Epilepsy Generalized Idiopathic Not IntractableEpilepsyNCT03587506

Periodic Limb Movement and Genetic Generalized Epilepsy

An observational study of Epilepsy Generalized Idiopathic Not Intractable, run by University of Alexandria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The study aimed to study the correlation between periodic limb movement occurring during sleep and the different parameters of genetic generalized epilepsy Read more about this study

Who is it for?: Ages 9 to 29 yearsHealthy volunteers can take part
Conditions the study is for: Epilepsy Generalized Idiopathic Not Intractable
How many people: 60 participants
Where: No sites listed yet
Study dates: 3 Sep 2015to Dec 2016
Phase: Observational
Are there results?: None posted in the registry

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 9 to 29 years
All sexes
Healthy volunteers accepted
Child, Adult

Study population: Thirty patients and thirty volunteer healthy controls were recruited. Patients were newly diagnosed with genetic generalized epilepsy according to the ILAE 2010 criteria who did not previously receive AEDs. The clinical seizures were either eye-witnessed by physicians or video-recorded to ensure they were true epileptic seizures. Age of participants ranged from 9 to 29 years. All patients recruited in this study had at least two unprovoked seizures occurring >24 hours apart. Patients with pre-existing psychiatric illnesses those with seizures due to toxic or metabolic causes ), infections, or structural causes, and those using hypnotic drugs were excluded. The control subjects were healthy volunteers who were not related to the patients and had no family history of epilepsy.

Who may be able to join

Newly diagnosed with genetic generalized epilepsy according to the ILAE 2010 criteria
did not previously receive AEDs.
The clinical seizures were either eyewitnessed by physicians or video-recorded to ensure they were true epileptic seizures.
At least two unprovoked seizures occurring >24 hours apart

Who cannot join

Patients with pre-existing psychiatric illnesses
Patients with seizures due to toxic or metabolic causes (including glucose disturbance, uremia, and electrolytes disturbance), infections, or structural causes (such as neoplasms)
Patients using hypnotic drugs

About this study

Official title: The Relationship Between Periodic Limb Movement and Seizure Recurrence in Genetic Generalized Epilepsy

The study aimed to study the correlation between periodic limb movement occurring during sleep and the different parameters of genetic generalized epilepsy

Read the detailed description

Although periodic limb movements are prevalent among patients with epilepsy, the exact relationship between these movements and epilepsy remains elusive. Objective: The aim of this work was to study the periodic limb movements among patients with genetic generalized epilepsy in relation to different clinical characteristics and seizure recurrence. Methods: Sixty individuals participated in this study: thirty of them were newly diagnosed with genetic generalized epilepsy and thirty were healthy individuals. Sleep quality was assessed using the Pittsburgh Sleep Quality Index questionnaire, and a standard polysomnographic study was conducted to all subjects. All patients then received sodium valproate in therapeutic doses and were followed up for six months. Electroencephalogram (EEG) was done after the follow-up period and seizure recurrence was assessed. Accordingly, patients were classified into three groups according to clinical seizure recurrence and follow-up EEG findings.

Periodic limb movement index and frequency were compared among the patients' groups and were correlated with different clinical characteristics.

Conditions: Epilepsy Generalized Idiopathic Not Intractable
Keywords: Generalized epilepsy, idiopathic, periodic limb movement
Medical subject headings: Epilepsy, Generalized

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03587506
Study group	Role	What they receive
Patients: group		Group I (n=10) included patients who did not develop any major or minor seizure during the follow-up period and their follow up EEG was free of any epileptiform discharge
Patients: group II		Group II (n=11) included patients who developed only minor seizures and their follow up EEG showed epileptiform discharge
Patients: group III		Group III (n=9) were patients who developed one or more major seizures during the follow-up period whatever their EEG findings.
Controls		healthy volunteers (n=30) who were not related to the patients and had no family history of epilepsy.

What is being measured

The primary outcome is the main question the study is designed to answer.

