Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03100149 | A Study to Evaluate the Efficacy of Prasinezumab (RO7046015/PRX002) in Participants With Early Parkinson's Disease | PHASE2 | ACTIVE NOT_RECRUITING | 316 | — | — | Jun 27, 2017 | Dec 1, 2031 | Mar 17, 2026 | 55 | United States, Austria +3 |
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...