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| ID | Type | Description | Link |
|---|---|---|---|
| P60AA013759 | U.S. NIH Grant/Contract | View source | |
| 1R01AA015923 | U.S. NIH Grant/Contract | View source |
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Recruitment goals could not be met before ending of funding for this project.
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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This is a double-blind, placebo-controlled, parallel group design study with 4 treatment groups; levetiracetam, zonisamide, topiramate, and placebo control. Subjects will receive study medications for 14 weeks. Potential subjects will be initially screened for interest in study participation and alcohol consumption level to determine basic eligibility by telephone, or in person. Individuals who meet telephone screening criteria will be scheduled for a clinic appointment to obtain informed consent and conduct screening assessments. Subjects who report average drinks per day that are within the guidelines for safe levels of alcohol consumption (i.e. 2 drinks/ day males; 1 drink/day females-HHS standard) in the two weeks prior to screening will be excluded. Subjects meeting screening criteria will be scheduled for a second randomization visit. During this visit baseline assessments will be obtained. Eligible subjects will then be randomized to a treatment group and will be provided with the first week's study medications. The goal is to directly compare the efficacy and tolerability of two novel anticonvulsants, zonisamide and levetiracetam, with placebo, and using topiramate, which has extensive evidence supporting its efficacy in alcoholism, as a positive control group. We believe that this will be the first direct comparison of these agents in alcoholism, and the results will provide information on the efficacy and safety of the medications.
This is a double-blind, placebo-controlled, parallel group design study with 4 treatment groups; levetiracetam, zonisamide, topiramate, and placebo control. This study evaluated the effects of zonisamide (400 mg per day) on alcohol consumption and its neurotoxic effects in subjects with AUDS. A double-blind placebo-controlled clinical trial was conducted using two comparator anticonvulsant drugs, topiramate (300 mg daily) and levetiracetam (2000 mg/day), which does not impair cognition. Topiramate was used as an active control in this study.
Study medications were administered for 14 weeks, including a 2-week taper period. Target maintenance doses of study medications were administered to subjects during study weeks 8-12. Dosage reductions were made if needed to allow subjects to tolerate their study medication. During the medication taper phase of the study (Weeks 13-14) the Principal Investigator is allowed flexibility in the titration schedule in instances when the subject is experiencing events consistent with withdrawal, for example anxiety. Neurotoxicity of study drugs was assessed using neuropsychological tests and the AB-Neurotoxicity scale.
An adaptive randomization procedures with sex and heavy drinking history being factors in the assignment of subjects to the treatment groups. will be done using sex and very heavy drinking. Very heavy drinking is defined as male subjects consuming more then 10 standard drinks per day and female subjects consuming more then 8 standard drinks per day for more then 40 percent of the days in the screening TLFB.
Medication adherence was facilitated using Brief Behavioral Compliance Enhancement Treatment. It is a brief, standardized therapy that emphasizes medication adherence as being crucial to the improvement of drinking behavior.
Subject assessments included, but were not limited to the following:
1) TLFB, 2) Adverse Events (AEs) assessment ,3) A-B Neurotoxicity Scale (weeks 1,4,8,12,15),and 4) Neuropsychological battery Assessments- including the Controlled Word Association Test (COWAT) and Digit and Spatial Span portions of the Wechsler Memory Scale- 3rd (weeks 1,12).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zonisamide | Experimental | Encapsulated zonisamide with a target maintenance doses of 400 mg/day administered as 4 capsules per day. |
|
| Levetiracetam | Experimental | Encapsulated levetiracetam with a target maintenance doses of 2000 mg/day administered as 4 capsules per day . |
|
| Topiramate | Active Comparator | Encapsulated topiramate with a target maintenance doses of 300 mg/day administered as 4 capsules per day . |
|
| Sugar Pill | Placebo Comparator | Encapsulated sugar pill with a target maintenance dose administered as 4 capsules per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topiramate | Drug | Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate. |
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Efficacy Measure is the Mean Number of Drinks Consumed Per Day Over the Period From Treatment Weeks 10 Through 12 When All Study Medications Should be at Their Maximum Steady Levels Based on Their Known Pharmacokinetic Properties. | Mean standard drinks consumed per day for each treatment week, weeks 10 thru 12. Actual mean values obtained are shown. Analyses are based on model generated least squares means for a two -way repeated measures mixed models analysis for data obtained for weeks 1 through 12, with baseline values used as covariates. Week (time) was used as the within subject factor and treatment group was the between group factor. | Weeks 10, 11, 12 |
| Measure | Description | Time Frame |
|---|---|---|
| AB-Neurotoxicity Scale. | Total Scores AB-Neurotoxicity Scale Week 12. This scale provides subject ratings of anticonvulsant neurotoxic effects. Scores may range 0 to 72, with possibility of an additional 30 points being for complaints not listed in the list of complaints provides. Total scores, therefore, may be as high as 102, with higher scores indicating greater severity of problems. Actual mean scores are shown. Means for the analysis are least means squares values obtained from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates. |
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Inclusion Criteria:
To be admitted into this study candidates must meet the following criteria:
Exclusion Criteria:
Subjects meeting the following criteria will be excluded from the study:
Dependent on DSM IV-TR drugs or substances other than ethanol, nicotine, or caffeine.
