A Study to Assess the Efficacy and Safety of Adjunctive Zonisamide in Paediatric Partial Onset Seizures (CATZ Extension Study)

NCT01136954 | Completed Phase 3 Results

• 2 other identifiers: E2090-E044-3132007-000198-53
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the long-term safety and efficacy of zonisamide used as an adjunctive treatment in pediatric subjects treated with 1 or 2 other anti-epileptic drugs (AEDs).

Conditions

Partial Seizures

Outcome Measures

Primary Outcomes (1)

• Treatment Emergent Non-Serious Adverse Events With Greater Than 5% Frequency

  Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event with a start date on or after Day 1 and within 15 days of last dose. For each event, each participant experiencing an event is only counted once even if they had multiple episodes.

  Week 1 through Week 59

Secondary Outcomes (3)

• Percentage of Participants With a Decrease From Baseline in 28-day Seizure Frequency of =50%(Responder) in the Open Label Period

  Baseline through Week 59

• Median Change From Study 312 Baseline in the 28-day Seizure Frequency During the Open Label Period

  Baseline of study 312 (Week -8 to Week 0) to Week 59 of study 313

• Median Percent Change From Study 312 Baseline in the 28-day Seizure Frequency During the Open Label Period

  Baseline of study 312 (Week -8 to Week 0) to Week 59 of study 313

Study Arms (1)

1

EXPERIMENTAL

Drug: Zonisamide

Interventions

Zonisamide DRUG

Transition Period from Study E2090-E044-312: Placebo Open-Label Period: 1 to 8 mg/kg orally per day for approximately 59 weeks.

Also known as: Zonegran

1

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subject has completed the double-blind study E2090-E044-312.
• Parent/caregiver is willing to sign an informed consent where the subject is under the age of consent.
• Subject is male or female aged 6 to 18 years who is willing to give informed (written or verbal) assent, if applicable. If mandated by local regulations, subjects of relevant age will be required to sign an appropriate informed consent.
• Subject is in general good health as determined by medical history, physical exam and screening laboratory results.

You may not qualify if:

• Subject has a body weight \< 20 kg.
• Subject has developed a history of renal calculi or renal insufficiency (creatinine level \> 135 µmol/l (1.5 mg/dl).
• Subject has a known diagnosis of human immunodeficiency virus (HIV) or hepatitis B or C.
• Subject has a history of sensitivity to sulfonamide drugs or zonisamide and its excipients.
• Female subject of 10 years of age or greater, or of child bearing potential (i.e. started menses) and is not taking or prepared to take a medically acceptable form of contraception (i.e. oral contraceptive pill, surgical sterilization, an implant or injected form of contraception, or intrauterine device), or who is not prepared to abstain from sexual activity for the duration of the study and for one month after the last administration of study medication. NOTE: Should a female subject become of child bearing potential during the study, they must be reconsented in order to given consent to undergo pregnancy testing and either confirm abstinence or receive a medically appropriate form of contraception.
• Subject has a recent history of excessive alcohol use or drug abuse.
• Subject has a history of suicide attempt.
• Subject has a clinically significant organic disease.
• Subject has a history of demonstrated non-compliance with treatment or subject or parent/legal guardian can be reasonably expected not to be compliant with study procedures or to complete the study.
• Frequent need of rescue benzodiazepines (one or more times a month).
• Concomitant use of acetazolamide, carbonic anhydrase inhibitors such as topiramate, furosemide and drugs with anticholinergic activity.
• Concomitant use of felbamate or use of felbamate within 2 months prior to Visit 1 of the E2090-E044-312 study.

Sponsors & Collaborators

• Eisai Limited: lead

Study Sites (1)

Unknown Facility

Firenze, 50132, FI, 50132, Italy

Location

MeSH Terms

Conditions

Seizures

Interventions

Zonisamide

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Eisai Inc.
• Organization: Eisai Call Center

888-422-4743

Study Officials

• Rob van Maanen, M.D., MFPM

  Eisai Limited

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2010
• First Posted: June 4, 2010
• Study Start: July 1, 2008
• Primary Completion: January 1, 2012
• Study Completion: March 1, 2012
• Last Updated: January 25, 2016
• Results First Posted: February 6, 2013

Record last verified: 2015-11

Locations

IT (1)