Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Optimized Medical Treatment · 1 trial · 1 indication
The NMSS consists of 30 questions in 9 domains (cardiovascular/falls, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, GI tract, urinary, sexual function, miscellaneous). Score of each question is calculated by multiplying severity\*frequency. Severity and frequency are rated using a scale ranging from 0 (none) to 3 (severe) for severity and from 1 (rarely) to 4 (very frequent) for frequency. Total score is the sum of 9 domains, and ranges from 0 to 360, with a lower value indicating a more desirable outcome. Repeated-measure analysis.
The PDSS-2 addresses PD-specific sleep disturbances such as restless leg syndrome (RLS), morning akinesia, pain, and sleep apnea. The frequency is assessed for the 15 sleep problems based on a 5-point Likert-type scale (ranging from 0 \[never\] to 4 \[very often\]). Scores are calculated for each of the 3 domains (motor symptoms at night, PD symptoms at night, and disturbed sleep) as well as a total score. The PDSS-2 domain scores range from 0 to 20 and the total score is a sum of the 3 domains and ranges from 0 to 60. Repeated measure analysis.
| Arm | Type | Description |
|---|---|---|
| Optimized Medical Treatment (OMT) | ACTIVE_COMPARATOR | Participants randomized to continue OMT remain on their current optimized regimen. During the 26-week treatment phase, changes to anti-PD and NMS medications are to remain stable and can only be made if medically indicated. Eligible participants may elect to enter an extension/transition follow-up period to receive an individually optimized LCIG dose (after NJ and/or PEG-J placement), in order to transition to commercially available LCIG. |
| Levodopa-Carbidopa Intestinal Gel (LCIG) | EXPERIMENTAL | Participants randomized to LCIG at an individually optimized dose (after NJ and/or PEG-J placement), in accordance with the LCIG approved product label for countries participating in the study. During the 26-week treatment phase, changes to anti-PD and NMS medications are to remain stable and can only be made if medically indicated. The total daily dose of LCIG was composed of 3 components: (i) the morning dose, (ii) continuous maintenance infusion dose and (iii) extra doses. The continuous infusion is expected to run over a period of 16 consecutive hours each day. Eligible participants may elect to enter an extension/transition follow-up period to receive an individually optimized LCIG dose, in order to transition to commercially available LCIG. |
| Name | Type | Description |
|---|---|---|
| Optimized Medical Treatment | DRUG | Oral, sublingual or transdermal anti-PD medications and medications to treat NMS per Investigator discretion and/or in accordance with approved product label of the prescribed medications. |
| Levodopa-Carbidopa Intestinal Gel | DRUG | - |
| Nasojejunal (NJ) tube | DEVICE | optional prior to PEG-J placement |
| Percutaneous endoscopic gastrostomy with a jejunal (PEG-J) tube | DEVICE | - |
Inclusion Criteria: 1. Participant(s) must have a diagnosis of idiopathic Parkinson's disease according to the United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria. 2. Participant(s) demonstrates persistent motor fluctuations in spite of individually optimized treatment. 3. The pa...
Optimized Medical Treatment is a small molecule therapy being studied for use in Advanced Parkinson's Disease. It is being evaluated as a control treatment in a Phase 3 clinical trial, where it is compared against Levodopa-Carbidopa Intestinal Gel (LCIG) therapy to examine effects on non-motor symptoms associated with the condition.
Optimized Medical Treatment is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The company is conducting a Phase 3 clinical trial to evaluate this treatment in patients with Advanced Parkinson's Disease.
Optimized Medical Treatment is in Phase 3 clinical development. It is being studied as an active control in a completed Phase 3 trial for Advanced Parkinson's Disease, with a total enrollment of 89 participants. The treatment is investigational and has not been approved by regulatory authorities.
Optimized Medical Treatment is associated with one completed Phase 3 clinical trial, identified as NCT02549092. This randomized, active-controlled study enrolled 89 participants across multiple countries, including the United States, Australia, Canada, Germany, Greece, Italy, South Korea, Spain, and Sweden, to compare the therapy against Levodopa-Carbidopa Intestinal Gel.
Optimized Medical Treatment is a small molecule therapy. Its specific molecular target has not been disclosed in the available information, so the precise mechanism of action is not detailed here. It is being evaluated as a comparator in a clinical trial for Advanced Parkinson's Disease.