NCT00279851

Brief Summary

The purpose of this study is to determine if there is a significant percentage of children with the diagnosis of idiopathic seizures who have undiagnosed or unrecognized hypoglycemia (low blood sugar).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2006

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 20, 2006

Completed
12 days until next milestone

Study Start

First participant enrolled

February 1, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

January 6, 2021

Status Verified

January 1, 2021

Enrollment Period

1 year

First QC Date

January 18, 2006

Last Update Submit

January 5, 2021

Conditions

Keywords

idiopathic seizurehypoglycemiahyperammonemia/hyperinsulinism syndrome

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Patients with idiopathic seizure disorders under age 18 years of age.

You may qualify if:

  • The age range will be from birth to 17 years of age.
  • Study subjects may be on anti-convulsants; the study does not alter current drug therapy.

You may not qualify if:

  • congenital causes (CNS malformation, cerebral palsy)
  • CNS infection toxic/known metabolic abnormality
  • CNS neoplasm perinatal insults (birth trauma, asphyxia/hypoxia),
  • traumatic
  • All others who have an anatomic or known biochemical lesion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108, United States

Location

Related Publications (12)

  • Hsu BY, Kelly A, Thornton PS, Greenberg CR, Dilling LA, Stanley CA. Protein-sensitive and fasting hypoglycemia in children with the hyperinsulinism/hyperammonemia syndrome. J Pediatr. 2001 Mar;138(3):383-9. doi: 10.1067/mpd.2001.111818.

    PMID: 11241047BACKGROUND
  • Hauser WA. The prevalence and incidence of convulsive disorders in children. Epilepsia. 1994;35 Suppl 2:S1-6. doi: 10.1111/j.1528-1157.1994.tb05932.x.

    PMID: 8275976BACKGROUND
  • Sperling MA, Menon RK. Differential diagnosis and management of neonatal hypoglycemia. Pediatr Clin North Am. 2004 Jun;51(3):703-23, x. doi: 10.1016/j.pcl.2004.01.014.

    PMID: 15157593BACKGROUND
  • Vilke GM, Castillo EM, Ray LU, Murrin PA, Chan TC. Evaluation of pediatric glucose monitoring and hypoglycemic therapy in the field. Pediatr Emerg Care. 2005 Jan;21(1):1-5. doi: 10.1097/01.pec.0000150980.94571.10.

    PMID: 15643315BACKGROUND
  • Valencia I, Sklar E, Blanco F, Lipsky C, Pradell L, Joffe M, Legido A. The role of routine serum laboratory tests in children presenting to the emergency department with unprovoked seizures. Clin Pediatr (Phila). 2003 Jul-Aug;42(6):511-7. doi: 10.1177/000992280304200605.

    PMID: 12921452BACKGROUND
  • Hirtz D, Ashwal S, Berg A, Bettis D, Camfield C, Camfield P, Crumrine P, Elterman R, Schneider S, Shinnar S. Practice parameter: evaluating a first nonfebrile seizure in children: report of the quality standards subcommittee of the American Academy of Neurology, The Child Neurology Society, and The American Epilepsy Society. Neurology. 2000 Sep 12;55(5):616-23. doi: 10.1212/wnl.55.5.616.

    PMID: 10980722BACKGROUND
  • Raizen DM, Brooks-Kayal A, Steinkrauss L, Tennekoon GI, Stanley CA, Kelly A. Central nervous system hyperexcitability associated with glutamate dehydrogenase gain of function mutations. J Pediatr. 2005 Mar;146(3):388-94. doi: 10.1016/j.jpeds.2004.10.040.

    PMID: 15756227BACKGROUND
  • Hauser WA. Seizure disorders: the changes with age. Epilepsia. 1992;33 Suppl 4:S6-14. doi: 10.1111/j.1528-1157.1992.tb06222.x.

    PMID: 1425495BACKGROUND
  • Melegh B, Pap M, Morava E, Molnar D, Dani M, Kurucz J. Carnitine-dependent changes of metabolic fuel consumption during long-term treatment with valproic acid. J Pediatr. 1994 Aug;125(2):317-21. doi: 10.1016/s0022-3476(94)70218-7.

    PMID: 8040784BACKGROUND
  • Nishida N, Sugimoto T, Araki A, Woo M, Sakane Y, Kobayashi Y. Carnitine metabolism in valproate-treated rats: the effect of L-carnitine supplementation. Pediatr Res. 1987 Nov;22(5):500-3. doi: 10.1203/00006450-198711000-00003.

    PMID: 3120144BACKGROUND
  • al-Hosani H, Salah M, Saade D, Osman H, al-Zahid J. United Arab Emirates National Newborn Screening Programme: an evaluation 1998-2000. East Mediterr Health J. 2003 May;9(3):324-32.

    PMID: 15751925BACKGROUND
  • Schweitzer-Krantz S. Early diagnosis of inherited metabolic disorders towards improving outcome: the controversial issue of galactosaemia. Eur J Pediatr. 2003 Dec;162 Suppl 1:S50-3. doi: 10.1007/s00431-003-1352-2. Epub 2003 Nov 12.

    PMID: 14614623BACKGROUND

MeSH Terms

Conditions

SeizuresHypoglycemiaHyperammonemiaHyperinsulinemic hypoglycemia, familial, 6

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPathologic Processes

Study Officials

  • Chetanbabu M Patel, MD

    Children's Mercy Hospital Kansas City

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2006

First Posted

January 20, 2006

Study Start

February 1, 2006

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

January 6, 2021

Record last verified: 2021-01

Locations