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Baclofen

Phase 2

Alcohol Dependence | Small molecule | Psychiatry |Pulmonx Corporation|Last Updated: Sep 5, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment56

FDA Designations

No designations recorded

Clinical trial landscape

Baclofen · 1 trial · 1 indication

Phase 2 1
NCT01266655Baclofen for the Treatment of Alcohol DependenceAlcohol Dependence
COMPLETED56 Analytics
PHASE2COMPLETED
Baclofen for the Treatment of Alcohol Dependence
Alcohol DependenceUnlock trial analytics

Study Endpoints

Primary Endpoints

Total abstinence from alcohol and cumulative abstinence duration
13-16 weeks (depending on the individually tolerated baclofen dose)

Secondary Endpoints

Number of adverse events
24 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BaclofenEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
BaclofenDRUGBaclofen will be administered orally for a maximum of 20 consecutive weeks. For the first 3 days, patients will receive baclofen in a dose of 5 milligrams t.i.d.; subsequently, the daily dose of baclofen will be increased to a maximum of 90 milligrams t.i.d. within 4 weeks. In case of intolerance, dosage can be decreased to a minimum of 10 mg t.i.d.. Patients will receive maximum tolerated dosage of baclofen for 12 weeks. Medication will then gradually be tapered over a maximum of 4 weeks.
PlaceboDRUGPlacebo
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Eligibility Criteria

Age Range18 Years to 64 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Diagnosis of alcohol dependence according to ICD-10 (International Classification of Mental and Behavioural Disorders, 10th revision) and DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th revision) criteria * An alcohol intake of at least two heavy drinking da...

Countries:Germany
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Frequently asked questions about Baclofen

What is Baclofen used for in alcohol dependence?

Baclofen is an investigational small molecule being studied for the treatment of alcohol dependence. In a Phase 2 clinical trial, it was evaluated in 56 patients with alcohol dependence. The trial was randomized, double-blind, and placebo-controlled, and it has been completed.

Who is developing Baclofen for alcohol dependence?

Pulmonx Corporation (NASDAQ: LUNG) is the developer of Baclofen for the treatment of alcohol dependence. The company conducted a Phase 2 clinical trial of the drug in this indication.

What phase is Baclofen in for alcohol dependence?

Baclofen is in Phase 2 clinical development for alcohol dependence. The Phase 2 trial has been completed. Baclofen is an investigational drug for this indication and is not approved for alcohol dependence.

What clinical trials has Baclofen been in for alcohol dependence?

Baclofen has been studied in one completed Phase 2 clinical trial, identified as NCT01266655, titled "Baclofen for the Treatment of Alcohol Dependence." The trial enrolled 56 participants in Germany and was randomized, double-blind, and placebo-controlled.

Is Baclofen the same as Lioresal?

Baclofen is the generic name for a drug that is also known by the brand name Lioresal. In the context of alcohol dependence, Baclofen is being studied as an investigational treatment, and it is not approved for this use.