Drug Resistant EpilepsyNCT02982824
Effect of Magnesium Supplementation for Children With Drug Resistant Idiopathic Epilepsy
A study testing Magnesium in people with Drug Resistant Epilepsy, run by Ain Shams University at 1 site in Egypt.
Trial summary
Effect of oral magnesium sulfate (Mg) supplementation will be studied. Children with drug resistant idiopathic epilepsy following up in Pediatric Neurology Clinic, Ain Shams University, will be randomized to either Mg add-on treatment group or anti-epileptic drugs AEDs alone. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Drug Resistant Epilepsy
- What is being tested?
- Magnesium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2016to Mar 2017
- Phase
- Interventional
- 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 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with drug resistant idiopathic epilepsy
Who cannot join
- Structural, Metabolic, Infectious and Unknown etiology epilepsy
- Any neurological disease other than epilepsy
- Any nutritional disorder
- Any other systemic diseases (including Renal disease, Cardiac arrhythmia)
- Drug intake other than antiepileptic drugs (AED)
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Children's Hospital, Faculty of Medicine, Ain Shams University
Cairo, 11381
About this study
Official title: Magnesium Supplementation for Children With Drug Resistant Idiopathic Epilepsy: A Pilot Study
Effect of oral magnesium sulfate (Mg) supplementation will be studied. Children with drug resistant idiopathic epilepsy following up in Pediatric Neurology Clinic, Ain Shams University, will be randomized to either Mg add-on treatment group or anti-epileptic drugs AEDs alone. Serum magnesium, seizure control and Intelligent quotation (IQ) will be done at base line and after 6 months of treatment.
Read the detailed description
The Aim of this work was to study the effect of Magnesium as add on therapy on clinical seizure control in drug resistant idiopathic epilepsy and IQ.
- Conditions
- Drug Resistant Epilepsy
- Being tested
- Magnesium, Placebo - Concentrate
- Keywords
- Children, IQ, Idiopathic epilepsy, Magnesium supplementation, Seizure control, Chalfont score
- Medical subject headings
- Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagnesiumDietary supplement
Oral magnesium
Placebo - ConcentrateDrug
Placebo will be given
| Study group | Role | What they receive |
|---|---|---|
| Magnesium add-on | Experimental | 20 children with drug resistant epilepsy will receive oral magnesium sulfate 6 ml per day which equivalent to 400 mg elemental magnesium (Yuen \& Sander, 2012) for 6 months and their regular antiepileptic drugs. Receives: Dietary Supplement: Magnesium |
| Antiepileptic drugs only | Placebo comparator | 20 children with drug resistant epilepsy will receive their regular antiepileptic drugs and placebo for 6 months. Receives: Drug: Placebo - Concentrate |
| Healthy controls | No intervention | To asses serum magnesium level for comparison with the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure control
Change from base line seizure frequency, severity (Chalfont scale) at 6 months.
Measured: 6 months
IQ improvement
Change from base line IQ (Wechsler Intelligence Scale-Revised for Children and Adults)
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study startSep 2016
- Primary completionFeb 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Drug Resistant EpilepsyStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sahar M.A. Hassanein, MD, Ain Shams University
- Investigators
- Sahar MA Hassanein, PhD. MD, Principal investigator, Pediatrics, Faculty of Medicine, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02982824
- Sponsor's protocol ID
- FMASU M.S 20/2016
- Status last verified
- Dec 2016
- First submitted
- 22 Nov 2016
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Gontijo-Amaral C, Ribeiro MA, Gontijo LS, Condino-Neto A, Ribeiro JD. Oral magnesium supplementation in asthmatic children: a double-blind randomized placebo-controlled trial. Eur J Clin Nutr. 2007 Jan;61(1):54-60. doi: 10.1038/sj.ejcn.1602475. Epub 2006 Jun 21.