DSM IV-TR diagnosis of any current Axis I diagnosis other than alcohol dependence, nicotine dependence, or caffeine dependence that in the opinion of the study physicians might require intervention with either pharmacological or non-pharmacological therapy that will interfere with the course of the study.
Receiving inpatient treatment for alcohol dependence, other then alcohol detoxification, within 4 weeks prior to enrollment into this study.
Subjects with a score of 10 or greater on the Clinical Institute Withdrawal Assessment for Alcohol-Revised on first or second visits.
Being treated with acamprosate, disulfiram or naltrexone within two weeks prior to randomization:
Currently being treated with any of the following medications: a) antipsychotic agents. b) antimanic or anticonvulsant agents. c) sedative- hypnotics. d) chronic opioid treatment. e) psychomotor stimulants- amphetamine derivatives, methylphenidate
Subjects who are legally mandated to participate in an alcohol treatment program.
Use of any medication known to inhibit or induce cytochrome P450 3A4 enzymes.
Subjects who have attempted suicide or who have had suicidal ideation within 30 days of their first visit.
Subjects with renal disease or history of kidney stones.
Subjects with AST or ALT >3 times the upper limit of the normal range during screening.
History of significant neurological disorder.
Subjects who are pregnant (as assessed by serum HCG) or lactating.
Subjects known to have clinically significant medical conditions that in the opinion of the study physician would preclude administration of the study medications or limit participation in the clinical trial.
Subjects with history of treatment with levetiracetam, topiramate or zonisamide.
Score of 25 or less on the Folstein Mini- Mental examination.
History of anticonvulsant-induced rash.
Taking drugs that contain "sulfa" moiety, such as sulfonamides, sulfonylureas, carbonic anhydrase inhibitors, thiazides, and loop diuretics (except ethacrynic acid).
During the 2 weeks prior to screening subjects who report average drinks per day that are within the guidelines for safe levels of alcohol consumption (i.e. 2 drinks/ day males; 1 drink/day females-HHS standard) will be excluded.
Subjects with a sulfa allergy.
-
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| Name | Affiliation | Role |
|---|---|---|
| Domenic A Ciraulo, MD | Boston University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston University School of Medicine | Boston | Massachusetts | 02118 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25427171 | Derived | Knapp CM, Ciraulo DA, Sarid-Segal O, Richardson MA, Devine E, Streeter CC, Oscar-Berman M, Surprise C, Colaneri L, Putnam M, Waters M, Richambault C. Zonisamide, topiramate, and levetiracetam: efficacy and neuropsychological effects in alcohol use disorders. J Clin Psychopharmacol. 2015 Feb;35(1):34-42. doi: 10.1097/JCP.0000000000000246. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Zonisamide | zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide. |
| FG001 | Levetiracetam | Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules. |
| FG002 | Topiramate | Topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate. |
| FG003 | Sugar Pill | Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Zonisamide | zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide. |
| BG001 | Levetiracetam |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Primary Efficacy Measure is the Mean Number of Drinks Consumed Per Day Over the Period From Treatment Weeks 10 Through 12 When All Study Medications Should be at Their Maximum Steady Levels Based on Their Known Pharmacokinetic Properties. | Mean standard drinks consumed per day for each treatment week, weeks 10 thru 12. Actual mean values obtained are shown. Analyses are based on model generated least squares means for a two -way repeated measures mixed models analysis for data obtained for weeks 1 through 12, with baseline values used as covariates. Week (time) was used as the within subject factor and treatment group was the between group factor. | Alcohol dependent subjects. Number of participants analyzed are provided for the number of subjects for data that was available for the timeframe for the specific analyses, i.e. Weeks 10,11,12. | Posted | Mean | Standard Error | Standard Drinks per day | Weeks 10, 11, 12 |
|
Adverse event data was collected for a period of 17 weeks for each subject and for a total of throughout the entire study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zonisamide | zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicide Attempt | Psychiatric disorders | Non-systematic Assessment | Rated as being only remotely to zonisamide use. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | Systematic Assessment |
Early termination lead to a small number of subjects in each group being analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Domenic A Ciraulo, Professor | Department of Psychiatry, Boston Univ School of Medicine | 617-414-1990 | dciraulo@bu.edu |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D019966 | Substance-Related Disorders |
| D000435 | Alcoholic Intoxication |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077236 | Topiramate |
| D000078305 | Zonisamide |
| D000077287 | Levetiracetam |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D005632 | Fructose |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D002241 | Carbohydrates |
| D007661 |
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|
| Zonisamide | Drug | Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide. |
|
|
| Levetiracetam | Drug | Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules. |
|
|
| Sugar Pill | Drug | Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. |
|
|
| Week 12 |
| Mean Percent Days Heavy Drinking | Mean weekly values for each treatment group for percent days heavy drinking. Heavy drinking was defined as 4 or more drinks per day for women and 5 or more drinks per day for men. | Weeks 10, 11, 12 |
| Percent Days Drinking | Mean percent days drinking for Weeks 10, 11, 12. A drinking day is considered to be a day in which 1 or more drinks have been consumed. Means are model generated least means squares values obtained from a two-way repeated measures analysis from data obtained from Weeks 1 through 12, with Week as the within subject factor and treatment group as the between group factor. | Weeks 10, 11, 12 |
| Controlled Word Association Test (COWAT)- Letter Fluency | Number of words generated that start with a set of 3 letters. The COWAT provides a measure of verbal fluency. Actual means for COWAT results are shown. | Baseline & Week 12 |
| COWAT-Category | Number of words produced by subjects over 60 seconds for a semantic category (Animals). The COAWAT-Category sub-test provides a measure of verbal fluency. Mean value shown are actual means for the number of words produced. | Baseline, Week12 |
| Wechsler Memory Scales (WMS)-3d Ed Digit Span-Age Adjusted Total | WMS Digit Span is a measure of working memory. Subjects respond by repeating lists of number sequences presented by the test administrator. Age adjusted scores are presented below. Scores may range between 1 and 19, with lower scores indicating poorer performance on the task. | Baseline, Week 12 |
| Wechsler Memory Scale-3rd Ed. Spatial Span | WMS Spatial Span test measures working memory for a spatial sequence of numbers. This assesses visual working memory. Age adjusted scaled scores are presented. Score may range between 1 and 19, with lower scores indicating greater impairment in performance. | Baseline, Week 12 |
Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules. |
| BG002 | Topiramate | topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate. |
| BG003 | Sugar Pill | Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Education | Mean | Standard Deviation | years |
|
| Alcohol Use Identification Test (AUDIT) | The AUDIT assesses the extent to which an individual exhibits patterns of harmful or hazardous alcohol use. Scale scores for this test can range from 0 to 40, with higher scores indicating greater levels of harmful or hazardous alcohol use. | Mean | Standard Deviation | units on a scale |
|
| Wechsler Abbreviated Scale of Intelligence (WAIS) | The WASI assesses general cognitive functioning. The Vocabulary and Matrix Reasoning subtests were administered to subjects in this study. The Vocabulary subtest is used to evaluate verbal knowledge, verbal expressiveness, and fund of information. The Matrix Reasoning subtest measures nonverbal reasoning and general intellectual ability. Scores range between 55 to 157, with the higher scores indicating greater intelligence. The mean score for this test is set to be 100. | Mean | Standard Deviation | scale scores |
|
zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide. |
| OG001 | Sugar Pill | Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. |
| OG002 | Topiramate | Topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate. |
| OG003 | Levetiracetam | Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules. |
|
|
|
| Secondary | AB-Neurotoxicity Scale. | Total Scores AB-Neurotoxicity Scale Week 12. This scale provides subject ratings of anticonvulsant neurotoxic effects. Scores may range 0 to 72, with possibility of an additional 30 points being for complaints not listed in the list of complaints provides. Total scores, therefore, may be as high as 102, with higher scores indicating greater severity of problems. Actual mean scores are shown. Means for the analysis are least means squares values obtained from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates. | Alcohol dependent subjects. | Posted | Mean | Standard Error | Scale Scores | Week 12 |
|
|
|
|