Seizure recurrence
Clinical major or minor seizure, and electrical seizure
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Sep 2015Dec 2016

First posted16 Jul 2018
Study start3 Sep 2015
Primary completionSep 2016
Study completionDec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Epilepsy Generalized Idiopathic Not IntractableStudies of the same condition, open and under way.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03587506
Sponsor's protocol ID: Alexandria Faculty of Medicine
Acronym: Epilepsy
Status last verified: Jul 2018
First submitted: 1 Jul 2018
Last updated: 16 Jul 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Bazil CW. Sleep and Epilepsy. Semin Neurol. 2017 Aug;37(4):407-412. doi: 10.1055/s-0037-1604352. Epub 2017 Aug 24. No abstract available.
PubMed 28837987
Malow BA, Fromes GA, Aldrich MS. Usefulness of polysomnography in epilepsy patients. Neurology. 1997 May;48(5):1389-94. doi: 10.1212/wnl.48.5.1389.
PubMed 9153478
Yazdi Z, Sadeghniiat-Haghighi K, Naimian S, Zohal MA, Ghaniri M. Prevalence of Sleep Disorders and their Effects on Sleep Quality in Epileptic Patients. Basic Clin Neurosci. 2013 Winter;4(1):36-41.
PubMed 25337326
Vetrugno R, D'Angelo R, Montagna P. Periodic limb movements in sleep and periodic limb movement disorder. Neurol Sci. 2007 Jan;28 Suppl 1:S9-S14. doi: 10.1007/s10072-007-0733-0. No abstract available.
PubMed 17235435
Karadeniz D, Ondze B, Besset A, Billiard M. EEG arousals and awakenings in relation with periodic leg movements during sleep. J Sleep Res. 2000 Sep;9(3):273-7. doi: 10.1046/j.1365-2869.2000.00202.x.
PubMed 11012867
Parrino L, Ferri R, Bruni O, Terzano MG. Cyclic alternating pattern (CAP): the marker of sleep instability. Sleep Med Rev. 2012 Feb;16(1):27-45. doi: 10.1016/j.smrv.2011.02.003. Epub 2011 May 26.
PubMed 21616693
Allena M, Campus C, Morrone E, De Carli F, Garbarino S, Manfredi C, Sebastiano DR, Ferrillo F. Periodic limb movements both in non-REM and REM sleep: relationships between cerebral and autonomic activities. Clin Neurophysiol. 2009 Jul;120(7):1282-90. doi: 10.1016/j.clinph.2009.04.021. Epub 2009 Jun 7.
PubMed 19505849
Berg AT, Millichap JJ. The 2010 revised classification of seizures and epilepsy. Continuum (Minneap Minn). 2013 Jun;19(3 Epilepsy):571-97. doi: 10.1212/01.CON.0000431377.44312.9e.
PubMed 23739099
Fisher RS, Acevedo C, Arzimanoglou A, Bogacz A, Cross JH, Elger CE, Engel J Jr, Forsgren L, French JA, Glynn M, Hesdorffer DC, Lee BI, Mathern GW, Moshe SL, Perucca E, Scheffer IE, Tomson T, Watanabe M, Wiebe S. ILAE official report: a practical clinical definition of epilepsy. Epilepsia. 2014 Apr;55(4):475-82. doi: 10.1111/epi.12550. Epub 2014 Apr 14.
PubMed 24730690
Jagannath A, Peirson SN, Foster RG. Sleep and circadian rhythm disruption in neuropsychiatric illness. Curr Opin Neurobiol. 2013 Oct;23(5):888-94. doi: 10.1016/j.conb.2013.03.008. Epub 2013 Apr 23.
PubMed 23618559
Flink R, Pedersen B, Guekht AB, Malmgren K, Michelucci R, Neville B, Pinto F, Stephani U, Ozkara C; Commission of European Affairs of the International League Against Epilepsy: Subcommission on European Guidelines. Guidelines for the use of EEG methodology in the diagnosis of epilepsy. International League Against Epilepsy: commission report. Commission on European Affairs: Subcommission on European Guidelines. Acta Neurol Scand. 2002 Jul;106(1):1-7. doi: 10.1034/j.1600-0404.2002.01361.x.
PubMed 12067321
Glauser T, Ben-Menachem E, Bourgeois B, Cnaan A, Guerreiro C, Kalviainen R, Mattson R, French JA, Perucca E, Tomson T; ILAE Subcommission on AED Guidelines. Updated ILAE evidence review of antiepileptic drug efficacy and effectiveness as initial monotherapy for epileptic seizures and syndromes. Epilepsia. 2013 Mar;54(3):551-63. doi: 10.1111/epi.12074. Epub 2013 Jan 25.
PubMed 23350722
Khatami R, Zutter D, Siegel A, Mathis J, Donati F, Bassetti CL. Sleep-wake habits and disorders in a series of 100 adult epilepsy patients--a prospective study. Seizure. 2006 Jul;15(5):299-306. doi: 10.1016/j.seizure.2006.02.018. Epub 2006 Mar 20.
PubMed 16546407
Parrino L, Boselli M, Buccino GP, Spaggiari MC, Di Giovanni G, Terzano MG. The cyclic alternating pattern plays a gate-control on periodic limb movements during non-rapid eye movement sleep. J Clin Neurophysiol. 1996 Jul;13(4):314-23. doi: 10.1097/00004691-199607000-00005.
PubMed 8858493
Parrino L, Smerieri A, Spaggiari MC, Terzano MG. Cyclic alternating pattern (CAP) and epilepsy during sleep: how a physiological rhythm modulates a pathological event. Clin Neurophysiol. 2000 Sep;111 Suppl 2:S39-46. doi: 10.1016/s1388-2457(00)00400-4.
PubMed 10996553

Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Relationship Between Periodic Limb Movement and Seizure Recurrence in Genetic Generalized Epilepsy
ClinicalTrials.gov ID: NCT03587506
Acronym / sponsor ID: Epilepsy / Alexandria Faculty of Medicine
Conditions: Epilepsy Generalized Idiopathic Not Intractable
Keywords: Generalized epilepsy, idiopathic, periodic limb movement
Study type: Observational
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: University of AlexandriaUniversity, hospital or other
Study start: 3 Sep 2015 (actual)
Primary completion: Sep 2016 (actual)
Study completion: Dec 2016 (actual)
First posted: 16 Jul 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study aimed to study the correlation between periodic limb movement occurring during sleep and the different parameters of genetic generalized epilepsy

Detailed description

Periodic limb movement index and frequency were compared among the patients' groups and were correlated with different clinical characteristics.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 4

Arm	Type	Receives
Patients: group	–	–Group I (n=10) included patients who did not develop any major or minor seizure during the follow-up period and their follow up EEG was free of any epileptiform discharge
Patients: group II	–	–Group II (n=11) included patients who developed only minor seizures and their follow up EEG showed epileptiform discharge
Patients: group III	–	–Group III (n=9) were patients who developed one or more major seizures during the follow-up period whatever their EEG findings.
Controls	–	–healthy volunteers (n=30) who were not related to the patients and had no family history of epilepsy.

Who may qualify

Ages: 9 to 29 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult
Study population: Thirty patients and thirty volunteer healthy controls were recruited. Patients were newly diagnosed with genetic generalized epilepsy according to the ILAE 2010 criteria who did not previously receive AEDs. The clinical seizures were either eye-witnessed by physicians or video-recorded to ensure they were true epileptic seizures. Age of participants ranged from 9 to 29 years. All patients recruited in this study had at least two unprovoked seizures occurring >24 hours apart. Patients with pre-existing psychiatric illnesses those with seizures due to toxic or metabolic causes ), infections, or structural causes, and those using hypnotic drugs were excluded. The control subjects were healthy volunteers who were not related to the patients and had no family history of epilepsy.

Key inclusion criteria (4 listed)

Newly diagnosed with genetic generalized epilepsy according to the ILAE 2010 criteria
did not previously receive AEDs.
The clinical seizures were either eyewitnessed by physicians or video-recorded to ensure they were true epileptic seizures.
At least two unprovoked seizures occurring >24 hours apart

Key exclusion criteria (3 listed)

Patients with pre-existing psychiatric illnesses
Patients with seizures due to toxic or metabolic causes (including glucose disturbance, uremia, and electrolytes disturbance), infections, or structural causes (such as neoplasms)
Patients using hypnotic drugs

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Seizure recurrence
Time frame: 6 months
Clinical major or minor seizure, and electrical seizure

