An interventional study of Sodium bicarbonate in Epilepsy, Metabolic Acidosis and Tubular Acidosis; Renal, sponsored by McMaster Children's Hospital. Status unknown at 1 site in Canada. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2017-11-28.
Sponsored by McMaster Children's Hospital · Not applicable, Interventional, and Treatment
Among 96 studies in Epilepsy with a site in Canada — 18 open to participants now, 21 under way, 6 of them phase 3. Epilepsy · Canada.
Among the 96 studies in Epilepsy with a site in Canada, this one is the 57th largest by planned enrollment of the 77 interventional ones that give a count, is one of 10 that started in 2018, is one of 19 with no phase, and was the 57th registered.
1,848 studies on the registry are indexed under Epilepsy; 422 are open to participants now.
Browse Epilepsy studies →18 of the 96 studies in Epilepsy with a site in Canada are open now. Recruiting first, the newest first:
University Health Network, Toronto · Sites in Canada
Ages 18–85 · Healthy volunteers
University of Manitoba · Sites in Canada, United States
Ages 18+
University of Manitoba · Sites in Canada
Ages 3–17
Dr. Gavin Winston · Sites in Canada
Ages 18–65 · Healthy volunteers
Istituto Giannina Gaslini · Sites in Canada, United States, Australia and 10 more countries
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 285 Epilepsy studies recruiting now, 113 (40%) set no upper age limit and 149 (52%) stop at 75 or younger; 139 take children under 18; 56 take healthy volunteers.
This study: 2 Years to 18 Years · all sexes · no healthy volunteers.
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96 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 10 · Phase 3 45 · Phase 4 4
First in 2000; this study’s year is marked. 10 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 40 is below the median of 50 across 1,239 interventional studies indexed under Epilepsy.
Median enrollment 108 across the 77 interventional studies, 300 across the 18 observational. Of the 68 that completed or were terminated, 39 (57%) have results posted.
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52 of 96 have an industry lead sponsor. The 10 most frequent:
McMaster Children's Hospital is the lead sponsor of 22 studies on the registry; 3 are open to participants now.
McMaster Children's Hospital has 1 study filed under Epilepsy — fewer than ten, so there is no comparison to draw.
7 of the studies in Epilepsy with a site in Canada that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06660394Phase 3Longboard PharmaceuticalsA Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults With Dravet Syndrome (DS) | 2026-12-31 |
| NCT05667142Phase 3Xenon Pharmaceuticals Inc.A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures | 2027-04 |
| NCT06908226Phase 3Longboard PharmaceuticalsA Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathy (DEE) | 2027-11-11 |
| NCT07881185Istituto Giannina GasliniArtificial Intelligence for Brain MRI Analysis in Epilepsy | 2026-12-31 |
| NCT06138808Duke University5-SENSE Score Validation Study | 2027-01 |
Add all 7 to your calendar (.ics) → With an account.
Among the 96 studies in Epilepsy with a site in Canada, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Effect of oral sodium bicarbonate therapy on renal tubular acidosis in epilepsy patients taking topiramate.
Children on topiramate are at a risk of renal tubular acidosis and subsequent development of renal stones. Sodium bicarbonate has been shown to reduce renal tubular acidosis in other populations. To date, no data exist on the efficacy of correction of renal tubular acidosis in pediatric patients on topiramate. We are proposing to investigate the efficacy of 4 weeks of oral sodium bicarbonate therapy to reduce tubular acidosis in patients on topiramate.
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Exclusion Criteria:
Patients will receive sodium bicarbonate for 4 weeks, based on pre-calculated weight based doses. Patients are selected if they have metabolic acidosis at baseline. \< 24 kg : 1/4 teaspoon bid. 24 - 42 kg : 1/2 teaspoon bid. \> 42kg : 3/4 teaspoon bid.
Dietary Supplement: Sodium bicarbonate
Patients will not receive treatment if they do not have metabolic acidosis at baseline.
Sodium bicarbonate. See arms.
Changes in measured urine parameters
Spot urine sample will be tested for calcium, creatinine and citrate
Time frame: Baseline, then at 4 weeks
Changes in measured blood parameters.
sodium, potassium, chloride, calcium, magnesium, phosphate, bicarbonate, alkaline phosphatase, urea, creatinine, venous blood gas
Time frame: Baseline, then at 4 weeks
Changes in frequency of seizures.
Changes in seizure entries in seizure diary
Time frame: Baseline, then at 4 weeks
Plan to share: No
Start is estimated for Jan 2018; primary completion for Dec 2018, 11 months later.
Of 337 non-industry interventional studies with no phase under Epilepsy, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 77. This study's planned 11 months is below that.
Counting every sponsor, half of 358 studies reached it within 42 months; a quarter within 19 and three quarters within 77.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sodium Bicarbonate
McMaster Children's Hospital