NCT00848549 is a Phase 3 clinical trial of Zonisamide in Epilepsy, sponsored by Eisai Inc..

Who is sponsoring NCT00848549?

NCT00848549 is sponsored by Eisai Inc..

What drugs are being tested in NCT00848549?

Interventions in NCT00848549: Zonisamide, Carbamazepine.

Is NCT00848549 still recruiting?

NCT00848549 is currently completed. Last updated 21 December 2015.

Are results published for NCT00848549?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2015-12-21 · How we verify

NCT00848549

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Randomized, Double-Blind Extension Study To Assess The Long-Term Safety And To Explore The Long-Term Efficacy Of Zonisamide As Monotherapy In Newly Diagnosed Partial Seizures

Completed Phase 3 Results posted Last updated 21 December 2015

What this trial tests

Phase 3 trial testing Zonisamide in Epilepsy in 295 participants. Completed in 1 November 2011.

Timeline

1 October 2008

Primary endpoint
1 June 2011

1 November 2011

Quick facts

Lead sponsor	Eisai Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	295
Start date	1 October 2008
Primary completion	1 June 2011
Estimated completion	1 November 2011
Sites	133 locations across Australia, Denmark, France, Germany, Greece, Hungary, India, Italy

Drugs / interventions tested

Zonisamide — full drug profile →
Carbamazepine (carbamazepine) — full drug profile →

Conditions studied

Epilepsy — all drugs for Epilepsy →

Sponsor

Eisai Inc. — full company profile →

Who can join

Adults 18 to 78, any sex, with Epilepsy. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Percentage of Participants Remaining in the Study at Each Visit
Time frame: At 3, 6, 9, 12, 15, 18, 21, 24, and 27 months
The retention rate is defined as the percentage of subjects remaining on the study at each visit, starting from the first dose of study drug in the extension phase.

Sponsor's own description

The purpose of this study is to assess the long-term safety and tolerability and to explore the long-term efficacy of zonisamide as monotherapy treatment in subjects with newly diagnosed partial seizures.

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:

Other trials of Zonisamide

Trials testing the same drug.

NCT05134857 — The Zonisamide and Reinforcement for Reducing Alcohol Use (ZARRA) Study · Phase 2 · recruiting
NCT05205811 — The Effects of Combination Zonisamide and Bupropion on Switching to an Electronic Cigarette · Phase 3 · completed
NCT04388319 — Zonisamide/Bupropion Effects on Switching to Electronic Cigarettes · Phase 3 · completed
NCT03376139 — Zonisamide Outpatient Study · Phase 2 · withdrawn
NCT02049073 — Prevention of Noise-induced Hearing Loss · Phase 1, PHASE2 · withdrawn

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 Inc. trials

Trials by the same sponsor.

NCT07493265 — A Study to Evaluate the Efficacy and Safety of E2086 in Adults With Narcolepsy · Phase 2 · not yet recruiting
NCT07308236 — A Study to Determine the Metabolism and Excretion of [14C]E2086 in Healthy Male Participants · Phase 1 · recruiting
NCT06854042 — A Study of Oral E1018 in Healthy Adult Participants · Phase 1 · recruiting
NCT06744673 — A Study to Assess the Pregnancy Outcome in Women Exposed to Dayvigo® During Pregnancy Compared to an Unexposed Control P · active not recruiting
NCT06602258 — A Study of E2814 With Concurrent Lecanemab Treatment in Participants With Early Alzheimer's Disease · Phase 2 · active not recruiting

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 NCT00848549 (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 Inc.
Last refreshed: 21 December 2015

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/NCT00848549.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing