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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-004997-23 | EudraCT Number | ||
| 2023-507132-21-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Prothena Biosciences Limited | INDUSTRY |
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This is a multicenter, randomized, double-blind, placebo-controlled study that will evaluate the efficacy and safety of intravenous (IV) prasinezumab versus placebo in participants with Early Parkinson's Disease (PD) who are on stable symptomatic PD medication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prasinezumab | Experimental | Participants will receive an IV infusion of prasinezumab every 4 weeks (Q4W). Participants will enter into the optional Open Label Extension (OLE) once the double-blind treatment period has completed. |
|
| Placebo | Placebo Comparator | Participants will receive placebo as an IV infusion Q4W. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prasinezumab | Drug | Prasinezumab will be administered as an IV infusion to participants Q4W. |
|
| Measure | Description | Time Frame |
|---|---|---|
| DBT Period: Time to Confirmed Motor Progression Event Assessed by Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III | 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. | From study start to end of DBT period to at least 76 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| DBT Period: Time-to-worsening of Participant's Motor Function as Reported by the Participant in the Presence of a Confirmed Motor Progression Event | Time to worsening of the motor function was defined as ≥3 points increase in MDS-UPDRS Part II score from baseline in the presence of a confirmed motor progression event. For the confirmed motor progression event the definition is as per primary endpoint definition. MDS-UPDRS Part II assesses motor experiences of daily living & contained 13 questions answered by participant. For each question a numeric score is assigned between 0-4, 0 = Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Score range: 0 to 52 with higher score=severe impairment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Barrow Neurological Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42208564 | Derived | Nikolcheva T, Pagano G, Anzures-Cabrera J, Trundell D, Kustermann T, Simuni T, Marek K, Pavese N, Seppi K, Stocchi F, Postuma RB, Pross N, Monnet A, Respondek G, Schlegel V, Boak L, Rutten-Jacobs L, Kerchner GA, Brundin P, Svoboda H, Bonni A; PADOVA Investigators; Prasinezumab Study Group. Efficacy and safety of intravenous prasinezumab in individuals with early-stage Parkinson's disease on stable symptomatic monotherapy (PADOVA): a phase 2b, multicentre, randomised, double-blind, placebo-controlled study. Lancet. 2026 May 30;407(10544):2227-2240. doi: 10.1016/S0140-6736(26)00865-2. |
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For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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After completing the DBT period, consenting & eligible participants entered the OLE period to receive prasinezumab. 3 participants in the prasinezumab arm and 1 participant in the placebo arm were randomized but not treated and 2 participants randomized to placebo arm received 1 dose of prasinezumab and were included in the prasinezumab arm for safety analysis. The study is still ongoing.
A total of 586 participants with early-stage Parkinson's disease (PD) took part in the study across 110 investigative sites in 9 countries. The study consisted of double-blind treatment (DBT), where participants were randomized in 1:1 ratio to receive prasinezumab or placebo and an optional open-label extension (OLE).
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| ID | Title | Description |
|---|---|---|
| FG000 | DBT Period: Placebo | Participants received prasinezumab matching placebo as an intravenous (IV) infusion, every 4 weeks (Q4W) up to at least 76 weeks. |
| FG001 | DBT Period: Prasinezumab |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| DBT Period |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 15, 2025 | Sep 9, 2025 |
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| Placebo | Drug | Prasinezumab placebo will be administered to participants. |
|
| From study start to end of DBT period to at least 76 weeks |
| DBT Period: Time to Meaningful Worsening in Participant Global Impression of Change (PGI-C) Overall Disease Subscale | The PGI is a measure commonly used in PD clinical trials to provide a concise assessment of overall health state. The change component (PGI-C) was intended to measure health state changes as reported by the participant on a 7-point scale (1=Very much improved to 7=Very much worse). The meaningfulness of the change was assessed and reported by the participant. | From study start to end of DBT period to at least 76 weeks |
| DBT Period: Time to Meaningful Worsening in Clinician Global Impression of Change (CGI-C) Overall Disease Subscale | The CGI was a measure commonly used in PD clinical trials to provide a concise assessment of overall health state. The change component (CGI-C) was intended to measure health state changes as reported by the clinician on a 7-point scale (1=Very much improved to 7=Very much worse). | From study start to end of DBT period to at least 76 weeks |
| DBT Period: Time to Onset of Motor Complications as Assessed Through MDS-UPDRS Part IV | MDS-UPDRS Part IV assessed motor complications of symptomatic treatment, dyskinesias, and motor fluctuations. The rater completed this assessment only for participants on L-Dopa treatment. | From study start to end of DBT period to at least 76 weeks |
| DBT Period: Change in Motor Function From Baseline to Week 76, as Measured by the MDS-UPDRS Part III Score | 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. | From baseline up to Week 76 |
| DBT Period: Change in Bradykinesia and Rigidity From Baseline to Week 76, as Measured by the MDS-UPDRS Part III Bradykinesia and Rigidity Subscore | 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. For bradykinesia, subscore ranges from 0 to 52, while rigidity subscore ranges from 0 to 20, with higher scores indicating greater impairment. Change in bradykinesia and rigidity was assessed in "OFF" medication state. Adjusted mean is reported here. | From baseline up to Week 76 |
| DBT Period: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptoms, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. SAE is any significant hazard, contraindication, or side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention. Number of participants with atleast 1 AE and SAE are reported here. | From study start to end of DBT period to at least 76 weeks |
| DBT Period: Number of Participants With Adverse Events of Special Interest (AESI) | An AE was any untoward medical occurrence in participant administered a pharmaceutical product & which does not necessarily have to have a causal relationship with treatment. It can therefore be any unfavorable and unintended sign (including abnormal laboratory values/ abnormal clinical test results), symptoms/disease temporally associated with use of pharmaceutical product, whether/not considered related to product. AESIs included potential drug-induced liver injury that include an elevated alanine transaminase (ALT) & aspartate aminotransferase (AST) in combination with either an elevated bilirubin/clinical jaundice defined by Hy's law and suspected transmission of an infectious agent by study drug. | From study start to end of DBT period to at least 76 weeks |
| DBT Period: Number of Participants With Treatment Discontinuation Due to AEs | An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptoms, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. | From study start to end of DBT period to at least 76 weeks |
| DBT Period: Number of Participants With Infusion Related Reactions (IRRs) | IRRs were defined as any signs and symptoms (AEs) occurring during infusion and/or within 24 hours administration after the end of infusion and were considered related to study treatment by the investigator. Symptoms include flushing, rash, respiratory difficulty, hypotension, tachycardia. | From study start to end of DBT period to at least 76 weeks |
| DBT Period: Number of Participants With in Suicidal Ideation, as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) | C-SSRS=assessment tool used to assess lifetime suicidality of participant (at baseline) as well as any new instances of suicidality (C-SSRS since last visit). Structured interview prompts recollection of suicidal ideation, including intensity of ideation, behavior, and attempts with actual/potential lethality. Categories have binary responses (yes/no) and include Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent, Preparatory Acts and Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Suicidal ideation/behavior is indicated by a "yes" answer to any of the listed categories. Score of 0 is assigned if no suicide risk is present. Score of 1 or higher= suicidal ideation or behavior. Categories with non-zero values are only reported here. | From study start to end of DBT period to at least 76 weeks |
| DBT Period: Maximum Observed Concentration at Steady-state (Cmax,SS) | Day 1 of Weeks 1, 2, 4, 8, 12, 24, 36, 52, 64, 76 |
| DBT Period: Minimum Observed Concentration at Steady-state (Cmin,SS) | Day 1 of Weeks 1, 2, 4, 8, 12, 24, 36, 52, 64, 76 |
| DBT Period: Area Under the Serum Concentration Time Curve Over the Dosing Interval (AUCTau,SS) | Day 1 of Weeks 1, 2, 4, 8, 12, 24, 36, 52, 64, 76 |
| DBT Period: Percentage of Participants With Anti-Drug Antibodies (ADAs) at Baseline and Post-Treatment | From study start to end of DBT period to at least 76 weeks |
| OLE Period: Number of Participants With AEs and SAEs | An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptoms, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. SAE is any significant hazard, contraindication, or side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention. | From signing of informed consent form up to 70 days after final dose of study treatment (Up to 66.6 months) |
| OLE Period: Number of Participants With AESI | An AE was any untoward medical occurrence in participant administered a pharmaceutical product & which does not necessarily have to have a causal relationship with treatment. It can therefore be any unfavorable and unintended sign (including abnormal laboratory values/ abnormal clinical test results), symptoms/disease temporally associated with use of pharmaceutical product, whether/not considered related to product. AESIs included potential drug-induced liver injury that include an elevated ALT & AST in combination with either an elevated bilirubin/clinical jaundice defined by Hy's law and suspected transmission of an infectious agent by study drug. | From signing of informed consent form up to 70 days after final dose of study treatment (Up to 66.6 months) |
| OLE Period: Number of Participants With IRRs | IRRs were defined as any signs and symptoms (AEs) occurring during infusion and/or within 24 hours administration after the end of infusion and were considered related to study treatment by the investigator. Symptoms include flushing, rash, respiratory difficulty, hypotension, tachycardia. | From signing of informed consent form up to 70 days after final dose of study treatment (Up to 66.6 months) |
| OLE Period: Number of Participants With in Suicidal Ideation, as Measured by the C-SSRS | C-SSRS=assessment tool used to assess lifetime suicidality of participant (at baseline) as well as any new instances of suicidality (C-SSRS since last visit). Structured interview prompts recollection of suicidal ideation, including intensity of ideation, behavior, and attempts with actual/potential lethality. Categories have binary responses (yes/no) and include Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent, Preparatory Acts and Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Suicidal ideation/behavior is indicated by a "yes" answer to any of the listed categories. Score of 0 is assigned if no suicide risk is present. Score of 1 or higher= suicidal ideation or behavior. | From signing of informed consent form up to 70 days after final dose of study treatment (Up to 66.6 months) |
