55 completed, 12 terminated, 10 unknown, 4 withdrawn. 30 Phase 2, 21 Phase 3, 17 Phase 4, 14 Not applicable, 9 Phase 1.
Follow Baclofen: new trials by email Literature Review of Baclofen trials Research Report on Baclofen
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| An Artificial Intelligence Driven Approach to Optimize Patient Selection for a Transitional Pain Service TPS-Select, Pharmacologic Pain Management, Interventional Pain Procedures - Postsurgical Pain Management, Postsurgical Pain, Chronic | Phase 3 | Not yet recruiting | University of California, San Francisco | 474 | 2026-10-01 | 2026-10-09 |
| Synaptic Mechanisms of Continuous Theta Burst Stimulation in Depression D-Cycloserine (DCS), Continuous theta-burst stimulation (cTBS), Transcranial Magnetic Stimulation Sham - Major Depression | Early Phase 1 | Recruiting | Mclean Hospital | 80 | 2026-03-11 | 2026-05-13 |
| Baclofen for Improving Benzodiazepine Titration in Benzodiazepine Dependence Baclofen 30 mg, Baclofen 60 mg, Placebo - Benzodiazepine Dependence | Phase 2 / Phase 3 | Recruiting | Hospices Civils de Lyon | 93 | 2026-01-15 | 2026-05-11 |
| Effect of Baclofen in Management of Patients With Gastroesophageal Reflux Disease Symptoms Baclofen 10mg, Placebo - GERD - PPI Non-responders | Phase 2 / Phase 3 | Recruiting | Adnan Imtiaj Rahul | 60 | 2025-08-01 | 2025-08-20 |
| Neuromodulation to Reduce Muscle Stiffness Following Spinal Cord Injury Transcutaneous spinal stimulation at 100 Hz, Transcutaneous spinal stimulation at 50 Hz, Transcutaneous spinal stimulation at 50 Hz and single dose of baclofen - Spinal Cord Injuries, Spinal Cord Injury | Early Phase 1 | Unknown | University of Mississippi Medical Center | 16 | 2024-03-01 | 2024-07-01 |
| Efficacy of Baclofen Vs Naltrexon in Achieving & Maintaining Abstinence in Alcohol Dependence. Naltrexon, Baclofen - Alcohol Liver Disease | Not applicable | Unknown | Institute of Liver and Biliary Sciences, India | 110 | 2023-12-25 | 2023-12-19 |
| Effect of Baclofen to Prevent Post-Traumatic Stress Disorder Baclofen, Placebo - Alcoholism, Post Traumatic Stress Disorder | Completed | Nantes University Hospital | 94 | 2023-09-03 | 2024-06-17 | |
| Baclofen Versus Gabapentin in Preventing Postoperative Pain After Laparoscopic Sleeve Gastrectomy Baclofen 10mg, Gabapentin - Post Operative Pain | Phase 3 | Active not recruiting | Tanta University | 100 | 2023-06-30 | 2025-04-24 |
| Baclofen for Children With Rumination Syndrome Baclofen, Placebo - Rumination Syndrome | Phase 3 | Completed | Nationwide Children's Hospital | 50 | 2023-01-31 | 2026-03-06 |
| Safety & Efficacy of Baclofen for Alcohol Withdrawal in Chronic Liver Disease With Active Alcohol Consumption Baclofen - Alcoholic Cirrhosis, Alcohol Abstinence | Enrolling by invitation | Corporacion Parc Tauli | 120 | 2022-12-22 | 2025-02-21 | |
| BTA vs Baclofen for Pelvic Myofascial Pain Syndrome Baclofen 10mg, Botulinum toxin type A - Chronic Pain, Chronic Pelvic Pain Syndrome | Unknown | Saint Petersburg State University, Russia | 52 | 2022-12-01 | 2023-04-11 | |
| Evaluating the Neurophysiologic and Clinical Effects of Single Dose Drug Challenge Baclofen, Memantine, Roflumilast - Fragile X Syndrome | Phase 2 | Active not recruiting | Children's Hospital Medical Center, Cincinnati | 45 | 2022-09-08 | 2025-12-23 |
| Baclofen in Preventing Postoperative Nausea and Vomiting After Bariatric Surgery Baclofen Tablets - Postoperative Nausea and Vomiting, Laparoscopic Sleeve Gastrectomy | Phase 2 / Phase 3 | Completed | Tanta University | 100 | 2022-08-22 | 2025-04-22 |
| Electrical Neuromodulation for Modifying Spinal Network Involved in Spasticity Transcutaneous spinal stimulation at 30 Hz, Transcutaneous spinal stimulation at 75 Hz, Tizanidine - Spinal Cord Injuries (Complete and Incomplete), Spinal Cord Injury | Not applicable | Active not recruiting | University of Mississippi Medical Center | 12 | 2022-07-13 | 2026-08-28 |
| Effect of Baclofen Treatment on Nocturnal Muscle Cramps in Patients With Lumbar Spinal Stenosis: a Randomized Clinical Trial gabapentin (neurontin® capsule 300mg) treatment, baclofen (baclofen Tab. 10mg) treatment - Lumbar Spinal Stenosis With Nocturnal Calf Cramps | Not applicable | Completed | Yonsei University | 40 | 2022-06-09 | 2023-03-30 |
| Pharmacokinetic and Bioequivalence Comparison of Baclofen and Chlorzoxazone Administered Individually or Concurrently Baclofen 20 mg Tablet, Chlorzoxazone 500 mg Tablet, Baclofen 20mg tablet and Chlorzoxazone 500 mg tablet - Pharmacokinetics | Phase 1 | Completed | University of Texas Southwestern Medical Center | 19 | 2022-04-27 | 2023-03-31 |
| Evaluating the Safety of Acute Baclofen in Methadone-maintained Individuals With Opiate Dependence. Baclofen, Vitamin D3 - Addiction Opiate | Phase 4 | Completed | Imperial College London | 16 | 2021-07-23 | 2024-11-18 |
| Buprenorphine Plus Baclofen to Increase Analgesia in Healthy Volunteers Placebos, Baclofen 5 mg, Baclofen 10mg - Acute Pain, Analgesia | Phase 2 / Phase 3 | Terminated | University of Alabama at Birmingham | 19 | 2021-01-21 | 2026-01-07 |
| Baclocur® Post-Authorisation Safety Study in Real-life Settings in France Baclofen Tablets - Alcohol Use Disorder | Unknown | Ethypharm | 975 | 2020-12-22 | 2021-01-05 | |
| Baclofen as a Perioperative Analgesic Adjuvant Baclofen 10mg, Placebo - Pain | Phase 4 | Terminated | University of Alabama at Birmingham | 34 | 2020-10-27 | 2024-09-05 |
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Alcoholism (19) · Muscle Spasticity (11) · Cerebral Palsy (7) · Gastroesophageal Reflux (4) · Pain (4) · Spinal Cord Injuries (4) · Alcohol Drinking (3) · Cocaine-Related Disorders (3) · Tobacco Use Disorder (3) · Alcohol Withdrawal Delirium (2) · Behavior, Addictive (2) · Fibrosis (2) · Fragile X Syndrome (2) · Liver Cirrhosis (2) · Liver Cirrhosis, Alcoholic (2)
Tanta University (3) · University of North Carolina, Chapel Hill (3) · VA Office of Research and Development (3) · Assistance Publique - Hôpitaux de Paris (2) · Children's Hospital Medical Center, Cincinnati (2) · Essentia Health (2) · Ethypharm (2) · Imperial College London (2) · Nantes University Hospital (2) · National Institute on Drug Abuse (NIDA) (2) · New York State Psychiatric Institute (2) · Sathbhavana Brain Clinic (2) · Universitaire Ziekenhuizen KU Leuven (2) · University of Alabama at Birmingham (2) · University of Mississippi Medical Center (2)
United States (41) · France (10) · Canada (4) · Egypt (4) · Israel (3) · United Kingdom (3) · Belgium (2) · India (2) · Russia (2) · Switzerland (2) · Australia (1) · Bangladesh (1) · China (1) · Germany (1) · Netherlands (1)
James C Garbutt, MD (2) · Teresa R Franklin, Ph.D. (2) · Adrienne D Bonham, MD (1) · Alexander M Ponizovsky, MD, PhD (1) · Andreas Heinz, Prof., M.D. (1) · Andrew Baillie, PhD (1) · Andrew Bishara, MD (1) · Anne Lingford-Hughes, MRCPsych PhD (1) · Asem A Elfert, MD (1) · Assem Elfert (1) · Aya Moussa (1) · B. T. Walsh, MD (1) · Bernard Le Foll, MD, PhD (1) · Christian Straus, MD, PhD (1)
PMID 33012365, PMID 18068515, PMID 19414226, PMID 19560604, PMID 20496177, PMID 21479990, PMID 23262301, PMID 23939511, PMID 24589669, PMID 24607242, PMID 27542731, PMID 28440812, PMID 28867665, PMID 29206813, PMID 29716670, PMID 30146330, PMID 30217552, PMID 30524317, PMID 30561840, PMID 30788529, PMID 30955985, PMID 31618539, PMID 31833590, PMID 33620407, PMID 35425938, PMID 36167501, PMID 36258248, PMID 38063320, PMID 41329966, PMID 41507241, PMID 41981586, PMID 42246466
2015 (2), P50DA009236 (1), P50DA009260 (1), R01AA020824 (1), R01DA030394 (1), R01MH139697 (1), R21DK077678 (1), R21MH065024 (1), U54HD082008 (1), U54HD104461 (1)