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Prasinezumab · 2 trials · 2 indications
Time to confirmed motor progression event was the first time point of a worsening event defined as either \>= 5 points increase in MDS-UPDRS Part III score (assessed in "OFF" medication state) from baseline sustained over 2 consecutive assessments or a change in medication after first occurrence of \>= 5 points increase in MDS-UPDRS Part III score from baseline \& before follow-up assessment. MDS-UPDRS Part III is a clinician rater scale that assessed the motor signs of PD. The scale is composed of 18 clinical domains or tasks, which yield 33 distinct scores or ratings. For each distinct rating, a numeric score is assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, and 4 = Severe. The total MDS-UPDRS Part III score (ranging from 0 to 132) is calculated by summing these 33 individual ratings, with higher scores indicating severe impairment.
| Arm | Type | Description |
|---|---|---|
| Prasinezumab | EXPERIMENTAL | Participants will receive Prasinezumab as an IV infusion in the double blind treatment period. Upon completion, eligible participants will enter into the Open Label Extension (OLE) phase. |
| Placebo | EXPERIMENTAL | Participants will receive placebo as an IV Infusion. |
| Name | Type | Description |
|---|---|---|
| Prasinezumab | DRUG | Participants will receive Prasinezumab as an IV Infusion as per the schedule mentioned in the protocol. |
| Placebo | DRUG | Participants will receive Placebo as an IV Infusion per the schedule mentioned in the protocol |
Inclusion Criteria: * Body weight within 40-110 kilograms (kg) (88-242 pounds \[lbs\]) and a body mass index within the range 18-34 kg/m2 * Diagnosis of idiopathic PD based on Movement Disorder Society (MDS) criteria * Has received monotherapy treatment * An MDS-UPDRS Part IV score of 0 at screenin...
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Prasinezumab is an investigational drug being studied for the treatment of early-stage Parkinson's Disease. It is administered intravenously and is currently in Phase 3 clinical development. The drug is designed to target the SNCA protein, which is associated with the progression of Parkinson's Disease.
Prasinezumab targets SNCA, also known as alpha-synuclein, a protein that forms clumps in the brains of people with Parkinson's Disease. As a binding agent, it is intended to interfere with the harmful effects of this protein. This mechanism is being evaluated in clinical trials for early-stage Parkinson's Disease.
Prasinezumab is being developed by Prothena Corporation plc, a biopharmaceutical company traded on the NASDAQ under the ticker symbol PRTA. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for Parkinson's Disease.
Prasinezumab is currently in Phase 3 clinical development for early-stage Parkinson's Disease. It is an investigational drug, meaning it has not been approved by regulatory authorities. A Phase 3 trial is actively recruiting participants to further assess its efficacy and safety.
Prasinezumab is being studied in two clinical trials. NCT04777331 is a Phase 2 study in early Parkinson's Disease with 586 participants, and NCT07174310 is a Phase 3 study in early-stage Parkinson's Disease with 900 participants. Both are randomized, double-blind, and controlled trials.
Prasinezumab is a unique investigational drug and is not known by any other names. It is being developed specifically for Parkinson's Disease and is not the same as any approved medication. Its distinct mechanism targets the SNCA protein, which sets it apart from other treatments.