Dextromethorphan (DrugBank: Dextromethorphan)
11 diseases| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 2 | Amyotrophic lateral sclerosis | 3 |
| 6 | Parkinson disease | 2 |
| 8 | Huntington disease | 2 |
| 13 | Multiple sclerosis/Neuromyelitis optica | 7 |
| 21 | Mitochondrial disease | 1 |
| 46 | Malignant rheumatoid arthritis | 1 |
| 78 | Hypopituitarism | 1 |
| 85 | Idiopathic interstitial pneumonia | 1 |
| 96 | Crohn disease | 2 |
| 97 | Ulcerative colitis | 2 |
| 156 | Rett syndrome | 5 |
| 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 | NCT03883581 (ClinicalTrials.gov) | July 25, 2019 | 12/3/2019 | Impact of Nuedexta on Bulbar Physiology and Function in ALS | Impact of Nuedexta on Bulbar Physiology and Function in ALS | Amyotrophic Lateral Sclerosis | Drug: dextromethorphan HBr and quinidine sulfate | University of Florida | Holy Cross Hospital, Florida;ALS Association | Recruiting | 18 Years | 90 Years | All | 40 | Phase 1;Phase 2 | United States |
| 2 | NCT00573443 (ClinicalTrials.gov) | December 2007 | 13/12/2007 | Safety and Efficacy of AVP-923 in PBA Patients With ALS or MS | A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy and to Determine the Pharmacokinetics of Two Doses of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Pseudobulbar Affect (PBA) in Patients With Amyotrophic Lateral Sclerosis (ALS) and Multiple Sclerosis (MS) | Pseudobulbar Affect (PBA) | Drug: dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg;Drug: dextromethorphan hydrobromide 30 mg and quinidine sulfate 10 mg;Drug: Placebo | Avanir Pharmaceuticals | INC Research | Completed | 18 Years | 80 Years | All | 326 | Phase 3 | United States;Argentina;Brazil |
| 3 | NCT00021697 (ClinicalTrials.gov) | January 2001 | 1/8/2001 | Safety/Efficacy of AVP-923 in the Treatment of Emotional Lability (Uncontrolled Crying & Laughing) in Patients With ALS | A Double-Blind Controlled, Multicenter Phase II/III Study to Assess the Safety and Efficacy of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Pseudobulbar Affect in Patients With Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: AVP-923 | Avanir Pharmaceuticals | NULL | Completed | 18 Years | 80 Years | Both | 100 | Phase 3 | United States |
| 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 | NCT01767129 (ClinicalTrials.gov) | July 2013 | 9/1/2013 | Safety and Efficacy of AVP-923 in the Treatment of Levodopa-induced Dyskinesia in Parkinson's Disease Patients | A Phase 2a, Double-blind, Randomized, Placebo-controlled, Crossover Study to Evaluate the Safety and Efficacy of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Levodopa-induced Dyskinesia in Parkinson's Disease Patients. | Dyskinesia;Parkinson's Disease | Drug: AVP-923-45;Drug: Placebo | Avanir Pharmaceuticals | Michael J. Fox Foundation for Parkinson's Research | Completed | 30 Years | 80 Years | All | 14 | Phase 2 | United States;Canada |
| 2 | NCT00001365 (ClinicalTrials.gov) | July 1993 | 3/11/1999 | Dextromethorphan for the Treatment of Parkinson's Disease and Similar Conditions of the Nervous System | NMDA Receptor Antagonist Treatment of Neurodegenerative Disease | Neurodegenerative Disease;Parkinson's Disease | Drug: dextromethorphan | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Completed | N/A | N/A | Both | 42 | Phase 2 | United States |
| 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 | NCT03854019 (ClinicalTrials.gov) | August 5, 2019 | 22/2/2019 | Evaluating the Efficacy of Dextromethorphan/Quinidine in Treating Irritability in Huntington's Disease | Evaluating the Efficacy of Dextromethorphan/Quinidine in Treating Irritability in Huntington's Disease | Huntington Disease;Irritability | Drug: Dextromethorphan/quinidine 20mg/10mg (DM/Q 20mg/10mg);Drug: Placebo | The University of Texas Health Science Center, Houston | Cures Within Reach | Recruiting | 18 Years | 75 Years | All | 22 | Phase 3 | United States |
| 2 | NCT00788047 (ClinicalTrials.gov) | November 2008 | 7/11/2008 | A Phase 1 Study To Evaluate The Effect Of Dimebon On The Pharmacokinetics Of Dextromethorphan | A Phase 1, Randomized, Open-Label, Two-Way Crossover Study To Evaluate The Steady-State Effect Of Dimebon [PF-01913539] On The Single-Dose Pharmacokinetics Of The CYP2D6 Substrate Dextromethorphan In Healthy Subjects | Huntington Disease;Alzheimer Disease | Drug: Dextromethorphan;Drug: Dimebon + Dextromethorphan | Pfizer | Medivation, Inc. | Completed | 18 Years | 55 Years | Both | 14 | Phase 1 | United States |
| 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 | EUCTR2011-002178-22-GB (EUCTR) | 27/04/2012 | 29/03/2012 | A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis | A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis | Central Neuropathic Pain in Multiple Sclerosis MedDRA version: 14.1;Level: LLT;Classification code 10054095;Term: Neuropathic pain;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A | Avanir Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | United States;Czech Republic;Argentina;Spain;Poland;Bulgaria;Germany;United Kingdom | ||
| 2 | EUCTR2011-002178-22-PL (EUCTR) | 20/03/2012 | 25/11/2011 | A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis | A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis | Central Neuropathic Pain in Multiple Sclerosis MedDRA version: 15.1;Level: LLT;Classification code 10054095;Term: Neuropathic pain;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A | Avanir Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | United States;Czech Republic;Argentina;Spain;Poland;Bulgaria;Germany;United Kingdom | ||
| 3 | EUCTR2011-002178-22-CZ (EUCTR) | 08/02/2012 | 02/11/2011 | A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis | A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis | Central Neuropathic Pain in Multiple Sclerosis MedDRA version: 14.1;Level: LLT;Classification code 10054095;Term: Neuropathic pain;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A | Avanir Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | United States;Czech Republic;Argentina;Spain;Poland;Bulgaria;Germany;United Kingdom | ||
| 4 | EUCTR2011-002178-22-ES (EUCTR) | 26/12/2011 | 31/10/2011 | A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis | A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis | Central Neuropathic Pain in Multiple Sclerosis MedDRA version: 14.0;Level: LLT;Classification code 10054095;Term: Neuropathic pain;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dextrometorfano/Quinidina Product Code: AVP-923 INN or Proposed INN: DEXTROMETORFANO HIDROBROMURO Other descriptive name: N/A INN or Proposed INN: Quinidina sulfato Other descriptive name: N/A Product Name: Dextrometorfano/Quinidina Product Code: AVP-923 INN or Proposed INN: DEXTROMETORFANO HiDROBROMURO Other descriptive name: N/A INN or Proposed INN: Quinidina sulfato Other descriptive name: N/A Product Name: Dextrometorfano/Quinidina Product Code: AVP-923 INN or Proposed INN: DEXTROMETORFANO HIDROBROMURO Other descriptive name: N/A INN or Proposed INN: Quinidina sulfato Other descriptive name: N/A | Avanir Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | United States;Czech Republic;Argentina;Poland;Spain;Bulgaria;United Kingdom | ||
| 5 | NCT01462318 (ClinicalTrials.gov) | November 2011 | 14/7/2011 | An Open-Label Immunogenicity and Pharmacokinetics Study of Daclizumab High Yield Process Prefilled Syringe in Relapsing Remitting Multiple Sclerosis | A Multicenter, Single-Arm, Open-Label Study to Evaluate the Immunogenicity and Pharmacokinetics of BIIB019, Daclizumab High Yield Process (DAC HYP), Prefilled Syringe Administered by Subcutaneous Injection in Subjects With Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Drug: Midazolam;Other: Caffeine;Drug: S-warfarin;Other: Vitamin K;Drug: Omeprazole;Drug: Dextromethorphan;Biological: BIIB019 (Daclizumab) | Biogen | NULL | Completed | 18 Years | 65 Years | All | 133 | Phase 3 | United States;Czech Republic;Hungary;Poland;Russian Federation |
| 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 |
| 6 | NCT01324232 (ClinicalTrials.gov) | September 2011 | 23/3/2011 | Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis | A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients With Multiple Sclerosis | Central Neuropathic Pain;Multiple Sclerosis | Drug: AVP-923;Drug: Placebo | Avanir Pharmaceuticals | NULL | Completed | 18 Years | 85 Years | All | 200 | Phase 2 | United States;Argentina;Czechia;Poland;Spain;Czech Republic;Germany;United Kingdom |
| 7 | NCT00573443 (ClinicalTrials.gov) | December 2007 | 13/12/2007 | Safety and Efficacy of AVP-923 in PBA Patients With ALS or MS | A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy and to Determine the Pharmacokinetics of Two Doses of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Pseudobulbar Affect (PBA) in Patients With Amyotrophic Lateral Sclerosis (ALS) and Multiple Sclerosis (MS) | Pseudobulbar Affect (PBA) | Drug: dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg;Drug: dextromethorphan hydrobromide 30 mg and quinidine sulfate 10 mg;Drug: Placebo | Avanir Pharmaceuticals | INC Research | Completed | 18 Years | 80 Years | All | 326 | Phase 3 | United States;Argentina;Brazil |
| 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 | NCT04643249 (ClinicalTrials.gov) | November 10, 2020 | 13/11/2020 | Drug-drug Interaction Study of KL1333 in Healthy Subjects | A Phase I, Open-label, Fixed-sequence, Crossover, Drug-drug Interaction Study to Investigate the Inhibition Potential of KL1333 on CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4 in Healthy Subjects | Mitochondrial Disease | Drug: KL1333;Drug: Flurbiprofen;Drug: Dextromethorphan;Drug: Bupropion;Drug: Midazolam injection;Drug: Omeprazole;Drug: Caffeine;Drug: Repaglinide | Abliva AB | NULL | Recruiting | 18 Years | 65 Years | All | 14 | Phase 1 | United Kingdom |
| 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 | NCT02368093 (ClinicalTrials.gov) | January 2010 | 4/2/2015 | Efficacy Study of Dextromethorphan to Treat Rheumatoid Arthritis | A Double-blind, Placebo-controlled, Therapeutic Trial With Antitussive Drug-Dextromethorphan: Aimed to Determine Its Therapeutic Effect in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Dextromethorphan hydrobromide | Taichung Veterans General Hospital | TSH Biopharm Corporation Limited | Completed | 18 Years | N/A | All | 48 | N/A | NULL |
| 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 | NCT00458991 (ClinicalTrials.gov) | June 2001 | 9/4/2007 | rhGH Therapy on Hepatic Drug Metabolism | Recombinant Human Growth Hormone Therapy and Drug Metabolism | Growth Hormone Deficiency, Dwarfism | Drug: Dextromethorphan and Caffeine | University of Louisville | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Completed | 4 Years | 14 Years | All | 9 | N/A | United States |
| 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 | ChiCTR2000037602 | 2020-01-01 | 2020-08-29 | Clinical observation and study of pirfenidone combined with dextromethorphan on idiopathic pulmonary fibrosis | Clinical observation and study of pirfenidone combined with dextromethorphan on idiopathic pulmonary fibrosis | Interstitial lung disease | 1:Dextromethorphan+Pirfenidone;2:Pirfenidone; | Tianjin Medical University General Hospital | NULL | Recruiting | 18 | 75 | Both | 1:100;2:100; | Phase 4 | China |
| 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 | NCT03358706 (ClinicalTrials.gov) | February 2, 2018 | 27/11/2017 | A Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Active Crohn's Disease or Ulcerative Colitis | A Phase 1, Open-label, Drug Interaction Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Active Crohn's Disease or Ulcerative Colitis. | Crohn Disease;Ulcerative Colitis | Drug: Ustekinumab IV Infusion;Drug: Ustekinumab SC Injection;Drug: Midazolam 2 mg;Drug: Warfarin 10 mg;Drug: Vitamin K 10 mg;Drug: Omeprazole 20 mg;Drug: Dextromethorphan 30 mg;Drug: Caffeine 100 mg | Janssen Research & Development, LLC | NULL | Recruiting | 18 Years | 75 Years | All | 57 | Phase 1 | United States;Belgium;Germany;Sweden;United Kingdom;Austria;Denmark |
| 2 | NCT02760615 (ClinicalTrials.gov) | November 1, 2016 | 2/5/2016 | Phase 4, Vedolizumab-4002 Post-marketing, Disease-Drug-Drug Interaction Study | An Open-Label, 2-Part, Multicenter, Post-marketing Study to Evaluate the Effect of Moderately or Severely Active Ulcerative Colitis or Crohn's Disease on Cytochrome P-450 Enzyme Substrates Compared to Healthy Subjects and the Effect of Vedolizumab Treatment on Cytochrome P-450 Enzyme Substrates in Subjects With Ulcerative Colitis or Crohn's Disease | Colitis, Ulcerative;Crohn Disease | Drug: Caffeine;Drug: Losartan;Drug: Omeprazole;Drug: Dextromethorphan;Drug: Midazolam;Drug: Vedolizumab | Takeda | NULL | Withdrawn | 18 Years | 55 Years | All | 0 | Phase 4 | United States |
| 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 | NCT03358706 (ClinicalTrials.gov) | February 2, 2018 | 27/11/2017 | A Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Active Crohn's Disease or Ulcerative Colitis | A Phase 1, Open-label, Drug Interaction Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Active Crohn's Disease or Ulcerative Colitis. | Crohn Disease;Ulcerative Colitis | Drug: Ustekinumab IV Infusion;Drug: Ustekinumab SC Injection;Drug: Midazolam 2 mg;Drug: Warfarin 10 mg;Drug: Vitamin K 10 mg;Drug: Omeprazole 20 mg;Drug: Dextromethorphan 30 mg;Drug: Caffeine 100 mg | Janssen Research & Development, LLC | NULL | Recruiting | 18 Years | 75 Years | All | 57 | Phase 1 | United States;Belgium;Germany;Sweden;United Kingdom;Austria;Denmark |
| 2 | NCT02760615 (ClinicalTrials.gov) | November 1, 2016 | 2/5/2016 | Phase 4, Vedolizumab-4002 Post-marketing, Disease-Drug-Drug Interaction Study | An Open-Label, 2-Part, Multicenter, Post-marketing Study to Evaluate the Effect of Moderately or Severely Active Ulcerative Colitis or Crohn's Disease on Cytochrome P-450 Enzyme Substrates Compared to Healthy Subjects and the Effect of Vedolizumab Treatment on Cytochrome P-450 Enzyme Substrates in Subjects With Ulcerative Colitis or Crohn's Disease | Colitis, Ulcerative;Crohn Disease | Drug: Caffeine;Drug: Losartan;Drug: Omeprazole;Drug: Dextromethorphan;Drug: Midazolam;Drug: Vedolizumab | Takeda | NULL | Withdrawn | 18 Years | 55 Years | All | 0 | Phase 4 | United States |
| 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 | NCT01520363 (ClinicalTrials.gov) | March 2012 | 25/1/2012 | Placebo Controlled Trial of Dextromethorphan in Rett Syndrome | Placebo Controlled Trial of Dextromethorphan in Rett Syndrome | Rett Syndrome | Drug: dextromethorphan;Drug: placebo | Hugo W. Moser Research Institute at Kennedy Krieger, Inc. | The Johns Hopkins Institute for Clinical and Translational Research (ICTR) | Completed | 1 Year | 10 Years | All | 57 | Phase 2 | United States |
| 2 | NCT00069550 (ClinicalTrials.gov) | September 2004 | 29/9/2003 | Independent Studies of Dextromethorphan and of Donepezil Hydrochloride for Rett Syndrome | Pathogenesis of Rett Syndrome: Natural History and Treatment | Rett Syndrome | Drug: dextromethorphan;Drug: donepezil hydrochloride | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NULL | Recruiting | 1 Year | 15 Years | Both | 90 | Phase 3 | United States |
| 3 | NCT00593957 (ClinicalTrials.gov) | August 2004 | 4/1/2008 | Trial of Dextromethorphan in Rett Syndrome | Trial of Dextromethorphan in Rett Syndrome | Rett Syndrome | Drug: Dextromethorphan | Hugo W. Moser Research Institute at Kennedy Krieger, Inc. | NULL | Terminated | 2 Years | 15 Years | All | 38 | Phase 2 | United States |
| 4 | NCT00004807 (ClinicalTrials.gov) | January 1995 | 24/2/2000 | Study of the Pathogenesis of Rett Syndrome | Rett Syndrome | Drug: dextromethorphan;Drug: topiramate;Drug: Donepezil | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Johns Hopkins University | Completed | N/A | 45 Years | Both | 120 | N/A | NULL | |
| 5 | EUCTR2008-005571-10-NO (EUCTR) | 09/01/2009 | DEXTROMETORPHAN IN RETT SYNDROME | DEXTROMETORPHAN IN RETT SYNDROME | Rett syndrome (RTT) is a neurological disorder with devastating consequences on the brain. It is characterized by stagnation of development followed by regression, both occurring between age 6 months and 3 years. The clinical picture is dominated by cognitive impairment, loss of communication skills, purposeful hand movements, hand stereotypies, progressive deceleration of head growth, and abnormal locomotion. RTT syndrome presently has no effective therapy other than pallitative care | Product Name: Dextromethorphan | Kennedy Krieger Inst. Johns Hopkins Medicine | NULL | NA | Female: yes Male: no | 90 | Phase 2 | Norway |