An add-on Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-epileptic Drugs (AEDs) - Full Text View

Sponsored by:	Eisai Inc.
Information provided by:	Eisai Medical Research Inc.
ClinicalTrials.gov Identifier:	NCT00849212

Purpose

The purpose of this study is to explore the maximum tolerated dose of E2007 in Japanese patients with refractory partial seizures which are uncontrolled with other anti-epileptic drugs (AEDs). Thirty patients will receive E2007 (dose escalating to the maximum of 12 mg per day). The dose of E2007 will be adjusted during 6 weeks.

Subsequently, the dose will be fixed and maintained during 4 weeks.

Condition	Intervention	Phase
Refractory Partial Seizures	Drug: E2007	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Phase II, Open-label, Ascending High-dose, add-on Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-epileptic Drugs (AEDs)

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Epilepsy Seizures

U.S. FDA Resources

Further study details as provided by Eisai Medical Research Inc.:

Primary Outcome Measures:

Primary outcome measure will include the assessment of adverse events, laboratory examinations, vital signs, 12-lead electrocardiograms, and withdrawal questionnaires. [ Time Frame: 18 weeks. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Secondary outcome measure will include the evaluation of patient diaries for seizures. [ Time Frame: 18 weeks. ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	February 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: E2007 The dose of E2007 will start from 2 mg and will be increased by 2 mg every week up to 12 mg (the maximum dose). The dose will be adjusted during 6 weeks (i.e., titration period). Subsequently, the dose will be fixed and maintained during 4 weeks (Maintenance period). Patients must visit study site at Weeks -4, 1, 2, 3, 4, 5, 6, 8, 10 and 14 to confirm.

Eligibility

Ages Eligible for Study:	20 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Male or female aged between 20 and 64 years old.
Patients diagnosed with partial seizure (including secondarily generalized seizure).
Patients who have at least 3 counts of partial seizures during the previous 4 weeks prior to observation start and no seizure-free for 21 days during 8 weeks before the treatment start based on medical records.

Simple partial seizure without motor signs will not be counted.
Patients who have been treated for at least 12 weeks but confirmed to be uncontrolled with more than one standard AED for 2 years.
Patients treated with stable doses of up to three AEDs. Only one cytochrome P450 (CYP) 3A4 inducer shown below will be allowed for concomitant use:
- Carbamazepine
- Phenytoin
- Phenobarbital
- Primidone
Patients on stable dose of anti-depressants, anti-anxiety drugs, or mood stabilizers from before 8 weeks.

Exclusion criteria:

Patients with present or a history of Lennox-Gastaut syndrome.
Patients with present generalized seizures (e.g., absence, myoclonic).
Patients with a history of status epilepticus within 1 year.
Patients with seizure clusters where individual seizure cannot be counted within 8 weeks.
Patients with a history of psychogenic seizure.
Patients who underwent surgical operation for epilepsy within 2 years.
Patients using rescue benzodiazepines at least twice in a 4-week duration within 8 weeks (if 1 or 2 doses over 24-hour period considered one-time rescue).
Patients whose alanine aminotransferase (ALT) or aspartate aminotransferase (AST) at enrollment in observation period exceeds 1.5-fold the upper limit of normal (ULN), but those whose ALT or AST are constantly higher than ULN, they can enroll if ALT or AST remain in 3-fold the ULN.
Patients with significant active hematological disease; white blood cell (WBC) count <=2500/uL or neutrophil count <=1000 uL.
Patients on anti-psychotics or who have psychotic disorder and/or psychotic disorder(s) or unstable recurrent affective disorder(s) with a history of suicidal attempt within 2 years.
Patients who operate heavy equipment or drive should not be recruited into the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00849212

Contacts

Contact: Customer Information Services Department. CRC and QA

_ML_CLNCL@hhc.eisai.co.jp

Locations

Japan
	Recruiting
Shizuoka, Japan
Japan, Fukuoka
	Recruiting
Kitakyushu, Fukuoka, Japan
Japan, Hyogo
	Recruiting
Kobe, Hyogo, Japan
Japan, Miyagi
	Recruiting
Sendai, Miyagi, Japan

Sponsors and Collaborators

Eisai Inc.

Investigators

Study Director:

Hidetaka Hiramatsu

New Drug Development Department, Eisai Company Limited

More Information

No publications provided

Responsible Party:	New Drug Development Department, Eisai Company Limited ( Hidetaka Hiramatsu, Study Director )
Study ID Numbers:	E2007-J081-231
Study First Received:	February 20, 2009
Last Updated:	August 26, 2009
ClinicalTrials.gov Identifier:	NCT00849212 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Eisai Medical Research Inc.:

Seizures
epilepsy

Study placed in the following topic categories:

Signs and Symptoms
Epilepsy
Seizures
Neurologic Manifestations

Central Nervous System Diseases
Brain Diseases
Anticonvulsants

Additional relevant MeSH terms:

Signs and Symptoms
Epilepsy
Therapeutic Uses
Nervous System Diseases
Seizures
Neurologic Manifestations

Central Nervous System Diseases
Brain Diseases
Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants

ClinicalTrials.gov processed this record on August 30, 2009