BACLOFEN SUMMARY
BACLOFEN TABLETS, USP
Baclofen USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid.
Baclofen tablets are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.
Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function.
Baclofen may also be of some value in patients with spinal cord injuries and other spinal cord diseases.
Baclofen is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.
The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.
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BACLOFEN NEWS HIGHLIGHTS Media Articles Related to Baclofen
XenoPort Reports Positive Results From A Phase 2 Trial Of Arbaclofen Placarbil In Spinal Cord Injury Patients With Spasticity
Source: Clinical Trials / Drug Trials News From Medical News Today [2009.07.02]
XenoPort, Inc. (Nasdaq:XNPT) announced positive preliminary results from a Phase 2 clinical trial of arbaclofen placarbil (AP), also known as XP19986, for the treatment of patients with spasticity due to spinal cord injury (SCI). Doses of 20 and 30 mg of AP, given twice daily (BID), demonstrated statistically significant improvements compared to placebo for the primary endpoint of the study. AP was well tolerated during the trial.
Published Studies Related to Baclofen
Effectiveness and safety of baclofen for maintenance of alcohol abstinence in alcohol-dependent patients with liver cirrhosis: randomised, double-blind controlled study. [2007.12.08]
BACKGROUND: Intervention to achieve alcohol abstinence represents the most effective treatment for alcohol-dependent patients with liver cirrhosis; however, anticraving drugs might worsen liver disease. We aimed to investigate the effectiveness and safety of baclofen in achieving and maintaining alcohol abstinence in patients with liver cirrhosis... INTERPRETATION: Baclofen is effective at promoting alcohol abstinence in alcohol-dependent patients with liver cirrhosis. The drug is well tolerated and could have an important role in treatment of these individuals.
Dysfunctional voiding confirmed by transdermal perineal electromyography, and its effective treatment with baclofen in women with lower urinary tract symptoms: a randomized double-blind placebo-controlled crossover trial. [2007.09]
OBJECTIVES To assess the activity of baclofen, a potent gamma-aminobutyric acid-ergic agonist, against dysfunctional voiding (DV) and lower urinary tract symptoms (LUTS) in a clinical trial, as DV is a leading cause of LUTS in women, but there is no effective treatment. PATIENTS AND METHODS We conducted a randomized double-blind placebo-controlled crossover trial in 60 women with DV and LUTS between January 2003 and January 2006; patients were randomly assigned either baclofen 10 mg three times daily, then matching placebo for 4 weeks, or matching placebo then baclofen 10 mg three times daily for 4 weeks, separated by a 2-week washout period...
Intrathecal baclofen in children with spastic cerebral palsy: a double-blind, randomized, placebo-controlled, dose-finding study. [2007.09]
Intrathecal baclofen (ITB) therapy can be very effective in the treatment of intractable spasticity, but its effectiveness and safety have not yet been thoroughly studied in children with cerebral palsy (CP). The aims of this double-blind, randomized, placebo-controlled, dose-finding study were to select children eligible for continuous ITB infusion, to assess the effective ITB bolus dose, and to evaluate the effects, side effects, and complications...
Suppression of LTP-like plasticity in human motor cortex by the GABAB receptor agonist baclofen. [2007.06]
Previous experiments in slice preparations revealed that pharmacological activation of GABAB receptors down- or up-regulates long-term potentiation (LTP), depending on whether increase of GABAB receptor mediated inhibitory postsynaptic potentials or decrease of presynaptic auto-inhibition of GABAA receptor mediated inhibition predominates.
Dysfunctional voiding confirmed by transdermal perineal electromyography, and its effective treatment with baclofen in women with lower urinary tract symptoms: a randomized double-blind placebo-controlled crossover trial. [2007.05.19]
OBJECTIVES To assess the activity of baclofen, a potent gamma-aminobutyric acid-ergic agonist, against dysfunctional voiding (DV) and lower urinary tract symptoms (LUTS) in a clinical trial, as DV is a leading cause of LUTS in women, but there is no effective treatment. PATIENTS AND METHODS We conducted a randomized double-blind placebo-controlled crossover trial in 60 women with DV and LUTS between January 2003 and January 2006; patients were randomly assigned either baclofen 10 mg three times daily, then matching placebo for 4 weeks, or matching placebo then baclofen 10 mg three times daily for 4 weeks, separated by a 2-week washout period...
Clinical Trials Related to Baclofen
Comparative Bioavailability Study of Baclofen 20 mg Tablets in Healthy Male Volunteers / Fasting State [Completed]
The objective of this study was to investigate the bioequivalence of Genpharm's baclofen
tablets following a single, oral 20 mg (1 x 20 mg) dose compared to the Baclofen USP (Watson
Laboratories Inc., USA) administered under fasting conditions. Twenty-seven (27) healthy,
light-, non- or ex-smoking subjects of at least 18 a years of age were randomized, in this
two-period, two-treatment crossover bioequivalence study conducted by Eric Sicard, M. D. at
Algorithme Pharma Inc. Montreal, Canada.
Statistical analysis of the data reveals that 90% confidence intervals are within the
acceptable bioequivalent range of 80% and 125% for the natural log transformed parameters
AUCT, AUCI and Cmax. This study demonstrates that Genpharm's baclofen 20 mg tablets are
bioequivalent to Baclofen USP 20 mg tablets (Watson Laboratories Inc., USA) administered
under fasting conditions.
Treating Alcohol Withdrawal With Oral Baclofen [Completed]
The purpose of this study is determine if subjects with alcohol withdrawal who receive oral
baclofen, plus standard benzodiazepine therapy, will experience less severe withdrawal
symptoms than those who receive placebo plus standard benzodiazepine therapy. Subjects with
alcohol withdrawal syndrome(AWS)who receive baclofen plus standard benzodiazepine therapy
will experience fewer complications of AWS (as measured by use of additional sedatives,
restraints, and/or ICU admissions) compared with subjects who receive placebo plus standard
benzodiazepine therapy.
Efficacy of Baclofen in the Treatment of Alcohol Addiction [Completed]
Intervention to achieve alcohol abstinence represents the most effective treatment for
alcoholic patients with liver cirrhosis. However no trials have evaluated the efficacy of
anti-craving drugs in these patients because of the concern that these medications might
worsen liver disease. Baclofen is effective to reduce alcohol craving improving abstinence in
alcohol-dependent patients. It is mainly eliminated by kidney. No hepatic side-effects have
been reported in treated patients. The present study investigates the efficacy and safety of
baclofen in achieving and maintaining abstinence in alcoholic cirrhotic patients.
Effectiveness of Baclofen in the Treatment of People With Bulimia Nervosa or Binge Eating Disorder [Active, not recruiting]
This study will evaluate the effectiveness of the drug baclofen in reducing binge eating and
associated food cravings in people with bulimia nervosa or binge eating disorder.
Will the Use of Baclofen Reduce Cocaine Use in Patients With Cocaine Dependence? [Active, not recruiting]
Cocaine is a powerfully addictive stimulant. Cocaine dependence is a significant public
health problem associated with serious medical, psychiatric, social and economic
consequences. In 1997, an estimated 1. 5 million Americans were chronic cocaine users; in
1999, the Office of National Drug Control Policy estimated the number of chronic cocaine
users in U. S. at 3. 6 million. However, despite intensive investment of resources and some
promising data from a recent trial with Selegiline, no medications so far, have demonstrated
clear evidence of efficacy for the treatment of cocaine dependence.
This study investigated a new drug, Baclofen, as a potential medication for cocaine
dependency. Each subject was assigned either to the Baclofen group or a matched placebo (or
dummy medication) group by chance, after a 2-week screening period. The treatment period was
8 weeks long, when the medication was administered orally, with follow-up assessments for 4
weeks after completion of the treatment period. The main objective of this study was to
assess the suitability and safety of Baclofen to treat the craving of cocaine use among the
heavy cocaine users.
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BACLOFEN PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 1 ratings/reviews, Baclofen has an overall score of 8. The effectiveness score is 8 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
| | Baclofen review by 51 year old female patient | | | Rating |
| Overall rating: | |   |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | multiple sclerosis |
| Dosage & duration: | | 10 mg taken daily for the period of still taking it. started about 5-7 years |
| Other conditions: | | acid reflux, heart beat problems |
| Other drugs taken: | | lopressor, nexium | | |
Reported Results |
| Benefits: | | i could sleep at night. my ms caused tightness everywhere, so i had alot of sleepless nights. lack of sleep made everything worse w/ my ms |
| Side effects: | | a little tired in the am ,but nothing horrible |
| Comments: | | 10 mg at nite b4 bed |
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Page last updated: 2009-07-02
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