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Adjunctive Zonisamide in Primary Generalised Tonic Clonic Seizures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00692003
Recruitment Status : Terminated (Sponsor's decision)
First Posted : June 6, 2008
Results First Posted : October 12, 2012
Last Update Posted : March 14, 2017
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Limited )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Epilepsy
Interventions Drug: Zonisamide
Drug: Placebo
Enrollment 21
Recruitment Details This study was recruited at 6 centers (3 in Romania and 1 in Australia, Hungary, and Lithuania) during the period of 01 August 2008 to 28 January 2009.
Pre-assignment Details Twenty-one subjects were screened and 14 participants did not continue the study after screening. Seven participants entered the study but 1 participant did not receive any treatment. Consequently, 6 participants were enrolled and treated during the study. None of the 6 subjects completed treatment & all discontinued due to the Sponsor's decision.
Arm/Group Title Zonisamide Placebo
Hide Arm/Group Description

25-400 mg capsules orally once daily in the evening.

Maximum study duration of 28 weeks comprising:

Baseline Period (Week-8/-4 to Week 0) no treatment

Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg;

>= 12 years old: 50 mg daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4

Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)

Down Titration Period (4 weeks)

25-400 mg Zonisamide Placebo capsules orally once daily in the evening.

Maximum study duration of 28 weeks comprising:

Baseline Period (Week-8/-4 to Week 0) no treatment

Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg Zonisamide Placebo;

>= 12 years old: 50 mg Zonisamide Placebo capsules daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4

Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)

Down Titration Period (4 weeks)

Period Title: Overall Study
Started 5 1
Completed 0 0
Not Completed 5 1
Reason Not Completed
Sponsor Decision             5             1
Arm/Group Title Zonisamide Placebo Total
Hide Arm/Group Description

25-400 mg capsules orally once daily in the evening.

Maximum study duration of 28 weeks comprising:

Baseline Period (Week-8/-4 to Week 0) no treatment

Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg;

>= 12 years old: 50 mg daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4

Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained(4 mg/kg or 200 mg in the event of dose limiting adverse events)

Down Titration Period (4 weeks)

25-400 mg Zonisamide Placebo capsules orally once daily in the evening.

Maximum study duration of 28 weeks comprising:

Baseline Period (Week-8/-4 to Week 0) no treatment

Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg Zonisamide Placebo; >= 12 years old: 50 mg Zonisamide Placebo capsules daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4

Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)

Down Titration Period (4 weeks)

Total of all reporting groups
Overall Number of Baseline Participants 5 1 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 1 participants 6 participants
38.4  (18.66) 27.0 [1]   (NA) 36.5  (17.33)
[1]
N=1
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 1 participants 6 participants
Female
3
  60.0%
0
   0.0%
3
  50.0%
Male
2
  40.0%
1
 100.0%
3
  50.0%
1.Primary Outcome
Title Number of Participants Considered Responders as Assessed During the Maintenance Period
Hide Description The number of participants who were considered responders during the 12 week Maintenance Period (Week 4 to Week 16). A responder was defined as a participant with a decrease from baseline in Primary Generalised Tonic-Clonic Seizures (PGTCS) frequency of >= 50% (i.e. 28-day PGTC seizure frequency in the period from Week 4 to the Week 16 visit compared to Week -8/-4 to randomization at Week 0). Each participant's response to treatment was assessed on the basis of their seizure diaries. The diary was dispensed at the Screening Visit and maintained by the participant (parent/caregiver) through out the titration and maintenance treatment periods until the Early termination Visit at Week 16. Due to early termination of the study by the Sponsor, no formal analyses were conducted.
Time Frame Baseline (Week -8/-4 to Week 0) and Maintenance Phase (Week 4 to Week 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Due to early termination of the study by the Sponsor, no formal analyses were conducted.
Arm/Group Title Zonisamide Placebo
Hide Arm/Group Description:

25-400 mg capsules orally once daily in the evening.

Maximum study duration of 28 weeks comprising:

Baseline Period (Week-8/-4 to Week 0) no treatment

Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg;

>= 12 years old: 50 mg daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4

Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained(4 mg/kg or 200 mg in the event of dose limiting adverse events)

Down Titration Period (4 weeks)

25-400 mg Zonisamide Placebo capsules orally once daily in the evening.

Maximum study duration of 28 weeks comprising:

Baseline Period (Week-8/-4 to Week 0) no treatment

Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg Zonisamide Placebo; >= 12 years old: 50 mg Zonisamide Placebo capsules daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4

Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)

Down Titration Period (4 weeks)

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Absolute Change From Baseline in 28-day PGTC Seizure Frequency
Hide Description Absolute Change from Baseline in 28-day PGTC Seizure Frequency was assessed both for the Maintenance Period alone (Week 4 to Week 16) and for the entire double-blind treatment period (Week 0 to Week 16). Due to early termination of the study by the Sponsor, no formal analyses were conducted.
Time Frame Baseline and up to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Due to early termination of the study by the Sponsor, no formal analyses were conducted.
Arm/Group Title Zonisamide Placebo
Hide Arm/Group Description:

25-400 mg capsules orally once daily in the evening.

Maximum study duration of 28 weeks comprising:

Baseline Period (Week-8/-4 to Week 0) no treatment

Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg;

>= 12 years old: 50 mg daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4

Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained(4 mg/kg or 200 mg in the event of dose limiting adverse events)

Down Titration Period (4 weeks)

25-400 mg Zonisamide Placebo capsules orally once daily in the evening.

Maximum study duration of 28 weeks comprising:

Baseline Period (Week-8/-4 to Week 0) no treatment

Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg Zonisamide Placebo; >= 12 years old: 50 mg Zonisamide Placebo capsules daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4

Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)

Down Titration Period (4 weeks)

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events were collected for approximately 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Zonisamide
Hide Arm/Group Description

25-400 mg Zonisamide Placebo capsules orally once daily in the evening.

Maximum study duration of 28 weeks comprising:

Baseline Period (Week-8/-4 to Week 0) no treatment

Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg Zonisamide Placebo; >= 12 years old: 50 mg Zonisamide Placebo capsules daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4

Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)

Down Titration Period (4 weeks)

25-400 mg capsules orally once daily in the evening.

Maximum study duration of 28 weeks comprising:

Baseline Period (Week-8/-4 to Week 0) no treatment

Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg; >= 12 years old: 50 mg daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4

Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)

Down Titration Period (4 weeks)

All-Cause Mortality
Placebo Zonisamide
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Placebo Zonisamide
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/5 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Zonisamide
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   2/5 (40.00%) 
General disorders     
Fatigue  1  0/1 (0.00%)  1/5 (20.00%) 
Gait disturbance  1  0/1 (0.00%)  1/5 (20.00%) 
Infections and infestations     
Nasopharyngitis  1  0/1 (0.00%)  1/5 (20.00%) 
Urinary tract infection  1  0/1 (0.00%)  1/5 (20.00%) 
Nervous system disorders     
Dizziness  1  0/1 (0.00%)  1/5 (20.00%) 
Postictal headache  1  0/1 (0.00%)  1/5 (20.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
This study was terminated early at the Sponsor's discretion. When this study was discontinued, only 6 subjects had been treated. Data from the 5 subjects treated with zonisamide were insufficient to draw firm conclusions regarding efficacy.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Antonio Laurenza, MD, Executive Director
Organization: Eisai Inc
Phone: 1 201 949-4157
EMail: antonio_laurenza@eisai.com
Layout table for additonal information
Responsible Party: Eisai Inc. ( Eisai Limited )
ClinicalTrials.gov Identifier: NCT00692003    
Other Study ID Numbers: E2090-E044-315
Eudra ID #2007-003557-91.
First Submitted: June 3, 2008
First Posted: June 6, 2008
Results First Submitted: August 13, 2012
Results First Posted: October 12, 2012
Last Update Posted: March 14, 2017