The Percentage of Participants With Seizure Free Rate
Primary
· 24 weeks
The percentage of participants who had no seizure during the trial.
| Group | Value | 95% CI |
|---|---|---|
| Zonisamide | 73.7 | |
| Carbamazepine | 83.1 |
Last reviewed · How we verify
NCT01127256
Comparative Study of Zonisamide and Carbamazepine as an Initial Monotherapy: Efficacy and Safety Evaluation
Completed
Phase 4
Results posted
Last updated 4 January 2022
What this trial tests
Phase 4 trial testing zonisamide in Epilepsy in 200 participants. Completed in 31 July 2009.
Timeline
31 May 2006
Primary endpoint
31 May 2009
31 May 2009
31 July 2009
Quick facts
| Lead sponsor | Eisai Korea Inc. |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 200 |
| Start date | 31 May 2006 |
| Primary completion | 31 May 2009 |
| Estimated completion | 31 July 2009 |
| Sites | 12 locations across South Korea |
Drugs / interventions tested
- zonisamide — full drug profile →
- carbamazepine (carbamazepine) — full drug profile →
Conditions studied
- Epilepsy — all drugs for Epilepsy →
Sponsor
Eisai Korea Inc. — full company profile →
Who can join
15 and older, any sex, with Epilepsy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The Percentage of Participants With Retention Rate
Secondary
· 24 weeks
The percentage of participants who completed the trial.
| Group | Value | 95% CI |
|---|---|---|
| Zonisamide | 59.4 | |
| Carbamazepine | 62.5 |
Quality of Life in Epilepsy (QoL-QOLIE31)
Secondary
· 24 weeks
Quality of life assessment tool. Overall scores is calculated by summing subsections, and it ranges from 0 to 100. Higher score presents higher quality of life.
Pre-QOLIE 31
| Group | Value | 95% CI |
|---|---|---|
| Zonisamide | 60.72 | ± 14.69 |
| Carbamazepine | 61.96 | ± 16.67 |
Post-QOLIE 31
| Group | Value | 95% CI |
|---|---|---|
| Zonisamide | 67.27 | ± 16.34 |
| Carbamazepine | 69.51 | ± 17.61 |
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Zonisamide
Serious: 5/96 (5%)
Deaths: —
Carbamazepine
Serious: 9/104 (9%)
Deaths: —
Serious adverse events (16 terms)
| Reaction | System | Zonisamide | Carbamazepine |
|---|---|---|---|
| Urticaria | Skin and subcutaneous tissue disorders | — | — |
| Worsening Insomnia | Psychiatric disorders | — | — |
| Diabetic Ketoacidosis | Metabolism and nutrition disorders | — | — |
| Depressive Mood | Psychiatric disorders | — | — |
| Right Shoulder Injury | General disorders | — | — |
| Visual Hallucination | Psychiatric disorders | — | — |
| Cervical Sprain | General disorders | — | — |
| Memory And Judgement Disturbance | Psychiatric disorders | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — |
| Dysuria | Renal and urinary disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Uterine Fibroid | Reproductive system and breast disorders | — | — |
| Sgpt Increased | Investigations | — | — |
| Sgot Increased | Investigations | — | — |
| Mental Torpor | Psychiatric disorders | — | — |
Other adverse events (19 terms — click to expand)
| Reaction | System | Zonisamide | Carbamazepine |
|---|---|---|---|
| Dizziness | Nervous system disorders | — | — |
| Drowsiness | Psychiatric disorders | — | — |
| Anorexia | Gastrointestinal disorders | — | — |
| Weight Decrease | Investigations | — | — |
| Headache | Nervous system disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Mental Torpor | Psychiatric disorders | — | — |
| Memory Impairment | Psychiatric disorders | — | — |
| Pyrexia | General disorders | — | — |
| Gastrointestinal Pain | Gastrointestinal disorders | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — |
| Fatigue | General disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Sleep Disorder | Psychiatric disorders | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Urticaria | Skin and subcutaneous tissue disorders | — | — |
| Depression | Psychiatric disorders | — | — |
Most-reported serious reactions: Urticaria, Worsening Insomnia, Diabetic Ketoacidosis, Depressive Mood, Right Shoulder Injury, Visual Hallucination, Cervical Sprain, Memory And Judgement Disturbance.
Data from ClinicalTrials.gov NCT01127256 adverse events section.
Sponsor's own description
The purpose of this study is to compare the efficacy and safety of zonisamide with carbamazepine and to determine the optimum dose of zonisamide in patients with epilepsy.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01127256
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of zonisamide
Trials testing the same drug.
- NCT03196466 — Population Pharmacokinetics of Antiepileptic in Pediatrics · completed
- NCT01140867 — Open-label, Multi-center Trial of Zonisamide as Adjunctive Therapy in Patients With Uncontrolled Partial Epilepsy · Phase 4 · completed
Other recruiting trials for Epilepsy
Currently open trials in the same condition.
- NCT07095933 — The Safety and Efficacy Evaluation of Everolimus as an Adjunctive Treatment for Focal Refractory Epilepsy · EARLY_PHASE1 · recruiting
- NCT07224191 — Hippocampal Oscillations During Exploration · NA · recruiting
- NCT07219407 — A Long-term Study of the Safety and Effectiveness of RAP-219 in Adults With Focal Onset Seizures · Phase 2 · recruiting
- NCT07417280 — LIFUS For Neurological Disorders · NA · recruiting
- NCT07490769 — Levetiracetam Three Times Daily in Epilepsy · Phase 3 · recruiting
Other Eisai Korea Inc. trials
Trials by the same sponsor.
- NCT06964113 — A Study of Filgotinib 200 mg in Korean Participants With Moderately to Severely Active Ulcerative Colitis Under Routine · Phase 4 · recruiting
- NCT06810960 — A Postmarketing Study of Lecanemab in South Korean Participants With Alzheimer's Disease · recruiting
- NCT06625242 — A Study of Filgotinib in Korean Participants With Rheumatoid Arthritis · Phase 4 · active not recruiting
- NCT06246123 — A Study of Jyseleca Tablet (Filgotinib Maleate) in Korean Participants · recruiting
- NCT05533814 — A Study to Evaluate the Efficacy and Safety of Perampanel Monotherapy in Untreated Participants With Focal Onset Seizure · Phase 4 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT01127256 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Eisai Korea Inc.
- Last refreshed: 4 January 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01127256.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing