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ClinicalTrials.gov public records Last synced Oct 30, 2026, 9:50 PM EDT

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Showing 1–21 of 21 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Oral baclofen Clear all
Terminated Phase 2 Interventional Results available

Baclofen Effects on Smoking Urge and Withdrawal

NCT00257894
View directory record Official record
Conditions
Nicotine Use Disorder, Nicotine Dependence, Smoking, Tobacco Use Disorder
Interventions
Baclofen, Placebo
Drug
Lead sponsor
VA Office of Research and Development
Federal
Eligibility
18 Years to 65 Years
Enrollment
41 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2008
U.S. locations
1
States / cities
Providence, Rhode Island
Source: ClinicalTrials.gov public record
Updated Nov 4, 2015 · Synced Oct 30, 2026, 9:50 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Oral and IV Baclofen in Adult Volunteers

NCT01749319
View directory record Official record
Conditions
Baclofen Withdrawal Syndrome
Interventions
Oral baclofen, Intervenous baclofen
Drug
Lead sponsor
University of Minnesota
Other
Eligibility
18 Years to 65 Years
Enrollment
12 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2013 – 2014
U.S. locations
1
States / cities
Minneapolis, Minnesota
Source: ClinicalTrials.gov public record
Updated Aug 5, 2014 · Synced Oct 30, 2026, 9:50 PM EDT
Completed Phase 1Phase 2 Interventional

Oral Baclofen Pharmacokinetics and Pharmacodynamics in Children With Spasticity

NCT00607542
View directory record Official record
Conditions
Spasticity, Cerebral Palsy
Interventions
baclofen
Drug
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Eligibility
2 Years to 16 Years
Enrollment
61 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2011
U.S. locations
11
States / cities
Chicago, Illinois • New Orleans, Louisiana • Baltimore, Maryland + 8 more
Source: ClinicalTrials.gov public record
Updated Dec 6, 2011 · Synced Oct 30, 2026, 9:50 PM EDT
Terminated Phase 3 Interventional Results available

Preventing Alcohol Withdrawal Syndrome With Oral Baclofen

NCT02052440
View directory record Official record
Conditions
Alcohol Withdrawal Syndrome
Interventions
Baclofen, Placebo
Drug
Lead sponsor
Denver Health and Hospital Authority
Other
Eligibility
21 Years and older
Enrollment
102 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2017
U.S. locations
1
States / cities
Denver, Colorado
Source: ClinicalTrials.gov public record
Updated May 23, 2018 · Synced Oct 30, 2026, 9:50 PM EDT
Completed Phase 4 Interventional Results available

SISTERS: Spasticity In Stroke Study - Randomized Study

NCT01032239
View directory record Official record
Conditions
Severe Spasticity
Interventions
intrathecal baclofen
Drug
Lead sponsor
MedtronicNeuro
Industry
Eligibility
18 Years to 75 Years
Enrollment
61 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2016
U.S. locations
9
States / cities
Irvine, California • Washington D.C., District of Columbia • Doral, Florida + 6 more
Source: ClinicalTrials.gov public record
Updated Feb 15, 2018 · Synced Oct 30, 2026, 9:50 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Dose Escalation Study of Intravenous Baclofen in Healthy Adult Volunteers

NCT01931319
View directory record Official record
Conditions
Safety and Pharmacokinetics of Intravenous Baclofen
Interventions
Intravenous baclofen
Drug
Lead sponsor
University of Minnesota
Other
Eligibility
18 Years to 65 Years
Enrollment
39 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2014
U.S. locations
1
States / cities
Minneapolis, Minnesota
Source: ClinicalTrials.gov public record
Updated May 7, 2019 · Synced Oct 30, 2026, 9:50 PM EDT
Recruiting Early Phase 1 Interventional

Synaptic Mechanisms of Continuous Theta Burst Stimulation in Depression

NCT07560878
View directory record Official record
Conditions
Major Depression
Interventions
D-Cycloserine (DCS), Continuous theta-burst stimulation (cTBS), Transcranial Magnetic Stimulation Sham, Memantine, Lorazepam (drug), Baclofen, Placebo
Drug · Device
Lead sponsor
Mclean Hospital
Other
Eligibility
18 Years and older
Enrollment
80 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2030
U.S. locations
1
States / cities
Belmont, Massachusetts
Source: ClinicalTrials.gov public record
Updated May 13, 2026 · Synced Oct 30, 2026, 9:50 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Pharmacokinetic and Bioequivalence Comparison of Baclofen and Chlorzoxazone Administered Individually or Concurrently

NCT05257447
View directory record Official record
Conditions
Pharmacokinetics
Interventions
Baclofen 20 mg Tablet, Chlorzoxazone 500 mg Tablet, Baclofen 20mg tablet and Chlorzoxazone 500 mg tablet
Drug
Lead sponsor
University of Texas Southwestern Medical Center
Other
Eligibility
18 Years to 55 Years
Enrollment
19 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2022
U.S. locations
1
States / cities
Dallas, Texas
Source: ClinicalTrials.gov public record
Updated Mar 31, 2023 · Synced Oct 30, 2026, 9:50 PM EDT
Active, not recruiting Not applicable Interventional

Electrical Neuromodulation for Modifying Spinal Network Involved in Spasticity

NCT07792616
View directory record Official record
Conditions
Spinal Cord Injuries (Complete and Incomplete), Spinal Cord Injury, Spinal Cord Injury Cervical, Spinal Cord Injury Thoracic, Spinal Cord Injuries, Spasticity, Spasm, Muscle Spasticity, Muscle Hypertonia, Muscle Spasm
Interventions
Transcutaneous spinal stimulation at 30 Hz, Transcutaneous spinal stimulation at 75 Hz, Tizanidine, Baclofen, Placebo
Other · Drug
Lead sponsor
University of Mississippi Medical Center
Other
Eligibility
18 Years and older
Enrollment
12 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2027
U.S. locations
2
States / cities
Jackson, Mississippi
Source: ClinicalTrials.gov public record
Updated Aug 28, 2026 · Synced Oct 30, 2026, 9:50 PM EDT
Completed Not applicable Interventional Results available

Treating Alcohol Withdrawal With Oral Baclofen

NCT00597701
View directory record Official record
Conditions
Alcohol Withdrawal Delirium
Interventions
Baclofen, Placebo, Lorazepam
Drug
Lead sponsor
Essentia Health
Other
Eligibility
18 Years and older
Enrollment
79 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2003 – 2008
U.S. locations
1
States / cities
Duluth, Minnesota
Source: ClinicalTrials.gov public record
Updated Jul 27, 2011 · Synced Oct 30, 2026, 9:50 PM EDT
Not listed Phase 2 Interventional

Safety, Tolerability, and Efficacy of Arbaclofen in 16p11.2 Deletion

NCT04271332
View directory record Official record
Conditions
16P11.2 Deletion Syndrome
Interventions
Arbaclofen, Placebo oral tablet
Drug
Lead sponsor
Clinical Research Associates, LLC
Other
Eligibility
5 Years to 17 Years
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2025
U.S. locations
4
States / cities
Boston, Massachusetts • New York, New York • Houston, Texas + 1 more
Source: ClinicalTrials.gov public record
Updated May 30, 2024 · Synced Oct 30, 2026, 9:50 PM EDT
Terminated Phase 2 Interventional

An Open Label Extension Study of STX209 in Subjects With Autism Spectrum Disorders

NCT01064973
View directory record Official record
Conditions
Autism Spectrum Disorders
Interventions
arbaclofen
Drug
Lead sponsor
Seaside Therapeutics, Inc.
Industry
Eligibility
6 Years to 17 Years
Enrollment
32 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2012
U.S. locations
8
States / cities
Phoenix, Arizona • Los Angeles, California • New Haven, Connecticut + 5 more
Source: ClinicalTrials.gov public record
Updated Dec 20, 2012 · Synced Oct 30, 2026, 9:50 PM EDT
Completed Phase 3 Interventional

Efficacy Study of Arbaclofen to Treat Spasticity in Multiple Sclerosis

NCT01743651
View directory record Official record
Conditions
Spasticity, Multiple Sclerosis
Interventions
arbaclofen, baclofen, Placebo
Drug
Lead sponsor
RVL Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
353 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2014
U.S. locations
25
States / cities
Cullman, Alabama • Long Beach, California • Aurora, Colorado + 20 more
Source: ClinicalTrials.gov public record
Updated Apr 25, 2022 · Synced Oct 30, 2026, 9:50 PM EDT
Completed Phase 2 Interventional

Effectiveness of GABA Agonists in Reducing the Reinforcing Effects of Cocaine

NCT00218166
View directory record Official record
Conditions
Cocaine-Related Disorders
Interventions
GABA Agonists
Drug
Lead sponsor
National Institute on Drug Abuse (NIDA)
NIH
Eligibility
18 Years to 50 Years
Enrollment
78 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2001 – 2005
U.S. locations
1
States / cities
Lexington, Kentucky
Source: ClinicalTrials.gov public record
Updated Jan 11, 2017 · Synced Oct 30, 2026, 9:50 PM EDT
Terminated Phase 1 Interventional

Botox vs. Baclofen for Upper Limb Spasticity

NCT00280280
View directory record Official record
Conditions
Spasticity
Interventions
intramuscular Botox versus oral baclofen
Drug
Lead sponsor
Vanderbilt University
Other
Eligibility
18 Years and older
Enrollment
8 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2009
U.S. locations
1
States / cities
Nashville, Tennessee
Source: ClinicalTrials.gov public record
Updated Jan 20, 2012 · Synced Oct 30, 2026, 9:50 PM EDT
Terminated Phase 1 Interventional Accepts healthy volunteers

TMS Measures of Plasticity and Excitatory/Inhibitory Ratio as Biomarkers: R-baclofen Effects in Normal Volunteers

NCT01172509
View directory record Official record
Conditions
Autism
Interventions
R-baclofen
Drug
Lead sponsor
Gonzalez-Heydrich, Joseph, M.D.
Individual
Eligibility
18 Years to 30 Years
Enrollment
6 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2010 – 2012
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Aug 21, 2015 · Synced Oct 30, 2026, 9:50 PM EDT
Completed Early Phase 1 Interventional

Baclofen Treatment of Ataxia Telangiectasia

NCT00640003
View directory record Official record
Conditions
Ataxia Telangiectasia
Interventions
Baclofen, Placebo
Drug
Lead sponsor
Johns Hopkins University
Other
Eligibility
12 Years and older
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2011
U.S. locations
2
States / cities
Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated Dec 20, 2017 · Synced Oct 30, 2026, 9:50 PM EDT
Not listed Phase 3 Interventional

Assessing Long Term Safety and Tolerability of PXT3003 in Patients With Charcot-Marie-Tooth Disease Type 1A

NCT03023540
View directory record Official record
Conditions
Charcot-Marie-Tooth Disease, Type IA
Interventions
PXT3003
Drug
Lead sponsor
Pharnext S.C.A.
Other
Eligibility
17 Years to 67 Years
Enrollment
187 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2024
U.S. locations
9
States / cities
Los Angeles, California • Gainesville, Florida • Kansas City, Kansas + 6 more
Source: ClinicalTrials.gov public record
Updated Feb 20, 2024 · Synced Oct 30, 2026, 9:50 PM EDT
Not listed Phase 3 Interventional

Phase III Trial Assessing the Efficacy and Safety of PXT3003 in CMT1A Patients

NCT04762758
View directory record Official record
Conditions
Charcot-Marie-Tooth Disease
Interventions
(RS)-baclofen, naltrexone hydrochloride and D-sorbitol, Placebo
Drug
Lead sponsor
Pharnext S.C.A.
Other
Eligibility
16 Years to 65 Years
Enrollment
350 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2024
U.S. locations
20
States / cities
Los Angeles, California • Sacramento, California • New Britain, Connecticut + 16 more
Source: ClinicalTrials.gov public record
Updated Apr 3, 2024 · Synced Oct 30, 2026, 9:50 PM EDT
Terminated Phase 2 Interventional Results available

Preventing Alcohol Withdrawal With Oral Baclofen

NCT01937364
View directory record Official record
Conditions
Alcoholism, Alcohol Withdrawal
Interventions
Baclofen, Placebo
Drug
Lead sponsor
Essentia Health
Other
Eligibility
21 Years and older
Enrollment
17 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2015
U.S. locations
2
States / cities
Duluth, Minnesota • Fargo, North Dakota
Source: ClinicalTrials.gov public record
Updated May 5, 2017 · Synced Oct 30, 2026, 9:50 PM EDT
Not listed Early Phase 1 Interventional

Neuromodulation to Reduce Muscle Stiffness Following Spinal Cord Injury

NCT06274021
View directory record Official record
Conditions
Spinal Cord Injuries, Spinal Cord Injury, Spinal Cord Injury Cervical, Spinal Cord Injury Thoracic
Interventions
Transcutaneous spinal stimulation at 100 Hz, Transcutaneous spinal stimulation at 50 Hz, Transcutaneous spinal stimulation at 50 Hz and single dose of baclofen, Transcutaneous spinal stimulation at 50 Hz and single dose of tizanidine, Sham transcutaneous spinal stimulation
Device · Combination Product
Lead sponsor
University of Mississippi Medical Center
Other
Eligibility
18 Years and older
Enrollment
16 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2025
U.S. locations
2
States / cities
Jackson, Mississippi
Source: ClinicalTrials.gov public record
Updated Jul 1, 2024 · Synced Oct 30, 2026, 9:50 PM EDT