Clinical Trials

Numerous clinical trials evaluate (R)-baclofen across Early Phase 1 through Phase 4 for a broad spectrum of neurological, developmental, and substance use disorders, including spasticity, cerebral palsy, Fragile X syndrome, alcohol dependence, gastroesophageal reflux disease, and traumatic brain injury. These investigations encompass completed, active, recruiting, and terminated recruitment statuses, supported by diverse sponsors including biotechnology companies like Seaside Therapeutics, government institutes such as the National Institute on Alcohol Abuse and Alcoholism, and international university hospitals.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07560878 RECRUITING
Major Depression
Mclean Hospital
 2026-03-11 EARLY_PHASE1
NCT06835907 RECRUITING
Alcohol Use Disorder (AUD)
Universitair Ziekenhuis Brussel
 2024-10-28
NCT06606574 RECRUITING
Dystonic Cerebral Palsy
Baylor College of Medicine
 2024-11-01
NCT06564714 NOT_YET_RECRUITING
Traumatic Spinal Cord Injury
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
 2024-12 PHASE4
NCT05935553 RECRUITING
Benzodiazepine Dependence
Hospices Civils de Lyon
 2026-01-15 PHASE2; PHASE3
NCT07378046 RECRUITING
Herpes Zoster; Pain
Beijing Tiantan Hospital
 2025-12-15
NCT07583277 NOT_YET_RECRUITING
Post Traumatic Induced Spasticity
Assiut University
 2026-06-01
NCT07792616 ACTIVE_NOT_RECRUITING
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
University of Mississippi Medical Center
 2022-07-13
NCT07063576 RECRUITING
GERD - PPI Non-responders
Adnan Imtiaj Rahul
 2025-08-01 PHASE2; PHASE3
NCT05968937 COMPLETED
Chronic Pelvic Pain Syndrome
University of Louisville
 2024-01-01 PHASE2
NCT06274021 UNKNOWN
Spinal Cord Injuries; Spinal Cord Injury; Spinal Cord Injury Cervical; Spinal Cord Injury Thoracic
University of Mississippi Medical Center
 2024-03-01 EARLY_PHASE1
NCT05418049 ACTIVE_NOT_RECRUITING
Fragile X Syndrome
Children's Hospital Medical Center, Cincinnati
 2022-09-08 PHASE2
NCT05921604 ACTIVE_NOT_RECRUITING
Post Operative Pain
Tanta University
 2023-06-30 PHASE3
NCT06175507 UNKNOWN
Alcohol Liver Disease
Institute of Liver and Biliary Sciences, India
 2023-12-25
NCT05516953 COMPLETED
Postoperative Nausea and Vomiting; Laparoscopic Sleeve Gastrectomy; Morbid Obesity
Tanta University
 2022-08-22 PHASE2; PHASE3
NCT04271332 UNKNOWN
16P11.2 Deletion Syndrome
Clinical Research Associates, LLC
 2022-09-01 PHASE2
NCT05975684 COMPLETED
Rumination Syndrome
Nationwide Children's Hospital
 2023-01-31 PHASE3
NCT04251819 TERMINATED
Acute Pain; Analgesia
University of Alabama at Birmingham
 2021-01-21 PHASE2; PHASE3
NCT04762758 UNKNOWN
Charcot-Marie-Tooth Disease
Pharnext S.C.A.
 2021-03-30 PHASE3
NCT05392361 COMPLETED
Lumbar Spinal Stenosis With Nocturnal Calf Cramps
Yonsei University
 2022-06-09
NCT05495282 COMPLETED
Educational Problems
Carilion Clinic
 2022-08-06
NCT03682978 COMPLETED
Autism Spectrum Disorder
Celso Arango, MD, PhD
 2019-09-19 PHASE2
NCT05257447 COMPLETED
Pharmacokinetics
University of Texas Southwestern Medical Center
 2022-04-27 PHASE1
NCT05161351 COMPLETED
Addiction Opiate
Imperial College London
 2021-07-23 PHASE4
NCT03720717 TERMINATED
Pain
University of Alabama at Birmingham
 2020-10-27 PHASE4
NCT04471714 WITHDRAWN
Spasticity, Muscle; Spinal Cord Injuries
University of Alberta
 2020-01-10 PHASE2
NCT03293017 UNKNOWN
Alcohol Use Disorder; Alcohol Withdrawal
Universitair Ziekenhuis Brussel
 2016-02-01 PHASE4
NCT04509336 TERMINATED
Cirrhosis
Mansoura University
 2020-08-20
NCT02998151 COMPLETED
Fragile X Syndrome
Children's Hospital Medical Center, Cincinnati
 2016-01 EARLY_PHASE1
NCT04523935 COMPLETED
Cerebral Palsy; Excessive Crying; Pain
Sathbhavana Brain Clinic
 2005-12-07 PHASE4
NCT03594552 COMPLETED
Autism Spectrum Disorder
King's College London
 2018-02-01
NCT03319732 COMPLETED
Multiple Sclerosis; Spasticity, Muscle
RVL Pharmaceuticals, Inc.
 2018-04-03 PHASE3
NCT03778281 UNKNOWN
Hiccup
Second Affiliated Hospital of Nanchang University
 2018-12-12 PHASE4
NCT02462317 COMPLETED
Muscle Spasticity
University Hospital, Toulouse
 2015-04 PHASE4
NCT02723383 COMPLETED
Alcoholism
Nantes University Hospital
 2016-06-27 PHASE3
NCT03860662 COMPLETED
Stroke Sequelae; Spastic Hemiplegia
Mustafa Kemal University
 2018-05-26 PHASE4
NCT02903823 COMPLETED
Muscle Spasticity
Vanderbilt University
 2016-04-22 PHASE4
NCT03427216 UNKNOWN
Pelvic Floor Dyssynergia
Dr. John A. Thiel Medical Professional Corporation
 2018-09-01
NCT02596763 TERMINATED
Alcohol Use Disorder
University Hospital, Lille
 2015-12-24 PHASE4
NCT03034408 COMPLETED
Alcohol Use Disorder
Prof. Daniele Zullino
 2016-07-01 PHASE2
NCT03068897 COMPLETED
Low Back Pain
Montefiore Medical Center
 2017-05-03 PHASE4
NCT03065998 UNKNOWN
Drug Abuse
Ministry of Health, Israel
 2017-03 EARLY_PHASE1
NCT01980706 COMPLETED
Alcoholism
University of North Carolina, Chapel Hill
 2013-12-12 PHASE2
NCT02760992 UNKNOWN
Intravenous Baclofen
Allaysis, LLC
 2017-05 PHASE1; PHASE2
NCT02705950 COMPLETED
Neuropathic Pain
Institut Guttmann
 2014-12
NCT01821560 COMPLETED
Nicotine Dependence
University of Pennsylvania
 2013-03 PHASE2
NCT01711125 COMPLETED
Alcoholic Liver Disease; Alcohol Dependence
South West Sydney Local Health District
 2013-03 PHASE3
NCT02052440 TERMINATED
Alcohol Withdrawal Syndrome
Denver Health and Hospital Authority
 2014-03-15 PHASE3
NCT03113396 COMPLETED
Rumination; Supra-gastric Belching
Universitaire Ziekenhuizen KU Leuven
 2012-02-01 PHASE4
NCT03347240 COMPLETED
Secondary Dystonia
Ain Shams University
 2013-12-01
NCT01265550 COMPLETED
GERD
VA Office of Research and Development
 2012-08-13 PHASE3
NCT03835442 COMPLETED
Gastro Esophageal Reflux
Universitaire Ziekenhuizen KU Leuven
 2010-01
NCT01032239 COMPLETED
Severe Spasticity
MedtronicNeuro
 2009-11 PHASE4
NCT01751386 COMPLETED
Alcoholism; Alcohol Dependence; Alcohol Drinking Related Problems; Alcohol Drinking; Anxiety Disorder
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
 2012-12-03 PHASE2
NCT01520545 COMPLETED
Severe Spasticity
Piramal Critical Care, Ltd.