| Secondary | Mean Percent Days Heavy Drinking | Mean weekly values for each treatment group for percent days heavy drinking. Heavy drinking was defined as 4 or more drinks per day for women and 5 or more drinks per day for men. | Alcohol dependent subjects. Alcohol dependent subjects. Number of participants analyzed are provided for the number of subjects for data that was available for the time frame for the specific analyses, i.e. Weeks 10,11,12. | Posted | Mean | Standard Error | Percentage of Days/Week | Weeks 10, 11, 12 |
|
|
|
|
| Secondary | Percent Days Drinking | Mean percent days drinking for Weeks 10, 11, 12. A drinking day is considered to be a day in which 1 or more drinks have been consumed. Means are model generated least means squares values obtained from a two-way repeated measures analysis from data obtained from Weeks 1 through 12, with Week as the within subject factor and treatment group as the between group factor. | Alcohol dependent subjects. Alcohol dependent subjects. Number of participants analyzed are provided for the number of subjects for data that was available for the timeframe for the specific analyses, i.e. Weeks 10,11,12. | Posted | Mean | Standard Error | Percentage of Days/ Week | Weeks 10, 11, 12 |
|
|
|
|
| Secondary | Controlled Word Association Test (COWAT)- Letter Fluency | Number of words generated that start with a set of 3 letters. The COWAT provides a measure of verbal fluency. Actual means for COWAT results are shown. | Alcohol Dependent Subjects. Number of participants analyzed represent the number for whom Week 12 data was available. | Posted | Mean | Standard Error | Number of Words Produced | Baseline & Week 12 |
|
|
|
|
| Secondary | COWAT-Category | Number of words produced by subjects over 60 seconds for a semantic category (Animals). The COAWAT-Category sub-test provides a measure of verbal fluency. Mean value shown are actual means for the number of words produced. | Alcohol Dependent Subjects. Number of participants analyzed represent the number for whom Week 12 data was available. | Posted | Mean | Standard Error | Number of Words Produced | Baseline, Week12 |
|
|
|
|
| Secondary | Wechsler Memory Scales (WMS)-3d Ed Digit Span-Age Adjusted Total | WMS Digit Span is a measure of working memory. Subjects respond by repeating lists of number sequences presented by the test administrator. Age adjusted scores are presented below. Scores may range between 1 and 19, with lower scores indicating poorer performance on the task. | Alcohol Dependent Subjects. Number of participants analyzed represent the number for whom Week 12 data was available. | Posted | Mean | Standard Error | units on a scale | Baseline, Week 12 |
|
|
|
|
| Secondary | Wechsler Memory Scale-3rd Ed. Spatial Span | WMS Spatial Span test measures working memory for a spatial sequence of numbers. This assesses visual working memory. Age adjusted scaled scores are presented. Score may range between 1 and 19, with lower scores indicating greater impairment in performance. | Alcohol Dependent Subjects. Number of participants analyzed represent the number for whom Week 12 data was available. | Posted | Mean | Standard Error | units on a scale | Baseline, Week 12 |
|
|
|
|
| 1 |
| 19 |
| 15 |
| 19 |
| EG001 | Levetiracetam | Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules. | 0 | 21 | 11 | 21 |
| EG002 | Topiramate | topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate. | 0 | 21 | 13 | 21 |
| EG003 | Sugar Pill | Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. | 0 | 24 | 11 | 24 |
|
| Altered Taste | General disorders | Systematic Assessment |
|
| Confusion | Nervous system disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Decreased Libido | Nervous system disorders | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Dissociation | Psychiatric disorders | Systematic Assessment |
|
| Disoriented | Psychiatric disorders | Systematic Assessment |
|
| Erectile Dsyfunction | Reproductive system and breast disorders | Systematic Assessment |
|
| Fatigue | Nervous system disorders | Systematic Assessment |
|
| GI Distress | Gastrointestinal disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Impaired Concentration | Nervous system disorders | Systematic Assessment |
|
| Impaired Memory | Nervous system disorders | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Irritability | Nervous system disorders | Systematic Assessment |
|
| Lightheaded | Nervous system disorders | Systematic Assessment |
|
| Loss of Appetite | Nervous system disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | Systematic Assessment |
|
| Prurtitus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Sedation | Nervous system disorders | Systematic Assessment |
|
| Sinus Infection | Infections and infestations | Systematic Assessment |
|
| Slowed Thinking | Nervous system disorders | Systematic Assessment |
|
| Weight Loss | Nervous system disorders | Systematic Assessment |
|
| Word Finding | Nervous system disorders | Systematic Assessment |
|
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| Ketoses |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000081 | Acetamides |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
Comparison of means for the zonisamide and placebo group for Week 12. Mixed models generated means were used in this analysis. |
| ANOVA |
| 0.784 |
p< 0.05 is considered to be significant. |
| Mean Difference Week 12 |
| 0.98 |
| Standard Error of the Mean |
| 3.6 |
| 2-Sided |
| No |
| Superiority or Other |
| Comparison of means for the levetiracetam and placebo groups for Week 12. Model generated least mean squares were used for this analysis. | ANOVA | 0.264 | p< 0.05 is considered to be significant. | Mean difference Week 12 | 3.65 | Standard Error of the Mean | 3.3 | 2-Sided | No | Superiority or Other |
| Week 11 |
|
| Week 12 |
|
| Comparison of Week 11 means for mean percent heavy drinking days obtained for the placebo and zonisamide groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates. | ANOVA | 0.036 | p<0.05 is considered to be significant | Difference between least squares means | -20.9 | Standard Error of the Mean | 9.8 | 2-Sided | No | Superiority or Other |
| Comparison of Week 12 means for mean percent heavy drinking days obtained for the placebo and zonisamide groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates. | ANOVA | 0.24 | p< 0.05 is considered to be significant | Difference between least squares means | -22.8 | Standard Error of the Mean | 9.9 | 2-Sided | No | Superiority or Other |
| Comparison of Week 10 means for mean percent heavy drinking days obtained for the placebo and topiramate groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates. | ANOVA | 0.0004 | p<0.05 is considered to be significant. | Difference between least squares means | -33.0 | Standard Error of the Mean | 9.0 | 2-Sided | No | Superiority or Other |
| Comparison of Week 11 means for mean percent heavy drinking days obtained for the placebo and topiramate groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates. | ANOVA | 0.0015 | p< 0.05 is considered to be significant | Difference between least squares means | -29.7 | Standard Error of the Mean | 9.2 | 2-Sided | No | Superiority or Other |
| Comparison of Week 12 means for mean percent heavy drinking days obtained for the placebo and topiramate groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates. | ANOVA | <0.0001 | p<0.05 is considered to be significant. | Difference between least squares means | -37.7 | Standard Error of the Mean | 9.3 | 2-Sided | No | Superiority or Other |
| Comparison of Week 10 means for mean percent heavy drinking days obtained for the placebo and levetiracetam groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates. | ANOVA | 0.04 | p< 0.05 is considered to be significant | Difference between least squares means | -20.7 | Standard Error of the Mean | 10.0 | 2-Sided | No | Superiority or Other |
| Comparison of Week 11 means for mean percent heavy drinking days obtained for the placebo and levetiracetam groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates. | ANOVA | 0.025 | p< 0.05 is considered to be significant | Difference between least squares means | -23.3 | Standard Error of the Mean | 10.2 | 2-Sided | No | Superiority or Other |
| Comparison of Week 12 means for mean percent heavy drinking days obtained for the placebo and levetiracetam groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates. | ANOVA | 0.018 | p<0.05 is considered to be significant | Difference between least squares means | -24.8 | Standard Error of the Mean | 10.3 | 2-Sided | No | Superiority or Other |
| Week 11 |
|
| Week 12 |
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| Comparison of Week 11 means for mean percent drinking days obtained for the placebo and zonisamide groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates. | ANOVA | 0.003 | Difference between least squares means | -24.1 | Standard Error of the Mean | 7.9 | 2-Sided | No | Superiority or Other |
| Comparison of Week 12 means for mean percent drinking days obtained for the placebo and zonisamide groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates. | ANOVA | 0.044 | p< 0.05 is considered to be significant. | Difference between least square means | -16.3 | Standard Error of the Mean | 8.0 | 2-Sided | No | Superiority or Other |
| Comparison of Week 10 means for mean percent drinking days obtained for the placebo and topiramate. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factors. Baseline values were used as covariates. | ANOVA | <0.0001 | p< 0.05 is considered to be significant | Difference between least squares means | -38.1 | Standard Error of the Mean | 9.0 | 2-Sided | No | Superiority or Other |
| Comparison of Week 11 means for mean percent drinking days obtained for the placebo and topiramate. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates. | ANOVA | <0.0001 | p<0.05 is considered to be significant. | Difference between least squares means | -47.6 | Standard Error of the Mean | 9.1 | 2-Sided | No | Superiority or Other |
| Week 12.Comparison of Week 12 means for mean percent drinking days obtained for the placebo and topiramate. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates. | ANOVA | 0.0004 | p<0.05 is considered to be significant. | Difference between least squares means | -34.0 | Standard Error of the Mean | 9.2 | 2-Sided | No | Superiority or Other |
| Comparison of Week 10 means for mean percent drinking days obtained for the placebo and levetiracetam groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis. Baseline values were used as covariates. | ANOVA | 0.017 | p<0.05 is considered to be significant | Difference between least squares means | -19.3 | Standard Deviation | 8.0 | 2-Sided | No | Superiority or Other |
| Comparison of Week 11 means for mean percent drinking days obtained for the placebo and levetiracetam groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis. Baseline values were used as covariates. | ANOVA | 0.0002 | p<0.05 is considered to be significant. | Difference between least squares means | -31.2 | Standard Error of the Mean | 8.1 | 2-Sided | No | Superiority or Other |
| .Comparison of Week 12 means for mean percent drinking days obtained for the placebo and levetiracetam groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis.Baseline values were used as covariates. | ANOVA | 0.026 | p< 0.05 is considered to be significant | Difference between least squares means | -18.5 | Standard Error of the Mean | 8.2 | 2-Sided | No | Superiority or Other |
| Week 12 |
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| Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that COWAT-Letter Fluency scores would change towards a downward direction for the topiramate as compared to the placebo group resulting in a significant treatment x time interaction. | Mixed Models Analysis | p value is for group x time interaction term for the comparison of data for the topiramate and placebo group. | <0.0001 | p<0.01 is considered to be significant | 2-Sided | No | Superiority or Other |
| Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that COWAT-Letter Fluency scores would change towards a downward direction for the levetiracetam as compared to the placebo group resulting in a significant treatment x time interaction. | Mixed Models Analysis | p value is for interaction effect for the comparison of data for the levetiracetam and placebo groups. | 0.30 | p<0.01 is considered to be significant. | 2-Sided | No | Superiority or Other |
| Week 12 |
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| Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that COWAT-Category scores would change towards a downward direction for the topiramate as compared to the placebo group resulting in significant treatment x time interaction | Mixed Models Analysis | The p value shown is for the group x time interaction effect for the comparison of data from the topiramate and the placebo groups. | 0.01 | p< 0.01 is considered to be significant. | 2-Sided | No | Superiority or Other |
| Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that COWAT-Category scores would change towards a downward direction for the levetiracetam as compared to the placebo group resulting in significant treatment x time interaction | Mixed Models Analysis | The p value is for the group x time interaction effect for the comparison of the levetiracetam and placebo groups. | 0.36 | p<0.01 is considered to be significant. | 2-Sided | No | Superiority or Other |
| Week 12 |
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| Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that age adjusted Digit Span scores would change towards a downward direction for the topiramate as compared to the placebo group resulting in significant treatment x time interaction. | Mixed Models Analysis | p value shown is for the group X time interaction effect. | <0.0001 | p<0.01 is considered to be significant. | 2-Sided | No | Superiority or Other |
| Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that Digit span scores would change towards a downward direction for the levetiracetam as compared to the placebo group resulting in significant treatment x time interaction. | Mixed Models Analysis | p value shown is for the group x time interaction effect. | 0.95 | p<0.01 is considered to be significant. | 2-Sided | No | Superiority or Other |
| Week 12 |
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| Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that Digit span scores would change towards a downward direction for the topiramate as compared to the placebo group resulting in significant treatment x time interaction. | Mixed Models Analysis | p value shown is for the group x time interaction effect. | 0.0025 | p<0.01 is considered to be significant. | 2-Sided | No | Superiority or Other |
| Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that Digit span scores would change towards a downward direction for the levetiracetam as compared to the placebo group resulting in significant treatment x time interaction. | Mixed Models Analysis | p value shown is for the group x time interaction effect. | 0.3 | p<0.01 is considered to be significant | 2-Sided | No | Superiority or Other |