A Study of AB-1005 Gene Therapy in Japanese Adults With Moderate Parkinson's Disease (J-REGENERATE-PD) (J-REGENERATE-P)
A Phase 2, Open-label, Single Group, Fixed-dose Study to Evaluate the Safety and Efficacy of a Single Bilateral Intraputaminal Administration of AB-1005 (AAV2-GDNF Gene Therapy) in Japanese Participants With Moderate Stage Parkinson's Disease
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 2
Kontakter og plasseringer
Studiekontakt
- Navn: Bayer Clinical Trials Contact
- Telefonnummer: 18888422937
- E-post: clinical-trials-contact@bayer.com
Studiesteder
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Kyoto, Japan, 616-8255
- National Hospital Organization Utano National Hospital - Neurology
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Aichi-ken
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Nagoya, Aichi-ken, Japan, 453-0801
- Nagoya Central Hospital - Neurosurgery
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Nagoya, Aichi-ken, Japan, 466-8560
- Nagoya University Hospital - Neurology
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Kanagawa
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Yokohama, Kanagawa, Japan, 232-0024
- Yokohama City University Medical Center - Neurology
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Osaka
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Toyonaka, Osaka, Japan, 560-8552
- National Hospital Organization Osaka Toneyama Medical Center - Neurology
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Tokyo
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Bunkyo-ku, Tokyo, Japan, 113-8431
- Juntendo University Hospital - Neurology
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Male and female adults 45-75 years of age inclusive, at the time of signing of informed consent
Diagnosed with Parkinson's disease in the past 4-10 years (inclusive) and currently meeting all the following criteria:
- Presence of bradykinesia PLUS any of the following: rigidity, rest tremor, postural instability
- Presence of motor fluctuations as measured by the PD Motor Diary
- Stable anti-parkinsonian medication regimen for 4 weeks or more, prior to screening
- Responsiveness to levodopa therapy
Exclusion Criteria:
- Known history or current evidence of medical, genetic, or neurological conditions that may provide an alternative to idiopathic PD diagnosis
- Presence or history of significant vascular and/or cardiovascular disease
- Presence of clinically significant cognitive impairment
- Presence or history of psychosis or impulse control disorder
- History of malignancy other than treated cutaneous squamous or basal cell carcinomas
- Presence of clinically relevant conditions that could compromise surgical suitability and/or subject safety
- Contraindication to magnetic resonance imaging and/or use gadolinium-based contrast agents
- Prior history of brain surgery including, but no limited: DBS, pallidotomy focused ultrasound thalamotomy, or other experimental neurosurgical procedure
- Chronic immunosuppressive therapy
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: AB-1005 infusion
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Bilateral image-guided infusion of AAV2-GDNF into putamen, single dose
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence of adverse events up to Month 18 after study intervention
Tidsramme: Up to 18 months
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Number and proportion of participants with at least one adverse event
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Up to 18 months
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Change from Baseline to Month 18 in normalized Good ON time measured with PD Motor Diary
Tidsramme: Up to 18 months
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Up to 18 months
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
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
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 23015
- ASK-PD5-CS203 (Annen identifikator: Study ID)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access.
As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.
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