 2012-12 PHASE3
NCT02529514 SUSPENDED
Sleep
University of Liege
 2015-07 PHASE4
NCT01937364 TERMINATED
Alcoholism; Alcohol Withdrawal
Essentia Health
 2013-11 PHASE2
NCT02011516 COMPLETED
Marijuana Dependence
University of Pennsylvania
 2013-12 PHASE2
NCT00752934 TERMINATED
Cerebral Palsy
Shaare Zedek Medical Center
 2010-10 PHASE4
NCT02099006 COMPLETED
Female Genital Diseases
University of Rochester
 2013-11 PHASE2; PHASE3
NCT01352611 WITHDRAWN
Autism Spectrum Disorder
University of Missouri-Columbia
 2014-09
NCT02003664 WITHDRAWN
Cocaine Dependence
University of Pennsylvania
 2013-11 PHASE2
NCT02221570 UNKNOWN
Muscle Cramps; Liver Cirrhosis
Tanta University
 2014-06
NCT01563224 COMPLETED
No Condition; Brain GABA-B Function
Imperial College London
 2013-07
NCT01604330 COMPLETED
Alcoholism
Assistance Publique - Hôpitaux de Paris
 2012-05-29 PHASE2; PHASE3
NCT01738282 COMPLETED
Alcohol Dependence
Ethypharm
 2012-12 PHASE3
NCT01931319 COMPLETED
Safety and Pharmacokinetics of Intravenous Baclofen
University of Minnesota
 2014-01 PHASE1
NCT01266655 COMPLETED
Alcohol Dependence
Charite University, Berlin, Germany
 2011-02 PHASE2; PHASE3
NCT02001584 COMPLETED
Healthy Volunteers;; Obese, Otherwise Healthy Volunteers
Gedeon Richter Plc.
 PHASE1
NCT01743651 COMPLETED
Spasticity; Multiple Sclerosis
RVL Pharmaceuticals, Inc.
 2012-11 PHASE3
NCT01008280 COMPLETED
Hepatitis C; Alcohol Use Disorders
VA Office of Research and Development
 2010-10 PHASE4
NCT01749319 COMPLETED
Baclofen Withdrawal Syndrome
University of Minnesota
 2013-01 PHASE1
NCT02298868 COMPLETED
Muscle Cramps; Cirrhosis
University of Virginia
 2012-10 PHASE2
NCT01955655 COMPLETED
Recurrent Crying Spells
Sathbhavana Brain Clinic
 2005-12 PHASE4
NCT01325220 COMPLETED
Fragile X Syndrome
Seaside Therapeutics, Inc.
 2011-06 PHASE3
NCT01003249 TERMINATED
Overactive Bladder; Constipation; Lower Urinary Tract Symptoms
Wake Forest University Health Sciences
 2009-09 PHASE4
NCT01064973 TERMINATED
Autism Spectrum Disorders
Seaside Therapeutics, Inc.
 2010-02 PHASE2
NCT01013480 TERMINATED
Fragile X Syndrome
Seaside Therapeutics, Inc.
 2009-11 PHASE2
NCT01228994 TERMINATED
Nicotine Dependence
Centre for Addiction and Mental Health
 2010-10 PHASE2
NCT01288716 COMPLETED
Autism Spectrum Disorders
Seaside Therapeutics, Inc.
 2011-05 PHASE2
NCT01172509 TERMINATED
Autism
Gonzalez-Heydrich, Joseph, M.D.
 2010-10 PHASE1
NCT01002105 COMPLETED
Alcohol Dependence
Sha'ar Menashe Mental Health Center
 2010-01 PHASE4
NCT01386255 WITHDRAWN
Cerebral Palsy; GERD
Boston Children's Hospital
 2009-04 PHASE4
NCT01095679 COMPLETED
CHEYNE Stokes Respiration
Assistance Publique - Hôpitaux de Paris
 2010-03 PHASE1
NCT01053585 COMPLETED
Gastroesophageal Reflux Disease
University of Zurich
 2007-02
NCT00640003 COMPLETED
Ataxia Telangiectasia
Johns Hopkins University
 2007-04 EARLY_PHASE1
NCT00493428 WITHDRAWN
Hepatocellular Carcinoma
University of Manitoba
 2007-07 PHASE2
NCT00607542 COMPLETED
Spasticity; Cerebral Palsy
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
 2008-11 PHASE1; PHASE2
NCT01051128 WITHDRAWN
Spasticity
Flowonix Medical
 2010-01 PHASE3
NCT01076283 COMPLETED
Alcoholism
Brown University
 2009-12 PHASE2
NCT00914290 COMPLETED
Spasticity; Multiple Sclerosis
Impax Laboratories, LLC
 2009-04 PHASE2
NCT00614328 COMPLETED
Alcohol Dependence
University of North Carolina, Chapel Hill
 2007-07 PHASE1
NCT00516503 COMPLETED
Chronic Myeloproliferative Disorders; Leukemia; Lymphoma; Lymphoproliferative Disorder; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms; Neurotoxicity; Pain; Unspecified Adult Solid Tumor, Protocol Specific
Alliance for Clinical Trials in Oncology
 2008-02 PHASE3
NCT00280280 TERMINATED
Spasticity
Vanderbilt University
 2006-02 PHASE1
NCT00257894 TERMINATED
Nicotine Use Disorder; Nicotine Dependence; Smoking; Tobacco Use Disorder
VA Office of Research and Development
 2005-12 PHASE2
NCT00802035 COMPLETED
Alcohol Dependence
Alkermes, Inc.
 2008-11 PHASE1
NCT00488839 COMPLETED
Multiple Sclerosis
Impax Laboratories, LLC
 2007-06 PHASE3
NCT00597701 COMPLETED
Alcohol Withdrawal Delirium
Essentia Health
 2003-04
NCT00373295 COMPLETED
Marijuana Dependence
New York State Psychiatric Institute
 2006-05 PHASE2
NCT00871455 COMPLETED
Spinal Cord Injury
US Department of Veterans Affairs
 2003-04
NCT00877734 COMPLETED
Alcohol Dependence
University of North Carolina, Chapel Hill
 2005-04 PHASE2; PHASE3
NCT00082485 COMPLETED
Cocaine-Related Disorders
National Institute on Drug Abuse (NIDA)
 2004-06 PHASE2
NCT00320047 COMPLETED
Eating Disorders; Bulimia Nervosa
New York State Psychiatric Institute
 2005-04
NCT00139789 COMPLETED
Multiple Sclerosis
UCB Pharma
 2005-01 PHASE3
NCT00647738 COMPLETED
Healthy
Mylan Pharmaceuticals Inc
 2003-10 PHASE1
NCT00000303 COMPLETED
Cocaine-Related Disorders
University of California, Los Angeles
 1997-10 PHASE2
NCT00164801 TERMINATED
Non-Cardiac Chest Pain
Chinese University of Hong Kong
 2004-11
NCT00179114 COMPLETED
Spasticity
Vanderbilt University
 2002-08 PHASE4
NCT00221689 TERMINATED
Traumatic Brain Injury; Cerebral Anoxia; Coma; Hypertonia; Dysautonomia
University Hospital, Bordeaux
 2003-03 PHASE2
NCT00525252 COMPLETED
Liver Cirrhosis, Alcoholic
Catholic University of the Sacred Heart
 2003-02 PHASE1; PHASE2
NCT00221611 COMPLETED
Cerebral Palsy
University Hospital, Ghent
 2000-01 PHASE2
NCT00367068 COMPLETED
Cerebral Palsy; Spasticity
Maastricht University
 2002-01 PHASE3
NCT00004431 COMPLETED
Trigeminal Neuralgia
University of Pittsburgh
 1998-06
NCT00255073 COMPLETED
Spastic Diplegic Cerebral Palsy
University of Southern California
 2005-01 PHASE2
NCT00414856 COMPLETED
Gastroesophageal Reflux Disease
Novartis
 2006-08 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-05-13)

Check the (R)-baclofen product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

(R)-baclofen selectively activates metabotropic GABA-B receptors to induce membrane hyperpolarization and suppress voltage-gated calcium entry, thereby inhibiting the presynaptic release of excitatory neurotransmitters. This reduction in synaptic transmission dampens hyperactive spinal reflexes and central neuronal excitability, providing the therapeutic rationale for mitigating spasticity and addictive behaviors in clinical conditions such as cerebral palsy and alcohol dependence.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.