DRONABINOL ( DrugBank: Dronabinol )
5 diseases
| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 2 | Amyotrophic lateral sclerosis | 1 |
| 13 | Multiple sclerosis/Neuromyelitis optica | 10 |
| 46 | Malignant rheumatoid arthritis | 1 |
| 271 | Ankylosing spondylitis | 1 |
| 298 | Hereditary pancreatitis | 2 |
2. Amyotrophic lateral sclerosis
Clinical trials : 624 / Drugs : 611 - (DrugBank : 160) / Drug target genes : 172 - Drug target pathways : 225
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT00812851 (ClinicalTrials.gov) | April 2005 | 21/11/2008 | Randomized Placebo-Controlled Crossover Trial With THC (Delta 9-Tetrahydrocannabinol) for the Treatment of Cramps in Amyotrophic Lateral Sclerosis (ALS) | Randomized Placebo-Controlled Crossover Trial With THC (Delta 9-Tetrahydrocannabinol) for the Treatment of Cramps in Amyotrophic Lateral Sclerosis (ALS) | Cramps;Amyotrophic Lateral Sclerosis | Drug: Dronabinol | Cantonal Hospital of St. Gallen | ALS Association | Completed | 18 Years | N/A | Both | 24 | N/A | Switzerland |
13. Multiple sclerosis/Neuromyelitis optica
Clinical trials : 3,342 / Drugs : 2,355 - (DrugBank : 406) / Drug target genes : 269 - Drug target pathways : 241
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2018-000001-23-CZ (EUCTR) | 13/01/2020 | 16/08/2018 | Clinical study to investigate the efficacy and safety of the test substance BX-1 (dronabinol) for the symptomatic relief of spasticity in patients with multiple sclerosis | A phase III, multi-centre, randomised, double-blind, placebo-controlled, parallel-group clinical trial to investigate the efficacy and safety of BX-1 for the symptomatic relief of spasticity in patients with multiple sclerosis - BX-1 in spasticity due to MS | Symptomatic relief of spasticity in patients with multiple sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dronabinol 25 mg/ml, oral drops Product Code: BX-1 INN or Proposed INN: Dronabinol Other descriptive name: Dronabinol | Bionorica SE | NULL | Not Recruiting | Female: yes Male: yes | 548 | Phase 3 | Hungary;Czech Republic;Spain | ||
| 2 | EUCTR2018-002315-98-DK (EUCTR) | 06/12/2018 | 09/07/2018 | The effect of cannabis products on nerve pain and muscle stiffness in patients with multiple sclerosis and in patients with spinal cord injury. | The effect of medical cannabis on neuropathic pain and spasticity in patients with Multiple Sclerosis and in patients with spinal cord injury. A multicenter national placebo-controlled trial - The effect of medical cannabis on neuropathic pain and spasticity in patients with MS and SCI | Central neuropathic pain and spasticity MedDRA version: 20.0;Level: PT;Classification code 10028335;Term: Muscle spasticity;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: LLT;Classification code 10077975;Term: Central neuropathic pain;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cannabidiol capsule 5 mg Product Code: N/A INN or Proposed INN: Cannabidiol Other descriptive name: CBD Product Name: Dronabinol capsule 2,5 mg Product Code: N/A INN or Proposed INN: DRONABINOL Other descriptive name: THC Product Name: Cannabidiol / Dronabinol capsule 5 mg+2,5 mg Product Code: N/A INN or Proposed INN: DRONABINOL Other descriptive name: THC INN or Proposed INN: Cannabidiol Other descriptive name: CBD | Aarhus Universitetshospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 448 | Phase 2 | Denmark | ||
| 3 | EUCTR2018-000001-23-ES (EUCTR) | 06/11/2018 | 23/08/2018 | Clinical study to investigate the efficacy and safety of the test substance BX-1 (dronabinol) for the symptomatic relief of spasticity in patients with multiple sclerosis | A phase III, multi-centre, randomised, double-blind, placebo-controlled, parallel-group clinical trial to investigate the efficacy and safety of BX-1 for the symptomatic relief of spasticity in patients with multiple sclerosis - BX-1 in spasticity due to MS | Symptomatic relief of spasticity in patients with multiple sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dronabinol Product Code: BX-1 INN or Proposed INN: Dronabinol Other descriptive name: Dronabinol | Bionorica SE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 548 | Phase 3 | Hungary;Spain | ||
| 4 | EUCTR2018-000001-23-HU (EUCTR) | 25/10/2018 | 16/08/2018 | Clinical study to investigate the efficacy and safety of the test substance BX-1 (dronabinol) for the symptomatic relief of spasticity in patients with multiple sclerosis | A phase III, multi-centre, randomised, double-blind, placebo-controlled, parallel-group clinical trial to investigate the efficacy and safety of BX-1 for the symptomatic relief of spasticity in patients with multiple sclerosis - BX-1 in spasticity due to MS | Symptomatic relief of spasticity in patients with multiple sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dronabinol 25 mg/ml, oral drops Product Code: BX-1 INN or Proposed INN: Dronabinol Other descriptive name: Dronabinol | Bionorica SE | NULL | Not Recruiting | Female: yes Male: yes | 548 | Phase 3 | Czech Republic;Hungary;Spain | ||
| 5 | EUCTR2010-022033-28-NL (EUCTR) | 10/01/2011 | 26/10/2010 | A study investigating safety, tolerability and efficacy of ECP002A (?9-THC) in Multiple Sclerosis patients suffering from spasticity and pain. | A two-phased, randomized, double blind, placebo-controlled study of ECP002A (?9-THC) to determine safety, tolerability and efficacy in Multiple Sclerosis patients suffering from spasticity and pain. - ECP002A (?9-THC) in MS patients | Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Namisol Product Code: ECP002A INN or Proposed INN: dronabinol Other descriptive name: Namisol | Echo Pharmaceuticals B.V. | NULL | Not Recruiting | Female: yes Male: yes | Netherlands | ||||
| 6 | NCT00959218 (ClinicalTrials.gov) | June 2007 | 13/8/2009 | Efficacy and Safety of the Pain Relieving Effect of Dronabinol in Central Neuropathic Pain Related to Multiple Sclerosis | Multi-centre, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of the Pain Relieving Effect of Dronabinol in Patients With Multiple Sclerosis Associated With Central Neuropathic Pain | Central Neuropathic Pain in Multiple Sclerosis | Drug: Dronabinol;Drug: Placebo | Bionorica Research GmbH | NULL | Completed | 18 Years | 70 Years | Both | 240 | Phase 3 | Germany |
| 7 | EUCTR2006-004255-38-DE (EUCTR) | 17/01/2007 | 20/02/2007 | Multi-centre, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of the pain relieving effect of Dronabinol in patients with multiple sclerosis associated with central neuropathic pain | Multi-centre, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of the pain relieving effect of Dronabinol in patients with multiple sclerosis associated with central neuropathic pain | Patients with multiple sclerosis associated with central neuropathic pain MedDRA version: 8.1;Level: LLT;Classification code 10054095;Term: Neuropathic pain | Product Name: dronabinol Product Code: cnp-MS-0601 INN or Proposed INN: dronabinol Other descriptive name: (-)-trans-delta-9-Tetrahydrocannabinol | Bionorica research GmbH | NULL | Not Recruiting | Female: yes Male: yes | 240 | Austria;Germany | |||
| 8 | EUCTR2006-004255-38-DK (EUCTR) | 15/01/2007 | 18/12/2006 | Multi-centre, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of the pain relieving effect of Dronabinol in patients with multiple sclerosis associated with central pain | Multi-centre, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of the pain relieving effect of Dronabinol in patients with multiple sclerosis associated with central pain | Patients with multiple sclerosis associated with central neuropathic pain MedDRA version: 8.1;Level: LLT;Classification code 10054095;Term: Neuropathic pain | Product Name: dronabinol Product Code: cnp-MS-0601 INN or Proposed INN: dronabinol Other descriptive name: (-)-trans-delta-9-Tetrahydrocannabinol | Bionorica research GmbH | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | Austria;Denmark;Germany | ||
| 9 | EUCTR2006-004255-38-AT (EUCTR) | 05/01/2007 | 06/11/2006 | Multi-centre, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of the pain relieving effect of Dronabinol in patients with multiple sclerosis associated with central neuropathic pain | Multi-centre, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of the pain relieving effect of Dronabinol in patients with multiple sclerosis associated with central neuropathic pain | Patients with multiple sclerosis associated with central neuropathic pain MedDRA version: 16.0;Level: LLT;Classification code 10054095;Term: Neuropathic pain;System Organ Class: 100000004852 | Product Name: dronabinol Product Code: cnp-MS-0601 INN or Proposed INN: dronabinol Other descriptive name: (-)-trans-delta-9-Tetrahydrocannabinol | Bionorica research GmbH | NULL | Not Recruiting | Female: yes Male: yes | 240 | Austria;Germany | |||
| 10 | EUCTR2005-002728-33-GB (EUCTR) | 28/02/2006 | 29/12/2005 | Cannabinoid Use in Progressive Inflammatory brain Disease - CUPID | Cannabinoid Use in Progressive Inflammatory brain Disease - CUPID | Progressive multiple sclerosis | Product Name: Dronabinol INN or Proposed INN: Dronabinol | Plymouth Hospitals NHS Trust | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 492 | United Kingdom |
46. Malignant rheumatoid arthritis
Clinical trials : 4,325 / Drugs : 2,671 - (DrugBank : 417) / Drug target genes : 187 - Drug target pathways : 224
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2017-004226-15-DK (EUCTR) | 26/10/2018 | 05/01/2018 | Can-Art Effect and safety of using Canabis derivatives for the treatment of pain in patients with inflammatory Arthritis, such as reumatoid arthritis and ankylosing spondylitis, the latter being a type of arthritis that causes a long term inflammation of the joints of the spine. A randomized, double blinded, placebo controlled trial, i.e. in this drug trial, a control group is given a placebo while another group is given the Cannabis derivative being studied. | CAN-ART The efficacy and safety of using cannabis derivatives cannabidiol (CBD) and tetrahydrocannabinol (THC) for the treatment of pain in patients with inflammatory arthritis (RA, AS). A randomized, double blinded, placebo controlled trial - Can-Art | Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS) MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Cannabidiol tablet 10 mg Other descriptive name: CANNABIDIOL Product Name: Dronabinol capsule 2.5. mg INN or Proposed INN: DRONABINOL | King Christian 10th Hospital for Rheumatology | NULL | Not Recruiting | Female: yes Male: yes | 180 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Denmark |
271. Ankylosing spondylitis
Clinical trials : 563 / Drugs : 372 - (DrugBank : 72) / Drug target genes : 41 - Drug target pathways : 145
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2017-004226-15-DK (EUCTR) | 26/10/2018 | 05/01/2018 | Can-Art Effect and safety of using Canabis derivatives for the treatment of pain in patients with inflammatory Arthritis, such as reumatoid arthritis and ankylosing spondylitis, the latter being a type of arthritis that causes a long term inflammation of the joints of the spine. A randomized, double blinded, placebo controlled trial, i.e. in this drug trial, a control group is given a placebo while another group is given the Cannabis derivative being studied. | CAN-ART The efficacy and safety of using cannabis derivatives cannabidiol (CBD) and tetrahydrocannabinol (THC) for the treatment of pain in patients with inflammatory arthritis (RA, AS). A randomized, double blinded, placebo controlled trial - Can-Art | Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS) MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Cannabidiol tablet 10 mg Other descriptive name: CANNABIDIOL Product Name: Dronabinol capsule 2.5. mg INN or Proposed INN: DRONABINOL | King Christian 10th Hospital for Rheumatology | NULL | Not Recruiting | Female: yes Male: yes | 180 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Denmark |
298. Hereditary pancreatitis
Clinical trials : 98 / Drugs : 180 - (DrugBank : 57) / Drug target genes : 53 - Drug target pathways : 142
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2012-000730-19-NL (EUCTR) | 23/08/2012 | 12/03/2012 | ?9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal Pain | The analgesic efficacy of ?9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal Pain: a Randomized, Double-blinded, Placebo-controlled, Parallel Design - Delta-Pain II | Chronic pancreatitis with persistant abdominal pain MedDRA version: 14.1;Level: PT;Classification code 10033649;Term: Pancreatitis chronic;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Name: Namisol Product Code: A04AD10 INN or Proposed INN: DRONABINOL Other descriptive name: Tetrahydro-6,6,9-tri methyl-3-penthyl-6 H-dibenzo[ b,d ]pyran-1-ol | Radboud University Nijmegen Medical Centre | NULL | Not Recruiting | Female: yes Male: yes | 68 | Phase 2 | Netherlands | ||
| 2 | EUCTR2011-000647-24-NL (EUCTR) | 26/07/2011 | 12/05/2011 | Efficacy study of ?9-THC to treat persistent abdominal pain as a result of chronic pancreas inflammation | The safety, tolerability, and analgesic efficacy of ?9-THC (Namisol®) in chronic pancreatitis patients suffering from persistent abdominal pain - ?9-THC in chronic pain | patients with abdominal pain as a result of chronic pancreatitis MedDRA version: 13.1;Level: PT;Classification code 10033649;Term: Pancreatitis chronic;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 13.1;Level: LLT;Classification code 10009093;Term: Chronic pancreatitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Namisol Product Code: A04AD10 INN or Proposed INN: DRONABINOL | Radboud University Nijmegen Medical Centre | NULL | Not Recruiting | Female: no Male: yes | Netherlands |