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Topamax (Topiramate) - Summary

 
 



TOPAMAX SUMMARY

TOPAMAX®(topiramate)
Tablets
TOPAMAX®(topiramate capsules)
Sprinkle Capsules

Topiramate is a sulfamate-substituted monosaccharide that is intended for use as an antiepileptic drug. TOPAMAX® (topiramate) Tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. TOPAMAX® (topiramate capsules) Sprinkle Capsules are available as 15 mg and 25 mg sprinkle capsules for oral administration as whole capsules or opened and sprinkled onto soft food.

TOPAMAX® (topiramate) Tablets and TOPAMAX® (topiramate capsules) Sprinkle Capsules are indicated as adjunctive therapy for adults and pediatric patients ages 2 - 16 years with partial onset seizures, or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome.


See all Topamax indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Topamax (Topiramate)

FDA approves Topamax for migraine prevention in adolescents
Source: Headache / Migraine News From Medical News Today [2014.04.01]
The U.S. Food and Drug Administration has approved Topamax (topiramate) for prevention (prophylaxis) of migraine headaches in adolescents ages 12 to 17.

Topamax Approval for Migraines Expanded to Younger Users
Source: MedicineNet topiramate Specialty [2014.04.01]
Title: Topamax Approval for Migraines Expanded to Younger Users
Category: Health News
Created: 3/31/2014 12:36:00 PM
Last Editorial Review: 4/1/2014 12:00:00 AM

Migraine, Epilepsy Drug Topamax May Cause Newborn Cleft Palate
Source: Cleft Palate News From Medical News Today [2011.03.04]
The FDA has warned that the drug prescribed for epilepsy named Topamax (topiramate) should not be used by women who are pregnant or plan on childbearing, due to a very high risk of offspring bearing...

more news >>

Published Studies Related to Topamax (Topiramate)

A comparative study of the effects of low-dose topiramate versus sodium valproate in migraine prophylaxis. [2012]
The present study was performed to evaluate the efficacy of low-dose topiramate and compare it with sodium valproate that is prevalently prescribed as a migraine prophylaxis. This was a randomized, double-blind, parallel-group clinical trial on 56 patients who completed the course of study... Topiramate dose of 50 mg/day with fewer side effects in comparison with its higher doses may be an appropriate substitution for first-line migraine prophylaxis such as valproate.

Controlled-Release Phentermine/Topiramate in Severely Obese Adults: A Randomized Controlled Trial (EQUIP). [2011.11.03]
A 56-week randomized controlled trial was conducted to evaluate safety and efficacy of a controlled-release combination of phentermine and topiramate (PHEN/TPM CR) for weight loss (WL) and metabolic improvements. Men and women with class II and III obesity (BMI >/= 35 kg/m(2)) were randomized to placebo, PHEN/TPM CR 3.75/23 mg, or PHEN/TPM CR 15/92 mg, added to a reduced-energy diet...

Topiramate plus nortriptyline in the preventive treatment of migraine: a controlled study for nonresponders. [2011.10.19]
A sizeable proportion of migraineurs in need of preventive therapy do not significantly benefit from monotherapy. The objective of the study is to conduct a randomized controlled trial testing whether combination therapy of topiramate and nortriptyline is useful in patients who had less than 50% decrease in headache frequency with the use of the single agents...

Exercise as migraine prophylaxis: a randomized study using relaxation and topiramate as controls. [2011.10]
AIM: Scientific evidence regarding exercise in migraine prophylaxis is required. Therefore this study aimed to evaluate the effects of exercise in migraine prevention... CONCLUSION: Exercise may be an option for the prophylactic treatment of migraine in patients who do not benefit from or do not want to take daily medication.

A double-blind randomized controlled trial to study the efficacy of topiramate in a civilian sample of PTSD. [2011.10]
CONCLUSION: Topiramate was effective in improving reexperiencing and avoidance/numbing symptom clusters in patients with PTSD. This study supports the use of anticonvulsants for the improvement of symptoms of PTSD. (c) 2010 Blackwell Publishing Ltd.

more studies >>

Clinical Trials Related to Topamax (Topiramate)

Aripiprazole and Topiramate on Free-Choice Alcohol Use [Recruiting]
The current study investigates the effects of two potential alcohol treatment medications on drinking in a laboratory setting. Aripiprazole (APZ), effects dopamine and serotonin receptors with fewer limiting side effects seen with other atypical antipsychotics. Topiramate (TPMT), an antiepileptic, affects glutamate and GABA-A receptors and shows promise in reducing heavy drinking. Few studies have used two medications with such a diverse combination of actions to examine a potential synergistic effect on reducing alcohol consumption.

The primary aims are to:

1. determine if APZ and TPMT are each more effective than placebo, and the combination of APZ and TPMT is more effective than either drug alone or placebo, in reducing alcohol use in non-treatment seeking alcohol dependent subjects in a laboratory based alcohol self-administration experiment (ASAE)

2. examine a hypothesized dose-response for three doses of APZ (0, 7. 5 mg/d and 15 mg/d) along with three doses of TPMT (0, 100mg/d and 200mg/d)

3. examine the putative mechanisms of action of APZ, TPMT alone and together on craving, subjective stimulation, candidate gene influences and other behavioral effects associated with alcohol consumption

4. establish the safety of giving APZ and TPMT together. Non-treatment seeking, alcohol dependent Participants (N=216) will be recruited from the community and randomly assigned to one of the 9 cells. Subjects drinking and safety is monitored over a 5-week titration to their target dose, leading to an in-laboratory alcohol self administration session, during which clinical and behavioral effects are assessed during access to alcohol. A 1 month follow-up assesses adverse events and drinking.

Topiramate Treatment of Alcohol Use Disorders in Veterans With PTSD: A Pilot Controlled Trial of Augmentation Therapy [Not yet recruiting]
The proposed project aims to:

1. Obtain a preliminary assessment of the efficacy of topiramate treatment in reducing alcohol use in veterans with PTSD and alcohol dependence;

2. Obtain preliminary assessments of safety/tolerability of topiramate in these patients;

3. Assess the feasibility of recruitment and retention for topiramate treatment in this comorbid population; and 4) to inform the design of a planned subsequent larger controlled trial of topiramate.

PRIMARY HYPOTHESIS: Topiramate treatment combined with Medical Management alcohol counseling will be associated with a significant increase in percent days abstinent from baseline to end of treatment.

SECONDARY HYPOTHESIS: There will be a significantly greater percent of days abstinent from alcohol use in the topiramate treatment group compared to the placebo group.

Pilot Study to Compare Frovatriptan vs. Topiramate for Prevention of Migraine [Recruiting]
Subjects enrolled at 2 investigative sites will complete 3 visits. Following Visit 1, during a 1-month Baseline Period, subjects will treat with their usual medication and document any warning signs (Prodrome pre-headache) that a migraine will occur. Following randomization (like a flip of the coin) at Visit 2, subjects will treat daily with topiramate or during Prodrome with frovatriptan. Subjects complete a 2-month Treatment Period before exit at Visit 3. This study will compare the effectiveness of daily treatment vs. treatment during the pre-headache phase for prevention of migraine.

Topiramate in the Treatment of Post Traumatic Stress Disorder (PTSD) [Completed]

Topiramate for Alcohol Use in Posttraumatic Stress Disorder [Recruiting]
Alcohol abuse and dependence (alcohol use disorders, AUDs) and posttraumatic stress disorder (PTSD) are both prevalent in Veterans. Treating AUDs in Veterans with PTSD may be more difficult than treating AUDs in the general population. The FDA-approved medication topiramate has been shown to improve drinking outcomes in people with AUDs. Topiramate has also improved symptoms in people with PTSD. This study is designed to investigate whether topiramate will improve drinking outcomes in Veterans with PTSD.

more trials >>

Reports of Suspected Topamax (Topiramate) Side Effects

Depression (94)Cleft Palate (85)Maternal Exposure During Pregnancy (78)Anxiety (78)Convulsion (63)Self Injurious Behaviour (60)Weight Decreased (55)Cleft LIP and Palate (47)Developmental Delay (43)Cleft LIP (43)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 35 ratings/reviews, Topamax has an overall score of 6.83. The effectiveness score is 7.71 and the side effect score is 6.34. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Topamax review by 43 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   Migraine prevention
Dosage & duration:   Five 25 mg tablets Twice a Day taken daily for the period of 3 Years
Other conditions:   Allergies
Other drugs taken:   Benadryl, Aleve. birth control pills
  
Reported Results
Benefits:   Topamax helped decrease the frequency and intensity of my migraines.
Side effects:   Treatment side effects include paresthesia of my hands and mild drowsiness.
Comments:   Topamax was taken in order to prevent migraines. I also monitored my diet to avoid migraine triggers such as caffeine, aged cheeses, preserved meats, bananas, avocados, beans, dairy products, beer, wine, etc. In addition, I took birth control pills to control hormonal fluctuations. This helped prevent menstrual migraines.

 

Topamax review by 44 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   migraine
Dosage & duration:   25mg taken 2 x daily for the period of 1 year and current
Other conditions:   none
Other drugs taken:   hormone replacement therapy (natural cream)
  
Reported Results
Benefits:   My conclusions of the medication are that it has definately lessened the amount of migraine headaches that I was encountering. I have not had to have an emergency hospital visit in almost a year. This went from a visit occuring almost every other month with horrible painful headaches in between this time. I still get headaches which are tollerable, and if I have a migraine have not had to go to the hospital for pain relief. It has been tolerable. I have now gotten my dose down to 15mg at night time only and am still having the same benefit. My only side effect were some memory difficulty in the beginning. I drove to my doctors office and became disoriented. Rather than panic I laughed it off and pulled over and had to think about where I was going. It has definately had a positive influence on the migraines. It seems to have some sort of effect on eating though. I did loose a bit more weight which I did not need to loose, but now have been able to be back at my normal weight.
Side effects:   Some forgetfulness,, tiredness at onset. Nothing unbearable.
Comments:   25mg morning and night. 9 months, then went to 15mg capsules morning and night for a few months. Now down to 15mg at night time only.

 

Topamax review by 50 year old female patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   Migraines
Dosage & duration:   50 mg taken once daily for the period of 6 months
Other conditions:   None
Other drugs taken:   None
  
Reported Results
Benefits:   I did not experience any treatment benefits from Topamax for my severe and incapacitating migraines. I did not get relief for my migraine headaches. My migraine headaches did not stop. My migraine headaches did not decrease in duration(3 days per migraine) or intensity (severe). I had one - 3 day a week migraine for over seven years.
Side effects:   The Topamax treatment side effects were extreme when I was taking it. I experienced extreme weight loss, I went from one hundred thirty pounds down to ninety eight pounds. I experienced mental confusion and had a hard time focusing on anything including family, relationships and work. I experienced a deep depression and had suicidal ideations that I had never before had. I also experienced loss of my word finding skills.
Comments:   The treatment details for Topamax which is used to treat seizure disorders was also supposed to treat migraines are as follows. As the patient I was to take fifty milligrams per day and was told I would lose perhaps two percent of my body weight but that after a thirty day period my migraines would decrease in intensity and decrease in duration.

See all Topamax reviews / ratings >>

Page last updated: 2014-04-01

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