Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DM-1992 · 1 trial · 2 indications
"OFF" indicates wearing off motor fluctuations before the next levodopa dose. Percent "OFF" time is calculated as the total "OFF" time divided by the total awake time for each day and multiplied by 100. Patient diary-every 30min while awake for 3days prior to initial Day1 as baseline \& during the last 3days before Day10 for both treatments for dyskinesia state. Baseline is the average of the 3 days recorded in the patient diary prior to Day 1 of Period 1. End of Period is the average of the 3 days recorded in the patient diary prior to Day 10 in each period. Clinician-Assess efficacy at pre-dose, every 30min for Day1 and hourly for Day10 for dyskinesia state \& motor fluctuations at clinic visits.
| Arm | Type | Description |
|---|---|---|
| DM-1992 | EXPERIMENTAL | DM-1992, a gastric-retentive extended-release tablet containing 72.5mg carbidopa (CD) and 230mg levodopa (LD) |
| Sinemet IR | ACTIVE_COMPARATOR | An Immediate-release (IR) tablet containing 25mg carbidopa (CD) and 100mg levodopa (LD) |
| Name | Type | Description |
|---|---|---|
| DM-1992 | DRUG | 72.5mg carbidopa/230mg levodopa |
| Sinemet IR | DRUG | Immediate-release tablet containing 25mg carbidopa and 100mg levodopa |
Inclusion Criteria: 1. Men and women at least 30 years and older at the time of informed consent with advanced idiopathic Parkinson's disease with predictable wearing-off motor fluctuations with Hoehn and Yahr Stage II-III when "on." 2. Patients should be able to differentiate between the "ON" and ...
DM-1992 is an investigational small molecule being studied for the treatment of Parkinson's Disease, specifically in patients with predictable motor fluctuations. It is in Phase 2 clinical development and has not been approved by the FDA. One clinical trial has been completed to evaluate its effects in this patient population.
DM-1992 is being developed by Assertio Holdings, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ASRT. The company is conducting clinical research to evaluate the safety and efficacy of this investigational small molecule for Parkinson's Disease.
DM-1992 is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received FDA approval. A Phase 2 study in advanced Parkinson's Disease patients with predictable motor fluctuations has been completed, and the drug remains under investigation for this indication.
DM-1992 has one completed clinical trial, identified as NCT01515410, titled "Study in Advanced Parkinson's Disease Patients With Predictable Motor Fluctuations." This Phase 2 study enrolled 34 participants in the United States and included patients aged 30 years and older with Parkinson's Disease and motor fluctuations.
No alternative names for DM-1992 have been disclosed. The drug is identified solely by its development code DM-1992 and is being studied by Assertio Holdings, Inc. for Parkinson's Disease. No other names or aliases are associated with this investigational compound in the available clinical trial information.