| Phoenix |
| Arizona |
| 85013 |
| United States |
| Neurology Center of North Orange County | Fullerton | California | 92835 | United States |
| UC San Diego | La Jolla | California | 92037 | United States |
| Keck School of Medicine of USC | Los Angeles | California | 90033 | United States |
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States |
| University of California San Francisco | San Francisco | California | 94143 | United States |
| CenExel Rocky Mountain Clinical Research, LLC | Englewood | Colorado | 80113 | United States |
| Institute for Neurodegenerative Disorders | New Haven | Connecticut | 06510 | United States |
| JEM Research LLC | Atlantis | Florida | 33462 | United States |
| Parkinson's Disease and Movement Disorders Center of Boca Raton | Boca Raton | Florida | 33486 | United States |
| Renstar Medical Research | Ocala | Florida | 34470 | United States |
| University of South Florida | Tampa | Florida | 33613-4706 | United States |
| Charter Research - Winter Park/Orlando | Winter Park | Florida | 32792 | United States |
| Northwestern University Feinberg School Of Medicine | Chicago | Illinois | 60611 | United States |
| Southern Illinois University, School of Medicine | Springfield | Illinois | 62702 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114-2759 | United States |
| Quest Research Institute | Farmington Hills | Michigan | 48334 | United States |
| Henry Ford Hospital | West Bloomfield | Michigan | 48322 | United States |
| Dent Neurological Institute | Amherst | New York | 14226 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| The Movement Disorder Clinic of Oklahoma | Tulsa | Oklahoma | 74136 | United States |
| University Pennsylvania Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Texas Neurology PA | Dallas | Texas | 75206 | United States |
| Baylor College of Medicine Medical Center | Houston | Texas | 77030 | United States |
| Central Texas Neurology Consultants | Round Rock | Texas | 78681 | United States |
| University of Vermont Medical Center | Burlington | Vermont | 05401 | United States |
| Sentara Neurology Specialists | Norfolk | Virginia | 23507 | United States |
| EvergreenHealth Investigational Drug Services | Kirkland | Washington | 98034 | United States |
| Inland Northwest Research | Spokane | Washington | 99202 | United States |
| Medizinische Universität Graz | Graz | 8036 | Austria |
| Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck | Innsbruck | 6020 | Austria |
| Klinik Ottakring | Vienna | 1160 | Austria |
| Toronto Memory Program | Toronto | Ontario | M3B 2S7 | Canada |
| Toronto Western Hospital | Toronto | Ontario | M5T 2S8 | Canada |
| Clinique Neuro Outaouais | Gatineau | Quebec | J8Y 1W2 | Canada |
| Montreal Neurological Institute and Hospital | Montreal | Quebec | H3A 2B4 | Canada |
| Groupe Hospitalier Pellegrin | Bordeaux | 33000 | France |
| Groupement Hospitalier Est - Hôpital Neurologique | Bron | 69677 | France |
| Hopital Gabriel Montpied | Clermont-Ferrand | 63003 | France |
| Hôpital Henri Mondor | Créteil | 94000 | France |
| Hôpital Michallon - Centre d'Investigation Clinique | Grenoble | 38043 | France |
| CHU de Limoges - Hôpital Dupuytren | Limoges | 87042 | France |
| hopital de la Timone | Marseille | 13385 | France |
| CHU Gui de Chauliac | Montpellier | 34000 | France |
| CHU de Nice Hopital Pasteur | Nice | 06002 | France |
| Hopital Pitie-Salpetriere APHP | Paris | 75013 | France |
| CHU Poitiers | Poitiers | 86021 | France |
| CHU Rouen Charles Nicolle | Rouen | 76031 | France |
| CHU de Nantes - Hopital Laennec | Saint-Herblain | 44800 | France |
| CHU Strasbourg Hpital Hautepierre | Strasbourg | 67098 | France |
| CIC - Hôpital Purpan | Toulouse | 31059 | France |
| Università degli studi della Campania Luigi Vanvitelli | Naples | Campania | 80138 | Italy |
| Az. Osp. OO.RR. S. Giovanni di Dio e Ruggi D' Aragona | Salerno | Campania | 84131 | Italy |
| Ospedale Bellaria | Bologna | Emilia-Romagna | 40139 | Italy |
| IRCCS San Raffaele;Clinical Trial Center | Rome | Lazio | 00166 | Italy |
| Policlinico Universitario Agostino Gemelli | Rome | Lazio | 00168 | Italy |
| Irccs A.O.U.San Martino Ist | Genoa | Liguria | 16132 | Italy |
| Azienda Ospedaliera Spedali Civili | Brescia | Lombardy | 25100 | Italy |
| IRCCS Ospedale San Raffaele | Milan | Lombardy | 20132 | Italy |
| IRCCS Istituto Neurologico Carlo Besta | Milan | Lombardy | 20133 | Italy |
| IRCCS Neuromed | Pozzilli (IS) | Molise | 86077 | Italy |
| A.O.U. Policlinico "G.Rodolico - San Marco" | Catania | Sicily | 95123 | Italy |
| A.O. Universitaria Pisana | Pisa | Tuscany | 56126 | Italy |
| AO di Perugia - Ospedale S. Maria della Misericordia | Perugia | Umbria | 06156 | Italy |
| Azienda Ospedaliera S. Maria | Terni | Umbria | 05100 | Italy |
| Azienda Ospedaliera di Padova | Padova | Veneto | 35128 | Italy |
| Centre Hospitalier de Luxembourg | Luxembourg | 1210 | Luxembourg |
| NeuroKlinika Gabinet Lekarski Prof. Andrzej Bogucki | ?ód? | 90-640 | Poland |
| NZOZ Vitamed | Bydgoszcz | 85-079 | Poland |
| Szpital Sw. Wojciecha | Gda?sk | 80-462 | Poland |
| Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K | Krakow | 31-505 | Poland |
| Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak. | Lublin | 20-016 | Poland |
| Nmedis sp. z o.o. | Rzeszów | 35-232 | Poland |
| Samodzielny Publiczny Szpital Kliniczny im. prof. Orlowskiego | Warsaw | 00-416 | Poland |
| Centrum Medyczne NeuroProtect | Warsaw | 01-684 | Poland |
| Mazowiecki Szpital Bródnowski w Warszawie Sp. z o.o. | Warsaw | 03-242 | Poland |
| Hospital General Universitario de Elche | Elche | Alicante | 03203 | Spain |
| Hospital General De Catalunya | Sant Cugat del Vallès | Barcelona | 8195 | Spain |
| PoliclÃnica Guipuzkoa | Donosti-San Sebastián | Guipuzcoa | 20014 | Spain |
| Complejo Hospitalario Universitario A Coruña (CHUAC) | A Coruña | LA Coruna | 15006 | Spain |
| Hospital Universitario Fundación Alcorcón | Alcorcón | Madrid | 28922 | Spain |
| HM Universitario Puerta del Sur CINAC (C.Integ.Neuroc); | Móstoles | Madrid | 28938 | Spain |
| Hospital Quiron de Madrid | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Clinica Universidad de Navarra | Pamplona | Navarre | 31008 | Spain |
| Hospital Virgen del Puerto | Plasencia | Palencia | 10600 | Spain |
| Hospital de Cruces | Barakaldo | Vizcaya | 48903 | Spain |
| Hospital Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Clinic Servicio de Neurologia | Barcelona | 08036 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08041 | Spain |
| Hospital Universitario de Burgos. Servicio de NeurologÃa | Burgos | 09006 | Spain |
| Hospital Ruber Juan Bravo | Madrid | 28006 | Spain |
| Hospital Universitario de la Princesa | Madrid | 28006 | Spain |
| Hospital General Universitario Gregorio Marañon | Madrid | 28007 | Spain |
| Hospital Universitario ClÃnico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Regional Universitario Carlos Haya | Málaga | 29010 | Spain |
| Hospital Universitario Virgen Macarena | Seville | 41009 | Spain |
| Hospital Virgen del RocÃo | Seville | 41013 | Spain |
| Hospital Universitario Dr. Peset | Valencia | 46017 | Spain |
| Hospital Universitari i Politecnic La Fe | Valencia | 46026 | Spain |
| Servicio de NeurologÃa Hospital Viamed Montecanal. | Zaragoza | 50012 | Spain |
| Ninewells Hospital, Dundee- Scotland | Dundee | DD2 1SY | United Kingdom |
| Kings College Hospital | London | SE5 9RS | United Kingdom |
| Charing Cross Hospital | London | W6 8RF | United Kingdom |
| Campus for Ageing and Vitality | Newcastle | NE4 5PL | United Kingdom |
| Oxford University Hospitals NHS Foundation Trust | Oxford | OX3 7LE | United Kingdom |
| North West Anglia NHS Foundation Trust | Peterborough | PE3 9GZ | United Kingdom |
| Derriford Hospital | Plymouth | PL6 8DH | United Kingdom |
Participants received prasinezumab, 1500 milligrams (mg), as an intravenous (IV) infusion, Q4W up to at least 76 weeks.
| FG002 | OLE Period: Prasinezumab | Eligible and consenting participants who completed the DBT period enrolled in the OLE period, to receive prasinezumab, 1500 mg, as an IV infusion, Q4W up to 104 weeks. |
| Safety Analysis Set (SAS) | SAS included all participants who received at least one dose of study drug, with participants grouped according to treatment received. |
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| COMPLETED |
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| NOT COMPLETED |
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| OLE Period |
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Full Analysis Set (FAS) included all randomized participants, with participants grouped according to their randomized treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | DBT Period: Placebo | Participants received prasinezumab matching placebo as an IV infusion, Q4W up to at least 76 weeks. |
| BG001 | DBT Period: Prasinezumab | Participants received prasinezumab, 1500 mg, as an IV infusion, Q4W up to at least 76 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | DBT Period: Time to Confirmed Motor Progression Event Assessed by Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III | 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. | FAS included all randomized participants, with participants grouped according to their randomized treatment. | Posted | Median | 95% Confidence Interval | weeks | From study start to end of DBT period to at least 76 weeks |
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| Secondary | DBT Period: Time-to-worsening of Participant's Motor Function as Reported by the Participant in the Presence of a Confirmed Motor Progression Event | Time to worsening of the motor function was defined as ≥3 points increase in MDS-UPDRS Part II score from baseline in the presence of a confirmed motor progression event. For the confirmed motor progression event the definition is as per primary endpoint definition. MDS-UPDRS Part II assesses motor experiences of daily living & contained 13 questions answered by participant. For each question a numeric score is assigned between 0-4, 0 = Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Score range: 0 to 52 with higher score=severe impairment. | FAS included all randomized participants, with participants grouped according to their randomized treatment. | Posted | Median | 95% Confidence Interval | weeks | From study start to end of DBT period to at least 76 weeks |
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| Secondary | DBT Period: Time to Meaningful Worsening in Participant Global Impression of Change (PGI-C) Overall Disease Subscale | The PGI is a measure commonly used in PD clinical trials to provide a concise assessment of overall health state. The change component (PGI-C) was intended to measure health state changes as reported by the participant on a 7-point scale (1=Very much improved to 7=Very much worse). The meaningfulness of the change was assessed and reported by the participant. | FAS included all randomized participants, with participants grouped according to their randomized treatment. | Posted | Median | 95% Confidence Interval | weeks | From study start to end of DBT period to at least 76 weeks |
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| Secondary | DBT Period: Time to Meaningful Worsening in Clinician Global Impression of Change (CGI-C) Overall Disease Subscale | The CGI was a measure commonly used in PD clinical trials to provide a concise assessment of overall health state. The change component (CGI-C) was intended to measure health state changes as reported by the clinician on a 7-point scale (1=Very much improved to 7=Very much worse). | FAS included all randomized participants, with participants grouped according to their randomized treatment. | Posted | Median | 95% Confidence Interval | weeks | From study start to end of DBT period to at least 76 weeks |
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| Secondary | DBT Period: Time to Onset of Motor Complications as Assessed Through MDS-UPDRS Part IV | MDS-UPDRS Part IV assessed motor complications of symptomatic treatment, dyskinesias, and motor fluctuations. The rater completed this assessment only for participants on L-Dopa treatment. | FAS included all randomized participants, with participants grouped according to their randomized treatment. | Posted | Median | 95% Confidence Interval | weeks | From study start to end of DBT period to at least 76 weeks |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | DBT Period: Change in Motor Function From Baseline to Week 76, as Measured by the MDS-UPDRS Part III Score | 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. | FAS included all randomized participants, with participants grouped according to their randomized treatment. Overall number analyzed is the number of participants with data available for analysis. | Posted | Mean | Standard Error | Units on a scale | From baseline up to Week 76 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | DBT Period: Change in Bradykinesia and Rigidity From Baseline to Week 76, as Measured by the MDS-UPDRS Part III Bradykinesia and Rigidity Subscore | 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. For bradykinesia, subscore ranges from 0 to 52, while rigidity subscore ranges from 0 to 20, with higher scores indicating greater impairment. Change in bradykinesia and rigidity was assessed in "OFF" medication state. Adjusted mean is reported here. | FAS included all randomized participants, with participants grouped according to their randomized treatment. Overall number analyzed is the number of participants with data available for analysis. | Posted | Mean | Standard Error | Units on a scale | From baseline up to Week 76 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | DBT Period: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptoms, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. SAE is any significant hazard, contraindication, or side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention. Number of participants with atleast 1 AE and SAE are reported here. | Safety Analysis Set (SAS) included all participants who received at least one dose of study drug, with participants grouped according to treatment received. 3 participants in the prasinezumab arm and 1 participant in the placebo arm were randomized but not treated and 2 participants randomized to placebo arm received 1 dose of prasinezumab and were included in the prasinezumab arm for safety analysis. | Posted | Count of Participants | Participants | From study start to end of DBT period to at least 76 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | DBT Period: Number of Participants With Adverse Events of Special Interest (AESI) | An AE was any untoward medical occurrence in participant administered a pharmaceutical product & which does not necessarily have to have a causal relationship with treatment. It can therefore be any unfavorable and unintended sign (including abnormal laboratory values/ abnormal clinical test results), symptoms/disease temporally associated with use of pharmaceutical product, whether/not considered related to product. AESIs included potential drug-induced liver injury that include an elevated alanine transaminase (ALT) & aspartate aminotransferase (AST) in combination with either an elevated bilirubin/clinical jaundice defined by Hy's law and suspected transmission of an infectious agent by study drug. | SAS included all participants who received at least one dose of study drug, with participants grouped according to treatment received. 3 participants in the prasinezumab arm and 1 participant in the placebo arm were randomized but not treated and 2 participants randomized to placebo arm received 1 dose of prasinezumab and were included in the prasinezumab arm for safety analysis. | Posted | Count of Participants | Participants | From study start to end of DBT period to at least 76 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | DBT Period: Number of Participants With Treatment Discontinuation Due to AEs | An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptoms, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. | SAS included all participants who received at least one dose of study drug, with participants grouped according to treatment received. 3 participants in the prasinezumab arm and 1 participant in the placebo arm were randomized but not treated and 2 participants randomized to placebo arm received 1 dose of prasinezumab and were included in the prasinezumab arm for safety analysis. | Posted | Count of Participants | Participants | From study start to end of DBT period to at least 76 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | DBT Period: Number of Participants With Infusion Related Reactions (IRRs) | IRRs were defined as any signs and symptoms (AEs) occurring during infusion and/or within 24 hours administration after the end of infusion and were considered related to study treatment by the investigator. Symptoms include flushing, rash, respiratory difficulty, hypotension, tachycardia. | SAS included all participants who received at least one dose of study drug, with participants grouped according to treatment received. 3 participants in the prasinezumab arm and 1 participant in the placebo arm were randomized but not treated and 2 participants randomized to placebo arm received 1 dose of prasinezumab and were included in the prasinezumab arm for safety analysis. | Posted | Count of Participants | Participants | From study start to end of DBT period to at least 76 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | DBT Period: Number of Participants With in Suicidal Ideation, as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) | C-SSRS=assessment tool used to assess lifetime suicidality of participant (at baseline) as well as any new instances of suicidality (C-SSRS since last visit). Structured interview prompts recollection of suicidal ideation, including intensity of ideation, behavior, and attempts with actual/potential lethality. Categories have binary responses (yes/no) and include Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent, Preparatory Acts and Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Suicidal ideation/behavior is indicated by a "yes" answer to any of the listed categories. Score of 0 is assigned if no suicide risk is present. Score of 1 or higher= suicidal ideation or behavior. Categories with non-zero values are only reported here. | SAS included all participants who received at least one dose of study drug, with participants grouped according to treatment received. | Posted | Count of Participants | Participants | From study start to end of DBT period to at least 76 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | DBT Period: Maximum Observed Concentration at Steady-state (Cmax,SS) | Pharmacokinetic (PK) Analysis Set (PAS) included all randomized participants exposed to study treatment with sufficient dosing information and at least one adequately documented and quantifiable prasinezumab concentration. | Posted | Median | 90% Confidence Interval | micrograms/milliliter (µg/mL) | Day 1 of Weeks 1, 2, 4, 8, 12, 24, 36, 52, 64, 76 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | DBT Period: Minimum Observed Concentration at Steady-state (Cmin,SS) | PAS included all randomized participants exposed to study treatment with sufficient dosing information and at least one adequately documented and quantifiable prasinezumab concentration. | Posted | Median | 90% Confidence Interval | µg/mL | Day 1 of Weeks 1, 2, 4, 8, 12, 24, 36, 52, 64, 76 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | DBT Period: Area Under the Serum Concentration Time Curve Over the Dosing Interval (AUCTau,SS) | PAS included all randomized participants exposed to study treatment with sufficient dosing information and at least one adequately documented and quantifiable prasinezumab concentration. | Posted | Median | 90% Confidence Interval | hours*microgram/milliter (h*µg/mL) | Day 1 of Weeks 1, 2, 4, 8, 12, 24, 36, 52, 64, 76 |
|
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| Secondary | DBT Period: Percentage of Participants With Anti-Drug Antibodies (ADAs) at Baseline and Post-Treatment | Immunogenicity population included all participants on active treatment with at least one ADA assessment. Percentages have been rounded off. | Posted | Number | percentage of participants | From study start to end of DBT period to at least 76 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | OLE Period: Number of Participants With AEs and SAEs | An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptoms, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. SAE is any significant hazard, contraindication, or side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention. | Not Posted | Dec 2027 | From signing of informed consent form up to 70 days after final dose of study treatment (Up to 66.6 months) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | OLE Period: Number of Participants With AESI | An AE was any untoward medical occurrence in participant administered a pharmaceutical product & which does not necessarily have to have a causal relationship with treatment. It can therefore be any unfavorable and unintended sign (including abnormal laboratory values/ abnormal clinical test results), symptoms/disease temporally associated with use of pharmaceutical product, whether/not considered related to product. AESIs included potential drug-induced liver injury that include an elevated ALT & AST in combination with either an elevated bilirubin/clinical jaundice defined by Hy's law and suspected transmission of an infectious agent by study drug. | Not Posted | Dec 2027 | From signing of informed consent form up to 70 days after final dose of study treatment (Up to 66.6 months) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | OLE Period: Number of Participants With IRRs | IRRs were defined as any signs and symptoms (AEs) occurring during infusion and/or within 24 hours administration after the end of infusion and were considered related to study treatment by the investigator. Symptoms include flushing, rash, respiratory difficulty, hypotension, tachycardia. | Not Posted | Dec 2027 | From signing of informed consent form up to 70 days after final dose of study treatment (Up to 66.6 months) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | OLE Period: Number of Participants With in Suicidal Ideation, as Measured by the C-SSRS | C-SSRS=assessment tool used to assess lifetime suicidality of participant (at baseline) as well as any new instances of suicidality (C-SSRS since last visit). Structured interview prompts recollection of suicidal ideation, including intensity of ideation, behavior, and attempts with actual/potential lethality. Categories have binary responses (yes/no) and include Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent, Preparatory Acts and Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Suicidal ideation/behavior is indicated by a "yes" answer to any of the listed categories. Score of 0 is assigned if no suicide risk is present. Score of 1 or higher= suicidal ideation or behavior. | Not Posted | Dec 2027 | From signing of informed consent form up to 70 days after final dose of study treatment (Up to 66.6 months) | Participants |
From study start until the end of DBT period for at least 76 weeks
SAS included all participants who received at least one dose of study drug, with participants grouped according to treatment received. Data collected up to primary completion date is reported. Final data would be reported 1 year after study completion. 3 participants in the prasinezumab arm and 1 participant in the placebo arm were randomized but not treated and 2 participants randomized to placebo arm received 1 dose of prasinezumab and were included in the prasinezumab arm for safety analysis.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DBT Period: Placebo | Participants received prasinezumab matching placebo as an IV infusion, Q4W up to at least 76 weeks. | 2 | 290 | 34 | 290 | 205 | 290 |
| EG001 | DBT Period: Prasinezumab | Participants received prasinezumab, 1500 mg, as an IV infusion, Q4W up to at least 76 weeks. | 1 | 292 | 34 | 292 | 206 | 292 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Epiretinal membrane | Eye disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Oesophageal food impaction | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Oesophageal perforation | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cyst | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Infusion site reaction | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia influenzal | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Shoulder fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Tendon disorder | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Metastatic malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Cerebrospinal fluid leakage | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Migraine with aura | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Appendicectomy | Surgical and medical procedures | MedDRA 27.1 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 5, 2024 | Sep 9, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Counts |
|---|
| Participants |
|
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|
|
|
|
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| Participants |
|
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| Units | Counts |
|---|
| Participants |
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| DBT Period: Prasinezumab |
Participants received prasinezumab, 1500 mg, as an IV infusion, Q4W up to at least 76 weeks. |
|
|
Participants received prasinezumab, 1500 mg, as an IV infusion, Q4W up to at least 76 weeks.
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Participants |
|
|
Participants received prasinezumab, 1500 mg, as an IV infusion, Q4W up to at least 76 weeks. |
|
|
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