Ambroxol Hydrochloride ( DrugBank: Ambroxol )
2 diseases
| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 6 | Parkinson disease | 2 |
| 19 | Lysosomal storage disease | 4 |
6. Parkinson disease
Clinical trials : 2,307 / Drugs : 2,007 - (DrugBank : 349) / Drug target genes : 188 - Drug target pathways : 199
| 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 | 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 |
19. Lysosomal storage disease
Clinical trials : 899 / Drugs : 684 - (DrugBank : 99) / Drug target genes : 51 - Drug target pathways : 182
| 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 | EUCTR2021-002550-82-NL (EUCTR) | 22/12/2022 | 30/07/2022 | Effectiveness of ambroxol for treating children and adults with Gaucher disease type 3 | Effectiveness of ambroxol in children and adults with Gaucher disease 3: n-of-1 series - ATTACK-GD3 | Gaucher disease type 3 MedDRA version: 20.0;Level: HLGT;Classification code 10027424;Term: Metabolic and nutritional disorders congenital;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: Ambroxol hydrochloride INN or Proposed INN: AMBROXOL Hydrochloride Other descriptive name: Mucoangin Product Name: Ambroxol hydrochloride INN or Proposed INN: AMBROXOL HYDROCHLORIDE Other descriptive name: AMBROXOL HYDROCHLORIDE PH. EUR. | Amsterdam UMC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 4 | Phase 3 | Netherlands | ||
| 2 | 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. | Yutaka Shunichiro | NULL | Complete | >= 20age old | < 35age old | Male | 16 | Phase 1 | Japan |
| 3 | 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 |
| 4 | 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 |