GABITRIL SUMMARY
GABITRIL®
(tiagabine hydrochloride)
Tablets
GABITRIL (tiagabine HCl) is an antiepilepsy drug available as 2 mg, 4 mg, 12 mg, 16 mg tablets for oral administration. Its chemical name is (-)-(R)-1-[4,4-Bis(3-methyl-2-thienyl)-3-butenyl]nipecotic acid hydrochloride, its molecular formula is C20H25NO2S2HCl, and its molecular weight is 412.0. Tiagabine HCl is a white to off-white, odorless, crystalline powder. It is insoluble in heptane, sparingly soluble in water, and soluble in aqueous base.
GABITRIL (tiagabine hydrochloride) is indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures.
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NEWS HIGHLIGHTSMedia Articles Related to Gabitril (Tiagabine)
Increased Risk Of Seizures Faced By Current Cigarette Smokers
Source: Health News from Medical News Today [2009.11.19]
A recent study determined there is a significant risk of seizure for individuals who currently smoke cigarettes. Boston-based researchers from Brigham and Women's Hospital and Harvard Medical School also found that long-term, moderate intake of caffeine or alcohol does not increase the chance of having a seizure or developing epilepsy.
Improved Understanding Of Why Seizures Occur With Alcohol Withdrawal
Source: Epilepsy News From Medical News Today [2009.10.19]
Epileptic seizures are the most dramatic and prominent aspect of the "alcohol withdrawal syndrome" that occurs when a person abruptly stops a long-term or chronic drinking habit. Researchers have shown that the flow of calcium ions into brain cells via voltage-gated calcium channels plays an important role in the generation of alcohol withdrawal seizures, because blocking this flow suppresses these seizures.
Gene Mutation Linked to Fever-Induced Seizures
Source: MedicineNet Seizure Specialty [2009.09.21]
Title: Gene Mutation Linked to Fever-Induced Seizures
Category: Health News
Created: 9/18/2009 2:10:00 PM
Last Editorial Review: 9/21/2009
Febrile Seizures And Severe Epilepsy In Infants Traced To A Sodium Channel Gene Mutation
Source: Epilepsy News From Medical News Today [2009.09.20]
Mutations in the SCN9A sodium channel gene are a cause of febrile seizures and contribute to a severe form of epilepsy in infants 6 months and younger, report researchers from the University of Utah, University of Antwerp, and University of Washington.
Febrile Seizures
Source: MedicineNet Pediatric Epilepsy Surgery Specialty [2008.05.09]
Title: Febrile Seizures
Category: Diseases and Conditions
Created: 5/9/2008
Last Editorial Review: 5/9/2008
Published Studies Related to Gabitril (Tiagabine)
Tiagabine for social anxiety disorder. [2007.06]
Tiagabine, a selective gamma-aminobutyric acid (GABA) reuptake inhibitor was evaluated for the treatment of patients with social anxiety disorder (SAD). Adults with SAD received open-label tiagabine 4-16 mg per day for 12 weeks...
Tiagabine does not attenuate alcohol-induced activation of the human reward system. [2007.05]
RATIONALE: The rewarding effects of ethanol and other drugs of abuse are mediated by activation of the mesolimbic dopamine system. Recent neuroimaging studies in primates and humans suggest that cocaine-induced dopamine stimulation might be diminished by drugs augmenting gamma-aminobutyric acid A (GABA-A) receptor function such as the GABA transaminase inhibitor vigabatrin. OBJECTIVES: The objective of this study was to test the property of the selective GABA transporter 1 (GAT1) inhibitor tiagabine to block ethanol-induced activation of the mesolimbic reward system in an i.v. ethanol challenge... CONCLUSIONS: Our ethanol challenge imaging study does not provide supporting evidence that the GAT1 inhibitor tiagabine diminishes the rewarding effects of ethanol. Further PET imaging studies using established anticraving compounds, such as the mu-opioid receptor antagonist naltrexone and antiepileptic drugs affecting the GABA-ergic system more broadly, will provide additional important insights on the interaction between the GABA-ergic and the brain reward system in vivo and the suitability of GABA-ergic drugs as anticraving compounds.
Comparison of the cognitive effects of tiagabine and carbamazepine as monotherapy in newly diagnosed adult patients with partial epilepsy: pooled analysis of two long-term, randomized, follow-up studies. [2006.07]
PURPOSE: Patients with epilepsy are at greater risk for cognitive impairment than are age- and education-matched controls. Cognitive decline is a significant adverse event associated with many first-generation anticonvulsant drugs (AEDs); however, the past decade has seen the introduction of several new AEDs with more-favorable cognitive profiles. Tiagabine (TGB) is indicated as adjunctive therapy for the treatment of partial seizures. The cognitive effects of TGB and carbamazepine (CBZ) monotherapy were evaluated in adult epilepsy patients with partial seizures... CONCLUSIONS: The results of this 52-week, follow-up study show that successful TGB monotherapy with 20-30 mg/day has a cognitive profile similar to that of successful long-term CBZ monotherapy with 400-800 mg/day in newly diagnosed patients with epilepsy and to that of untreated patients with a single seizure. We observed no significant decline in cognitive scores associated with TGB monotherapy.
Long-term effects of tiagabine monotherapy on cognition and mood in adult patients with chronic partial epilepsy. [2006.06]
The long-term effects of tiagabine monotherapy on cognition and mood were evaluated in adult patients with chronic partial epilepsy in a 48-week, open-label extension period that followed an 8-week, double-blind, titration study. Cognitive function was evaluated using neuropsychological evaluations that measured learning and memory, general intellectual ability, attention and mental speed, and reaction speed...
Tiagabine is associated with sustained attention during sleep restriction: evidence for the value of slow-wave sleep enhancement? [2006.04.01]
CONCLUSIONS: To our knowledge these findings are the first to be consistent with the hypothesis that pharmacologic SWS enhancement reduces selective aspects of the behavioral, psychological, and physiologic impact of sleep restriction.
Clinical Trials Related to Gabitril (Tiagabine)
Study To Evaluate The Effects Of Gabitril™ In Patients With Social Anxiety Disorder [Completed]
The main purpose of this study is to determine how safe and effective Gabitril is for
outpatients with Social Anxiety Disorder (SAD).
Effectiveness of Tiagabine for Cocaine Dependence in Methadone-Maintained Individuals - 1 [Completed]
Many opioid-dependent individuals are also dependent on cocaine. Methadone is a widely used
and effective method for treating opioid dependence. However, it is not effective in
treating other drugs of abuse. The purpose of this study is to determine the effectiveness
of another drug, tiagabine, for treating cocaine dependence in opioid-dependent individuals
already receiving methadone treatment.
Switching From an SSRI to Tiagabine(GABITRIL) in Order to Alleviate SSRI Induced Sexual Dysfunction [Completed]
Anxious patients are now treated with Selective Serotonin Reuptake Inhibitor medications
(common antidepressants) which elevate serotonin and thus alleviate anxiety. These
medications have clearly proven efficacy upwards of 70% for many anxiety disorders. In
regards to tolerability, they have a major problem in that they often produce sexual
dysfunction in men and women (ie. decreased libido, anorgasmia, impotence) upwards of 30% of
the time.
Benzodiazepine anxiolytics are also FDA approved to treat anxiety with equal efficacy and
greater tolerability (very little, if any sexual dysfunction). They do, however, carry a
substantial risk for addiction. Tiagabine is a Selective GABA Reuptake Inhibitor (SGRI)
that is FDA approved to treat certain types of epilepsy. Like benzodiazepines, Tiagabine
also increases the neurotransmitter, GABA, in the brain and is thought to alleviate anxiety
(see references below) this way too, but without any addiction risk common to Valium-type
drugs. The safety profile of Tiagabine is thought to be much safer. Two double blind
studies are ongoing which are looking at Tiagabine's effectiveness in PTSD and GAD. There
are many open label studies showing anxiety reduction and many psychiatrists in clinical
practice are utilizing this agent as an anxiety treatment in an off-label manner.
This study is designed to evaluate anxious patients who are taking SSRI medication, have had
a reasonable response, but are experiencing significant sexual side effects which are pushing
them towards noncompliance and possible relapse into anxiety. 30 subjects (15 men and 15
women) will be asked to join the study and be placed on Tiagabine as well as their current
SSRI. Once an acceptable dose of Tiagabine is reached in the first four weeks, the subjects'
SSRIs will be slowly stopped. Two weeks after enrollment, all subjects will be called in
order to check for any side effects to the study drug and to insure that each subject is
titrating to the proper dose of study drug according to the study protocol. An open-label,
non-placebo prospective 10 week follow up will occur, where the now Tiagabine monotherapy
subjects will be followed to see primarily if their sexual dysfunction improves and if there
anxiety remains controlled.
Evaluate the Safety of GABITRIL in Adults With Generalized Anxiety Disorder [Completed]
To assess the long-term safety and tolerability of tiagabine treatment in patients with
generalized anxiety disorder (GAD).
Study to Evaluate the Safety and Efficacy of GABITRIL Treatment in Adults With Generalized Anxiety Disorder. [Completed]
A 12-Month, Open-Label, Flexible-Dosage Study to Evaluate the Safety and Efficacy of GABITRIL
Treatment in Adults with Generalized Anxiety Disorder.
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