Pharmacologically modulating the noradrenergic arousal system to reduce freezing of gait in Parkinson’s disease: a multi-center and multi-modal approach.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Stichting Radboud universitair medisch centrum

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

19 Jan 2026 → ongoing

Decision date (initial)

2025-06-30

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

To study the effect of atomoxetine FOG severity in the dopaminergic OFF-state.

Secondary objectives 2

1. To study the effect of atomoxetine FOG severity in the dopaminergic ON-state.
2. To evaluate the effect of atomoxetine on brain network topology, and relate this to FOG severity.

Conditions and MedDRA coding

Parkinson's disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Male or female aged 18 years or older
2. Diagnosis of idiopathic Parkinson's disease according to Movement Disorders Society Diagnostic Criteria
3. Stabilised on optimal dopaminergic treatment for a minimum of four weeks prior to the baseline visit (Visit 1)
4. Presence of freezing of gait symptoms on a daily basis
5. Ability to walk for 10-meters unaided in the dopaminergic ON-state
6. Ability to provide written informed consent in accordance with ICH-GCP and local regulations
7. Willing and able to undergo all clinical trial assessments

Exclusion criteria 15

1. Current and/or previous (within 3 months) participation in a clinical trial
2. Any contra-indications for undergoing MRI-scanning (e.g. claustrophobia or metal parts within the body such as DBS, an infusion pump or a pacemaker)
3. Co-morbidity that significantly impacts ambulation (e.g. orthopaedic or rheumatological ailments)
4. Severe cognitive impairment hampering the ability to comply with the study protocol
5. Active psychosis that would impact the ability to comply with the study protocol
6. Severe cardiovascular disorders: severe hypertension (Sustained (Sitting) hypertension of ≥180 mmHg systolic or ≥110 mmHg diastolic, defined by the average of three observations, each at least 3 minutes apart, with the participant having assumed the required position for at least 3 minutes), heart failure, arterial occlusive disease, angina, haemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, potentially life-threatening arrhythmias, long QT interval syndrome (QTc > 500ms zettBa-formula) and channelopathies that would significantly compromise participant safety
7. Severe cerebrovascular disorders: cerebral aneurysm or recent/significant stroke
8. Hepatic or renal insufficiency
9. Narrow angle glaucoma
10. (History of) pheochromocytoma
11. Use of noradrenergic agents
12. Use of CYP2D6 inhibitors (SSRIs, quinidine, terbinafine)
13. Use of high dose salbutamol (or other beta2 agonists)
14. Pregnancy and/or breastfeeding
15. Known hypersensitivity to atomoxetine

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The effect of atomoxetine vs. placebo on the percentage of time frozen during FOG-provoking gait tasks in the dopaminergic OFF-state.

Secondary endpoints 2

1. The effect of atomoxetine vs. placebo on the percentage of time frozen during FOG-provoking gait tasks in the dopaminergic ON-state.
2. The effect of atomoxetine vs placebo on brain network topology, as calculated by the average integration/segregation coefficient.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Stichting Radboud universitair medisch centrum

Sponsor organisation

Stichting Radboud universitair medisch centrum

Address

Geert Grooteplein Zuid 10

City

Nijmegen

Postcode

6525 GA

Country

Netherlands

Scientific contact point

Organisation

Stichting Radboud universitair medisch centrum

Contact name

Franka Goossens

Public contact point

Organisation

Stichting Radboud universitair medisch centrum

Contact name

Franka Goossens

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 17 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications