Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00920946 | A Safety and Efficacy Study of Dimebon in Patients With Huntington Disease | PHASE3 | COMPLETED | 403 | — | — | Jul 30, 2009 | - | Oct 11, 2016 | - | — |
| NCT00788047 | A Phase 1 Study To Evaluate The Effect Of Dimebon On The Pharmacokinetics Of Dextromethorphan | PHASE1 | COMPLETED | 14 | — | — | Nov 1, 2008 | Jan 1, 2009 | Mar 9, 2009 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Regimen A (Reference) | OTHER | - |
| Regimen B (Test) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Dimebon | DRUG | 20 mg Dimebon orally TID |
| Placebo | OTHER | Orally TID |
| Dextromethorphan | DRUG | Dextromethorphan HCl 30 syrup single dose |
| Dimebon + Dextromethorphan | DRUG | Dimebon 20 mg tablets given three times daily for 14 days plus Dextromethorphan HCl 30 syrup single dose administered on Day 12 |
Inclusion Criteria: * Healthy adult subjects. * Extensive or ultra-rapid metabolizers of CYP2D6 substrates, predicted by genotype. Exclusion Criteria: * Existence of significant medical conditions that would impact study results or pose unacceptable risks to study subjects. * Pregnant or nursing ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 2 | PHASE3 | Votoplam |
| Neurocrine Biosciences, Inc. | NBIX | 2 | PHASE3 | Valbenazine |
| Alnylam Pharmaceuticals, Inc | ALNY | 1 | PHASE1 | ALN-HTT02 |
| uniQure N.V. | QURE | 2 | PHASE1 | intra-striatal rAAV5-miHTT |
| Sarepta Therapeutics, Inc. | SRPT | 1 | PHASE1 | SRP-1005 |