Up-to-date List of Baclofen Medical Research Studies

What Research is Being Done?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.

Latest Baclofen Medical Research Studies

RankStatusStudy
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

These studies may lead to new treatments and are adding insight into Baclofen etiology and treatment.

A major focus of Baclofen research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.


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