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Showing 25–48 of 24 matching trials from the live ClinicalTrials.gov search.
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Recruiting Not applicable Interventional

Intrathecal Baclofen and Pediatric Dystonia

NCT06606574
View directory record Official record
Conditions
Dystonic Cerebral Palsy
Interventions
Titration protocol
Other
Lead sponsor
Baylor College of Medicine
Other
Eligibility
Up to 17 Years
Enrollment
65 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2029
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Jul 29, 2025 · Synced Sep 3, 2026, 2:22 AM EDT
Terminated Phase 2Phase 3 Interventional Accepts healthy volunteers Results available

Buprenorphine Plus Baclofen to Increase Analgesia in Healthy Volunteers

NCT04251819
View directory record Official record
Conditions
Acute Pain, Analgesia
Interventions
Placebos, Baclofen 5 mg, Baclofen 10mg
Drug
Lead sponsor
University of Alabama at Birmingham
Other
Eligibility
18 Years and older
Enrollment
19 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2021 – 2024
U.S. locations
1
States / cities
Birmingham, Alabama
Source: ClinicalTrials.gov public record
Updated Jan 6, 2026 · Synced Sep 3, 2026, 2:22 AM EDT
Completed Phase 2 Interventional Accepts healthy volunteers Results available

Effect of Baclofen on Marijuana Withdrawal and Relapse

NCT00373295
View directory record Official record
Conditions
Marijuana Dependence
Interventions
Baclofen, Marijuana, Placebo
Drug
Lead sponsor
New York State Psychiatric Institute
Other
Eligibility
21 Years to 45 Years
Enrollment
13 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2006 – 2010
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated May 9, 2017 · Synced Sep 3, 2026, 2:22 AM 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 6, 2019 · Synced Sep 3, 2026, 2:22 AM EDT
Completed Phase 2Phase 3 Interventional Results available

Novel Topical Therapies for the Treatment of Genital Pain

NCT02099006
View directory record Official record
Conditions
Female Genital Diseases
Interventions
Amitriptyline, Baclofen, Ketoprofen, Ketamine, Loperamide, Gabapentin, placebo
Drug
Lead sponsor
University of Rochester
Other
Eligibility
18 Years to 65 Years · Female only
Enrollment
9 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2015
U.S. locations
1
States / cities
Rochester, New York
Source: ClinicalTrials.gov public record
Updated Jul 14, 2016 · Synced Sep 3, 2026, 2:22 AM 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 27, 2026 · Synced Sep 3, 2026, 2:22 AM 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 2, 2024 · Synced Sep 3, 2026, 2:22 AM 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 26, 2011 · Synced Sep 3, 2026, 2:22 AM EDT
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 3, 2015 · Synced Sep 3, 2026, 2:22 AM EDT
Terminated Phase 2 Interventional

An Open Label Extension Study of STX209 in Subjects With Fragile X Syndrome

NCT01013480
View directory record Official record
Conditions
Fragile X Syndrome
Interventions
Arbaclofen
Drug
Lead sponsor
Seaside Therapeutics, Inc.
Industry
Eligibility
6 Years to 40 Years
Enrollment
45 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2012
U.S. locations
9
States / cities
Los Angeles, California • Sacramento, California • Chicago, Illinois + 6 more
Source: ClinicalTrials.gov public record
Updated Dec 19, 2012 · Synced Sep 3, 2026, 2:22 AM EDT
Completed Phase 3 Interventional

Efficacy and Safety Study of STX209 (Arbaclofen) for the Treatment of Social Withdrawal in Children With Fragile X Syndrome

NCT01325220
View directory record Official record
Conditions
Fragile X Syndrome
Interventions
arbaclofen, Placebo
Drug
Lead sponsor
Seaside Therapeutics, Inc.
Industry
Eligibility
5 Years to 11 Years
Enrollment
172 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2011
U.S. locations
28
States / cities
Phoenix, Arizona • Long Beach, California • Sacramento, California + 24 more
Source: ClinicalTrials.gov public record
Updated Jul 30, 2013 · Synced Sep 3, 2026, 2:22 AM EDT
Withdrawn Not applicable Interventional

Open Label Treatment of Severe Tactile Defensiveness With Intrathecal Baclofen

NCT01352611
View directory record Official record
Conditions
Autism Spectrum Disorder
Interventions
baclofen, intrathecal
Drug
Lead sponsor
University of Missouri-Columbia
Other
Eligibility
10 Years to 65 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2015
U.S. locations
1
States / cities
Columbia, Missouri
Source: ClinicalTrials.gov public record
Updated Oct 5, 2016 · Synced Sep 3, 2026, 2:22 AM EDT
Completed Phase 3 Interventional

IPX056 in Subjects With Established Spasticity Resulting From Multiple Sclerosis

NCT00488839
View directory record Official record
Conditions
Multiple Sclerosis
Interventions
IPX056 20 mg, IPX056 40 mg, Encapsulated Baclofen 20 mg, Placebo Baclofen Tablet, IPX056 10 mg, IPX056 30 mg, IPX056 35 mg, Placebo IPX056 20 mg, Placebo IPX056 40 mg
Drug
Lead sponsor
Impax Laboratories, LLC
Industry
Eligibility
18 Years and older
Enrollment
173 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2008
U.S. locations
20
States / cities
Tucson, Arizona • Little Rock, Arkansas • Colorado Springs, Colorado + 16 more
Source: ClinicalTrials.gov public record
Updated Nov 5, 2019 · Synced Sep 3, 2026, 2:22 AM EDT
Completed Phase 2 Interventional

Baclofen for the Treatment of Cocaine Dependence - 1

NCT00082485
View directory record Official record
Conditions
Cocaine-Related Disorders
Interventions
Baclofen, Placebo
Drug · Other
Lead sponsor
National Institute on Drug Abuse (NIDA)
NIH
Eligibility
18 Years to 99 Years
Enrollment
160 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2004
U.S. locations
8
States / cities
San Francisco, California • Torrance, California • Denver, Colorado + 5 more
Source: ClinicalTrials.gov public record
Updated Jan 11, 2017 · Synced Sep 3, 2026, 2:22 AM EDT
Completed Phase 2 Interventional Accepts healthy volunteers Results available

Baclofen Effects in Cigarette Smokers

NCT01821560
View directory record Official record
Conditions
Nicotine Dependence
Interventions
Baclofen, placebo
Drug
Lead sponsor
University of Pennsylvania
Other
Eligibility
18 Years to 60 Years
Enrollment
44 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2013 – 2017
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Dec 18, 2018 · Synced Sep 3, 2026, 2:22 AM 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 4, 2014 · Synced Sep 3, 2026, 2:22 AM 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 5, 2011 · Synced Sep 3, 2026, 2:22 AM EDT
Completed Phase 4 Interventional Results available

Ibuprofen Plus Metaxolone, Tizanidine, or Baclofen for Low Back Pain

NCT03068897
View directory record Official record
Conditions
Low Back Pain
Interventions
Metaxalone, Tizanidine, Baclofen, Ibuprofen 600 mg, Educational intervention
Drug · Behavioral
Lead sponsor
Montefiore Medical Center
Other
Eligibility
18 Years and older
Enrollment
320 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2018
U.S. locations
1
States / cities
The Bronx, New York
Source: ClinicalTrials.gov public record
Updated Aug 11, 2020 · Synced Sep 3, 2026, 2:22 AM EDT
Completed Not applicable Interventional

Effectiveness of Baclofen in the Treatment of People With Bulimia Nervosa or Binge Eating Disorder

NCT00320047
View directory record Official record
Conditions
Eating Disorders, Bulimia Nervosa
Interventions
Baclofen
Drug
Lead sponsor
New York State Psychiatric Institute
Other
Eligibility
18 Years to 55 Years
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2007
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Aug 11, 2013 · Synced Sep 3, 2026, 2:22 AM 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 20, 2015 · Synced Sep 3, 2026, 2:22 AM EDT
Completed Phase 2 Interventional Accepts healthy volunteers

Vaginal Baclofen Suppositories in Chronic Pelvic Pain

NCT05968937
View directory record Official record
Conditions
Chronic Pelvic Pain Syndrome
Interventions
20 mg baclofen vaginal suppository daily per vagina, Placebo
Drug
Lead sponsor
University of Louisville
Other
Eligibility
18 Years to 65 Years · Female only
Enrollment
39 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2024 – 2026
U.S. locations
1
States / cities
Louisville, Kentucky
Source: ClinicalTrials.gov public record
Updated Apr 30, 2026 · Synced Sep 3, 2026, 2:22 AM 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 14, 2018 · Synced Sep 3, 2026, 2:22 AM 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 4, 2017 · Synced Sep 3, 2026, 2:22 AM EDT
Terminated Phase 4 Interventional Results available

Dysfunctional Voiding and Lower Urinary Tract Symptoms With Baclofen

NCT01003249
View directory record Official record
Conditions
Overactive Bladder, Constipation, Lower Urinary Tract Symptoms
Interventions
Baclofen, Placebo
Drug
Lead sponsor
Wake Forest University Health Sciences
Other
Eligibility
18 Years to 64 Years
Enrollment
12 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2013
U.S. locations
1
States / cities
Winston-Salem, North Carolina
Source: ClinicalTrials.gov public record
Updated Aug 13, 2018 · Synced Sep 3, 2026, 2:22 AM EDT