Disease: Parkinson's disease
Type of study: Interventional trial
Coordinating investigators: Geir Olve Skeie
Study director/Chief investigator: Charalampos Tzoulis
Background: There are no disease-modifying therapies (DMTs) for PD and current trial designs are highly inefficient. The HYDRA initiative aims to revolutionise PD trials through an adaptive, multi-arm, multi-stage (MAMS) platform trial. This innovative approach simultaneously evaluates multiple DMTs against a single placebo, with the flexibility to discontinue ineffective treatments and reallocate participants to more promising arms. HYDRA will include 800 participants from 12 centres across Norway and test the efficacy of three potential DMTs in delaying the progression of PD, assessed by the total MDS-UPDRS score. Secondary outcomes include cognitive function, daily life activities, quality of life, and caregiver impact. Exploratory objectives involve digital and molecular biomarkers, long-term treatment effects, and personalised medicine strategies.
HYDRA's adaptive design ensures rigorous drug selection and employs a decentralised approach to minimise participant discomfort and enhance national recruitment. This platform will provide conclusive evidence on DMT efficacy within a 5-year period, potentially leading to regulatory approval and transforming PD treatment paradigms. The HYDRA initiative promises to enhance trial efficiency, accelerate therapeutic breakthroughs, reduce trial costs and duration, and improve the quality of life for individuals with PD. The study will recruit patients from across all four health regions of Norway. Additional patients will be recruited by our international partners, as necessary.
The HYDRA initiative aims to accelerate breakthroughs in the field of PD therapeutics by testing multiple potential disease-modifying therapies (DMTs) in parallel, with significantly less participants, shorter trial time, and substantially lower costs, compared to testing these treatments individually.
The primary objective is to evaluate whether the tested compounds can delay the progression of PD.
Primary endpoint: The between-group (NR vs. placebo) difference of the change in motor severity, measured by MDS-UPDRS total score (sum of parts I, II, and III) between baseline and end of study (week 52).
Status: The study has established its governing bodies, with its board and PPI group having two meetings in 2025. HYDRA has received funding from the Regional Health Authority of Western Norway and the Norwegian Parkinson Association, and further funding is sought from KlinBeForsk. The compounds are currently being secured, and the master protocol and two subprotocols are being established. Recruitment is planned to start in early 2027.
Participating centres
- Haukeland University Hospital, Bergen, Norway
- University of Oslo, Campus Akershus University Hospital, Norway
- Akershus University Hospital, Norway
- Vestre Viken Hospital, Norway
- Østfold Hospital, Norway
- Nordlandssykehuset, Bodø, Norway
- University Hospital of North Norway, Tromsø, Norway
- Førde Hospital, Norway
- Sørlandsklinikken, Arendal, Norway
- Sørlandet Hospital, Kristiansand, Norway
- Haugesund Hospital, Haugesund, Norway
- Molde Hospital, Norway
- Lillehammer Hospital, Norway
- Telemark Hospital, Norway
Funding
- KLINBEFORSK
- The Regional Health Authority of Western Norway
- The Research Council of Norway, Neuro-SysMed
- Haukeland University Hospital
- Participating hospitals
- Norwegian Parkinson Association
- Participating hospitals
More information
For more information or to join the study, please contact: neurosysmedstudier@helse-bergen.no