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This is a study to determine whether a combination of low dose lacosamide and levetiracetam is more effective than high dose levetiracetam in patients who have failed low dose levetiracetam.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lacosamide + Low-Dose Levetiracetam | Experimental | Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam. |
|
| Control Group (High-Dose Levetiracetam) | Other | Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam >1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lacosamide | Drug | Lacosamide maximum of 200 mg/day, to be titrated as follows:
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Six Month Seizure Freedom | Seizure freedom is defined as having no seizures and was evaluated in the 6 month period after receiving the drug. | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Seizure-Free Days | 6 Months | |
| Time to First Seizure After Therapeutic Dose is Reached | Time in days until the first seizure after the therapeutic dose is reached occurs. | 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jong Woo Lee, MD, PhD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26992155 | Result | Lee JW, Alam J, Llewellyn N, Hurwitz S, Bubrick EB, Sarkis RA, Weisholtz D, Yu H, Putta S, Dworetzky BA, Pennell PB. Open Label Trial of Add on Lacosamide Versus High Dose Levetiracetam Monotherapy in Patients With Breakthrough Seizures. Clin Neuropharmacol. 2016 May-Jun;39(3):128-31. doi: 10.1097/WNF.0000000000000144. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lacosamide + Low-Dose Levetiracetam | Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam. |
| FG001 | Control Group (High-Dose Levetiracetam) | Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam >1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Lacosamide + Low-Dose Levetiracetam | Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam. |
| BG001 | Control Group (High-Dose Levetiracetam) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Achieving Six Month Seizure Freedom | Seizure freedom is defined as having no seizures and was evaluated in the 6 month period after receiving the drug. | All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis. | Posted | Number | percentage of participants | 6 Months |
|
6 Months
All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis. One participant never confirmed taking the study medication, never followed up, and was not included in the analysis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lacosamide + Low-Dose Levetiracetam | Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hair Loss | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jong Woo Lee, MD, PhD | Brigham and Women's Hospital | JLEE38@BWH.HARVARD.EDU |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000078334 | Lacosamide |
| D000077287 | Levetiracetam |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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|
| levetiracetam | Drug | Low dose ≤1500 mg/day, High dose >1500 mg/day |
|
| Retention Rate | Retention rate is defined as the percentage of participants who remained on the study drug after study completion. | 6 Months |
| Number of Participants With Treatment-Emergent Adverse Events (TEAE) | An Adverse Event (AE) is defined as any untoward medical occurrence (side effect) in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event that occurs after receiving the drug. | 6 Months |
| Side Effects of Hair Loss and Itchiness |
|
| Participant Stopped Taking Study Drug |
|
| Participant No-Show at Multiple Visits |
|
Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam >1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam >1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study. |
|
|
|
| Secondary | Number of Seizure-Free Days | All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis. | Posted | Mean | Standard Deviation | days | 6 Months |
|
|
|
| Secondary | Time to First Seizure After Therapeutic Dose is Reached | Time in days until the first seizure after the therapeutic dose is reached occurs. | All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis. | Posted | Median | Full Range | days | 6 Months |
|
|
|
| Secondary | Retention Rate | Retention rate is defined as the percentage of participants who remained on the study drug after study completion. | All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis. | Posted | Number | percentage of participants | 6 Months |
|
|
|
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAE) | An Adverse Event (AE) is defined as any untoward medical occurrence (side effect) in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event that occurs after receiving the drug. | All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included. One participant never confirmed taking the study medication, never followed up, and was not included in the analysis. | Posted | Count of Participants | Participants | 6 Months |
|
|
|
| 0 |
| 18 |
| 11 |
| 18 |
| EG001 | Control Group (High-Dose Levetiracetam) | Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam >1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study. | 0 | 36 | 26 | 36 |
| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Irritability/depression | Psychiatric disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Memory/cognitive difficulties/confusion | Psychiatric disorders | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Decreased libido | Reproductive system and breast disorders | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | Systematic Assessment |
|
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| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |