---
title: A study of safety and tolerability (acceptability of potential side effects) of exidavnemab, at 2 different doses, in patients with Parkinson’s disease and in Patients with Multiple System Atrophy
euct_id: 2024-511222-30-00
phase: Phase 4
status: Recruiting
sponsor: BioArctic AB
canonical_url: "https://parkinsonspathways.com/trials/eu/2024-511222-30-00"
eu_clinical_trials_register: "https://euclinicaltrials.eu/ctis-public/view/2024-511222-30-00"
ctis_last_updated: "2026-04-21T03:45:09.352947862"
source: EU Clinical Trials Information System (CTIS)
---
# A study of safety and tolerability (acceptability of potential side effects) of exidavnemab, at 2 different doses, in patients with Parkinson’s disease and in Patients with Multiple System Atrophy

**EU CT Number:** [2024-511222-30-00](https://euclinicaltrials.eu/ctis-public/view/2024-511222-30-00)

## Key Facts

- **Phase:** Phase 4
- **Status:** Recruiting
- **Sponsor:** BioArctic AB
- **Start Date:** 2024-09-16
- **Completion Date:** 2026-08-17
- **Conditions:** Multiple System Atrophy, Parkinson’s Disease (PD), Parkinson's disease
- **Interventions:** Exidavnemab, nothing (blank / empty saline solution)

## Member States

Trial is authorized in 2 member states: Poland, Spain.

## Sites (7)

- University Hospital Virgen Del Rocio S.L., Sevilla, Spain
- Hospital Universitario Ramon Y Cajal, Madrid, Spain
- Hospital Universitari Vall D Hebron, Barcelona, Spain
- Policlinica Gipuzkoa S.A., Donostia, Spain
- Hospital Universitari General De Catalunya, Sant Cugat Del Valles, Spain
- Centrum Medyczne Neuromed Sp. z o.o., Bydgoszcz, Poland
- Krakowska Akademia Neurologii Sp. z o.o., Cracow, Poland

## Eligibility (CTIS)

- **Minimum age:** 18 Years
- **Sex:** ALL

```
Condition: Multiple System Atrophy; Parkinson’s Disease (PD); Parkinson's disease
Age groups: adults 18-64, elderly 65+
Sex: male, female
Includes a vulnerable population.

Period: Cohort 1
00 mg exidavnemab versus placebo
Blinding: The exidavnemab will be provided to trial sites open-label. Unblinded personnel will include designated representatives from the Sponsor or CRO to review unblinded safety data. The preparation of the trial medication will be completed by an unblinded pharmacist or delegate at the trial site.
Blinded personnel will include designated representatives from the trial site, Sponsor, and CRO. Participants, trial partners, the participants’ primary care physician, Investigators, and the SMC will be blinded to treatment group assignment. Blinded trial site personnel will complete administration of the trial medication. The trial medication and placebo will be administered in the same manner to maintain blinding of the treatment allocation.

Period: Cohort 2a
00 mg exidavnemab versus placebo
Blinding: The exidavnemab will be provided to trial sites open-label. Unblinded personnel will include designated representatives from the Sponsor or CRO to review unblinded safety data. The preparation of the trial medication will be completed by an unblinded pharmacist or delegate at the trial site.
Blinded personnel will include designated representatives from the trial site, Sponsor, and CRO. Participants, trial partners, the participants’ primary care physician, Investigators, and the SMC will be blinded to treatment group assignment. Blinded trial site personnel will complete administration of the trial medication. The trial medication and placebo will be administered in the same manner to maintain blinding of the treatment allocation.

Period: Cohort 2b
00 mg exidavnemab versus placebo
Blinding: The exidavnemab will be provided to trial sites open-label. Unblinded personnel will include designated representatives from the Sponsor or CRO to review unblinded safety data. The preparation of the trial medication will be completed by an unblinded pharmacist or delegate at the trial site.
Blinded personnel will include designated representatives from the trial site, Sponsor, and CRO. Participants, trial partners, the participants’ primary care physician, Investigators, and the SMC will be blinded to treatment group assignment. Blinded trial site personnel will complete administration of the trial medication. The trial medication and placebo will be administered in the same manner to maintain blinding of the treatment allocation.
```

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