Rank |
Status |
Study |
1 |
Recruiting
|
Safety Study of 3 mg/mL Baclofen Injection (Intrathecal) Using A Programmable Pump
Condition: |
Severe Spasticity |
Intervention: |
Drug: Gablofen® 3 mg/mL (Baclofen injection) |
Outcome Measures: |
The rate of inflammatory granulomas in patients given 3 mg/mL Gablofen® (Baclofen injection) 3mg/mL by the intrathecal route of administration.; Overall safety of 3 mg/mL Gablofen® (Baclofen injection) given by the intrathecal route of administration |
|
2 |
Recruiting
|
Preventing Alcohol Withdrawal With Oral Baclofen
Conditions: |
Alcoholism; Alcohol Withdrawal |
Intervention: |
Drug: Baclofen |
Outcome Measures: |
Alcohol withdrawal severity as measured on CIWA-AR (Clinical Institute for Withdrawal Assessment) scale; Total benzodiazepine dose required |
|
3 |
Not yet recruiting
|
Oral and IV Baclofen in Adult Volunteers
Condition: |
Baclofen Withdrawal Syndrome |
Interventions: |
Drug: Oral Baclofen; Drug: Intervenous Baclofen |
Outcome Measures: |
oral bioavailability; Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]; Plasma Decay Half-Life (t1/2); Maximum concentration (Cmax); Tmax; assessment of sedation; Ataxia; Nystagmus; blood pressure |
|
4 |
Not yet recruiting
|
Dose Escalation Study of Intravenous Baclofen in Healthy Adult Volunteers
Condition: |
Safety and Pharmacokinetics of Intravenous Baclofen |
Intervention: |
Drug: Intravenous Baclofen |
Outcome Measures: |
Safety assessments; Maximum Concentration(Cmax); AUC(0-inf); Plasma Decay Half-life (T1/2) |
|
5 |
Not yet recruiting
|
Action of Baclofen Capsules in Spasticity Due to Multiple Sclerosis
Condition: |
Spasticity |
Interventions: |
Drug: Baclofen dose 1; Drug: Baclofen dose 2; Drug: Placebo |
Outcome Measures: |
Primary efficacy outcome: Improvement in Ashworth score; Spasm frequency; Nighttime awakening score; Clinical global impression of change; Subject's global impression of change |
|
6 |
Recruiting
|
Baclofen Effects in Cigarette Smokers
Condition: |
Nicotine Dependence |
Interventions: |
Drug: Baclofen; Drug: placebo |
Outcome Measures: |
fMRI response in the ventral striatum/medial orbitofrontal cortex during smoking cue exposure; Urine cotinine; Cigarettes smoked per day |
|
7 |
Recruiting
|
Efficacy and Safety of Baclofen ER Capsules (GRS) in Subjects With Spasticity Due to Multiple Sclerosis
Condition: |
Spasticity |
Interventions: |
Drug: Baclofen ER Capsules; Drug: Placebo GRS |
Outcome Measures: |
The primary efficacy outcome is the proportion of subjects who become a treatment failure during double-blind randomized withdrawal; Determining the safety profile when administered over >12 weeks; Subject Global Impression of Severity (SGIS)assessment |
|
8 |
Recruiting
|
Efficacy and Safety of High Dose Baclofen for Alcohol Dependence
Condition: |
Alcoholism |
Interventions: |
Drug: Baclofen; Drug: Placebo |
Outcome Measures: |
Mean % Heavy Drinking Days; Mean % Abstinent Drinking Days; Anxiety level based on Spielberger Scale for State Anxiety |
|
9 |
Recruiting
|
Baclofen Effects on Marijuana Dependence
Condition: |
Marijuana Dependence |
Interventions: |
Drug: Baclofen; Behavioral: Psychosocial; Drug: Placebo |
Outcome Measure: |
Change in brain and behavioral responses during reward and inhibitory tasks at fMRI 1, fMRI 2, and fMRI 3; A composite measure |
|
10 |
Recruiting
|
A Clinical Evaluation Of The Safety Of Baclofen Er Capsules (Grs) When Administered Once Daily To Subjects With Spasticity Due To Multiple Sclerosis (Ms): An Open Label, Long Term, Safety Trial
Condition: |
Spasticity |
Intervention: |
Drug: Baclofen |
Outcome Measures: |
No. of participants with adverse events; No. of participants with adverse vital signs; Number of participants with adverse laboratory parameters |
|
11 |
Not yet recruiting
|
Preventing Alcohol Withdrawal Syndrome With Oral Baclofen
Condition: |
Alcohol Withdrawal Syndrome |
Interventions: |
Drug: Baclofen; Drug: Placebo |
Outcome Measures: |
Prevention of Progression to Severe Alcohol withdrawal; Reduced Severity of alcohol withdrawal (measured be SEWS score); Reduced benzodiazepine administration in treatment group |
|
12 |
Unknown †
|
Baclofen as Add-On to Standard Treatment of Alcohol- Dependent Patients
Condition: |
Alcohol Dependence |
Intervention: |
Drug: Baclofen (as add-on to standard treatment of alcohol dependence) |
Outcome Measures: |
clinical efficacy and safe side-effect profile of Baclofen in patients suffering from alcohol dependence; an improvement of the quality of life and associated psychosocial variables such as self-perceptions |
|
13 |
Not yet recruiting
|
A Study of Baclofen ER
Condition: |
Cocaine Dependence |
Interventions: |
Drug: Baclofen ER; Drug: Placebo |
Outcome Measure: |
Urines positive for benzoylecgonine (BE), (a metabolite of cocaine) |
|
14 |
Unknown †
|
Placebo Controlled Study of Baclofen for GERD in Children With Cerebral Palsy
Conditions: |
Cerebral Palsy; GERD |
Interventions: |
Drug: Baclofen; Drug: placebo |
Outcome Measures: |
Symptom control; GERD control; side effects of Baclofen |
|
15 |
Recruiting
|
A Study to Examine the, Safety, Tolerability and Pharmacokinetics Co-Administered Baclofen and Memantine in Obese and Lean, Otherwise Healthy Adults
Conditions: |
Healthy Volunteers;; Obese, Otherwise Healthy Volunteers |
Interventions: |
Drug: Baclofen; Drug: Memantine; Drug: Placebo |
Outcome Measures: |
Safety and tolerability of co-administered Baclofen and memantine via C-SSRS; Safety and tolerability of co-administered Baclofen and memantine via Adverse Events; Safety and tolerability of co-administered Baclofen and memantine via Vital Signs; Safety and tolerability of co-administered Baclofen and memantine via ECG; Safety and tolerability of co-administered Baclofen and memantine via Clinical Laboratory Tests; Pharmacokinetic parameters of co-administered Baclofen and memantine via Cmax; Pharmacokinetic parameters of co-administered Baclofen and memantine via Tmax; Pharmacokinetic parameters of co-administered Baclofen and memantine via AUC; Pharmacokinetic parameters of co-administered Baclofen and memantine via MRT; Pharmacokinetic parameters of co-administered Baclofen and memantine via CL/F; Pharmacokinetic parameters of co-administered Baclofen and memantine via T1/2; Pharmacokinetic parameters of co-administered Baclofen and memantine via CLR |
|
16 |
Recruiting
|
Baclofen in the Treatment of Alcoholic Liver Disease
Condition: |
Alcoholic Liver Disease |
Interventions: |
Drug: Baclofen 30mg/day; Drug: Baclofen 75mg/day; Drug: Placebo |
Outcome Measures: |
alcohol consumption; clinical markers of liver injury; incidence of hepatic side effects; craving for alcohol; early termination due to side effects |
|
17 |
Recruiting
|
Baclofen for Treating Anxiety and Alcoholism
Conditions: |
Alcoholism; Alcohol Dependence; Alcohol Drinking Related Problems; Alcohol Drinking; Anxiety Disorder |
Intervention: |
Drug: Baclofen |
Outcome Measures: |
Alcohol drinking during the Alcohol Self-Administration, expressed as Standard Drinking Units (SDUs) will be measured as the primary outcome during the CR/ASA session.; Secondary objectives include Baclofen s effects on alcohol cue-induced responses (urge to drink, attention to cues, blood pressure, heart rate, saliva), on the subjective effects of alcohol and on anxiety levels. |
|
18 |
Unknown †
|
Open Label Treatment of Severe Tactile Defensiveness With Intrathecal Baclofen
Conditions: |
Tactile Defensiveness; Autism Spectrum Disorder |
Intervention: |
Drug: Baclofen, intrathecal |
Outcome Measures: |
Modified Short Sensory Profile.; Clinical Global Impression of Change in Autism Symptoms |
|
19 |
Unknown †
|
Does Oral Baclofen Improve Care and Comfort in Spastic Children in Nursing Homes?
Condition: |
Cerebral Palsy |
Interventions: |
Drug: oral Baclofen + placebo; Drug: placebo + oral Baclofen |
Outcome Measure: |
care and comport questionnaires |
|
20 |
Recruiting
|
GABA-B Receptor Function in Healthy Volunteers
Conditions: |
No Condition; Brain GABA-B Function |
Interventions: |
Drug: Baclofen 10mg; Drug: Baclofen 60mg; Drug: placebo |
Outcome Measure: |
EEG spectral power in theta band |
|