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 ...
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DM-1992 is an investigational small molecule being developed by Assertio Holdings, Inc. for Parkinson's disease. It is a Phase 2 candidate studied in patients with advanced Parkinson's disease who experience predictable motor fluctuations. It has not been approved by the FDA and remains in clinical development.
DM-1992 is being studied for advanced Parkinson's disease in patients with predictable motor fluctuations, the wearing-off periods when levodopa symptom control fades between doses. The Phase 2 trial enrolled patients with that specific profile. It is investigational and is not an approved treatment for Parkinson's disease.
DM-1992 is being developed by Assertio Holdings, Inc., which trades on the Nasdaq under the ticker ASRT. Assertio is the sponsor of the clinical program for the drug in Parkinson's disease.
DM-1992 is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The drug is investigational and has not received FDA approval for Parkinson's disease or any other indication.
DM-1992 has been studied in one completed Phase 2 trial, NCT01515410, titled Study in Advanced Parkinson's Disease Patients With Predictable Motor Fluctuations. It was a randomized, active-controlled trial that enrolled 34 patients in the United States, including adults aged 30 years and older.