Ambroxol ( DrugBank: Ambroxol )
2 diseases
| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 6 | Parkinson disease | 4 |
| 19 | Lysosomal storage disease | 7 |
6. Parkinson disease
Clinical trials : 2,298 / Drugs : 2,202 - (DrugBank : 350) / Drug target genes : 188 - Drug target pathways : 202
| 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 | NCT05287503 (ClinicalTrials.gov) | February 15, 2022 | 28/1/2022 | Ambroxol as a Disease-modifying Treatment in GBA-PD | Ambroxol as a Disease-modifying Treatment to Reduce the Risk of Cognitive Impairment in GBA-associated Parkinson's Disease. A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Trial | Parkinson Disease;GBA Gene Mutation | Drug: Ambroxol Hydrochloride;Drug: Placebo | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta | University of Campania Luigi Vanvitelli;IRCCS National Neurological Institute C. Mondino Foundation | Recruiting | 21 Years | 80 Years | All | 60 | Phase 2 | Italy |
| 2 | NCT02941822 (ClinicalTrials.gov) | December 2016 | 5/9/2016 | Ambroxol in Disease Modification in Parkinson Disease | A Phase IIA Prospective, Single-Centre, Open Label Clinical Trial to Evaluate the Safety, Tolerability and Pharmacodynamic Effects of Ambroxol in Patients With Parkinson Disease: Ambroxol in Disease Modification in Parkinson Disease | Parkinson Disease | Drug: Ambroxol | University College, London | The Cure Parkinson's Trust | Completed | 40 Years | 80 Years | All | 23 | Phase 2 | United Kingdom |
| 3 | EUCTR2015-002571-24-GB (EUCTR) | 14/10/2016 | 12/02/2019 | A Pilot Study to Evaluate the Safety, Tolerability (any side effects of the drug) and Pharmacodynamic (biochemical and physiological effects of drugs). The effects of Ambroxol in Patients with Parkinson Disease: Ambroxol in Disease Modification in Parkinson Disease. | A Phase IIA Prospective, Single-Centre, Open Label Clinical Trial to Evaluate the Safety, Tolerability and Pharmacodynamic Effects of Ambroxol in Patients with Parkinson Disease: Ambroxol in Disease Modification in Parkinson Disease - AiM-PD | Parkinson disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: AMBROSAN 60mg Tablets Product Name: Ambroxol INN or Proposed INN: Ambroxol hydrochloride | Joint Research Office | NULL | Not Recruiting | Female: yes Male: yes | 20 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 4 | NCT02914366 (ClinicalTrials.gov) | November 2015 | 8/9/2016 | Ambroxol as a Treatment for Parkinson's Disease Dementia | Ambroxol as a Novel Disease Modifying Treatment for Parkinson's Disease Dementia | Parkinson's Disease Dementia | Drug: Ambroxol;Other: Placebo | Lawson Health Research Institute | Weston Brain Institute;University of Western Ontario, Canada;London Health Sciences Centre | Recruiting | 50 Years | N/A | All | 75 | Phase 2 | Canada |
19. Lysosomal storage disease
Clinical trials : 854 / Drugs : 716 - (DrugBank : 105) / Drug target genes : 70 - Drug target pathways : 191
| 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 | JPRN-jRCT2051210024 | 10/06/2021 | 11/05/2021 | Investigation of the Food Effect on the Pharmacokinetics of JT408T | Investigation of the Food Effect on the Pharmacokinetics of JT408T | Improvement of neurological symptoms of Gaucher's disease | 1) After fasting, administer 400 mg of ambroxol hydrochloride orally in a single dose. 2) After meals, administer 400 mg of ambroxol hydrochloride orally in a single dose. | Ioroi Minoru | NULL | Not Recruiting | >= 20age old | < 35age old | Male | 16 | Phase 1 | Japan |
