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Trial record 85 of 146 for:    epilepsy AND Bethesda

Efficacy and Safety of Adjunctive Zonisamide in Myoclonic Seizures Associated With Idiopathic Generalised Epilepsy

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ClinicalTrials.gov Identifier: NCT00693017
Recruitment Status : Terminated (Sponsor's decision)
First Posted : June 6, 2008
Results First Posted : September 12, 2012
Last Update Posted : December 24, 2015
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 10
Recruitment Details This study was recruited at three study centers (1 in Australia and 2 in Hungary). A further 39 study centers in Europe and Australia were initiated. A total of 12 study sites in the following countries were not initiated; (2 in Finland), (3 in Czech Republic), and (7 in Ukraine) during the period of 04 June 2008 to 05 January 2009.
Pre-assignment Details 10 participants were screened for eligibility and six participants did not continue after the Screening Visit due to the Sponsor's decision to terminate the study. 4 participants were enrolled and treated during the study.
Arm/Group Title Zonisamide Placebo
Hide Arm/Group Description

50-400 mg capsules once daily in the evening orally.

Maximum study duration 28 weeks comprising:

Baseline Period (Week -8 to Week 0): no treatment

Titration Period (Week 0 to Week 4): 50 mg daily titrated weekly until 300 mg was reached by Week 4

Maintenance Period (Week 4 to Week 16) 400 mg (or 350 mg in the event of dose limiting adverse events)

Down Titration Period (4 Weeks)

50-400 mg Zonisamide Placebo capsules once daily in the evening orally.

Maximum study duration 28 weeks comprising:

Baseline Period (Week -8 to Week 0): no treatment

Titration Period (Week 0 to Week 4): 50 mg Zonisamide Placebo daily titrated weekly until 300 mg was reached by Week 4

Maintenance Period (Week 4 to Week 16) 400 mg Zonisamide Placebo (or 350 mg in the event of dose limiting adverse events)

Down Titration Period (4 Weeks)

Period Title: Overall Study
Started 2 2
Completed 0 0
Not Completed 2 2
Reason Not Completed
Sponsor Decision             2             1
Death             0             1
Arm/Group Title Zonisamide Placebo Total
Hide Arm/Group Description

50-400 mg capsules once daily in the evening orally.

Maximum study duration 28 weeks comprising:

Baseline Period (Week -8 to Week 0): no treatment

Titration Period (Week 0 to Week 4): 50 mg daily titrated weekly until 300 mg was reached by Week 4

Maintenance Period (Week 4 to Week 16) 400 mg (or 350 mg in the event of dose limiting adverse events)

Down Titration Period (4 Weeks)

50-400 mg Zonisamide Placebo capsules once daily in the evening orally.

Maximum study duration 28 weeks comprising:

Baseline Period (Week -8 to Week 0): no treatment

Titration Period (Week 0 to Week 4): 50 mg Zonisamide Placebo daily titrated weekly until 300 mg was reached by Week 4

Maintenance Period (Week 4 to Week 16) 400 mg Zonisamide Placebo (or 350 mg in the event of dose limiting adverse events)

Down Titration Period (4 Weeks)

Total of all reporting groups
Overall Number of Baseline Participants 2 2 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants 2 participants 4 participants
24.0  (16.97) 33.5  (23.33) 28.8  (17.54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 4 participants
Female
1
  50.0%
1
  50.0%
2
  50.0%
Male
1
  50.0%
1
  50.0%
2
  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 >= 50% from baseline in the number of days with myoclonic seizures per 28 days (i.e. 28-day myoclonic seizure frequency in Period from Week 4 to the Week 16 visit compared to Week -8 to randomization at Week 0 [Screening/ Baseline Period]). Occurrence of seizures was documented in a seizure diary. The diary was dispensed at the Screening Visit and maintained by the participant (parent/caregiver) and reviewed at each following visit. The diary was completed daily. All seizures except myoclonic seizures were counted individually in the the diary. Due to early termination of the study by the Sponsor, no formal analyses were conducted.
Time Frame Baseline (Week -8 to Week 0) and Maintenance Period (Week 4 to Week 16)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zonisamide Placebo
Hide Arm/Group Description:

50-400 mg capsules once daily in the evening orally.

Maximum study duration 28 weeks comprising:

Baseline Period (Week -8 to Week 0): no treatment

Titration Period (Week 0 to Week 4): 50 mg daily titrated weekly until 300 mg was reached by Week 4

Maintenance Period (Week 4 to Week 16) 400 mg (or 350 mg in the event of dose limiting adverse events)

Down Titration Period (4 Weeks)

50-400 mg Zonisamide Placebo capsules once daily in the evening orally.

Maximum study duration 28 weeks comprising:

Baseline Period (Week -8 to Week 0): no treatment

Titration Period (Week 0 to Week 4): 50 mg Zonisamide Placebo daily titrated weekly until 300 mg was reached by Week 4

Maintenance Period (Week 4 to Week 16) 400 mg Zonisamide Placebo (or 350 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 Percentage Change From Baseline in the Monthly Number of Days With Myoclonic Seizures
Hide Description Percentage Change from Baseline in the monthly number of days with myoclonic seizures 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
[Not Specified]
Arm/Group Title Zonisamide Placebo
Hide Arm/Group Description:

50-400 mg capsules once daily in the evening orally.

Maximum study duration 28 weeks comprising:

Baseline Period (Week -8 to Week 0): no treatment

Titration Period (Week 0 to Week 4): 50 mg daily titrated weekly until 300 mg was reached by Week 4

Maintenance Period (Week 4 to Week 16) 400 mg (or 350 mg in the event of dose limiting adverse events)

Down Titration Period (4 Weeks)

50-400 mg Zonisamide Placebo capsules once daily in the evening orally.

Maximum study duration 28 weeks comprising:

Baseline Period (Week -8 to Week 0): no treatment

Titration Period (Week 0 to Week 4): 50 mg Zonisamide Placebo daily titrated weekly until 300 mg was reached by Week 4

Maintenance Period (Week 4 to Week 16) 400 mg Zonisamide Placebo (or 350 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 [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Zonisamide Placebo
Hide Arm/Group Description

50-400 mg capsules once daily in the evening orally.

Maximum study duration 28 weeks comprising:

Baseline Period (Week -8 to Week 0): no treatment

Titration Period (Week 0 to Week 4): 50 mg daily titrated weekly until 300 mg was reached by Week 4

Maintenance Period (Week 4 to Week 16) 400 mg (or 350 mg in the event of dose limiting adverse events)

Down Titration Period (4 Weeks)

50-400 mg Zonisamide Placebo capsules once daily in the evening orally.

Maximum study duration 28 weeks comprising:

Baseline Period (Week -8 to Week 0): no treatment

Titration Period (Week 0 to Week 4): 50 mg Zonisamide Placebo daily titrated weekly until 300 mg was reached by Week 4

Maintenance Period (Week 4 to Week 16) 400 mg Zonisamide Placebo (or 350 mg in the event of dose limiting adverse events)

Down Titration Period (4 Weeks)

All-Cause Mortality
Zonisamide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Zonisamide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   1/2 (50.00%) 
General disorders     
Sudden unexplained death in epilepsy  0/2 (0.00%)  1/2 (50.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Zonisamide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   2/2 (100.00%)   2/2 (100.00%) 
Eye disorders     
Vision blurred  1/2 (50.00%)  1/2 (50.00%) 
Gastrointestinal disorders     
Vomiting  1/2 (50.00%)  0/2 (0.00%) 
Nervous system disorders     
Dizziness  1/2 (50.00%)  0/2 (0.00%) 
Headache  0/2 (0.00%)  1/2 (50.00%) 
Somnolence  1/2 (50.00%)  0/2 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Rhinitis allergic  0/2 (0.00%)  1/2 (50.00%) 
Due to early termination of the study by the Sponsor. No formal analyses were conducted.
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: NCT00693017     History of Changes
Other Study ID Numbers: E2090-E044-317
2007-003556-10 ( EudraCT Number )
First Submitted: June 3, 2008
First Posted: June 6, 2008
Results First Submitted: August 13, 2012
Results First Posted: September 12, 2012
Last Update Posted: December 24, 2015