Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
L-PZQ ODT · 1 trial · 1 indication
Overall palatability was assessed on a 0 to 100 unit VAS scale, where higher scores indicate better palatability.
| Arm | Type | Description |
|---|---|---|
| Period 1 and 2 | EXPERIMENTAL | A-B or B-A where A: L-PZQ ODT (MSC 2499550A) put on tongue; B: Rac-PZQ ODT (MSC1028703A) put on the tongue |
| Period 3, 4 and 5 | EXPERIMENTAL | C-D-E; C-E-D; D-E-C; D-C-E; E-C-D; E-D-C where C: L-PZQ ODT (MSC 2499550A) dispersed in water; D: Rac-PZQ ODT (MSC1028703A) dispersed in water; E: Cesol® 150 mg crushed in water |
| Name | Type | Description |
|---|---|---|
| L-PZQ ODT | DRUG | L-PZQ ODT (MSC2499550A) tablet at a dose of 150 milligram (mg) put and disintegrated in the mouth without water |
| Rac-PZQ ODT | DRUG | Rac-PZQ ODT (MSC1028703A) tablet at a dose of 150 mg put and disintegrated in the mouth without water |
| Cesol® | DRUG | Cesol® tablet at a dose of 150 mg crushed in water |
Inclusion criteria: 1. Children male or female aged 6-11 years (inclusive) 2. Parents or guardians gave written informed consent prior to any trial related procedure and child gave assent 3. Able to communicate well with the Investigator, understanding the protocol requirements and restrictions, an...
L-PZQ ODT is an orally disintegrating tablet formulation of praziquantel being developed for the treatment of schistosomiasis, a parasitic disease. It has been studied in healthy children and in children infected with Schistosoma parasites. The drug is currently in clinical development and is not yet approved.
L-PZQ ODT is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the palatability and efficacy of this new formulation of praziquantel in pediatric populations.
L-PZQ ODT has completed a Phase 1 clinical trial and a Phase 3 clinical trial. The Phase 1 study evaluated palatability in healthy children, while the Phase 3 study assessed the drug in children infected with Schistosoma. Both trials are completed, and the drug remains investigational.
L-PZQ ODT has been studied in two completed clinical trials. NCT02315352 was a Phase 1 cross-over study evaluating palatability of the orally disintegrating tablet versus current praziquantel tablets in healthy African children aged 6-11 years. NCT03845140 was a Phase 3 study in children with schistosomiasis.
L-PZQ ODT is a new orally disintegrating tablet formulation of praziquantel, an established antiparasitic drug. The 'L-PZQ' designation refers to the levo-enantiomer of praziquantel, which is the active form. This formulation is designed to improve palatability and ease of administration for children.