| 2 | JPRN-jRCTs061190017 | 21/11/2019 | 26/09/2019 | Japan-Ambroxol Chaperone Study | 2 cohort, Non-randomized, Multi-site Study to Evaluate the Efficacy and Safety of Chaperone Therapy with Ambroxol Hydrochloride in Patients with Neuronopathic Gaucher disease - J-ACT | Neuronopathic Gaucher disease | Ambroxol will be given. | Narita Aya | NULL | Recruiting | Not applicable | Not applicable | Both | 25 | Phase 3 | Japan |
| 3 | JPRN-JMA-IIA00421 | 07/05/2019 | 26/04/2019 | Phase II/III Study to Evaluate the Efficacy and Safety of Chaperone Therapy with Ambroxol Hydrochloride (JT408T) in Patients with Neuronopathic Gaucher disease (Japan- Lysosomal Optimization Study: J-LO study) | Phase II/III Study to Evaluate the Efficacy and Safety of Chaperone Therapy with Ambroxol Hydrochloride (JT408T) in Patients with Neuronopathic Gaucher disease (Japan- Lysosomal Optimization Study: J-LO study) | Neuronopathic Gaucher disease | Intervention type:DRUG. Intervention1:ADMINISTRATION, Dose form:TABLET, Route of administration:ORAL. | Tottori University Hospital, Departrment of Child Neurology | NULL | Completed | No Limit | No Limit | BOTH | 3 | Phase 2-3 | Japan |
| 4 | NCT03950050 (ClinicalTrials.gov) | March 1, 2019 | 6/8/2018 | Ambroxol Therapy for Patients With Type 1 Gaucher Disease and Suboptimal Response to Enzyme Replacement Therapy | Ambroxol Therapy for Patients With Type 1 Gaucher Disease and Suboptimal Response to Enzyme Replacement Therapy | Gaucher Disease, Type 1 | Drug: Ambroxol | Shaare Zedek Medical Center | NULL | Recruiting | 18 Years | 75 Years | All | 60 | Phase 2 | Israel |
| 5 | NCT01463215 (ClinicalTrials.gov) | December 2012 | 27/10/2011 | Clinical Trial of Ambroxol in Patients With Type I Gaucher Disease | An Open-Label, Dose Escalation With 2 Dose Levels, Proof-of-Concept Clinical Trial of Ambroxol for the Treatment of Type I Gaucher Disease | Type I Gaucher Disease | Drug: Ambroxol | Exsar Corporation | NULL | Suspended | 16 Years | N/A | Both | 20 | Phase 1/Phase 2 | United States |
| 6 | JPRN-UMIN000009392 | 2012/11/24 | 24/11/2012 | An Open-Label, Dose Escalation, Proof-of-Concept Clinical Trial of Chaperone therapy of Neuronopathic Gaucher Disease with Ambroxol | Neuronopathic Gaucher disease | Ambroxol at a dose level of 25 mg/kg/day (upper limit: 1g/day) will be given by mouth for 6 months. | Tottori University, Faculty of Medicine, Institute of Neurological Science | NULL | Recruiting | Not applicable | Not applicable | Male and Female | 5 | Phase 2,3 | Japan | |
| 7 | JPRN-jRCTs061180090 | 16/03/2010 | 22/03/2019 | Chaperone therapy of Neuronopathic Gaucher Disease with Ambroxol | An Open-Label, Dose Escalation, Proof-of-Concept Clinical Trial of Chaperone therapy of Neuronopathic Gaucher Disease with Ambroxol - Chaperone therapy of Neuronopathic Gaucher Disease with Ambroxol | Neuronopathic Gaucher disease Gaucher disease, Pharmacological chaperone therapy, ambroxol;D005776 | Ambroxol at a dose level of 25 mg/kg/day (upper limit: 1300mg/day) will be given by mouth for 6 months. | Maegaki Yoshihiro | NULL | Not Recruiting | Not applicable | Not applicable | Both | 25 | Phase 2 | Japan |