Study to Test Effects and Safety of RO7568282 in Early Parkinson's Disease (TARBELA-PD)
A Phase II, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of RO7568282 in Participants With Early-stage Parkinson's Disease
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of RO7568282 compared with placebo in participants with early-stage Parkinson's disease (PD) on stable symptomatic monotherapy with levodopa.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Studiekontakt
- Navn: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Studer Kontakt Backup
- Navn: Reference Study ID Number: BP46441 https://forpatients.roche.com/ No email attachments.
- Telefonnummer: 888-662-6728
- E-post: global-roche-genentech-trials@gene.com
Studiesteder
-
-
-
Dundee, Storbritannia, DD2 1SY
- Ninewells Hospital, Dundee- Scotland
-
London, Storbritannia, E1 1FR
- Royal London Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Must be aged 40 to 85 years inclusive
- Diagnosis of idiopathic PD
- Has received stable doses of monotherapy treatment with levodopa for at least 2 months prior to baseline
- Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV score of 0 at screening and prior to randomization at baseline
- Hoehn and Yahr (H&Y) Stage ≤ 3 (assessed in off medication state) at screening and prior to randomization at baseline
- Able to swallow whole capsules
Exclusion Criteria:
- Medical history indicating a parkinsonian syndrome other than idiopathic PD
- Diagnosis of PD dementia
- Diagnosis of a significant neurologic disease other than PD
- Within the last year, unstable or clinically significant cardiovascular disease
- Chronic uncontrolled hypertension
- History or presence of brain magnetic resonance imaging (MRI) scan showing evidence of structural abnormalities, other than related to PD
Note: Other protocol-defined inclusion/exclusion criteria also apply
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: RO7568282 High Dose
RO7568282 will be administered as per the schedule specified in the protocol. |
RO7568282 will be administered as per the schedule specified in the protocol. |
|
Eksperimentell: RO7568282 Low Dose
RO7568282 will be administered as per the schedule specified in the protocol. |
RO7568282 will be administered as per the schedule specified in the protocol. |
|
Placebo komparator: Placebo
Placebo will be administered as per the schedule specified in the protocol. |
Placebo will be administered as per the schedule specified in the protocol. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Time to a Confirmed Motor Progression Event From the Randomization Date, as Measured by the MDS-UPDRS Part III Score
Tidsramme: Up to at least Week 104
|
Up to at least Week 104
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in Motor Signs From Baseline at Week 104, as Measured by the MDS-UPDRS Part III Score
Tidsramme: Baseline and Week 104
|
Baseline and Week 104
|
|
Time to Worsening of Participants' Motor Function, as Reported by the Participant in the Presence of a Confirmed Motor Progression Event
Tidsramme: Up to at least Week 104
|
Up to at least Week 104
|
|
Incidence of Adverse Events (AEs)
Tidsramme: Up to at least Week 104
|
Up to at least Week 104
|
|
Change From Baseline in Columbia-suicide Severity Rating Scale (C-SSRS)
Tidsramme: Up to at least Week 104
|
Up to at least Week 104
|
|
Plasma Concentrations of RO7568282
Tidsramme: Up to at least Week 104
|
Up to at least Week 104
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Clinical Trials, Hoffmann-La Roche
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- BP46441
- 2025-524064-37-00 (Ctis)
- 2025 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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
Legemiddel- og utstyrsinformasjon, studiedokumenter
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