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Optimized antiparkinsonian treatment · 1 trial · 1 indication
The Unified Dyskinesia Rating Scale (UDysRS) is a tool used to assess dyskinesia in Parkinson's disease (PD) and contains both self-evaluation questions and items that are assessed directly by the physician to objectively rate the abnormal movements associated with PD. Part 1 contains 11 questions about the ON time dyskinesia and the impact of ON-dyskinesia on experiences of daily living. Part 2 contains 4 questions about OFF-dystonia rating. Part 3 contains 7 questions about objective evaluation of dyskinesia impairment and Part 4 contains 4 questions regarding dyskinesia disability. Each question is scored with respect to severity, which is rated on a scale where 0 = normal, 1 = slight, 2 = mild, 3= moderate and 4 = severe. The UDysRS total score is obtained by summing the item scores, ranging from 0 to 104. Higher scores are associated with more disability. Negative changes from baseline indicate improvement.
| Arm | Type | Description |
|---|---|---|
| Optimized Medical Treatment (OMT) | ACTIVE_COMPARATOR | Participants randomized to OMT continued their current anti Parkinson's disease (anti-PD) medication regimen for the duration of the study. All anti-PD medications and medications to treat dyskinesia must have remained stable for the duration of the study unless adjustments were medically indicated. The Investigator provided the prescription for continued OMT. |
| Levodopa-Carbidopa Intestinal Gel (LCIG) | EXPERIMENTAL | The total daily dose of infusion LCIG was composed of three components: (i) the morning dose, (ii) continuous maintenance infusion dose and (iii) extra doses. A temporary nasojejunal (NJ) tube may have been used initially with the infusion pump to determine a participant's response to this method of treatment and to optimize the dose of LCIG before treatment with a permanent percutaneous endoscopic gastrostomy - with jejunal extension (PEG-J) tube was started. Following optional NJ and/or PEG-J placement and, at the investigator's discretion, the participant may have begun initiation and titration of LCIG infusion on Day 1 once tube placement was confirmed. The dose of LCIG was adjusted to obtain the optimal clinical response. The rate of LCIG infusion is typically within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances and runs over a period of 16 consecutive hours each day. |
| Name | Type | Description |
|---|---|---|
| Optimized antiparkinsonian treatment | DRUG | Dose levels of prescribed antiparkinsonian medications were individually optimized to their maximum therapeutic effect. |
| Levodopa-Carbidopa Intestinal Gel (LCIG) | DRUG | Dose levels were individually optimized. |
| CADD-Legacy ambulatory infusion pump | DEVICE | (manufactured by Smiths Medical) |
| Percutaneous endoscopic gastrostomy tube | DEVICE | (PEG tube) |
| Jejunal extension tube | DEVICE | (J-tube) |
Inclusion Criteria: * Participants must have a diagnosis of idiopathic Parkinson's disease (PD) according to the United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria * Participants with advanced levodopa-responsive PD and persistent motor fluctuations who have not been controlled ...
Optimized antiparkinsonian treatment is used for Parkinson's Disease (PD). It is a small molecule therapy being developed by AbbVie Inc. (ABBV) and is currently in Phase 3 clinical development as an investigational treatment for advanced Parkinson's Disease.
Optimized antiparkinsonian treatment is a small molecule therapy for Parkinson's Disease. The specific molecular target is not disclosed in the available information, so its mechanism of action is not detailed here.
Optimized antiparkinsonian treatment is developed by AbbVie Inc., a biopharmaceutical company traded on the NYSE under the ticker ABBV. The drug is being studied for the treatment of Parkinson's Disease.
Optimized antiparkinsonian treatment is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed for this therapy.
Optimized antiparkinsonian treatment has one completed Phase 3 trial, NCT02799381, titled DYSCOVER. This study compared the efficacy of levodopa-carbidopa intestinal gel and optimized medical treatment on dyskinesia in subjects with advanced Parkinson's Disease. The trial enrolled 63 participants across multiple countries.
Optimized antiparkinsonian treatment is not the same as levodopa-carbidopa intestinal gel. In the DYSCOVER trial, optimized antiparkinsonian treatment was used as the active control arm, compared against levodopa-carbidopa intestinal gel, which is a separate treatment.