | HV is an activation technique used to provoke seizures. Participants were instructed to breathe through their mouths deeply and rapidly (at a rate of approximately 20-25 breaths/minute) for 4 continuous minutes while sitting using a pin-wheel and were observed for clinical signs of seizures like impairment of consciousness; staring; eye enrollment; eye blinking; chewing movements; hand movement; other automatisms; atonic, tonic, clonic components; autonomic components; or any other signs. During the Maintenace Phase, HV-clinical signs were assessed at Visit 1 (Week 4) and Visit 2 (Week 4). |
| Secondary | Number of Participants Who Were Seizure Free as Confirmed by HV-EEG at Each Assessment Point in the Extension Phase (ExP) | Extension Week 12 (Extension Visit 1 [Ext-V1]), every 24 weeks after Ext-V1 and until withdrawal | EEG is a diagnostic test for epilepsy. The EEG machine records the brain's electrical activity as a series of waveforms. HV is an activation technique used to provoke seizures during an EEG recording. An approximately 30-minute EEG with HV was performed on participants in a supine position. In the HV test, participants breathed through their mouths deeply and rapidly (at a rate of approximately 20-25 breaths/minute ) for 4 continuous minutes using a pin-wheel provided to them. Only participants data available at the analysis time point were analyzed (represented as n=X, X, X in category title). |
| Secondary | Number of Participants Who Were Seizure Free as Confirmed by HV-clinical Signs at Each Assessment Point in the Extension Phase (ExP) | Extension Week 24 (Extension Visit 2 [Ext-V2], every 24 weeks after the Ext-V2 and until withdrawal | HV is an activation technique used to provoke seizures. Participants were instructed to breathe through their mouths deeply and rapidly (at a rate of approximately 20-25 breaths/minute) for 4 continuous minutes while sitting using a pin-wheel and were observed for clinical signs of seizures like impairment of consciousness; staring; eye enrollment; eye blinking; chewing movements; hand movement; other automatisms; atonic, tonic, clonic components; autonomic components; or any other signs. During the ExP, HV-clinical signs were assessed to confirm a status of seizure free. Only participants data available at the analysis time point were analyzed (represented as n=X, X, X in category title). |
| Secondary | Number of Days With Seizure Episodes Per Week in the Main Study Phase (Fixed Escalation Phase [FEP], Escalation Phase [EP], Maintenance Phase [MP]), and FEP+EP+MP) | Up to Study Week 50 | Participants were asked to record the seizure codes, seizure duration, and their physical condition in a diary provided. Only participants data available at the analysis time point were analyzed (represented as n=X, X, X in category title) |
| Secondary | Number of Days With Seizure Episodes Per Week in the Extension Phase (ExP) Overall | Extension Week 12 (Extension Visit 1 [Ext-V1], every 12 week after Ext-V1 and until withdrawal | Participants were asked to record the seizure codes, seizure duration, and their physical condition in a diary provided. |
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 | Number of Participants Who Were Seizure Free as Confirmed by Hyperventilation (HV)-Electroencephalography (EEG) at the End of the Maintenance Phase (MP) | Week 12 of the Maintenance Phase (up to Study Week 50) | Full Analysis Set (FAS): all participants who took at least one dose of investigational product and contributed data to at least one efficacy measure after the first dosing of investigational product | Participants | NUMBER |
| SECONDARY | Number of Participants Who Were Seizure Free as Confirmed by HV-EEG at Two Consecutive Visits in the Escalation Phase (EP) | Up to Study Week 49 | FAS | Participants | NUMBER |
| SECONDARY | Number of Participants Who Were Seizure Free as Confirmed by HV-clinical Signs at Each Dose During the Escalation Phase | Up to Study Week 49 | FAS. Only those participants given the indicated dose of investigational product were analyzed. | Participants | NUMBER |
| SECONDARY | Number of Participants Who Were Seizure Free as Confirmed by HV-clinical Signs During Week 4 and Week 8 of the Maintenance Phase | Week 4 and Week 8 of the Maintenance Phase (up to Study Weeks 42 and 46, respectively) | FAS. Only those participants who were dosed with investigational product at the indicated time points were analyzed. | Participants | NUMBER |
