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Add on Lacosamide Versus High Dose Monotherapy
Phase 3 trial testing lacosamide in Epilepsy in 56 participants. Completed in 21 October 2014.
| Lead sponsor | Brigham and Women's Hospital |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 56 |
| Start date | 1 August 2011 |
| Primary completion | 15 February 2014 |
| Estimated completion | 21 October 2014 |
| Sites | 1 location across United States |
Brigham and Women's Hospital
18 and older, any sex, with Epilepsy. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Seizure freedom is defined as having no seizures and was evaluated in the 6 month period after receiving the drug.
| Group | Value | 95% CI |
|---|---|---|
| Lacosamide + Low-Dose Levetiracetam | 47.4 | |
| Control Group (High-Dose Levetiracetam) | 41.7 |
| Group | Value | 95% CI |
|---|---|---|
| Lacosamide + Low-Dose Levetiracetam | 118.11 | ± 68.59 |
| Control Group (High-Dose Levetiracetam) | 114.0 | ± 65.06 |
Time in days until the first seizure after the therapeutic dose is reached occurs.
| Group | Value | 95% CI |
|---|---|---|
| Lacosamide + Low-Dose Levetiracetam | 162.0 | 9.0 – 180.0 |
| Control Group (High-Dose Levetiracetam) | 116.5 | 6.0 – 180.0 |
Retention rate is defined as the percentage of participants who remained on the study drug after study completion.
| Group | Value | 95% CI |
|---|---|---|
| Lacosamide + Low-Dose Levetiracetam | 89 | |
| Control Group (High-Dose Levetiracetam) | 80 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Lacosamide + Low-Dose Levetiracetam | 11 | |
| Control Group (High-Dose Levetiracetam) | 26 |
Time frame: 6 Months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Lacosamide + Low-Dose Leve… | Control Group (High-Dose L… |
|---|---|---|---|
| Irritability/depression | Psychiatric disorders | — | — |
| Fatigue | General disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Memory/cognitive difficulties/confusion | Psychiatric disorders | — | — |
| Erectile dysfunction | Reproductive system and breast disorders | — | — |
| Hair Loss | Skin and subcutaneous tissue disorders | — | — |
| Itching | Skin and subcutaneous tissue disorders | — | — |
| Insomnia | Psychiatric disorders | — | — |
| Decreased libido | Reproductive system and breast disorders | — | — |
| Bradycardia | Cardiac disorders | — | — |
Data from ClinicalTrials.gov NCT01345058 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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