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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022534-84 | EudraCT Number |
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Slow progress despite recruitment boosting efforts e.g., expert advice obtained from leading study center Investigators; decision thus made to terminate.
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The purpose of the trial is to investigate whether changes in lipids and hormonal parameters can be observed in blood when Carbamazepine treatment is replaced with Lacosamide treatment, while Levetiracetam treatment remains unchanged.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lacosamide | Experimental | commercial 50 mg (pinkish) and 100 mg (yellow) tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lacosamide | Drug | 4-Week Titration Period: start dose Lacosamide (LCM) is 100 mg/day - up-titration of 100 mg/week LCM 8-Week Maintenance Period: dose can change first 4 weeks with 100 mg/week, must remain between 300 mg/day and 600 mg/day. Dose must remain stable last 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum Sex Hormone Binding Globulin (SHBG) From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period) | Due to premature termination of enrollment prior to achieving the planned sample size (a total of 28 subjects), this primary safety variable was assessed for descriptive purposes only. A negative value indicates an improvement. | From Day 1 (Baseline) to Day 84 (Treatment Period End) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sex Hormone Calculated Free Androgen Index Levels From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period) | The change in sex hormone calculated free androgen index (100 x Testosterone/sex hormone binding globulin) levels from Baseline to the end of Maintenance Period was summarized descriptively by visit. A negative value indicates an improvement. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 11 | Innsbruck | Austria | ||||
| 12 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27423106 | Derived | Elger CE, Rademacher M, Brandt C, Elmoufti S, Dedeken P, Eckhardt K, Tennigkeit F, De Backer M. Changes in hormone and lipid levels in male patients with focal seizures when switched from carbamazepine to lacosamide as adjunctive treatment to levetiracetam: A small phase IIIb, prospective, multicenter, open-label trial. Epilepsy Behav. 2016 Sep;62:1-5. doi: 10.1016/j.yebeh.2016.05.023. Epub 2016 Jul 15. |
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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The study consisted of a 1-week Screening Period, a 12-week Treatment Period (comprised of a 4-week Titration Period and an 8-week Maintenance Period), and a Taper/Safety Follow-Up Period 3 to 4 weeks in duration.
The study was conducted at 5 sites across Austria (1 site), Germany (3 sites), and Spain (1 site).
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| ID | Title | Description |
|---|---|---|
| FG000 | Lacosamide | commercial 50 mg (pinkish) and 100 mg (yellow) tablets
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Baseline Analysis Population refers to the Safety Set (SS). The SS consists of all patients who received at least 1 dose of Lacosamide.
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| ID | Title | Description |
|---|---|---|
| BG000 | Lacosamide | commercial 50 mg (pinkish) and 100 mg (yellow) tablets
|
| 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 | Change in Serum Sex Hormone Binding Globulin (SHBG) From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period) | Due to premature termination of enrollment prior to achieving the planned sample size (a total of 28 subjects), this primary safety variable was assessed for descriptive purposes only. A negative value indicates an improvement. | The Analysis Population refers to the Safety Set (SS). The SS consists of all subjects who received at least 1 dose of Lacosamide. | Posted | Median | Full Range | nmol/L | From Day 1 (Baseline) to Day 84 (Treatment Period End) |
|
Treatment Emergent Adverse Event were reported from Baseline until the Safety Follow-up Visit (two weeks after end of Treatment Period).
Only Treatment Emergent Adverse Events are presented.
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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 | commercial 50 mg (pinkish) and 100 mg (yellow) tablets
|
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA 16.1 | Non-systematic Assessment |
The results of this study are limited due to the small sample size.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB Clinical Trial Call Center | UCB | +1 877 822 9493 |
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| ID | Term |
|---|---|
| D004828 | Epilepsies, Partial |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| 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 | Levetiracetam (LEV) is taken at a stable dose 30 days before study entry and is ≥ 1000 mg/day at the first visit. The LEV dose may not be changed at any time. |
|
|
| From Day 1 (Baseline) to Day 84 (Treatment Period End) |
| Change in Serum Thyroid Hormone Free Thyroxine Level From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period) | The change in the serum thyroid hormone free thyroxine level from Baseline to the end of the Maintenance Period was summarized descriptively by visit. | From Day 1 (Baseline) to Day 84 (Treatment Period End) |
| Change in Total Cholesterol Level From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period) | The change in total cholesterol levels from Baseline to the end of the Maintenance Period was summarized descriptively by visit. A negative value indicates an improvement. | From Day 1 (Baseline) to Day 84 (Treatment Period End) |
| Salzburg |
| Austria |
| 2 | Bielefeld | Germany |
| 1 | Bonn | Germany |
| 5 | Erlangen | Germany |
| 22 | Alcorcón | Spain |
| 20 | Santiago de Compostela | Spain |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Weight | Mean | Standard Deviation | kilograms |
|
| Height | Mean | Standard Deviation | centimeters |
|
| Body Mass Index | Mean | Standard Deviation | kilogram per square meter |
|
|
|
| Secondary | Change in Sex Hormone Calculated Free Androgen Index Levels From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period) | The change in sex hormone calculated free androgen index (100 x Testosterone/sex hormone binding globulin) levels from Baseline to the end of Maintenance Period was summarized descriptively by visit. A negative value indicates an improvement. | The Analysis Population refers to the Safety Set (SS). The SS consists of all subjects who received at least 1 dose of Lacosamide. | Posted | Median | Full Range | Free Androgen Index | From Day 1 (Baseline) to Day 84 (Treatment Period End) |
|
|
|
| Secondary | Change in Serum Thyroid Hormone Free Thyroxine Level From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period) | The change in the serum thyroid hormone free thyroxine level from Baseline to the end of the Maintenance Period was summarized descriptively by visit. | The Analysis Population refers to the Safety Set (SS). The SS consists of all subjects who received at least 1 dose of Lacosamide. | Posted | Median | Full Range | pmol/L | From Day 1 (Baseline) to Day 84 (Treatment Period End) |
|
|
|
| Secondary | Change in Total Cholesterol Level From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period) | The change in total cholesterol levels from Baseline to the end of the Maintenance Period was summarized descriptively by visit. A negative value indicates an improvement. | The Analysis Population refers to the Safety Set (SS). The SS consists of all subjects who received at least 1 dose of Lacosamide. | Posted | Median | Full Range | mmol/L | From Day 1 (Baseline) to Day 84 (Treatment Period End) |
|
|
|
| 0 |
| 11 |
| 5 |
| 11 |
| Bronchitis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Partial seizures | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Aggression | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 16.1 | Non-systematic Assessment |
|
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |