Adjunctive Zonisamide in Primary Generalised Tonic Clonic Seizures

• Sponsor: Eisai Limited (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00692003
• Collaborator: (none)
• Enrollment: 21
• Locations: 73
• Arms: 2
• Actual Duration (Months): 5.3
• Patients Per Site: 0.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

Zonisamide is already marketed for the treatment of partial seizures in epilepsy. This study is intended to provide evidence that zonisamide is safe and effective in the treatment of primary generalised tonic-clonic seizures. The total trial duration will be 5.5-6.5 months. After that subjects who have completed the study will be eligible to enrol in an open-label extension study until zonisamide is marketed for this indication or further development in this indication stops. This extension study will be described in a separate protocol (E2090-E044-316).

Condition or Disease	Intervention/Treatment	Phase
Epilepsy	Drug: Zonisamide; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Double-blind, Randomised, Placebo-controlled Multi-centre Study to Assess the Efficacy and Safety of Adjunctive Zonisamide in Primary Generalised Tonic Clonic Seizures
• Actual Study Start Date: Aug 1, 2008
• Actual Primary Completion Date: Nov 1, 2008
• Actual Study Completion Date: Jan 9, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Zonisamide	Drug: Zonisamide; 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); Other Names: Zonegran
Placebo Comparator: Placebo	Drug: Placebo; 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)

Outcome Measures

Primary Outcome Measures

1. Number of Participants Considered Responders as Assessed During the Maintenance Period [Baseline (Week -8/-4 to Week 0) and Maintenance Phase (Week 4 to Week 16)]

   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.

Secondary Outcome Measures

1. Absolute Change From Baseline in 28-day PGTC Seizure Frequency [Baseline and up to 16 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subject is male or female and aged 6-65 years.

2. Subject has ≥ 3 PGTCS over the two months before screening and during the eight weeks Baseline Period with at least one seizure in each one month period. PGTCS must occur in the context of Idiopathic Generalized Epilepsy (IGE) and may be accompanied by other primary generalized seizures, provided these are also consistent with a diagnosis of IGE.

3. Subject (or parent/caregiver, for subjects below the age of consent) is willing to sign an informed consent form. For subjects below the age of consent in their country, where appropriate they must be willing to give informed (written or verbal) assent. Subjects from the age specified in local regulations will be required to sign an appropriate informed consent form.

4. Subject is taking a stable regimen of one or two other Antiepileptic Drugs (AEDs) for at least two weeks prior to Visit 1 (start of the Baseline Period).

5. Subject has a clinical diagnosis of any type of idiopathic generalized epilepsy which has PGTCS (and which may be accompanied by other generalized seizure types), according to the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures (1981) and the ILAE Classification of Epilepsies and Epileptic Syndromes (1989). Diagnosis should have been established by clinical history, electroencephalogram (EEG) and computed tomography/magnetic resonance imaging (CT/MRI) of the brain consistent with idiopathic generalized epilepsy. CT/MRI scan should have been performed within five years of the screening visit or, if not available from this period, should be performed in the Baseline Period.

6. EEG should have been performed within one year of the screening visit or, if not available from this period, should be performed in the Baseline Period.

7. Female subjects are pre-menarchal, or if of childbearing potential, are not pregnant or lactating or are post-menopausal.

8. Female subjects of childbearing potential must abide by the one of the following medically acceptable contraceptive measures: oral contraception pill, contraceptive injections, implants or patches, intrauterine device in place for at least three months or vasectomised partner or abstinence throughout the study.

9. Subject has a body weight ≥ 20 kg.

Exclusion Criteria:

1. Subject has progressive or focal neurological disease (as determined by pre-existing brain imaging such as CT or MRI performed maximally five years before the screening visit), or clinically significant organic disease.

2. Subject has a history of, or results of clinical investigations (including EEG data) that are suggestive of, partial seizures as defined by the ILAE, including generalized tonic clonic seizures which are suspected to be secondarily generalized.

3. Subjects with cryptogenic or symptomatic generalized epilepsy.

4. Subjects with psychogenic seizures.

5. Subject has a history of status epilepticus within a year of screening while complying with AEDs.

6. Subject has seizures that only occur in clustered patterns.

7. Subject has a history of renal calculi or renal insufficiency (above the upper normal limits of creatinine).

8. Subject has a known diagnosis of human immunodeficiency virus (HIV) or hepatitis B or

1. Subject had a predisposing condition that might interfere with absorption, distribution, or excretion of zonisamide.

2. Subject has a history of sensitivity to sulfonamide drugs or zonisamide and its excipients.

3. Subject has a recent history of excessive alcohol use or drug abuse.

4. Subject has a history of suicide attempt in the five years before the screening visit..

5. Subject has abnormal screening laboratory values that were clinically significant.

6. Subject has a history of demonstrated non-compliance with treatment or the subject or parent/caregiver can be reasonably expected not to be compliant with study procedures or to complete the study.

7. Subject has participated in a study of an investigational drug or device within 30 days prior to screening.

8. Subject has received previous treatment with zonisamide.

9. Subject is treated with ketogenic diet or vagus nerve stimulator.

10. Subject has a history of necessary treatment with rescue benzodiazepines which is foreseen to continue during the study. Rescue benzodiazepines will not be allowed in this study (stable dosing with a benzodiazepine as (one of the) baseline anti-epileptic drug(s) is allowed).

11. Current psychosis or moderate to severe depression, or use of anti-psychotic drugs, MAOIs, tricyclic antidepressants, benzodiazepine or barbiturate treatment for disorders other than epilepsy, and stimulants (amphetamine derivatives) within 28 days before the screening visit.

12. Concomitant use of acetazolamide, carbonic anhydrase inhibitors such as topiramate and drugs with anticholinergic activity.

13. Concomitant use of felbamate or use of felbamate within two months prior to Visit 1.

14. Subject is not able to swallow capsules.

15. Subject is not in general good health as determined by medical history, physical exam and screening laboratory results.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Strategic Health Evaluators Pty Ltd	Chatswood	New South Wales	Australia	2067
2	The Prince of Wales Hospital	Randwick	New South Wales	Australia	2031
3	Austin Health	Heidelburg	Victoria	Australia	3084
4	The Royal Melbourne Hospital	Melbourne	Victoria	Australia	3050
5	St. Vincents Hospital	Melbourne		Australia
6	CH Split	Split	HR	Croatia	10000
7	CH Sestre Milosrdnice University Hospital	Zagreb	HR	Croatia	10000
8	UHC Zagreb	Zagreb	HR	Croatia	10000
9	Neurologicke oddeleni	Hradec Kralove		Czech Republic	500 03
10	Private Neurologi Office	Kromeriz		Czech Republic	767 01
11	Fakultni nemocnice Olomouc	Olomouc		Czech Republic	775 20
12	Fakultni nemocnice s poliklinikou Ostrava	Ostrava		Czech Republic	708 52
13	Fakultni nemocnice Plzen	Plzen		Czech Republic	305 99
14	Nemocnice Na Homolce	Praha 5		Czech Republic	150 30
15	Centrum neurologicke pece	Rychnov nad Kneznou		Czech Republic	516 01
16	West-Tallinn Central Hospital	Tallinn		Estonia	10611
17	Neurodiagnostica AP OY	Tallinn		Estonia	11312
18	Tartu University Hospital	Tartu		Estonia	51014
19	Kuopio Epilepsy Center	Kuopio	SF	Finland	70211
20	Oulu University Central Hospital	Oulu		Finland	90220
21	Institut fur Diagnostik der Epilepsien	Berlin		Germany	10365
22	Neurochirurgische Klinik der Universitat Freiburg	Freiburg		Germany	79106
23	Interdisziplinares Epilepsiezentrum am Klinikum der Philipps-Universitat Marburg	Marburg		Germany	35039
24	Neurologische Gemeinschaftspraxis	Munchen		Germany	80333
25	Universitatsklinikum Ulm	Ulm		Germany	89081
26	National Institute of Psychiatry and Neurology	Budapest		Hungary	1021
27	Heim Pal Hospital	Budapest		Hungary	1089
28	Szent Istvan Hospital	Budapest		Hungary	1091
29	Orszagos Idegsebeszeti Tudomanyos Intezet	Budapest		Hungary	1145
30	Bethesda Hospital for Children	Budapest		Hungary	1146
31	Bekes County Pandy Kalman Hospital	Gyula		Hungary	5703
32	Bacs-Kiskun County ONK Hospital	Kecskemet		Hungary	6000
33	Vas County Markusovszky Hospital	Szombathely		Hungary	9400
34	Veszpem County Csolnoky F. Hospital	Veszpem		Hungary	8200
35	Kaunas Medical University Hospital	Kaunas		Lithuania	50009
36	Neuromeda	Kaunas		Lithuania	50185
37	Vilnius University Hospital Santariskiu klinikos	Vilnius		Lithuania	8661
38	Niepubliczny ZOZ KENDRON	Bialystok		Poland	15-420
39	Wojewodzki Szpital Specjalistyczny im. M. Kopernika	Gdansk		Poland	80-803
40	Specjalistyczny Szpital Wieloprofilowy	Katowice		Poland	40-635
41	Centrum Neurologii Klinicznej	Krakow		Poland	31-530
42	Szpital im. M. Kopernika	Lodz		Poland	93-513
43	Uniwersytet Medyczny	Poznan		Poland	60-355
44	Spitalul Clinic de Psihiatrie	Bucharest		Romania	041914
45	Spitalul Universitar de Urgenta Bucuresti	Bucharest		Romania	050098
46	Centrul Medical Sana	Bucharest		Romania	11025
47	Spitalul Clinic Judetean de Urgenta Cluj	Cluj-Napoca		Romania	400006
48	Spitalul Clinic Judetean de Urgenta Sf Spiridon Iasi	Iasi		Romania	700111
49	Spitalul Clinic de Urgenta Sfanta Treime	Iasi		Romania	700309
50	Spitalul Clinic Judetean de Urgenta Tg Mures	Tg Mures		Romania	540136
51	GOU VPO Krasnoyarskaya State Medical Academy of Roszdrav	Krasnoyarsk		Russian Federation	660022
52	FGU Moscow Research Institute of Psychiatry of Roszdrav	Moscow		Russian Federation	107076
53	GOU VPO Russian State Medical University of Roszdrav	Moscow		Russian Federation	117997/119034
54	GOU VPO Smolensk State Medical Academy of Roszdrav	Moscow		Russian Federation	119049
55	GOU VPO Moscow State University of Medicine and Dentistry of Roszdrav	Moscow		Russian Federation	127473 / 107006
56	GOU VPO Novosibirsk State Medical University of Roszdrav	Novosibirsk		Russian Federation	630091
57	GOU VPO Smolensk State Medical Academy of Roszdrav	Smolensk		Russian Federation	214018
58	GOU VPO Smolensk State Medical Academy of Roszdrav	Smolensk		Russian Federation	214019
59	St. Petersburg State Medical Pediatric Academy	St. Petersburg		Russian Federation	194100
60	GU St. Petersburg Research Institute of Psychoneurology	St.Petersburg		Russian Federation	192019
61	GOU VPO St. Petersburg State Medical University	St.Petersburg		Russian Federation	197022
62	Yaroslavskaya State Medical Academy	Yaroslavl		Russian Federation	150000
63	Clinical Center of Serbia	Belgrade		Serbia	11000
64	University Medical Center Zvezdara	Belgrade		Serbia	11000
65	Clinical Center Kragujevac	Kragujevac		Serbia	34000
66	Clinical Center of Nis	Nis		Serbia	18000
67	Tsentr Psihosomatychnoyi Patologiyi Dnipropetrovskoyi oblasnoyi klinichnoyi likarni imeni Mechnikova	Dniepropetrovsk		Ukraine	49005
68	Derzhavna Ustanova Institut Nevrologiy	Kharkiv		Ukraine	61068
69	Kyiv City Psychiatric Hospital #2, Poliklinichne Viddilenya	Kyiv		Ukraine	2660
70	Miska Klinichna psihonevrologichna Tsentr Epilepsiyi	Kyiv		Ukraine	3080
71	Lvivskyiy oblasnyi Protyepileptuchnyy tsentr	Lviv		Ukraine	7910
72	Odesskyy Derzhavnyy Medychnyy Universitet	Odesa		Ukraine	65006
73	Vinnitskyy Natsionalnyy Medychnyy Universitet	Vinnitsa		Ukraine	21005

Sponsors and Collaborators

• Eisai Limited

Investigators

• Study Director: Rob Van Maanen, Eisai Limited

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eisai Limited
• ClinicalTrials.gov Identifier: NCT00692003
• Other Study ID Numbers: E2090-E044-315; Eudra ID #2007-003557-91.
• First Posted: Jun 6, 2008
• Last Update Posted: Mar 14, 2017
• Last Verified: Feb 1, 2017

• Additional relevant MeSH terms: Seizures; Zonisamide

Study Results

Participant Flow

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 Detail	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
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

Baseline Characteristics

Arm/Group Title	Zonisamide	Placebo	Total
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 Participants	5	1	6
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	38.4 (18.66)	27.0 (NA)	36.5 (17.33)
Sex: Female, Male (Count of Participants)
Female	3 60%	0 0%	3 50%
Male	2 40%	1 100%	3 50%

Outcome Measures

1. Secondary Outcome

Title	Absolute Change From Baseline in 28-day PGTC Seizure Frequency
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

Outcome Measure Data

Analysis Population Description

Due to early termination of the study by the Sponsor, no formal analyses were conducted.

Arm/Group Title	Zonisamide	Placebo
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)
Measure Participants	0	0

2. Primary Outcome

Title	Number of Participants Considered Responders as Assessed During the Maintenance Period
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)

Outcome Measure Data

Analysis Population Description

Due to early termination of the study by the Sponsor, no formal analyses were conducted.

Arm/Group Title	Zonisamide	Placebo
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)
Measure Participants	0	0

Adverse Events

Time Frame	Adverse events were collected for approximately 3 months
Arm/Group Title	Placebo		Zonisamide
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Zonisamide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/5 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Zonisamide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		2/5 (40%)
General disorders
Fatigue	0/1 (0%)		1/5 (20%)
Gait disturbance	0/1 (0%)		1/5 (20%)
Infections and infestations
Nasopharyngitis	0/1 (0%)		1/5 (20%)
Urinary tract infection	0/1 (0%)		1/5 (20%)
Nervous system disorders
Dizziness	0/1 (0%)		1/5 (20%)
Postictal headache	0/1 (0%)		1/5 (20%)

Limitations/Caveats

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.

More Information

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.