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## Complete Summary

#### GUIDELINE TITLE

Efficacy and tolerability of the new antiepileptic drugs II: treatment
of refractory epilepsy: report of the Therapeutics and Technology
Assessment Subcommittee and Quality Standards Subcommittee of the
American Academy of Neurology and the American Epilepsy Society.

#### BIBLIOGRAPHIC SOURCE(S)

French JA, Kanner AM, Bautista J, Abou-Khalil B, Browne T, Harden CL,
Theodore WH, Bazil C, Stern J, Schachter SC, Bergen D, Hirtz D,
Montouris GD, Nespeca M, Gidal B, Marks WJ Jr, Turk WR, Fischer JH,
Bourgeois B, et al. Efficacy and tolerability of the new antiepileptic
drugs II: treatment of refractory epilepsy: report of the Therapeutics
and Technology Assessment Subcommittee and Quality Standards
Subcommittee of the American Academy of Neurology and the AES.
Neurology 2004 Apr 27;62(8):1261-73. \[83 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15111660)

#### GUIDELINE STATUS

This is the current release of the guideline.

### \*\* REGULATORY ALERT \*\*

#### FDA WARNING/REGULATORY ALERT

**Note from the National Guideline Clearinghouse**: This guideline
references a drug(s) for which important revised regulatory information
has been released.

-   [September 29, 2006, Lamictal
    (lamotrigine)](http://www.fda.gov/medwatch/safety/2006/safety06.htm#Lamictal):
    New preliminary information available regarding the effects of
    Lamictal on the baby if taken during the first three months of
    pregnancy.

-   [April 19, 2005, Trileptal
    (oxcarbazepine)](http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#triletpal):
    Revisions to the WARNINGS and PRECAUTIONS sections of the
    prescribing information. The updated WARNINGS section describes
    serious dermatological reactions in children and adults, and the
    PRECAUTIONS section has been updated to include language regarding
    multi-organ hypersensitivity reactions.

### COMPLETE SUMMARY CONTENT

 \*\* REGULATORY ALERT \*\*\
 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

-   Refractory partial epilepsy

-   Refractory idiopathic generalized epilepsy

-   Lennox-Gastaut syndrome

#### GUIDELINE CATEGORY

Assessment of Therapeutic Effectiveness\
Treatment

#### CLINICAL SPECIALTY

Neurology\
Pediatrics\
Pharmacology

#### INTENDED USERS

Physicians

#### GUIDELINE OBJECTIVE(S)

To assess the evidence demonstrating efficacy, tolerability, and safety
of seven new antiepileptic drugs (AEDs) (gabapentin, lamotrigine,
topiramate, tiagabine, oxcarbazepine, levetiracetam, and zonisamide) in
the treatment of children and adults with refractory partial and
generalized epilepsies

#### TARGET POPULATION

Children and adults with refractory partial and generalized epilepsies

#### INTERVENTIONS AND PRACTICES CONSIDERED

**Treatment**

1.  Gabapentin (Neurontin)

2.  Lamotrigine (Lamictal)

3.  Topiramate (Topamax)

4.  Tiagabine (Gabitril)

5.  Oxcarbazepine (Trileptal)

6.  Levetiracetam (Keppra)

7.  Zonisamide (Zonegran)

#### MAJOR OUTCOMES CONSIDERED

-   Time to first seizure

-   Percentage of patients rendered seizure free

-   Time to exit of the study due to lack of efficacy or adverse events

-   Incidence of adverse events

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Hand-searches of Published Literature (Primary Sources)\
Hand-searches of Published Literature (Secondary Sources)\
Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

A literature search was performed including MEDLINE and Current Contents
for relevant articles from 1987 until September 2001. A second hand
search was performed by panel members, covering September 2001 to May
2002. A hand search for class I articles was updated to March 2003. In
addition, the Cochrane library of randomized controlled trials in
epilepsy was searched in September 2002, and any appropriate articles
identified were added to the review.

**Criteria for Selection of Articles**

The literature search identified all articles that included the terms
epilepsy and one of the following: gabapentin, lamotrigine,
levetiracetam, oxcarbazepine, tiagabine, topiramate, and zonisamide: 1)
relevant to the clinical questions of efficacy, safety, tolerability,
mode of use; 2) human subjects only; 3) type of studies: randomized
controlled trials, cohort, case control, observational, case series; 4)
all languages for randomized controlled trials not available in English.

**Exclusion Criteria**

Reviews and meta-analyses, articles related to non-epilepsy uses of AEDs
unless they describe relevant idiosyncratic reactions or safety
concerns, and articles on basic AED mechanisms were excluded.

A total of 1,462 articles were identified: 240 on gabapentin, 433 on
lamotrigine, 244 on topiramate, 17 on levetiracetam, 212 on
oxcarbazepine, 177 on tiagabine, and 146 on zonisamide. Among these,
data were extracted for classification of evidence class from 353
articles: 91 on gabapentin, 63 on lamotrigine, 65 on topiramate, 46 on
tiagabine, 45 on oxcarbazepine, 33 on zonisamide, and 11 on
levetiracetam. Articles were then broken down into those relevant to
refractory epilepsy and those relevant to newly diagnosed epilepsy,
which are presented in a separate parameter.

#### NUMBER OF SOURCE DOCUMENTS

All relevant articles were included, for a total of 82.

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Weighting According to a Rating Scheme (Scheme Given)

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

**Rating of Therapeutic Article**

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

a.  Primary outcome(s) is/are clearly defined.

b.  Exclusion/inclusion criteria are clearly defined.

c.  Adequate accounting for dropouts and crossovers with numbers
    sufficiently low to have minimal potential for bias.

d.  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.

#### METHODS USED TO ANALYZE THE EVIDENCE

Systematic Review

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

The panel assessed efficacy and dose-related side effects from
double-blind controlled studies with 20 or more patients. Safety data
were also derived from open trials and case reports.

Data of each antiepileptic drug (AED) were reviewed by three panel
members (a different group for each drug). The panelists classified each
article as class I through IV (See above \"Rating Scheme for the
Strength of the Evidence\"). Disagreements on article classification
were resolved by discussion and consensus.

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Other

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

When formulating the recommendations the guideline developers considered
the *magnitude* of the effect (benefit or harm of therapy, accuracy of
tests, yield of studies) and the relative *value* of various outcomes.
Under most circumstances, there is a direct link between the level of
evidence used to formulate conclusions and the strength of the
recommendation. This linkage is illustrated in Appendix 9 of the 2004
AAN Guideline Process Manual (see Companion Documents field). Thus, an
\"established as\" (two class I) conclusion supports a \"should be
done\" (level A) recommendation; a \"probably effective\" (two class II)
conclusion supports a \"should be considered\" (level B) recommendation;
a \"possibly effective\" (two class III) conclusion supports a \"may be
considered\" recommendation. In those circumstances where the evidence
indicates that the intervention is not effective or useful, wording was
modified. For example, if multiple adequately powered class I studies
demonstrated that an intervention is not effective, the recommendation
read, \"should not be done.\"

There are important exceptions to the rule of having a direct linkage
between the level of evidence and the strength of recommendations. Some
situations where it may be necessary to break this linkage are listed
below:

-   A statistically significant but marginally important benefit of the
    intervention is observed

-   The intervention is exorbitantly costly

-   Superior and established alternative interventions are available

-   There are competing outcomes (both beneficial and harmful) that
    cannot be reconciled

Under such circumstances the guideline developers may have downgraded
the level of the recommendation.

Edlund W, Gronseth G, So Y, Franklin G. Clinical practice guideline
process manual. St. Paul (MN): American Academy of Neurology (AAN);
2004. 49 p.

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

**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.

#### COST ANALYSIS

A formal cost analysis was not performed and published cost analyses
were not reviewed.

#### METHOD OF GUIDELINE VALIDATION

External Peer Review\
Internal Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

Guidelines were approved by the Quality Standards Subcommittee (QSS) on
July 26, 2003, the Therapeutics and Technology Assessment Subcommittee
(TTA) on October 17, 2003, the Practice Committee on November 16, 2003,
and the American Academy of Neurology (AAN) Board of Directors on
January 18, 2004.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

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\*\***

  ------------------------------------------------------------------------------------------
  **Drug**        **Partial    **Partial       **Primary       **Symptomatic   **Pediatric
                  adjunctive   monotherapy**   generalized**   generalized**   partial**
                  adult**                                                      
  --------------- ------------ --------------- --------------- --------------- -------------
  Gabapentin      Yes          No              No              No              Yes

  Lamotrigine     Yes          Yes             No              Yes             Yes

  Topiramate      Yes          Yes\*           Yes (only       Yes             Yes
                                               generalized                     
                                               tonic-clonic)                   

  Tiagabine       Yes          No              No              No              No

  Oxcarbazepine   Yes          Yes             No              No              Yes

  Levetiracetam   Yes          No              No              No              No

  Zonisamide      Yes          No              No              No              No
  ------------------------------------------------------------------------------------------

\*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]{.underline}**:

**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:

a.  Primary outcome(s) is/are clearly defined.

b.  Exclusion/inclusion criteria are clearly defined.

c.  Adequate accounting for dropouts and crossovers with numbers
    sufficiently low to have minimal potential for bias.

d.  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.

#### CLINICAL ALGORITHM(S)

None provided

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

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

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

This assessment provides clinicians with evidence-based data on the
efficacy, safety, and mode of use of these seven new anti-epileptic
drugs, which can facilitate their choice of the appropriate drug in the
management of children and adults with refractory partial seizure
disorders, primary generalized epilepsy, and the Lennox-Gastaut
syndrome.

#### POTENTIAL HARMS

-   The Food and Drug Administration (FDA) has categorized antiepileptic
    drug (AED) medications into two classes, D and C. Category C drugs
    have demonstrated teratogenicity in animals, but human risk is not
    known. The newer AEDs are classified as Category C. In contrast,
    phenytoin, carbamazepine, and valproic acid are category D. Category
    D drugs are those drugs for which teratogenicity was seen in both
    animal and human pregnancies. In both categories, the recommendation
    remains the same: selection of AED in pregnancy should be decided
    upon risk-benefit ratio.

-   Adverse effects of AEDs: The adverse effects of the specific AEDs
    reviewed for this assessment are discussed in the original guideline
    document.

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

-   The guideline subcommittee recognizes that these drugs are not
    antiepileptic but antiseizure drugs. However, they chose to use the
    term antiepileptic drugs (AEDs), given its widespread use among all
    clinicians.

-   Selection of the appropriate drug for a given individual must be
    based on understanding of each drug´s pharmacology, side effect
    profile, and risks.

-   This parameter is the second in a two-part assessment of the new
    AEDs. Part I addresses the use of new AEDs in newly diagnosed
    epilepsy patients. Referral should be made to that article for
    background information on the older AEDs.

-   This statement is provided as an educational service of the American
    Academy of Neurology (AAN). It is based on an assessment of current
    scientific and clinical information. It is not intended to include
    all possible proper methods of care for a particular neurologic
    problem or all legitimate criteria for choosing to use a specific
    procedure. Neither is it intended to exclude any reasonable
    alternative methodologies. The AAN recognizes that specific patient
    care decisions are the prerogative of the patient and the physician
    caring for the patient, based on all of the circumstances involved.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

#### IMPLEMENTATION TOOLS

Patient Resources\
Personal Digital Assistant (PDA) Downloads\
Quick Reference Guides/Physician Guides\
Slide Presentation

For information about
[availability](#identifying-information-and-availability), see the
\"Availability of Companion Documents\" and \"Patient Resources\" fields
below.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Living with Illness

#### IOM DOMAIN

Effectiveness\
Patient-centeredness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

French JA, Kanner AM, Bautista J, Abou-Khalil B, Browne T, Harden CL,
Theodore WH, Bazil C, Stern J, Schachter SC, Bergen D, Hirtz D,
Montouris GD, Nespeca M, Gidal B, Marks WJ Jr, Turk WR, Fischer JH,
Bourgeois B, et al. Efficacy and tolerability of the new antiepileptic
drugs II: treatment of refractory epilepsy: report of the Therapeutics
and Technology Assessment Subcommittee and Quality Standards
Subcommittee of the American Academy of Neurology and the AES.
Neurology 2004 Apr 27;62(8):1261-73. \[83 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15111660)

