TOPIRAMATE (Page 8 of 11)

Incidence in Study 119 – Add-On Therapy– Adults with Partial Onset Seizures

Study 119 was a randomized, double-blind, placebo-controlled, parallel group study with 3 treatment arms: 1) placebo; 2) topiramate 200 mg/day with a 25 mg/day starting dose, increased by 25 mg/day each week for 8 weeks until the 200 mg/day maintenance dose was reached; and 3) topiramate 200 mg/day with a 50 mg/day starting dose, increased by 50 mg/day each week for 4 weeks until the 200 mg/day maintenance dose was reached. All patients were maintained on concomitant carbamazepine with or without another concomitant antiepileptic drug.

The incidence of adverse events (Table 8) did not differ significantly between the 2 topiramate regimens. Because the frequencies of adverse events reported in this study were markedly lower than those reported in the previous epilepsy studies, they cannot be directly compared with data obtained in other studies.

Table 8: Incidence of Treatment-Emergent Adverse Events in Study 119a,b Where Rate Was ≥ 2% in the Topiramate Group and Greater Than the Rate in Placebo-Treated Patients
Topiramate Dosage (mg/day)
Body System/ Adverse Eventc Placebo(N=92) 200(N=171)

a Patients in these add-on trials were receiving 1 to 2 concomitant antiepileptic drugs in addition to topiramate or placebo.

b Values represent the percentage of patients reporting a given adverse event. Patients may have reported more than one adverse event during the study and can be included in more than one adverse event category.

c Adverse events reported by at least 2% of patients in the topiramate 200 mg/day group and more common than in the placebo group are listed in this table.

Body as a Whole-General Disorders
Fatigue 4 9
Chest Pain 1 2
Cardiovascular Disorders, General
Hypertension 0 2
Central & Peripheral Nervous System Disorders
Paresthesia 2 9
Dizziness 4 7
Tremor 2 3
Hypoasthesia 0 2
Leg Cramps 0 2
Language Problems 0 2
Gastro-Intestinal System Disorders
Abdominal Pain 3 5
Constipation 0 4
Diarrhea 1 2
Dyspepsia 0 2
Dry Mouth 0 2
Hearing and Vestibular Disorders
Tinnitus 0 2
Metabolic and Nutritional Disorders
Weight Decrease 4 8
Psychiatric Disorders
Somnolence 9 15
Anorexia 7 9
Nervousness 2 9
Difficulty with Concentration/Attention 0 5
Insomnia 3 4
Difficulty with Memory 1 2
Aggressive Reaction 0 2
Respiratory System Disorders
Rhinitis 0 4
Urinary System Disorders
Cystitis 0 2
Vision Disorders
Diplopia 0 2
Vision Abnormal 0 2
Table 9: Incidence (%) of Dose-Related Adverse Events From Placebo-Controlled, Add-On Trials in Adults with Partial Onset Seizuresa
Topiramate Dosage (mg/day)
Adverse Event Placebo(N = 216) 200(N = 45) 400(N = 68) 600 to 1,000(N = 414)

a Dose-response studies were not conducted for other adult indications or for pediatric indications.

Fatigue 13 11 12 30
Nervousness 7 13 18 19
Difficulty with Concentration/Attention 1 7 9 14
Confusion 4 9 10 14
Depression 6 9 7 13
Anorexia 4 4 6 12
Language problems <1 2 9 10
Anxiety 6 2 3 10
Mood problems 2 0 6 9
Weight decrease 3 4 9 13
Table 10: Incidence (%) of Treatment-Emergent Adverse Events in Placebo-Controlled, Add-On Epilepsy Trials in Pediatric Patients Ages 2 to 16 Yearsa,b (Events that Occurred in at Least 1% of Topiramate-Treated Patients and Occurred More Frequently in Topiramate-Treated Than Placebo-Treated Patients)
Body System/ Adverse Event Placebo(N=101) Topiramate(N=98)

a Patients in these add-on trials were receiving 1 to 2 concomitant antiepileptic drugs in addition to topiramate or placebo.

b Values represent the percentage of patients reporting a given adverse event. Patients may have reported more than one adverse event during the study and can be included in more than one adverse event category.

Body as a Whole — General Disorders
Fatigue 5 16
Injury 13 14
Allergic Reaction 1 2
Back Pain 0 1
Pallor 0 1
Cardiovascular Disorders, General
Hypertension 0 1
Central & Peripheral Nervous System Disorders
Gait Abnormal 5 8
Ataxia 2 6
Hyperkinesia 4 5
Dizziness 2 4
Speech Disorders/Related Speech Problems 2 4
Hyporeflexia 0 2
Convulsions Grand Mal 0 1
Fecal Incontinence 0 1
Paresthesia 0 1
Gastro-Intestinal System Disorders
Nausea 5 6
Saliva Increased 4 6
Constipation 4 5
Gastroenteritis 2 3
Dysphagia 0 1
Flatulence 0 1
Gastroesophageal Reflux 0 1
Glossitis 0 1
Gum Hyperplasia 0 1
Heart Rate and Rhythm Disorders
Bradycardia 0 1
Metabolic and Nutritional Disorders
Weight Decrease 1 9
Thirst 1 2
Hypoglycemia 0 1
Weight Increase 0 1
Platelet, Bleeding, & Clotting Disorders
Purpura 4 8
Epistaxis 1 4
Hematoma 0 1
Prothrombin Increased 0 1
Thrombocytopenia 0 1
Psychiatric Disorders
Somnolence 16 26
Anorexia 15 24
Nervousness 7 14
Personality Disorder (Behavior Problems) 9 11
Difficulty with Concentration/Attention 2 10
Aggressive Reaction 4 9
Insomnia 7 8
Difficulty with Memory NOS 0 5
Confusion 3 4
Psychomotor Slowing 2 3
Appetite Increased 0 1
Neurosis 0 1
Reproductive Disorders, Female
Leukorrhoea 0 2
Resistance Mechanism Disorders
Infection Viral 3 7
Respiratory System Disorders
Pneumonia 1 5
Respiratory Disorder 0 1
Skin and Appendages Disorders
Skin Disorder 2 3
Alopecia 1 2
Dermatitis 0 2
Hypertrichosis 1 2
Rash Erythematous 0 2
Eczema 0 1
Seborrhoea 0 1
Skin Discoloration 0 1
Urinary System Disorders
Urinary Incontinence 2 4
Nocturia 0 1
Vision Disorders
Eye Abnormality 1 2
Vision Abnormal 1 2
Diplopia 0 1
Lacrimation Abnormal 0 1
Myopia 0 1
White Cell and RES Disorders
Leukopenia 0 2

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