EpilepsyPhase 4NCT01175954
Cognitive and Behavioral Effects of Lacosamide
A Phase 4 study testing Lacosamide in people with Epilepsy, run by Evan Fertig at 1 site in United States.
Trial summary
Primary Objective: Null hypothesis: A 24-week trial of adjunctive Lacosamide does not produce a decline in cognitive, mood or quality of life measures. To determine the cognitive and behavioral side effects of lacosamide in patients with partial epilepsy and follow them for a period of 24 weeks using a… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Lacosamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all the following inclusion criteria to be eligible for enrollment into the trial
- Age range 18-70
- Able and willing to provide written informed consent to participate in the study in accordance with the ICH and GCP guidelines, and per the judgement of the investigator be able to cooperate fully with neuropsychological testing
- Native English speaker or balanced bilingual
- Diagnosis of refractory partial onset epilepsy
- Historical mean seizure frequency of >/= 1 seizure per month on average during 6 months prior to Visit 1.
Who cannot join
- Subjects presenting with any of the following will not be included in the trial:
- History of drug/alcohol abuse
- Females who are pregnant or are on an unapproved method of contraception
- Psychiatric disorder (Diagnosis of Bipolar Disorder, Schizophrenia, psychotic disorder , Major Depression requiring hospitalization in the past 2 years, or other psychological or behavioral condition which in the judgement of the investigator should exclude the subject from the study.
- No active suicidal plan/intent or active suicidal thoughts in the last 6 months
- Current use of antidepressant, anxiolytic, or antipsychotic agents
Show all 10Show fewer
- Presence of any progressive,demyelinating, or degenerative neurological condition
- Diagnosis of psychogenic non-epileptic seizure disorder
- Traumatic brain injury within 6 months of enrollment or TBI with suspected cognition/memory changes after TBI that has not stabilized 6 months prior to enrollment
- Prior history of cardiac arrhythmia
Trial locations and contacts
1 site in 1 country.
United States1 site
Northeast Regional Epilepsy Group
Hackensack, New Jersey, 07601
About this study
Official title: Phase IV Study of Cognitive and Behavioral Effects of Lacosamide as Adjunctive Therapy in Patients With Partial Epilepsy
Primary Objective:
Null hypothesis: A 24-week trial of adjunctive Lacosamide does not produce a decline in cognitive, mood or quality of life measures.
To determine the cognitive and behavioral side effects of lacosamide in patients with partial epilepsy and follow them for a period of 24 weeks using a neuropsychological test battery drawing on tests commonly used and designed to maximize sensitivity to drug effects.
Secondary Objectives:
To determine if any significant changes in cognitive, mood or quality of life measures are dependent upon changes in seizure severity, neurotoxicity, adverse events, or Lacosamide dosage.
Read the detailed description
The investigators will examine a group of patients with partial epilepsy (chronic seizures arising from one particular part of the brain) whose seizures have not been controlled. If they consent to the study, they will be followed for 4 weeks to get a baseline seizure frequency. The patients will take a battery of tests assessing attention, memory, cognitive speed, and language, and fill out some inventories to assess their mood and quality of life. They will then receive a new anti-epileptic drug, lacosamide, to add to whatever epilepsy medications they are currently taking. They will be closely followed for 24 weeks with regular doctor's visits to monitor their physical health and seizure control, and will complete an inventory assessing the frequency and severity of their seizures. During that period of time, the other medication will remain unchanged. At the end of the 24-week period they will re-take the battery of cognitive tests and mood and quality of life inventories. The cognitive, mood, and quality of life variables will be analyzed to determine if they change for the better or worse after the course of lacosamide treatment. Any changes will also be analyzed with respect to seizure frequency and severity and to adverse events or side effects from the addition of the lacosamide, as well as to lacosamide dosage. The investigators chose this design since it closely represents what the investigators do in clinical practice.
- Conditions
- Epilepsy
- Being tested
- Lacosamide
- Keywords
- Partial Epilepsy
- Medical subject headings
- Epilepsy, Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LacosamideDrug
Also called Vimpat
Lacosamide will be titrated starting from visit 1 for 2 weeks (50mg bid) and maintained at 100mg bid for the rest of the study period. Dose Adjustments allowed up to 400 mg/day.
LacosamideDrug
Also called Vimpat
Lacosamide will be titrated starting from visit 1 for 2 weeks (50mg bid) and maintained at 100mg bid for the rest of the study period.
| Study group | Role | What they receive |
|---|---|---|
| Lacosamide Open-Label | Experimental | Lacosamide will be titrated starting from visit 1 for 2 weeks (50mg bid) and maintained at 100mg bid for the rest of the study period. Receives: Drug: Lacosamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Cognitive test scores
Changes in the composite measure of the cognitive test scores and in the composite measure of the mood/Quality Of Life scores from baseline (visit 1) to scores recorded at termination (visit 4).
Measured: 30 weeks
Secondary outcomes (1)
Relationship of Cognitive test scores with Seizure severity ,A-B Neurotoxicity,Adverse Events and Lacosamide Dosage
The relationship of the cognitive and mood/Quality Of Life composite measures to seizure severity, A-B Neurotoxicity, Adverse Events, and Lacosamide dosage
Measured: 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evan Fertig
- Sponsor type
- University, hospital or other
- Collaborators
- UCB Pharma
- Responsible party
- Sponsor-investigator, Evan Fertig, Northeast Regional Epilepsy Group
- Investigators
- Marcelo Lancman, MD, Principal investigator, Northeast Regional Epilepsy Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01175954
- Sponsor's protocol ID
- NEREG-002
- Status last verified
- Sep 2017
- First submitted
- 9 Jul 2010
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Lancman ME, Fertig EJ, Trobliger RW, Perrine K, Myers L, Iyengar SS, Malik M. The effects of lacosamide on cognition, quality-of-life measures, and quality of life in patients with refractory partial epilepsy. Epilepsy Behav. 2016 Aug;61:27-33. doi: 10.1016/j.yebeh.2016.04.049. Epub 2016 Jun 14.
PubMed 27315132
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study of Cognitive and Behavioral Effects of Lacosamide as Adjunctive Therapy in Patients With Partial Epilepsy
- ClinicalTrials.gov ID
- NCT01175954
- Acronym / sponsor ID
- NEREG-002
- Conditions
- Epilepsy
- Keywords
- Partial Epilepsy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Evan FertigUniversity, hospital or other
- Collaborators
- UCB Pharma
- Study start
- May 2010
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 5 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
Null hypothesis: A 24-week trial of adjunctive Lacosamide does not produce a decline in cognitive, mood or quality of life measures.
To determine the cognitive and behavioral side effects of lacosamide in patients with partial epilepsy and follow them for a period of 24 weeks using a neuropsychological test battery drawing on tests commonly used and designed to maximize sensitivity to drug effects.
Secondary Objectives:
To determine if any significant changes in cognitive, mood or quality of life measures are dependent upon changes in seizure severity, neurotoxicity, adverse events, or Lacosamide dosage.
Detailed description
The investigators will examine a group of patients with partial epilepsy (chronic seizures arising from one particular part of the brain) whose seizures have not been controlled. If they consent to the study, they will be followed for 4 weeks to get a baseline seizure frequency. The patients will take a battery of tests assessing attention, memory, cognitive speed, and language, and fill out some inventories to assess their mood and quality of life. They will then receive a new anti-epileptic drug, lacosamide, to add to whatever epilepsy medications they are currently taking. They will be closely followed for 24 weeks with regular doctor's visits to monitor their physical health and seizure control, and will complete an inventory assessing the frequency and severity of their seizures. During that period of time, the other medication will remain unchanged. At the end of the 24-week period they will re-take the battery of cognitive tests and mood and quality of life inventories. The cognitive, mood, and quality of life variables will be analyzed to determine if they change for the better or worse after the course of lacosamide treatment. Any changes will also be analyzed with respect to seizure frequency and severity and to adverse events or side effects from the addition of the lacosamide, as well as to lacosamide dosage. The investigators chose this design since it closely represents what the investigators do in clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lacosamide Open-Label | Experimental | Drug: LacosamideLacosamide will be titrated starting from visit 1 for 2 weeks (50mg bid) and maintained at 100mg bid for the rest of the study period. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects must meet all the following inclusion criteria to be eligible for enrollment into the trial
- Age range 18-70
- Able and willing to provide written informed consent to participate in the study in accordance with the ICH and GCP guidelines, and per the judgement of the investigator be able to cooperate fully with neuropsychological testing
- Native English speaker or balanced bilingual
- Diagnosis of refractory partial onset epilepsy
Key exclusion criteria (10 listed)
- History of drug/alcohol abuse
- Females who are pregnant or are on an unapproved method of contraception
- Psychiatric disorder (Diagnosis of Bipolar Disorder, Schizophrenia, psychotic disorder , Major Depression requiring hospitalization in the past 2 years, or other psychological or behavioral condition which in the judgement of the investigator should exclude the subject from the study.
- No active suicidal plan/intent or active suicidal thoughts in the last 6 months
- Current use of antidepressant, anxiolytic, or antipsychotic agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LacosamideAlso: VimpatLacosamide will be titrated starting from visit 1 for 2 weeks (50mg bid) and maintained at 100mg bid for the rest of the study period. Dose Adjustments allowed up to 400 mg/day. | Drug | Lacosamide Open-Label |
| LacosamideAlso: VimpatLacosamide will be titrated starting from visit 1 for 2 weeks (50mg bid) and maintained at 100mg bid for the rest of the study period. | Drug | Lacosamide Open-Label |
Primary outcome
Changes in Cognitive test scores
Time frame: 30 weeks
Changes in the composite measure of the cognitive test scores and in the composite measure of the mood/Quality Of Life scores from baseline (visit 1) to scores recorded at termination (visit 4).
1 secondary outcome
Relationship of Cognitive test scores with Seizure severity ,A-B Neurotoxicity,Adverse Events and Lacosamide Dosage
Time frame: 30 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
- Derived from this study: PubMed 27315132Lancman ME, Fertig EJ, Trobliger RW, Perrine K, Myers L, Iyengar SS, Malik M. The effects of lacosamide on cognition, quality-of-life measures, and quality of life in patients with refractory partial epilepsy. Epilepsy Behav. 2016 Aug;61:27-33. doi: 10.1016/j.yebeh.2016.04.049. Epub 2016 Jun 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcelo Lancman, MD principal investigator
Northeast Regional Epilepsy Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lacosamide in people with Epilepsy, run by Evan Fertig at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Cognitive test scores (time frame: 30 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01175954, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2017.