#### ADAPTATION

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

#### DATE RELEASED

2004 Apr 27

#### GUIDELINE DEVELOPER(S)

American Academy of Neurology - Medical Specialty Society

#### SOURCE(S) OF FUNDING

American Academy of Neurology (AAN)

#### GUIDELINE COMMITTEE

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

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*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

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

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).

#### GUIDELINE STATUS

This is the current release of the guideline.

#### GUIDELINE AVAILABILITY

Electronic copies: A list of American Academy of Neurology (AAN)
guidelines, along with a link to a Portable Document Format (PDF) file
for this guideline, is available at the [AAN Web
site](http://aan.com/go/practice/guidelines).

Print copies: Available from the AAN Member Services Center, (800)
879-1960, or from AAN, 1080 Montreal Avenue, St. Paul, MN 55116.

#### AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

-   Efficacy and tolerability of the new antiepileptic drugs, II:
    treatment of refractory epilepsy. AAN guideline summary for
    clinicians. St. Paul (MN): American Academy of Neurology. 2. p.
    Available in Portable Document Format (PDF) from the [American
    Academy of Neurology (AAN) Web
    site](http://aan.com/professionals/practice/pdfs/clinician_ep_refractory_e.pdf).

-   Practice parameter: efficacy and tolerability of the new
    antiepileptic drugs II: treatment of refractory epilepsy. St. Paul
    (MN): American Academy of Neurology. 2004. 18 p. Available for
    personal digital assistant (PDA) download from the [AAN Web
    site](http://www.aan.com/professionals/practice/guidelines/pda/Antiepileptic_refractory_epilepsy.pdf).

-   Slide presentation: efficacy and tolerability of the new
    antiepileptic drugs I: treatment of new onset epilepsy. St. Paul
    (MN): American Academy of Neurology. 2004. Available in Power Point
    from the [AAN Web
    site](http://aan.com/professionals/practice/guidelines/pwr_pnt/New_AEDs_refr_epil.ppt).

-   AAN guideline development process \[online\]. St. Paul (MN):
    American Academy of Neurology (AAN). Available from the [AAN Web
    site](http://www.aan.com/professionals/practice/development.cfm).

-   Edlund W, Gronseth G, So Y, Franklin G. Clinical practice guideline
    process manual. St. Paul (MN): American Academy of Neurology
    (AAN); 2004. 49 p. Electronic copies available in Portable Document
    Format (PDF) from the [AAN Web
    site](http://www.aan.com/globals/axon/assets/2535.pdf).

#### PATIENT RESOURCES

The following is available:

Efficacy and tolerability of the new antiepileptic drugs for treatment
of refractory epilepsy: AAN guideline summary for patients and their
families. St. Paul (MN): American Academy of Neurology (AAN). 2 p.

Electronic copies: Available in Portable Document Format (PDF) from the
[AAN Web
site](http://aan.com/professionals/practice/pdfs/patient_ep_refract_c.pdf).

Please note: This patient information is intended to provide health
professionals with information to share with their patients to help them
better understand their health and their diagnosed disorders. By
providing access to this patient information, it is not the intention of
NGC to provide specific medical advice for particular patients. Rather
we urge patients and their representatives to review this material and
then to consult with a licensed health professional for evaluation of
treatment options suitable for them as well as for diagnosis and answers
to their personal medical questions. This patient information has been
derived and prepared from a guideline for health care professionals
included on NGC by the authors or publishers of that original guideline.
The patient information is not reviewed by NGC to establish whether or
not it accurately reflects the original guideline\'s content.

#### NGC STATUS

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).

#### COPYRIGHT STATEMENT

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

### DISCLAIMER

#### NGC DISCLAIMER

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<http://www.guideline.gov/about/inclusion.aspx> .

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Date Modified: 11/3/2008