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RO7046015 · 1 trial · 1 indication
The MDS-UPDRS is a multimodal scale consisting of four parts. Part I assessed non-motor experiences of daily living and has 2 components (Range 0-52). Part IA contains 6 questions and are assessed by the examiner (Range 0-24). Part IB contains 7 questions on non-motor experiences of daily living which was completed by the participant (Range 0-28). Part II assessed motor experiences of daily living (Range 0-52). It contained 13 questions completed by the participant. Part III assessed the motor signs of Parkinson's Disease (PD) and was administered by the rater (Range 0-132). Part III contained 33 scores based on 18 items. For each question a numeric score is assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. The MDS-UPDRS Total Score equals the sum of Parts I,II, and III (Range: 0-236). A higher score indicated more severe symptoms of Parkinson's disease.
| Arm | Type | Description |
|---|---|---|
| Part 1: RO7046015 High Dose | EXPERIMENTAL | Participants will receive RO7046015 at high dose level as intravenous (IV) infusion every 4 weeks (Q4W) up to 52 weeks in Part 1. |
| Part 1: RO7046015 Low Dose | EXPERIMENTAL | Participants will receive RO7046015 at low dose level as IV infusion Q4W up to 52 weeks in Part 1. |
| Part 1: Placebo | PLACEBO_COMPARATOR | Participants will receive placebo as IV infusion Q4W up to 52 weeks in Part 1. |
| Part 2: RO7046015 High Dose | EXPERIMENTAL | Part 1 RO7046015 high dose group participants and placebo group participants randomized to high dose level will receive RO7046015 at high dose level as IV infusion Q4W for additional 52 weeks in Part 2. |
| Part 2: RO7046015 Low Dose | EXPERIMENTAL | Part 1 RO7046015 low dose group participants and placebo group participants randomized to low dose level will receive RO7046015 at low dose level as IV infusion Q4W for additional 52 weeks in Part 2. |
| Part 3: RO7046015 Low Dose | EXPERIMENTAL | All participants who complete Part 1 and Part 2 will receive monthly IV infusions of RO7046015. |
| Name | Type | Description |
|---|---|---|
| RO7046015 | DRUG | RO7046015 will be administered at dose of 4500 milligrams (mg) for participants with body-weight greater than or equal to (\>/=) 65 kilograms (kg) or 3500 mg for participants with body-weight less than (\<) 65 kg. |
| Placebo | DRUG | RO7046015 placebo will be administered to all participants in the indicated arm. |
Inclusion Criteria: * Idiopathic PD with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity) being present, without any other known or suspected cause of PD untreated or treated with MAO-B inhibitor * Body weight range between: \>/=45 kg/ 99 pounds (lbs) and less than...
RO7046015 is an investigational small molecule being studied for the treatment of early Parkinson's Disease. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The drug is being evaluated in a randomized, double-blind, placebo-controlled trial to assess its efficacy in participants with early-stage Parkinson's Disease.
RO7046015 is a small molecule designed to target and modify the course of Parkinson's Disease. While the specific molecular target is not disclosed, the drug is being investigated for its potential to slow or halt disease progression in early Parkinson's Disease. Its mechanism of action is under evaluation in clinical trials.
RO7046015 is being developed by Prothena Corporation plc, a biopharmaceutical company listed on the NASDAQ under the ticker symbol PRTA. The company is conducting a Phase 2 clinical trial to evaluate the drug's efficacy in early Parkinson's Disease.
RO7046015 is currently in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. The ongoing Phase 2 trial is active but not recruiting participants, and it is designed to evaluate the drug's efficacy in early Parkinson's Disease.
RO7046015 is being studied in a Phase 2 clinical trial registered as NCT03100149, titled 'A Study to Evaluate the Efficacy of Prasinezumab (RO7046015/PRX002) in Participants With Early Parkinson's Disease.' The trial is active but not recruiting, with an enrollment of 316 participants across the United States, Austria, France, Germany, and Spain.
Yes, RO7046015 is also known as prasinezumab and PRX002. The Phase 2 clinical trial NCT03100149 refers to the drug as prasinezumab (RO7046015/PRX002), confirming that these names refer to the same investigational therapy for early Parkinson's Disease.