This is the current release of the guideline.

Definitions of the strength of the recommendations (A, B, C, U) and classification of the evidence (Class I through Class IV) are provided at the end of the "Major Recommendations" field.

Effectiveness of New Antiepileptic Drugs (AEDs) in Refractory Partial Epilepsy as Adjunctive Therapy

1. It is appropriate to use gabapentin, lamotrigine, tiagabine, topiramate, oxcarbazepine, levetiracetam, and zonisamide as add-on therapy in patients with refractory epilepsy (Level A) (Please refer to the table below titled "Summary of American Academy of Neurology (AAN) Evidence-Based Guidelines Level A or B Recommendation for Use").

   Note: In a previous AAN parameter, felbamate was recommended for "intractable partial seizures in patients over 18 years who had failed standard AEDs."

Effectiveness of New AEDs as Monotherapy in Patients with Refractory Partial Epilepsy

1. Oxcarbazepine and topiramate can be used as monotherapy in patients with refractory partial epilepsy (Level A).
2. Lamotrigine can be used as monotherapy in patients with refractory partial epilepsy (Level B, downgraded due to dropouts).
3. There is insufficient evidence to recommend use of gabapentin, levetiracetam, tiagabine, or zonisamide in monotherapy for refractory partial epilepsy (Level U) (Please refer to the table below titled "Summary of AAN Evidence-Based Guidelines Level A or B Recommendation for Use").

Effectiveness of New AEDs in Patients with Refractory Idiopathic Generalized Epilepsy

1. Topiramate may be used for the treatment of refractory generalized tonic-clonic seizures in adults and children (Level A).
2. There is insufficient evidence to recommend gabapentin, lamotrigine, oxcarbazepine, tiagabine, levetiracetam, or zonisamide for the treatment of refractory generalized tonic-clonic seizures in adults and children (Level U) (Please refer to the table below titled "Summary of AAN Evidence-Based Guidelines Level A or B Recommendation for Use").

Effectiveness of New AEDs in Refractory Partial Epilepsy as Adjunctive in Children

1. Gabapentin, lamotrigine, oxcarbazepine, and topiramate may be used as adjunctive treatment of children with refractory partial seizures (Level A) (Please refer to the table below titled "Summary of AAN Evidence-Based Guidelines Level A or B Recommendation for Use").
2. There is insufficient evidence to recommend levetiracetam, tiagabine, or zonisamide as adjunctive treatment of children with refractory partial seizures (Level U) (Please refer to the table below titled "Summary of AAN Evidence-Based Guidelines Level A or B Recommendation for Use").

Effectiveness of New AEDs as Mono-therapy in Children with Refractory Partial Seizures

No monotherapy trials have been performed in this population.

Effectiveness of New AEDs for Refractory Idiopathic Generalized Epilepsy in Children

Studies of topiramate and gabapentin in idiopathic generalized tonic-clonic convulsions already discussed above included children as well.

Effectiveness of New AEDs in Children and/or Adults with the Lennox-Gastaut Syndrome

1. Topiramate and lamotrigine may be used to treat drop attacks associated with the Lennox Gastaut syndrome in adults and children (Level A) (Please refer to the table below titled "Summary of AAN Evidence-Based Guidelines Level A or B Recommendation for Use").

   Note: In a previous AAN parameter, felbamate was recommended in "Lennox-Gastaut patients over age 4 unresponsive to primary AEDs."

Table: Summary of AAN Evidence-Based Guidelines Level A or B Recommendation for Use**

*Not Food and Drug Administration approved for this indication

**In a previous parameter, felbamate was recommended for intractable partial seizures in patients over age 18 and patients over 4 with the Lennox-Gastaut syndrome. Felbamate is associated with significant and specific risks, and risk-benefit ratio must be considered.

Definitions:

Rating of Recommendations

A = Established as effective, ineffective, or harmful for the given condition in the specified population.

B = Probably effective, ineffective, or harmful for the given condition in the specified population.

C = Possibly effective, ineffective, or harmful for the given condition in the specified population.

U = Data inadequate or conflicting; given current knowledge, treatment is unproven.

Translation of Evidence to Recommendations

Level A rating requires at least one convincing class I study or at least two consistent, convincing class II studies.

Level B rating requires at least one convincing class II study or at least three consistent class III studies.

Level C rating requires at least two convincing and consistent class III studies.

Rating of Therapeutic Article

Class I: Prospective, randomized, controlled clinical trial (RCT) with masked outcome assessment, in a representative population. The following are required:

1. Primary outcome(s) is/are clearly defined.
2. Exclusion/inclusion criteria are clearly defined.
3. Adequate accounting for dropouts and crossovers with numbers sufficiently low to have minimal potential for bias.
4. Relevant baseline characteristics are presented and substantially equivalent among treatment groups or there is appropriate statistical adjustment for differences.

Class II: Prospective matched group cohort study in a representative population with masked outcome assessment that meets a–d above OR a RCT in a representative population that lacks one criterion a–d.

Class III: All other controlled trials (including well-defined natural history controls or patients serving as own controls) in a representative population, where outcome assessment is independent of patient treatment.

Class IV: Evidence from uncontrolled studies, case series, case reports, or expert opinion.

None provided

The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations").

Not applicable: The guideline was not adapted from another source.

2004 Apr 27

American Academy of Neurology - Medical Specialty Society

American Academy of Neurology (AAN)

Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology

Quality Standards Subcommittee of the American Academy of Neurology

American Epilepsy Society Guidelines Task Force

American Academy of Neurology (AAN) Therapeutics and Technology Assessment Subcommittee Members: Douglas Goodin, MD (chair); Yuen So, MD, PhD (vice-chair); Carmel Armon, MD, MHS; Richard Dubinsky, MD; Mark Hallett, MD; David Hammond, MD; Chung Hsu, MD, PhD; Andres Kanner, MD; David Lefkowitz, MD; Janis Miyasaki, MD; Michael Sloan, MD; James Stevens, MD

AAN Quality Standards Subcommittee Members: Gary Franklin, MD, MPH (co-chair); Gary Gronseth, MD (co-chair); Charles Argoff, MD; Christopher Bever, Jr., MD; Jody Corey-Bloom, MD, PhD; John England, MD; Gary Friday, MD; Michael Glantz, MD; Deborah Hirtz, MD; Donald Iverson, MD; David Thurman, MD; Samuel Wiebe, MD; William Weiner, MD; Stephen Ashwal, MD; Jacqueline French, MD; Catherine Zahn, MD

American Epilepsy Society Guidelines Task Force Members: Jacqueline French, MD; Andres Kanner, MD; Mimi Callanan, RN; Jim Cloyd, PhD; Pete Engel, MD, PhD; Ilo Leppik, MD; Martha Morrell, MD; Shlomo Shinnar, MD, PhD

Members did not review a given antiepileptic drug (AED) if they had served as advisors for the pharmaceutical company that manufactured the drug and/or if they had been awarded a research grant from that company (participation in multicenter studies was not a reason for exclusion) or if they had financial interests in that company (stock ownership or employee).

This is the current release of the guideline.

This NGC summary was completed by ECRI on August 17, 2004. The information was verified by the guideline developer on September 9, 2004. This summary was updated by ECRI on April 21, 2005 following the release of a public health advisory from the U.S. Food and Drug Administration (FDA) regarding Trileptal (oxcarbazepine). This summary was updated by ECRI on November 15, 2006, following the FDA advisory on Lamictal (lamotrigine).

This NGC summary is based on the original guideline, which is copyrighted by the American Academy of Neurology.