TOPAMAX SUMMARY
TOPAMAX® (topiramate) is an anticonvulsant.
Monotherapy Epilepsy
TOPAMAX® (topiramate) Tablets and TOPAMAX® (topiramate capsules) Sprinkle Capsules are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials [see Clinical Studies].
Adjunctive Therapy Epilepsy
TOPAMAX® Tablets and TOPAMAX® Sprinkle Capsules are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 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 Clinical Studies].
Migraine
TOPAMAX® Tablets and TOPAMAX® Sprinkle Capsules are indicated for adults for the prophylaxis of migraine headache [see Clinical Studies]. The usefulness of TOPAMAX® in the acute treatment of migraine headache has not been studied.
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NEWS HIGHLIGHTS
Published Studies Related to Topamax (Topiramate)
[Topiramate in substance-related and addictive disorders]. [Article in French] [2014] CONCLUSION: Topiramate showed interest mainly in alcoholism, binge eating
Topiramate as an adjuvant treatment for obsessive compulsive symptoms in patients
with bipolar disorder: a randomized double blind placebo controlled clinical
trial. [2014] treatment... CONCLUSIONS: The combination of lithium+olanzapine+clonazepam decreased the
Topiramate treatment of alcohol use disorder in veterans with posttraumatic
stress disorder: a randomized controlled pilot trial. [2014] veterans with both disorders... CONCLUSIONS: These preliminary results indicate that in veterans with
Topiramate for cocaine dependence during methadone maintenance treatment: a
randomized controlled trial. [2014] CONCLUSION: Topiramate is not efficacious for increasing cocaine abstinence in
Randomized clinical trial of topiramate for levodopa-induced dyskinesia in
Parkinson's disease. [2014] disease and levodopa-induced dyskinesia... CONCLUSIONS: Topiramate tended to worsen dyskinesia in patients with Parkinson's
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.
Pilot Study to Compare Frovatriptan vs. Topiramate for Prevention of Migraine [Completed]
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-Phentermine Combinations for Cocaine Dependence [Recruiting]
This study will determine the influence of topiramate (Topamax®) and phentermine (Adipex®),
alone and in combination, on the reinforcing, subjective and physiological effects of
cocaine.
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.
Efficacy and Safety of Topiramate in the Treatment of Sleep-Related Eating Disorder [Recruiting]
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 >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased 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. |
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| 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. |
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| 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. |
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Page last updated: 2015-08-10
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