Childhood Absence EpilepsyPhase 3NCT00088452
Childhood Absence Epilepsy Rx PK-PD-Pharmacogenetics Study
A Phase 3 study testing Ethosuximide, Lamotrigine and Valproic acid in people with Childhood Absence Epilepsy and Petit Mal Epilepsy, run by Children's Hospital Medical Center, Cincinnati at 31 sites in United States.
Trial summary
The purpose of this study is to determine the best initial treatment for childhood absence epilepsy. Read more about this study
- Who is it for?
- Ages 30 months to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Absence Epilepsy, Petit Mal Epilepsy, Epilepsy
- What is being tested?
- Ethosuximide, Lamotrigine and Valproic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 453 participants
- Where
- 31 sitesUnited States
- Study dates
- Jul 2004to 31 Aug 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 months to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Diagnosis: Clinical diagnosis of Childhood Absence Epilepsy consistent with the International League against Epilepsy Proposal for Revised Classification of Epilepsies and Epileptic Syndromes (3).
- EEG: Interictal EEG demonstrating bilateral synchronous symmetrical approximate 3 Hz spike waves on a normal background with at least one burst lasting >/= (greater than or equal to) 3 seconds.
- Age > 2.5 years and < 13 years of age at study entry.
- Body weight >/= (greater than or equal to) 10 kilograms.
- Body Mass Index: BMI for age =/< 99th percentile (based on the CDC BMI for age growth curves for boys/girls [http://www.cdc.gov/growthcharts], Appendix 1).
- Hepatic:
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- AST/ALT < 2.5 times the upper limit of normal
- Total bilirubin < 1.5 times the upper limit of normal.
- Hematologic:
- Absolute neutrophil count >/= (greater than or equal to) 1500/mm3.
- Platelets >/= (greater than or equal to) 120, 000 /mm3.
- Female subjects must be premenarchal at the time of enrollment and must be willing to practice abstinence for the duration of the study.
- Parent/legal guardian(s) willing to sign an IRB approved informed consent.
- Subject assent (when appropriate and as dictated by local IRB).
Who cannot join
- Treatment for CAE with anti-seizure medications (AED) for a period of greater than 7 days prior to randomization.
- History of a major psychiatric disease (e.g., psychosis, major depression).
- History of autism or pervasive development disorder.
- History of non-febrile seizures other than typical absence seizures. This includes a history of an afebrile generalized tonic clonic seizure.
- Clinical signs and symptoms consistent with a diagnosis of juvenile absence epilepsy or juvenile myoclonic epilepsy as delineated by the International League against Epilepsy Proposal for Revised Classification of Epilepsies and Epileptic Syndromes (3).
- History of recent or present significant or medical disease, i.e., cardiovascular, hepatic, renal, gynecologic, musculoskeletal, metabolic, or endocrine.
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- History of a severe dermatologic reaction (e.g., Stevens Johnson, toxic epidermolysis necrosis) to medication.
- Subject or parent/legal guardian might not be reasonably expected to be compliant with or to complete the study.
- Participation in a trial of an investigational drug or device within 30 days prior to screening.
- Use of systemic contraceptive for any indication, including acne.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Children's Healthcare of Atlanta
Atlanta, Georgia, 30342
The Children's Hospital of Alabama
Birmingham, Alabama, 35233
Women and Children's Hospital of Buffalo
Buffalo, New York, 14222
Children's Memorial Hospital
Chicago, Illinois, 60614
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Rainbow Babies & Children's Hospital
Cleveland, Ohio, 44106
Children's Hospital, Inc., PCTI
Columbus, Ohio, 43205
Dallas Pediatric Neurology Associates
Dallas, Texas, 75230
Children's Hospital of Denver
Denver, Colorado, 80218
Children's Hospital of Michigan
Detroit, Michigan, 48201
Cook Children's Medical Center
Fort Worth, Texas, 76104
Texas Children's Hospital
Houston, Texas, 77030
Nemours Children's Clinic
Jacksonville, Florida, 32207
University of California at San Diego
La Jolla, California, 92093
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Mattel Children's Hospital at UCLA
Los Angeles, California, 90095
LeBonheur Children's Medical Center
Memphis, Tennessee, 38103
Miami Children's Hospital
Miami, Florida, 33155
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53201-1997
Yale University School of Medicine
New Haven, Connecticut, 06520
NYU Comprehensive Epilepsy Center, Manhattan
New York, New York, 10016
Children's Hospital of The King's Daughter (Monarch Medical Research)
Norfolk, Virginia, 23510
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Doernbecher Children's Hospital
Portland, Oregon, 97239
University of Utah/Primary Children's Medical Center
Salt Lake City, Utah, 84113
Children's Hospital & Regional Medical Center
Seattle, Washington, 98105-0371
Washington University in St. Louis
St Louis, Missouri, 63110
Montefiore Medical Center
The Bronx, New York, 10467
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
The purpose of this study is to determine the best initial treatment for childhood absence epilepsy.
Read the detailed description
Childhood absence epilepsy (CAE) is a common pediatric epilepsy syndrome that affects 10 to 15 percent of all children with epilepsy. Individuals with CAE have brief staring spell seizures that occur suddenly, unpredictably, and frequently throughout the day. These seizures impair the children's ability to learn and play, and lead to higher injury rates.
There are many medications used to treat seizures, but only 3 generally are used as the first treatment for children with CAE: ethosuximide, lamotrigine, and valproic acid. The goal of this study is to determine which of these 3 medicines is the best first choice as treatment for children with CAE.
Approximately 439 children, recruited over a 3-year period at 32 medical centers in the US, will take part in this 5-year study. Participants will be randomly given one of the 3 common CAE treatments-ethosuximide, lamotrigine, or valproic acid-and will make regular visits to a clinic every 1 to 3 months for approximately 2 years. During the visits, participants will undergo regular testing to determine if the medicine is working, to watch for side effects, and to help researchers learn more about the responses to these medicines. In addition, researchers hope to develop methods that may be used in the future to help choose the best medicine for each individual diagnosed with CAE.
Also included in the study will be pharmacokinetics and pharmacogenetics research. Pharmacokinetics is the study of how the body absorbs, distributes, metabolizes, and excretes drugs. Pharmacogenetics is the study of genetic determinants of the response to drugs. Knowledge gained from this study may lead to individualized treatment for children with CAE, and may also be beneficial for other pediatric and adult seizure disorders.
- Conditions
- Childhood Absence Epilepsy, Petit Mal Epilepsy, Epilepsy, Seizures
- Being tested
- Ethosuximide, Lamotrigine, Valproic acid
- Keywords
- childhood absence epilepsy, CAE, petit mal epilepsy, epilepsy, seizures, ethosuximide, lamotrigine, valproic acid
- Medical subject headings
- Epilepsy, Absence, Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EthosuximideDrug
Also called Zarontin
Ethosuximide is a common treatment for childhood absence epilepsy.
LamotrigineDrug
Also called Lamictal
Lamotrigine is a common treatment for childhood absence epilepsy.
Valproic acidDrug
Also called Depakote
Valproic acid is a common treatment for childhood absence epilepsy.
| Study group | Role | What they receive |
|---|---|---|
| Ethosuximide | Active comparator | Ethosuximide
Frequency and Duration: twice a day, every day for the duration of the study treatment
Formulation: Two formulations were used (actual formulation used was dependent on the patient's weight and ability to swallow): 250mg Zarontin capsules OR 250 mg/5 mL Zarontin syrup
Dosing: Ethosuximide was titrated in predetermined increments every 1-2 weeks during a 16-week titration period. The titration continued until the patient a) achieved seizure freedom by clinical and EEG criteria, b) reached the maximal allowed study drug dose, c) reached the maximal tolerated dose, or d) developed dose-exiting criteria (treatment failure), whichever came first. Maximum allowed dose: 60 mg/kg/day or 2000 mg/day (whichever was lower) Receives: Drug: Ethosuximide |
| Lamotrigine | Active comparator | Lamotrigine
Frequency and Duration: twice a day, every day for the duration of the study treatment
Formulation: Three formulations were used (actual formulation used was dependent on the patient's weight): 5mg Lamictal chewable tablets OR 25 mg Lamictal chewable tablets OR 25 mg (Lamictal tablets
Dosing: Lamotrigine was titrated in predetermined increments every 1-2 weeks during a 16-week titration period. The titration continued until the patient a) achieved seizure freedom by clinical and EEG criteria, b) reached the maximal allowed study drug dose, c) reached the maximal tolerated dose, or d) developed dose-exiting criteria (treatment failure), whichever came first. Maximum allowed dose: 12 mg/kg/day or 600 mg/day (whichever was lower). Receives: Drug: Lamotrigine |
| Valproic acid | Active comparator | Valproic acid
Frequency and Duration: twice a day, every day for the duration of the study treatment
Formulation: Two formulations were used (actual formulation used was dependent on the patient's weight): 250mg Depakote capsules OR 125mg Depakote sprinkles.
Dosing: Depakote was titrated in predetermined increments every 1-2 weeks during a 16-week titration period. The titration continued until the patient a) achieved seizure freedom by clinical and EEG criteria, b) reached the maximal allowed study drug dose, c) reached the maximal tolerated dose, or d) developed dose-exiting criteria (treatment failure), whichever came first. Maximum allowed dose: 60 mg/kg/day or 3000 mg/day (whichever was lower) Receives: Drug: Valproic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Freedom From Treatment Failure at 16-20 Weeks of Double Blind Therapy
Treatment failure was defined as persistence of absence seizures at week 16 or week 20, a generalized tonic-clonic seizure at any time, excessive drug-related systemic toxicity, a moderately severe rash (possibly drug-related), pancreatitis, or increase in the body-mass index of at least 3.0 from baseline, dose-limiting toxicity after a single downward dose modification, or withdrawal initiated by the parent or physician.
Measured: First 16-20 weeks of double blind therapy
Secondary outcomes (2)
Number of Participants With Attention Deficit as Measured by the Confidence Index of the CPT-II and the K-CPT
A Confidence Index of 0.60 or higher on the Conners' Continuous Performance Test at the visit at 16 or 20 weeks or at an earlier visit when treatment was discontinued (as long as the discontinuation occurred 1 month or more after the baseline visit and was not due to intolerable adverse events). A Confidence Index of 0.60 corresponds to a 60% probability that the child has clinical attention deficit disorder.
Measured: First 16-20 weeks of double blind therapy
Number of Participants With Freedom From Treatment Failure at 12 Months of Double Blind Therapy
Treatment failure was defined as persistence of absence seizures at 12 months of double blind therapy, a generalized tonic-clonic seizure at any time, excessive drug-related systemic toxicity, a moderately severe rash (possibly drug-related), pancreatitis, or increase in the body-mass index of at least 3.0 from baseline, dose-limiting toxicity after a single downward dose modification, or withdrawal initiated by the parent or physician.
Measured: First 12 months of double blind therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2004 (estimated)
- Study startJul 2004
- Primary completionJan 2013
- Study completion31 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Childhood Absence EpilepsyStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 453 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tracy A. Glauser, MD, Principal investigator, Children's Hospital Medical Center, CincinnatiPeter Adamson, MD, Principal investigator, Children's Hospital of PhiladelphiaAvital Cnaan, PhD, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00088452
- Sponsor's protocol ID
- U01NS045911
- Other IDs
- U01NS045803
- Status last verified
- Feb 2017
- First submitted
- 26 Jul 2004
- Last updated
- 14 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Glauser TA, Cnaan A, Shinnar S, Hirtz DG, Dlugos D, Masur D, Clark PO, Adamson PC; Childhood Absence Epilepsy Study Team. Ethosuximide, valproic acid, and lamotrigine in childhood absence epilepsy: initial monotherapy outcomes at 12 months. Epilepsia. 2013 Jan;54(1):141-55. doi: 10.1111/epi.12028. Epub 2012 Nov 21.
PubMed 23167925Cnaan A, Shinnar S, Arya R, Adamson PC, Clark PO, Dlugos D, Hirtz DG, Masur D, Glauser TA; Childhood Absence Epilepsy Study Group. Second monotherapy in childhood absence epilepsy. Neurology. 2017 Jan 10;88(2):182-190. doi: 10.1212/WNL.0000000000003480. Epub 2016 Dec 16.
PubMed 27986874Shinnar S, Cnaan A, Hu F, Clark P, Dlugos D, Hirtz DG, Masur D, Mizrahi EM, Moshe SL, Glauser TA; Childhood Absence Epilepsy Study Group. Long-term outcomes of generalized tonic-clonic seizures in a childhood absence epilepsy trial. Neurology. 2015 Sep 29;85(13):1108-14. doi: 10.1212/WNL.0000000000001971. Epub 2015 Aug 26.
PubMed 26311751Glauser TA, Cnaan A, Shinnar S, Hirtz DG, Dlugos D, Masur D, Clark PO, Capparelli EV, Adamson PC; Childhood Absence Epilepsy Study Group. Ethosuximide, valproic acid, and lamotrigine in childhood absence epilepsy. N Engl J Med. 2010 Mar 4;362(9):790-9. doi: 10.1056/NEJMoa0902014.
PubMed 20200383Shinnar RC, Shinnar S, Cnaan A, Clark P, Dlugos D, Hirtz DG, Hu F, Liu C, Masur D, Weiss EF, Glauser TA; Childhood Absence Epilepsy Study Group. Pretreatment behavior and subsequent medication effects in childhood absence epilepsy. Neurology. 2017 Oct 17;89(16):1698-1706. doi: 10.1212/WNL.0000000000004514. Epub 2017 Sep 15.
PubMed 28916534
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Childhood Absence Epilepsy Rx PK-PD-Pharmacogenetics Study
- ClinicalTrials.gov ID
- NCT00088452
- Acronym / sponsor ID
- U01NS045911
- Conditions
- Childhood Absence Epilepsy, Petit Mal Epilepsy, Epilepsy, Seizures
- Keywords
- childhood absence epilepsy, CAE, petit mal epilepsy, epilepsy, seizures, ethosuximide, lamotrigine, valproic acid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 453 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Jul 2004 (actual)
- Primary completion
- Jan 2013 (actual)
- Study completion
- 31 Aug 2016 (actual)
- First posted
- 27 Jul 2004 (estimated)
- Results
- Posted 14 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the best initial treatment for childhood absence epilepsy.
Detailed description
Childhood absence epilepsy (CAE) is a common pediatric epilepsy syndrome that affects 10 to 15 percent of all children with epilepsy. Individuals with CAE have brief staring spell seizures that occur suddenly, unpredictably, and frequently throughout the day. These seizures impair the children's ability to learn and play, and lead to higher injury rates.
There are many medications used to treat seizures, but only 3 generally are used as the first treatment for children with CAE: ethosuximide, lamotrigine, and valproic acid. The goal of this study is to determine which of these 3 medicines is the best first choice as treatment for children with CAE.
Approximately 439 children, recruited over a 3-year period at 32 medical centers in the US, will take part in this 5-year study. Participants will be randomly given one of the 3 common CAE treatments-ethosuximide, lamotrigine, or valproic acid-and will make regular visits to a clinic every 1 to 3 months for approximately 2 years. During the visits, participants will undergo regular testing to determine if the medicine is working, to watch for side effects, and to help researchers learn more about the responses to these medicines. In addition, researchers hope to develop methods that may be used in the future to help choose the best medicine for each individual diagnosed with CAE.
Also included in the study will be pharmacokinetics and pharmacogenetics research. Pharmacokinetics is the study of how the body absorbs, distributes, metabolizes, and excretes drugs. Pharmacogenetics is the study of genetic determinants of the response to drugs. Knowledge gained from this study may lead to individualized treatment for children with CAE, and may also be beneficial for other pediatric and adult seizure disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ethosuximide | Active comparator | Drug: EthosuximideEthosuximide Frequency and Duration: twice a day, every day for the duration of the study treatment Formulation: Two formulations were used (actual formulation used was dependent on the patient's weight and ability to swallow): 250mg Zarontin capsules OR 250 mg/5 mL Zarontin syrup Dosing: Ethosuximide was titrated in predetermined increments every 1-2 weeks during a 16-week titration period. The titration continued until the patient a) achieved seizure freedom by clinical and EEG criteria, b) reached the maximal allowed study drug dose, c) reached the maximal tolerated dose, or d) developed dose-exiting criteria (treatment failure), whichever came first. Maximum allowed dose: 60 mg/kg/day or 2000 mg/day (whichever was lower) |
| Lamotrigine | Active comparator | Drug: LamotrigineLamotrigine Frequency and Duration: twice a day, every day for the duration of the study treatment Formulation: Three formulations were used (actual formulation used was dependent on the patient's weight): 5mg Lamictal chewable tablets OR 25 mg Lamictal chewable tablets OR 25 mg (Lamictal tablets Dosing: Lamotrigine was titrated in predetermined increments every 1-2 weeks during a 16-week titration period. The titration continued until the patient a) achieved seizure freedom by clinical and EEG criteria, b) reached the maximal allowed study drug dose, c) reached the maximal tolerated dose, or d) developed dose-exiting criteria (treatment failure), whichever came first. Maximum allowed dose: 12 mg/kg/day or 600 mg/day (whichever was lower). |
| Valproic acid | Active comparator | Drug: Valproic acidValproic acid Frequency and Duration: twice a day, every day for the duration of the study treatment Formulation: Two formulations were used (actual formulation used was dependent on the patient's weight): 250mg Depakote capsules OR 125mg Depakote sprinkles. Dosing: Depakote was titrated in predetermined increments every 1-2 weeks during a 16-week titration period. The titration continued until the patient a) achieved seizure freedom by clinical and EEG criteria, b) reached the maximal allowed study drug dose, c) reached the maximal tolerated dose, or d) developed dose-exiting criteria (treatment failure), whichever came first. Maximum allowed dose: 60 mg/kg/day or 3000 mg/day (whichever was lower) |
Who may qualify
- Ages
- 30 months to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- Diagnosis: Clinical diagnosis of Childhood Absence Epilepsy consistent with the International League against Epilepsy Proposal for Revised Classification of Epilepsies and Epileptic Syndromes (3).
- EEG: Interictal EEG demonstrating bilateral synchronous symmetrical approximate 3 Hz spike waves on a normal background with at least one burst lasting >/= (greater than or equal to) 3 seconds.
- Age > 2.5 years and < 13 years of age at study entry.
- Body weight >/= (greater than or equal to) 10 kilograms.
- Body Mass Index: BMI for age =/< 99th percentile (based on the CDC BMI for age growth curves for boys/girls [http://www.cdc.gov/growthcharts], Appendix 1).
Key exclusion criteria (10 listed)
- Treatment for CAE with anti-seizure medications (AED) for a period of greater than 7 days prior to randomization.
- History of a major psychiatric disease (e.g., psychosis, major depression).
- History of autism or pervasive development disorder.
- History of non-febrile seizures other than typical absence seizures. This includes a history of an afebrile generalized tonic clonic seizure.
- Clinical signs and symptoms consistent with a diagnosis of juvenile absence epilepsy or juvenile myoclonic epilepsy as delineated by the International League against Epilepsy Proposal for Revised Classification of Epilepsies and Epileptic Syndromes (3).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EthosuximideAlso: ZarontinEthosuximide is a common treatment for childhood absence epilepsy. | Drug | Ethosuximide |
| LamotrigineAlso: LamictalLamotrigine is a common treatment for childhood absence epilepsy. | Drug | Lamotrigine |
| Valproic acidAlso: DepakoteValproic acid is a common treatment for childhood absence epilepsy. | Drug | Valproic acid |
Primary outcome
Number of Participants With Freedom From Treatment Failure at 16-20 Weeks of Double Blind Therapy
Time frame: First 16-20 weeks of double blind therapy
Treatment failure was defined as persistence of absence seizures at week 16 or week 20, a generalized tonic-clonic seizure at any time, excessive drug-related systemic toxicity, a moderately severe rash (possibly drug-related), pancreatitis, or increase in the body-mass index of at least 3.0 from baseline, dose-limiting toxicity after a single downward dose modification, or withdrawal initiated by the parent or physician.
2 secondary outcomes
Number of Participants With Attention Deficit as Measured by the Confidence Index of the CPT-II and the K-CPT
Time frame: First 16-20 weeks of double blind therapy
Number of Participants With Freedom From Treatment Failure at 12 Months of Double Blind Therapy
Time frame: First 12 months of double blind therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23167925Glauser TA, Cnaan A, Shinnar S, Hirtz DG, Dlugos D, Masur D, Clark PO, Adamson PC; Childhood Absence Epilepsy Study Team. Ethosuximide, valproic acid, and lamotrigine in childhood absence epilepsy: initial monotherapy outcomes at 12 months. Epilepsia. 2013 Jan;54(1):141-55. doi: 10.1111/epi.12028. Epub 2012 Nov 21.
- Background: PubMed 27986874Cnaan A, Shinnar S, Arya R, Adamson PC, Clark PO, Dlugos D, Hirtz DG, Masur D, Glauser TA; Childhood Absence Epilepsy Study Group. Second monotherapy in childhood absence epilepsy. Neurology. 2017 Jan 10;88(2):182-190. doi: 10.1212/WNL.0000000000003480. Epub 2016 Dec 16.
- Background: PubMed 26311751Shinnar S, Cnaan A, Hu F, Clark P, Dlugos D, Hirtz DG, Masur D, Mizrahi EM, Moshe SL, Glauser TA; Childhood Absence Epilepsy Study Group. Long-term outcomes of generalized tonic-clonic seizures in a childhood absence epilepsy trial. Neurology. 2015 Sep 29;85(13):1108-14. doi: 10.1212/WNL.0000000000001971. Epub 2015 Aug 26.
- Results publication: PubMed 20200383Glauser TA, Cnaan A, Shinnar S, Hirtz DG, Dlugos D, Masur D, Clark PO, Capparelli EV, Adamson PC; Childhood Absence Epilepsy Study Group. Ethosuximide, valproic acid, and lamotrigine in childhood absence epilepsy. N Engl J Med. 2010 Mar 4;362(9):790-9. doi: 10.1056/NEJMoa0902014.
- Derived from this study: PubMed 28916534Shinnar RC, Shinnar S, Cnaan A, Clark P, Dlugos D, Hirtz DG, Hu F, Liu C, Masur D, Weiss EF, Glauser TA; Childhood Absence Epilepsy Study Group. Pretreatment behavior and subsequent medication effects in childhood absence epilepsy. Neurology. 2017 Oct 17;89(16):1698-1706. doi: 10.1212/WNL.0000000000004514. Epub 2017 Sep 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tracy A. Glauser, MD principal investigator
Children's Hospital Medical Center, Cincinnati
Peter Adamson, MD principal investigator
Children's Hospital of Philadelphia
Avital Cnaan, PhD principal investigator
Children's National Research Institute
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ethosuximide, Lamotrigine and Valproic acid in people with Childhood Absence Epilepsy and Petit Mal Epilepsy, run by Children's Hospital Medical Center, Cincinnati at 31 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Freedom From Treatment Failure at 16-20 Weeks of Double Blind Therapy (time frame: First 16-20 weeks of double blind therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00088452, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.