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2018.
Background: PubMed 28837987Bazil CW. Sleep and Epilepsy. Semin Neurol. 2017 Aug;37(4):407-412. doi: 10.1055/s-0037-1604352. Epub 2017 Aug 24. No abstract available.
Background: PubMed 9153478Malow BA, Fromes GA, Aldrich MS. Usefulness of polysomnography in epilepsy patients. Neurology. 1997 May;48(5):1389-94. doi: 10.1212/wnl.48.5.1389.
Background: PubMed 25337326Yazdi Z, Sadeghniiat-Haghighi K, Naimian S, Zohal MA, Ghaniri M. Prevalence of Sleep Disorders and their Effects on Sleep Quality in Epileptic Patients. Basic Clin Neurosci. 2013 Winter;4(1):36-41.
Background: PubMed 17235435Vetrugno R, D'Angelo R, Montagna P. Periodic limb movements in sleep and periodic limb movement disorder. Neurol Sci. 2007 Jan;28 Suppl 1:S9-S14. doi: 10.1007/s10072-007-0733-0. No abstract available.
Background: PubMed 11012867Karadeniz D, Ondze B, Besset A, Billiard M. EEG arousals and awakenings in relation with periodic leg movements during sleep. J Sleep Res. 2000 Sep;9(3):273-7. doi: 10.1046/j.1365-2869.2000.00202.x.
Background: PubMed 21616693Parrino L, Ferri R, Bruni O, Terzano MG. Cyclic alternating pattern (CAP): the marker of sleep instability. Sleep Med Rev. 2012 Feb;16(1):27-45. doi: 10.1016/j.smrv.2011.02.003. Epub 2011 May 26.
Background: PubMed 19505849Allena M, Campus C, Morrone E, De Carli F, Garbarino S, Manfredi C, Sebastiano DR, Ferrillo F. Periodic limb movements both in non-REM and REM sleep: relationships between cerebral and autonomic activities. Clin Neurophysiol. 2009 Jul;120(7):1282-90. doi: 10.1016/j.clinph.2009.04.021. Epub 2009 Jun 7.
Background: PubMed 23739099Berg AT, Millichap JJ. The 2010 revised classification of seizures and epilepsy. Continuum (Minneap Minn). 2013 Jun;19(3 Epilepsy):571-97. doi: 10.1212/01.CON.0000431377.44312.9e.
Background: PubMed 24730690Fisher RS, Acevedo C, Arzimanoglou A, Bogacz A, Cross JH, Elger CE, Engel J Jr, Forsgren L, French JA, Glynn M, Hesdorffer DC, Lee BI, Mathern GW, Moshe SL, Perucca E, Scheffer IE, Tomson T, Watanabe M, Wiebe S. ILAE official report: a practical clinical definition of epilepsy. Epilepsia. 2014 Apr;55(4):475-82. doi: 10.1111/epi.12550. Epub 2014 Apr 14.
Background: PubMed 23618559Jagannath A, Peirson SN, Foster RG. Sleep and circadian rhythm disruption in neuropsychiatric illness. Curr Opin Neurobiol. 2013 Oct;23(5):888-94. doi: 10.1016/j.conb.2013.03.008. Epub 2013 Apr 23.
Background: PubMed 12067321Flink R, Pedersen B, Guekht AB, Malmgren K, Michelucci R, Neville B, Pinto F, Stephani U, Ozkara C; Commission of European Affairs of the International League Against Epilepsy: Subcommission on European Guidelines. Guidelines for the use of EEG methodology in the diagnosis of epilepsy. International League Against Epilepsy: commission report. Commission on European Affairs: Subcommission on European Guidelines. Acta Neurol Scand. 2002 Jul;106(1):1-7. doi: 10.1034/j.1600-0404.2002.01361.x.
Background: PubMed 23350722Glauser T, Ben-Menachem E, Bourgeois B, Cnaan A, Guerreiro C, Kalviainen R, Mattson R, French JA, Perucca E, Tomson T; ILAE Subcommission on AED Guidelines. Updated ILAE evidence review of antiepileptic drug efficacy and effectiveness as initial monotherapy for epileptic seizures and syndromes. Epilepsia. 2013 Mar;54(3):551-63. doi: 10.1111/epi.12074. Epub 2013 Jan 25.
Individual participant dataSharing planned: Undecided

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Epilepsy Generalized Idiopathic Not Intractable, run by University of Alexandria.

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 4 inclusion and 3 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 16 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Seizure recurrence (time frame: 6 months). 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 NCT03587506, which also lists 15 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 16 Jul 2018.