Numerous clinical trials spanning Phase 1 through Phase 4 evaluate the therapeutic applications of amitriptyline, encompassing completed, recruiting, terminated, and unknown status studies. These investigations address primary indications such as major depression, neuropathic pain, and migraine prophylaxis, as well as secondary uses including postoperative analgesia, rosacea, dyspepsia, and leprosy neuropathy. Supported by academic institutions, medical centers, and pharmaceutical developers, current research focuses on genotype-guided dosing, topical delivery systems, and expanded therapeutic applications.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07640061 | NOT_YET_RECRUITING | Microvesicle Particles; Thermal Burn |
Wright State University |
2027-06 | PHASE1 |
| NCT07640061 | NOT_YET_RECRUITING | Microvesicle Particles; Thermal Burn |
Wright State University |
2027-06 | PHASE1 |
| NCT07716722 | NOT_YET_RECRUITING | Thermal Burn; Amitriptyline |
Wright State University |
2026-07 | PHASE1 |
| NCT07716722 | NOT_YET_RECRUITING | Thermal Burn; Amitriptyline |
Wright State University |
2026-07 | PHASE1 |
| NCT07655440 | NOT_YET_RECRUITING | Migraine Associated Vertigo; Tinnitus; Migraine; Vestibular Migraine |
Stanford University |
2026-07 | PHASE4 |
| NCT07655440 | NOT_YET_RECRUITING | Migraine Associated Vertigo; Tinnitus; Migraine; Vestibular Migraine |
Stanford University |
2026-07 | PHASE4 |
| NCT07556718 | RECRUITING | Quiescent Crohn's Disease (CD) |
University of Michigan |
2026-06-03 | PHASE2 |
| NCT07556718 | RECRUITING | Quiescent Crohn's Disease (CD) |
University of Michigan |
2026-06-03 | PHASE2 |
| NCT06312813 | RECRUITING | Rosacea |
Wright State University |
2024-02-27 | PHASE2 |
| NCT06312813 | RECRUITING | Rosacea |
Wright State University |
2024-02-27 | PHASE2 |
| NCT05889624 | RECRUITING | Headache; Headache Disorders; Headache, Migraine; Migraine; Migraine Disorders; Migraine With Aura; Migraine Without Aura; Chronic Migraine |
Children's Hospital Medical Center, Cincinnati |
2023-08-22 | |
| NCT05889624 | RECRUITING | Headache; Headache Disorders; Headache, Migraine; Migraine; Migraine Disorders; Migraine With Aura; Migraine Without Aura; Chronic Migraine |
Children's Hospital Medical Center, Cincinnati |
2023-08-22 | |
| NCT06261320 | ACTIVE_NOT_RECRUITING | Inflammatory Bowel Diseases |
Polyclinique de l'Europe |
2024-02-28 | PHASE2 |
| NCT06261320 | ACTIVE_NOT_RECRUITING | Inflammatory Bowel Diseases |
Polyclinique de l'Europe |
2024-02-28 | PHASE2 |
| NCT05110144 | RECRUITING | Refractory Chronic Cough |
Mayo Clinic |
2021-11-01 | PHASE2 |
| NCT06499116 | NOT_YET_RECRUITING | Migraine |
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina |
2024-10 | PHASE4 |
| NCT05110144 | RECRUITING | Refractory Chronic Cough |
Mayo Clinic |
2021-11-01 | PHASE2 |
| NCT06499116 | NOT_YET_RECRUITING | Migraine |
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina |
2024-10 | PHASE4 |
| NCT05120934 | RECRUITING | Interstitial Lung Disease |
Mayo Clinic |
2021-11-01 | PHASE2 |
| NCT05120934 | RECRUITING | Interstitial Lung Disease |
Mayo Clinic |
2021-11-01 | PHASE2 |
| NCT07593313 | RECRUITING | Central Post-Stroke Pain |
Nanchong Central Hospital |
2024-01-01 | |
| NCT07593313 | RECRUITING | Central Post-Stroke Pain |
Nanchong Central Hospital |
2024-01-01 | |
| NCT07008235 | RECRUITING | Functional Dyspepsia |
Md. Moktadirul Hoque Shuvo |
2025-07-01 | PHASE2; PHASE3 |
| NCT07008235 | RECRUITING | Functional Dyspepsia |
Md. Moktadirul Hoque Shuvo |
2025-07-01 | PHASE2; PHASE3 |
| NCT06417684 | WITHDRAWN | Vestibular Migraine |
Vanderbilt University Medical Center |
2024-06-19 | EARLY_PHASE1 |
| NCT06417684 | WITHDRAWN | Vestibular Migraine |
Vanderbilt University Medical Center |
2024-06-19 | EARLY_PHASE1 |
| NCT06301061 | UNKNOWN | Pain, Chronic; Lumbosacral Radiculopathy; Radicular; Neuropathic |
Federico II University |
2024-04-01 | |
| NCT06301061 | UNKNOWN | Pain, Chronic; Lumbosacral Radiculopathy; Radicular; Neuropathic |
Federico II University |
2024-04-01 | |
| NCT04725383 | TERMINATED | Autism Spectrum Disorder; Repetitive Compulsive Behavior |
University of Missouri, Kansas City |
2023-11-01 | PHASE3 |
| NCT04725383 | TERMINATED | Autism Spectrum Disorder; Repetitive Compulsive Behavior |
University of Missouri, Kansas City |
2023-11-01 | PHASE3 |
| NCT04704453 | COMPLETED | Head and Neck Cancer |
Institut Claudius Regaud |
2021-04-28 | PHASE2 |
| NCT04704453 | COMPLETED | Head and Neck Cancer |
Institut Claudius Regaud |
2021-04-28 | PHASE2 |
| NCT03472092 | COMPLETED | Headache, Migraine; Migraine; Migraine Disorders; Headache |
Children's Hospital Medical Center, Cincinnati |
2018-10-02 | PHASE2 |
| NCT03472092 | COMPLETED | Headache, Migraine; Migraine; Migraine Disorders; Headache |
Children's Hospital Medical Center, Cincinnati |
2018-10-02 | PHASE2 |
| NCT06245564 | COMPLETED | Itch |
Aalborg University |
2024-08-20 | |
| NCT06245564 | COMPLETED | Itch |
Aalborg University |
2024-08-20 | |
| NCT05658874 | TERMINATED | Interstitial Cystitis; Levator Spasm; Bladder Pain Syndrome |
Jocelyn Fitzgerald |
2022-12-06 | PHASE3 |
| NCT05658874 | TERMINATED | Interstitial Cystitis; Levator Spasm; Bladder Pain Syndrome |
Jocelyn Fitzgerald |
2022-12-06 | PHASE3 |
| NCT05279963 | RECRUITING | Bladder Pain Syndrome |
The Third Affiliated hospital of Zhejiang Chinese Medical University |
2022-03-16 | |
| NCT05279963 | RECRUITING | Bladder Pain Syndrome |
The Third Affiliated hospital of Zhejiang Chinese Medical University |
2022-03-16 | |
| NCT06091553 | UNKNOWN | Neuropathy in Cacer Patien |
Beni-Suef University |
2023-10-10 | PHASE2 |
| NCT06091553 | UNKNOWN | Neuropathy in Cacer Patien |
Beni-Suef University |
2023-10-10 | PHASE2 |
| NCT05593614 | ACTIVE_NOT_RECRUITING | Chemotherapy-induced Peripheral Neuropathy |
AlgoTherapeutix |
2023-02-28 | PHASE2 |
| NCT05593614 | ACTIVE_NOT_RECRUITING | Chemotherapy-induced Peripheral Neuropathy |
AlgoTherapeutix |
2023-02-28 | PHASE2 |
| NCT06162819 | UNKNOWN | Migraine; Prophylaxis |
Shalamar Institute of Health Sciences |
2024-01-01 | |
| NCT06162819 | UNKNOWN | Migraine; Prophylaxis |
Shalamar Institute of Health Sciences |
2024-01-01 | |
| NCT05917912 | COMPLETED | Erythromelalgia |
AlgoTherapeutix |
2023-06-14 | PHASE2 |
| NCT05917912 | COMPLETED | Erythromelalgia |
AlgoTherapeutix |
2023-06-14 | PHASE2 |
| NCT06312813 | Recruiting | Rosacea |
Wright State University |
2024-02-27 | Phase 2 |
| NCT06158230 | UNKNOWN | Migraine |
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh |
2023-03-19 | PHASE2 |
| NCT06158230 | UNKNOWN | Migraine |
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh |
2023-03-19 | PHASE2 |
| NCT05867550 | COMPLETED | Irritable Bowel Syndrome With Diarrhea |
Bahria University |
2023-01-03 | PHASE4 |
| NCT05867550 | COMPLETED | Irritable Bowel Syndrome With Diarrhea |
Bahria University |
2023-01-03 | PHASE4 |
| NCT05759845 | UNKNOWN | Migraine |
Dr. Reaz Mahmud |
2022-08-22 | PHASE4 |
| NCT05759845 | UNKNOWN | Migraine |
Dr. Reaz Mahmud |
2022-08-22 | PHASE4 |
| NCT04750967 | COMPLETED | Migraine; Headache |
Dr. Lutfi Kirdar Kartal Training and Research Hospital |
2021-04-03 | |
| NCT04750967 | COMPLETED | Migraine; Headache |
Dr. Lutfi Kirdar Kartal Training and Research Hospital |
2021-04-03 | |
| NCT04292470 | COMPLETED | GERD |
University of California, Davis |
2020-11-05 | |
| NCT04292470 | COMPLETED | GERD |
University of California, Davis |
2020-11-05 | |
| NCT03324035 | UNKNOWN | Pain, Neuropathic; Leprosy; Leprosy Neuropathy; Amitriptyline |
University of Sao Paulo |
2017-03-01 | PHASE3 |
| NCT03324035 | UNKNOWN | Pain, Neuropathic; Leprosy; Leprosy Neuropathy; Amitriptyline |
University of Sao Paulo |
2017-03-01 | PHASE3 |
| NCT04777838 | UNKNOWN | Muscle Type Temporomandibular Disorders; Myofascial Pain of the Masticatory Muscles |
University of Coimbra |
2021-03 | PHASE2; PHASE3 |
| NCT04777838 | UNKNOWN | Muscle Type Temporomandibular Disorders; Myofascial Pain of the Masticatory Muscles |
University of Coimbra |
2021-03 | PHASE2; PHASE3 |
| NCT02552225 | TERMINATED | Laryngeal Diseases |
Boston Medical Center |
2016-04 | PHASE2; PHASE3 |
| NCT02552225 | TERMINATED | Laryngeal Diseases |
Boston Medical Center |
2016-04 | PHASE2; PHASE3 |
| NCT04523935 | COMPLETED | Cerebral Palsy; Excessive Crying; Pain |
Sathbhavana Brain Clinic |
2005-12-07 | PHASE4 |
| NCT04523935 | COMPLETED | Cerebral Palsy; Excessive Crying; Pain |
Sathbhavana Brain Clinic |
2005-12-07 | PHASE4 |
| NCT02090998 | TERMINATED | Transformed Migraine; Chronic Daily Headache |
Rutgers, The State University of New Jersey |
2014-05 | PHASE4 |
| NCT02090998 | TERMINATED | Transformed Migraine; Chronic Daily Headache |
Rutgers, The State University of New Jersey |
2014-05 | PHASE4 |
| NCT03591458 | TERMINATED | Type1 Diabetes Mellitus; Hypoglycemia Unawareness |
University of Utah |
2018-08-01 | PHASE2 |
| NCT03591458 | TERMINATED | Type1 Diabetes Mellitus; Hypoglycemia Unawareness |
University of Utah |
2018-08-01 | PHASE2 |
| NCT03646526 | COMPLETED | Depressive Disorder |
First Affiliated Hospital of Zhejiang University |
2018-04-04 | PHASE1 |
| NCT03646526 | COMPLETED | Depressive Disorder |
First Affiliated Hospital of Zhejiang University |
2018-04-04 | PHASE1 |
| NCT03587025 | COMPLETED | Pain, Postoperative |
University of Campinas, Brazil |
2015-06-01 | PHASE3 |
| NCT03587025 | COMPLETED | Pain, Postoperative |
University of Campinas, Brazil |
2015-06-01 | PHASE3 |
| NCT02256943 | COMPLETED | Chronic Pain |
Insel Gruppe AG, University Hospital Bern |
2014-11 | PHASE4 |
| NCT02256956 | COMPLETED | Chronic Pain |
Insel Gruppe AG, University Hospital Bern |
2014-11 | PHASE4 |
| NCT02256943 | COMPLETED | Chronic Pain |
Insel Gruppe AG, University Hospital Bern |
2014-11 | PHASE4 |
| NCT02256956 | COMPLETED | Chronic Pain |
Insel Gruppe AG, University Hospital Bern |
2014-11 | PHASE4 |
| NCT02139098 | TERMINATED | Insomnia |
Philipps University Marburg |
2014-05 | PHASE3 |
| NCT02139098 | TERMINATED | Insomnia |
Philipps University Marburg |
2014-05 | PHASE3 |
| NCT02871661 | UNKNOWN | Vulvodynia |
University of Campinas, Brazil |
2016-07 | PHASE3 |
| NCT02871661 | UNKNOWN | Vulvodynia |
University of Campinas, Brazil |
2016-07 | PHASE3 |
| NCT03096444 | TERMINATED | Pruritus |
Gil Yosipovitch |
2017-05-23 | PHASE2 |
| NCT03096444 | TERMINATED | Pruritus |
Gil Yosipovitch |
2017-05-23 | PHASE2 |
| NCT02374567 | TERMINATED | Dementia; Depression; Schizophrenia; Psychosomatic Disorders; Anxiety Disorders |
Hannover Medical School |
2015-01 | PHASE3 |
| NCT02374567 | TERMINATED | Dementia; Depression; Schizophrenia; Psychosomatic Disorders; Anxiety Disorders |
Hannover Medical School |
2015-01 | PHASE3 |
| NCT02746250 | COMPLETED | Tension-type Headache |
Danish Headache Center |
2016-03 | |
| NCT02746250 | COMPLETED | Tension-type Headache |
Danish Headache Center |
2016-03 | |
| NCT01856270 | COMPLETED | Brain Injuries; Post-Traumatic Headache |
University of Washington |
2013-04 | PHASE2 |
| NCT02101892 | COMPLETED | Migraine; Preventive Treatment |
Rambam Health Care Campus |
2014-04 | |
| NCT02054299 | COMPLETED | Drug Metabolism; Membrane Transport |
University Medical Center Goettingen |
2013-04 | PHASE1 |
| NCT01856270 | COMPLETED | Brain Injuries; Post-Traumatic Headache |
University of Washington |
2013-04 | PHASE2 |
| NCT02101892 | COMPLETED | Migraine; Preventive Treatment |
Rambam Health Care Campus |
2014-04 | |
| NCT02054299 | COMPLETED | Drug Metabolism; Membrane Transport |
University Medical Center Goettingen |
2013-04 | PHASE1 |
| NCT02339662 | UNKNOWN | Myofacial Pain |
Doron Aframian |
2015-02 | PHASE4 |
| NCT02339662 | UNKNOWN | Myofacial Pain |
Doron Aframian |
2015-02 | PHASE4 |
| NCT02190526 | WITHDRAWN | Diarrhea- Predominant Irritable Bowel Syndrome; Quality of Life |
Tehran University of Medical Sciences |
2014-09 | PHASE4 |
| NCT02190526 | WITHDRAWN | Diarrhea- Predominant Irritable Bowel Syndrome; Quality of Life |
Tehran University of Medical Sciences |
2014-09 | PHASE4 |
| NCT02519400 | UNKNOWN | Depression |
Asan Medical Center |
2015-08 | PHASE1 |
| NCT02014363 | COMPLETED | Major Depressive Disorder |
e-Therapeutics PLC |
2013-10 | PHASE2 |
| NCT02519400 | UNKNOWN | Depression |
Asan Medical Center |
2015-08 | PHASE1 |
| NCT02014363 | COMPLETED | Major Depressive Disorder |
e-Therapeutics PLC |
2013-10 | PHASE2 |
| NCT02519400 | Unknown status | Depression |
Asan Medical Center |
2015-08 | Phase 1 |
| NCT02195115 | UNKNOWN | Gallbladder Dyskinesia |
CAMC Health System |
2014-02 | PHASE2 |
| NCT02195115 | UNKNOWN | Gallbladder Dyskinesia |
CAMC Health System |
2014-02 | PHASE2 |
| NCT02099006 | COMPLETED | Female Genital Diseases |
University of Rochester |
2013-11 | PHASE2; PHASE3 |
| NCT03587025 | Completed | Pain Postoperative |
University of Campinas Brazil |
2015-06-01 | Phase 3 |
| NCT02099006 | COMPLETED | Female Genital Diseases |
University of Rochester |
2013-11 | PHASE2; PHASE3 |
| NCT01581281 | TERMINATED | Migraine; Migraine Disorders; Headache |
Children's Hospital Medical Center, Cincinnati |
2012-06 | PHASE3 |
| NCT01581281 | TERMINATED | Migraine; Migraine Disorders; Headache |
Children's Hospital Medical Center, Cincinnati |
2012-06 | PHASE3 |
| NCT02434523 | TERMINATED | Laryngeal Diseases; Chronic Laryngeal Neuropathy |
Boston Medical Center |
2013-09 | PHASE2; PHASE3 |
| NCT02434523 | TERMINATED | Laryngeal Diseases; Chronic Laryngeal Neuropathy |
Boston Medical Center |
2013-09 | PHASE2; PHASE3 |
| NCT02237937 | UNKNOWN | Major Depression |
HolsboerMaschmeyer NeuroChemie GmbH |
2011-09 | PHASE4 |
| NCT01206478 | COMPLETED | Chronic Oral Food Refusal |
Ann Davis, PhD, MPH, ABPP |
2010-08 | PHASE2 |
| NCT02237937 | UNKNOWN | Major Depression |
HolsboerMaschmeyer NeuroChemie GmbH |
2011-09 | PHASE4 |
| NCT01206478 | COMPLETED | Chronic Oral Food Refusal |
Ann Davis, PhD, MPH, ABPP |
2010-08 | PHASE2 |
| NCT02451475 | COMPLETED | Fibromyalgia |
Mansoura University |
2013-02 | PHASE1; PHASE2 |
| NCT02127736 | COMPLETED | Healthy Participants |
Winfried Rief |
||
| NCT02451475 | COMPLETED | Fibromyalgia |
Mansoura University |
2013-02 | PHASE1; PHASE2 |
| NCT02127736 | COMPLETED | Healthy Participants |
Winfried Rief |
||
| NCT01896349 | UNKNOWN | Treatment Resistant Depression |
Hospital de Clinicas de Porto Alegre |
2013-04 | |
| NCT01869907 | COMPLETED | Neuropathic Pain Caused by Lumbar Radicular Pain |
Ziekenhuis Oost-Limburg |
2011-09 | PHASE4 |
| NCT01896349 | UNKNOWN | Treatment Resistant Depression |
Hospital de Clinicas de Porto Alegre |
2013-04 | |
| NCT01869907 | COMPLETED | Neuropathic Pain Caused by Lumbar Radicular Pain |
Ziekenhuis Oost-Limburg |
2011-09 | PHASE4 |
| NCT00220844 | TERMINATED | Dyspepsia |
Temple University |
2005-09 | |
| NCT01561209 | COMPLETED | Neck Pain |
St Joseph University, Beirut, Lebanon |
2012-03 | PHASE4 |
| NCT00220844 | TERMINATED | Dyspepsia |
Temple University |
2005-09 | |
| NCT01561209 | COMPLETED | Neck Pain |
St Joseph University, Beirut, Lebanon |
2012-03 | PHASE4 |
| NCT01161017 | COMPLETED | Migraine |
Rambam Health Care Campus |
2008-07 | |
| NCT01161017 | COMPLETED | Migraine |
Rambam Health Care Campus |
2008-07 | |
| NCT02101892 | Completed | Migraine|Preventive Treatment |
Rambam Health Care Campus|Migraine Research Foundation |
2014-04 | Not Applicable |
| NCT02041455 | UNKNOWN | Fibromyalgia |
Hospital de Clinicas de Porto Alegre |
2010-06 | PHASE2; PHASE3 |
| NCT02041455 | UNKNOWN | Fibromyalgia |
Hospital de Clinicas de Porto Alegre |
2010-06 | PHASE2; PHASE3 |
| NCT00471445 | COMPLETED | Neurotoxicity; Pain; Peripheral Neuropathy; Unspecified Adult Solid Tumor, Protocol Specific |
Gary Morrow |
2007-10 | PHASE3 |
| NCT00471445 | COMPLETED | Neurotoxicity; Pain; Peripheral Neuropathy; Unspecified Adult Solid Tumor, Protocol Specific |
Gary Morrow |
2007-10 | PHASE3 |
| NCT00248651 | COMPLETED | Dyspepsia and Other Specified Disorders of Function of Stomach |
Mayo Clinic |
2006-10 | PHASE2; PHASE3 |
| NCT00248651 | COMPLETED | Dyspepsia and Other Specified Disorders of Function of Stomach |
Mayo Clinic |
2006-10 | PHASE2; PHASE3 |
| NCT00862095 | TERMINATED | Headache |
Madigan Army Medical Center |
2008-06 | PHASE4 |
| NCT00862095 | TERMINATED | Headache |
Madigan Army Medical Center |
2008-06 | PHASE4 |
| NCT00389038 | UNKNOWN | Headache |
Children's Hospital Medical Center, Cincinnati |
2006-10 | PHASE3 |
| NCT00389038 | UNKNOWN | Headache |
Children's Hospital Medical Center, Cincinnati |
2006-10 | PHASE3 |
| NCT01357031 | COMPLETED | Migraine |
Hospital Israelita Albert Einstein |
2010-05 | PHASE3 |
| NCT01357031 | COMPLETED | Migraine |
Hospital Israelita Albert Einstein |
2010-05 | PHASE3 |
| NCT01367080 | COMPLETED | Depression; Depressive State; Enuresis |
Dong Wha Pharmaceutical Co. Ltd. |
2011-07 | PHASE1 |
| NCT01367080 | COMPLETED | Depression; Depressive State; Enuresis |
Dong Wha Pharmaceutical Co. Ltd. |
2011-07 | PHASE1 |
| NCT01306708 | COMPLETED | Adhesive Capsulitis |
Universidade do Sul de Santa Catarina |
2011-02 | PHASE2 |
| NCT01306708 | COMPLETED | Adhesive Capsulitis |
Universidade do Sul de Santa Catarina |
2011-02 | PHASE2 |
| NCT01309178 | UNKNOWN | Cystic Fibrosis; Pneumonia |
University Children's Hospital Tuebingen |
2009-05 | PHASE2 |
| NCT01309178 | UNKNOWN | Cystic Fibrosis; Pneumonia |
University Children's Hospital Tuebingen |
2009-05 | PHASE2 |
| NCT00740571 | UNKNOWN | Cancer; Neuralgia |
Radboud University Medical Center |
2008-09 | PHASE3 |
| NCT00740571 | UNKNOWN | Cancer; Neuralgia |
Radboud University Medical Center |
2008-09 | PHASE3 |
| NCT00312260 | COMPLETED | Pain |
The Hospital for Sick Children |
2006-04 | PHASE3 |
| NCT00312260 | COMPLETED | Pain |
The Hospital for Sick Children |
2006-04 | PHASE3 |
| NCT00766350 | COMPLETED | Fibromyalgia |
Universidad de Granada |
2008-11 | PHASE4 |
| NCT00766350 | COMPLETED | Fibromyalgia |
Universidad de Granada |
2008-11 | PHASE4 |
| NCT01014520 | UNKNOWN | Herniated Disc; Intervertebral Disc Displacement |
Tabriz University |
2009-05 | PHASE2 |
| NCT01014520 | UNKNOWN | Herniated Disc; Intervertebral Disc Displacement |
Tabriz University |
2009-05 | PHASE2 |
| NCT00798083 | COMPLETED | Neuropathic Pain Secondary to Radiation Therapy |
British Columbia Cancer Agency |
2008-04 | PHASE3 |
| NCT00798083 | COMPLETED | Neuropathic Pain Secondary to Radiation Therapy |
British Columbia Cancer Agency |
2008-04 | PHASE3 |
| NCT01566825 | COMPLETED | Healthy Subjects |
Dieter Kunz, MD |
2008-08 | |
| NCT00370656 | COMPLETED | Diabetes Mellitus; Peripheral Neuropathies |
University of Surrey |
2007-02 | PHASE2; PHASE3 |
| NCT01566825 | COMPLETED | Healthy Subjects |
Dieter Kunz, MD |
2008-08 | |
| NCT00370656 | COMPLETED | Diabetes Mellitus; Peripheral Neuropathies |
University of Surrey |
2007-02 | PHASE2; PHASE3 |
| 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 |
| 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 |
| NCT00475904 | COMPLETED | Post Herpetic Neuralgia; PHN; Neuropathy; Nerve Pain |
EpiCept Corporation |
2007-07 | PHASE2 |
| NCT00475904 | COMPLETED | Post Herpetic Neuralgia; PHN; Neuropathy; Nerve Pain |
EpiCept Corporation |
2007-07 | PHASE2 |
| NCT00124306 | COMPLETED | Bladder Diseases; Interstitial Cystitis |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
2005-02 | PHASE3 |
| NCT00476151 | COMPLETED | Diabetic Peripheral Neuropathy; Neuralgia |
EpiCept Corporation |
2007-07 | PHASE2 |
| NCT00124306 | COMPLETED | Bladder Diseases; Interstitial Cystitis |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
2005-02 | PHASE3 |
| NCT00476151 | COMPLETED | Diabetic Peripheral Neuropathy; Neuralgia |
EpiCept Corporation |
2007-07 | PHASE2 |
| NCT00006428 | COMPLETED | Spinal Cord Injuries; Pain |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
1996-08 | PHASE4 |
| NCT00006428 | COMPLETED | Spinal Cord Injuries; Pain |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
1996-08 | PHASE4 |
| NCT02256878 | COMPLETED | Healthy |
Boehringer Ingelheim |
2004-08 | PHASE1 |
| NCT02256878 | COMPLETED | Healthy |
Boehringer Ingelheim |
2004-08 | PHASE1 |
| NCT00029497 | COMPLETED | Cumulative Trauma Disorders; Repetitive Strain Injury; Carpal Tunnel Syndrome; Pain |
National Center for Complementary and Integrative Health (NCCIH) |
PHASE2 | |
| NCT00029497 | COMPLETED | Cumulative Trauma Disorders; Repetitive Strain Injury; Carpal Tunnel Syndrome; Pain |
National Center for Complementary and Integrative Health (NCCIH) |
PHASE2 | |
| NCT00000428 | COMPLETED | Fibromyalgia |
Tufts Medical Center |
2000-09 | PHASE4 |
| NCT00000428 | COMPLETED | Fibromyalgia |
Tufts Medical Center |
2000-09 | PHASE4 |
| NCT00006427 | COMPLETED | Amputation, Traumatic; Pain; Postoperative Pain |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
1996-08 | PHASE4 |
| NCT00006427 | COMPLETED | Amputation, Traumatic; Pain; Postoperative Pain |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
1996-08 | PHASE4 |
| NCT01049347 | COMPLETED | Unipolar Depression |
Central Institute of Mental Health, Mannheim |
1997-10 | PHASE3 |
| NCT01049347 | COMPLETED | Unipolar Depression |
Central Institute of Mental Health, Mannheim |
1997-10 | PHASE3 |
| NCT00210821 | COMPLETED | Migraine; Headache |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2004-02 | PHASE3 |
| NCT00000817 | COMPLETED | HIV Infections; Peripheral Nervous System Disease |
National Institute of Allergy and Infectious Diseases (NIAID) |
1994-11 | |
| NCT00189059 | TERMINATED | Chronic Neuropathic Pain |
UMC Utrecht |
2002-10 | PHASE4 |
| NCT00497562 | COMPLETED | Fibromyalgia; Growth Hormone Deficiency |
Centro Medico Teknon |
2004-05 | PHASE2 |
| NCT00351910 | COMPLETED | Major Depressive Disorder |
AstraZeneca |
2006-05 | PHASE3 |
| NCT00000793 | COMPLETED | HIV Infections; Peripheral Nervous System Disease |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE2 | |
| NCT00355277 | COMPLETED | Healthy Volunteers |
University Hospital, Clermont-Ferrand |
2005-11 | PHASE1 |
| NCT00515229 | COMPLETED | Cystic Fibrosis; Infection; Pseudomonas Aeruginosa |
University Hospital Tuebingen |
2006-10 | PHASE2 |
| NCT00564525 | COMPLETED | Functional Gastrointestinal Disorders |
Ann & Robert H Lurie Children's Hospital of Chicago |
2002-10 | PHASE4 |
| NCT00381199 | COMPLETED | Fibromyalgia; Sleep Initiation and Maintenance Disorders |
McGill University Health Centre/Research Institute of the McGill University Health Centre |
2006-04 | |
| NCT00325000 | TERMINATED | Major Depression |
German Research Foundation |
2000-11 | |
| NCT00266643 | COMPLETED | Diabetic Neuropathy, Painful |
Eli Lilly and Company |
2005-12 | PHASE4 |
| NCT00210821 | COMPLETED | Migraine; Headache |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2004-02 | PHASE3 |
| NCT00000817 | COMPLETED | HIV Infections; Peripheral Nervous System Disease |
National Institute of Allergy and Infectious Diseases (NIAID) |
1994-11 | |
| NCT00189059 | TERMINATED | Chronic Neuropathic Pain |
UMC Utrecht |
2002-10 | PHASE4 |
| NCT00497562 | COMPLETED | Fibromyalgia; Growth Hormone Deficiency |
Centro Medico Teknon |
2004-05 | PHASE2 |
| NCT00351910 | COMPLETED | Major Depressive Disorder |
AstraZeneca |
2006-05 | PHASE3 |
| NCT00000793 | COMPLETED | HIV Infections; Peripheral Nervous System Disease |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE2 | |
| NCT00355277 | COMPLETED | Healthy Volunteers |
University Hospital, Clermont-Ferrand |
2005-11 | PHASE1 |
| NCT00515229 | COMPLETED | Cystic Fibrosis; Infection; Pseudomonas Aeruginosa |
University Hospital Tuebingen |
2006-10 | PHASE2 |
| NCT00564525 | COMPLETED | Functional Gastrointestinal Disorders |
Ann & Robert H Lurie Children's Hospital of Chicago |
2002-10 | PHASE4 |
| NCT00381199 | COMPLETED | Fibromyalgia; Sleep Initiation and Maintenance Disorders |
McGill University Health Centre/Research Institute of the McGill University Health Centre |
2006-04 | |
| NCT00325000 | TERMINATED | Major Depression |
German Research Foundation |
2000-11 | |
| NCT00266643 | COMPLETED | Diabetic Neuropathy, Painful |
Eli Lilly and Company |
2005-12 | PHASE4 |
(data from https://clinicaltrials.gov, updated on 2026-07-17)
Check the
Amitriptyline
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
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>).
Note: Technical data last updated: Sep 1, 2026.