| SECONDARY | Number of Participants Who Were Seizure Free as Confirmed by HV-EEG at Each Assessment Point in the Extension Phase (ExP) | Extension Week 12 (Extension Visit 1 [Ext-V1]), every 24 weeks after Ext-V1 and until withdrawal | FAS. Only those participants given the indicated dose of investigational product were analyzed. | Participants | NUMBER |
| SECONDARY | Number of Participants Who Were Seizure Free as Confirmed by HV-clinical Signs at Each Assessment Point in the Extension Phase (ExP) | Extension Week 24 (Extension Visit 2 [Ext-V2], every 24 weeks after the Ext-V2 and until withdrawal | FAS. Only those participants given the indicated dose of investigational product were analyzed. | Participants | NUMBER |
| SECONDARY | Number of Days With Seizure Episodes Per Week in the Main Study Phase (Fixed Escalation Phase [FEP], Escalation Phase [EP], Maintenance Phase [MP]), and FEP+EP+MP) | Up to Study Week 50 | FAS | Days | MEAN |
| SECONDARY | Number of Days With Seizure Episodes Per Week in the Extension Phase (ExP) Overall | Extension Week 12 (Extension Visit 1 [Ext-V1], every 12 week after Ext-V1 and until withdrawal | FAS. Only those participants given the indicated dose of investigational product were analyzed. | Days | MEAN |
Source ClinicalTrials.gov
Results by group39
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Were Seizure Free as Confirmed by Hyperventilation (HV)-Electroencephalography (EEG) at the End of the Maintenance Phase (MP) | Lamotrigine | 7 | Participants | ||
| Number of Participants Who Were Seizure Free as Confirmed by HV-EEG at Two Consecutive Visits in the Escalation Phase (EP) | Lamotrigine | 8 | Participants | ||
| Number of Participants Who Were Seizure Free as Confirmed by HV-clinical Signs at Each Dose During the Escalation Phase | Lamotrigine | 0.6 mg/kg, n=17 | 1 | Participants | |
| Number of Participants Who Were Seizure Free as Confirmed by HV-clinical Signs at Each Dose During the Escalation Phase | Lamotrigine | 1.2 mg/kg, n=17 | 1 | Participants | |
| Number of Participants Who Were Seizure Free as Confirmed by HV-clinical Signs at Each Dose During the Escalation Phase | Lamotrigine | 1.8 mg/kg, n=16 | 2 | Participants | |
| Number of Participants Who Were Seizure Free as Confirmed by HV-clinical Signs at Each Dose During the Escalation Phase | Lamotrigine | 2.4 mg/kg, n=16 | 2 | Participants | |
| Number of Participants Who Were Seizure Free as Confirmed by HV-clinical Signs at Each Dose During the Escalation Phase | Lamotrigine | 3.0 mg/kg, n=16 | 2 | Participants | |
| Number of Participants Who Were Seizure Free as Confirmed by HV-clinical Signs at Each Dose During the Escalation Phase | Lamotrigine | 3.6 mg/kg, n=15 | 1 | Participants | |
| Number of Participants Who Were Seizure Free as Confirmed by HV-clinical Signs at Each Dose During the Escalation Phase | Lamotrigine | 4.2 mg/kg, n=15 | 0 | Participants | |
| Number of Participants Who Were Seizure Free as Confirmed by HV-clinical Signs at Each Dose During the Escalation Phase | Lamotrigine | 4.8 mg/kg, n=14 | 4 | Participants |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lamotrigine | 20 | |
| Overall Study | COMPLETED | Lamotrigine | 6 | |
| Overall Study | NOT COMPLETED | Lamotrigine | 14 |
Source ClinicalTrials.gov
Adverse events51
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 | Bronchitis | Infections and infestations | Lamotrigine | 5 | 20 | |
| other | Nasopharyngitis | Infections and infestations | Lamotrigine | 7 | 20 | |
| other | Upper respiratory tract infection | Infections and infestations | Lamotrigine | 3 | 20 | |
| other | Cellulitis | Infections and infestations | Lamotrigine | 1 | 20 | |
| other | Gastroenteritis | Infections and infestations | Lamotrigine | 1 | 20 | |
| other | Influenza | Infections and infestations | Lamotrigine | 5 | 20 | |
| other | Paronychia | Infections and infestations | Lamotrigine | 1 | 20 | |
| other | Pharyngitis | Infections and infestations | Lamotrigine | 2 | 20 | |
| other | Pneumonia mycoplasmal | Infections and infestations | Lamotrigine | 1 | 20 | |
| other | Scarlet fever | Infections and infestations | Lamotrigine | 1 | 20 |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lamotrigine | ||
| Total, other adverse events | Lamotrigine | 17 | 20 |
| Total, serious adverse events | Lamotrigine | 0 | 20 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26518979 | 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 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/NCT01431976
GET https://conductscience.org/api/trials/v1/NCT01431976/results?page=2