PubMed 16788707Osborn KE, Shytle RD, Frontera AT, Soble JR, Schoenberg MR. Addressing potential role of magnesium dyshomeostasis to improve treatment efficacy for epilepsy: A reexamination of the literature. J Clin Pharmacol. 2016 Mar;56(3):260-5. doi: 10.1002/jcph.626. Epub 2015 Oct 26.
PubMed 26313363
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnesium Supplementation for Children With Drug Resistant Idiopathic Epilepsy: A Pilot Study
- ClinicalTrials.gov ID
- NCT02982824
- Acronym / sponsor ID
- FMASU M.S 20/2016
- Conditions
- Drug Resistant Epilepsy
- Keywords
- Children, IQ, Idiopathic epilepsy, Magnesium supplementation, Seizure control, Chalfont score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 6 Dec 2016 (estimated)
- 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.
Effect of oral magnesium sulfate (Mg) supplementation will be studied. Children with drug resistant idiopathic epilepsy following up in Pediatric Neurology Clinic, Ain Shams University, will be randomized to either Mg add-on treatment group or anti-epileptic drugs AEDs alone. Serum magnesium, seizure control and Intelligent quotation (IQ) will be done at base line and after 6 months of treatment.
Detailed description
The Aim of this work was to study the effect of Magnesium as add on therapy on clinical seizure control in drug resistant idiopathic epilepsy and IQ.
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 |
|---|---|---|
| Magnesium add-on | Experimental | Dietary Supplement: Magnesium20 children with drug resistant epilepsy will receive oral magnesium sulfate 6 ml per day which equivalent to 400 mg elemental magnesium (Yuen \& Sander, 2012) for 6 months and their regular antiepileptic drugs. |
| Antiepileptic drugs only | Placebo comparator | Drug: Placebo - Concentrate20 children with drug resistant epilepsy will receive their regular antiepileptic drugs and placebo for 6 months. |
| Healthy controls | No intervention | –To asses serum magnesium level for comparison with the intervention group. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children with drug resistant idiopathic epilepsy
Key exclusion criteria (5 listed)
- Structural, Metabolic, Infectious and Unknown etiology epilepsy
- Any neurological disease other than epilepsy
- Any nutritional disorder
- Any other systemic diseases (including Renal disease, Cardiac arrhythmia)
- Drug intake other than antiepileptic drugs (AED)
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 |
|---|---|---|
| MagnesiumOral magnesium | Dietary supplement | Magnesium add-on |
| Placebo - ConcentratePlacebo will be given | Drug | Antiepileptic drugs only |
Primary outcome
Seizure control
Time frame: 6 months
Change from base line seizure frequency, severity (Chalfont scale) at 6 months.
IQ improvement
Time frame: 6-months
Change from base line IQ (Wechsler Intelligence Scale-Revised for Children and Adults)
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 9 May 2017.
- Background: PubMed 16788707Gontijo-Amaral C, Ribeiro MA, Gontijo LS, Condino-Neto A, Ribeiro JD. Oral magnesium supplementation in asthmatic children: a double-blind randomized placebo-controlled trial. Eur J Clin Nutr. 2007 Jan;61(1):54-60. doi: 10.1038/sj.ejcn.1602475. Epub 2006 Jun 21.
- Background: PubMed 26313363Osborn KE, Shytle RD, Frontera AT, Soble JR, Schoenberg MR. Addressing potential role of magnesium dyshomeostasis to improve treatment efficacy for epilepsy: A reexamination of the literature. J Clin Pharmacol. 2016 Mar;56(3):260-5. doi: 10.1002/jcph.626. Epub 2015 Oct 26.
- Individual participant dataSharing planned: Yes
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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.
Sahar MA Hassanein, PhD. MD principal investigator
Pediatrics, Faculty of Medicine, Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium in people with Drug Resistant Epilepsy, run by Ain Shams University at 1 site in Egypt.
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 1 inclusion and 5 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 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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. Some participants in this study may receive a placebo. 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 control (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT02982824, which also lists 2 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 9 May 2017.