Parkinson's Disease (PD)Phase 3AnTi-FREEZENCT07316296
Pharmacologically Modulating the Noradrenergic Arousal System to Reduce Freezing of Gait in Parkinson's Disease: a Multi-centre and Multi-modal Approach
A Phase 3 study testing Atomoxetine in people with Parkinson's Disease (PD) and Freezing of Gait, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The goal of this clinical trial is to learn if the medication atomoxetine can reduce freezing of gait in people with Parkinson's disease. The main questions it aims to answer is: Does atomoxetine reduce the frequency or severity of freezing of gait? What role does noradrenaline play in freezing of gait? Researchers… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease (PD), Freezing of Gait, Freezing of Gait Symptoms in Parkinson Disease
- What is being tested?
- Atomoxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2026to 31 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older;
- Diagnosis of idiopathic PD according to MDS Diagnostic Criteria;
- Stabilised on optimal dopaminergic PD treatment for a minimum of four weeks prior to the baseline visit (Visit 1) and for the duration of the trial;
- Presence of FOG symptoms on a daily basis;
- Ability to walk for 10-meters unaided in the dopaminergic ON-state;
- Ability to provide written informed consent in accordance with ICH-GCP and local regulations;
- Willing and able to undergo all clinical trial assessments.
Who cannot join
- Current and/or previous (within 3 months) participation in a clinical trial;
- 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);
- Co-morbidity that significantly impacts ambulation (e.g. orthopaedic or rheumatological ailments);
- Severe cognitive impairment hampering the ability to comply with the study protocol;
- Active psychosis that would impact the ability to comply with the study protocol;
- 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 Bazett-formula) and channelopathies that in the opinion of the study PI would significantly compromise participant safety;
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- Severe cerebrovascular disorders: cerebral aneurysm or recent/significant stroke;
- Hepatic or renal insufficiency that in the opinion of the Principal Investigator would impact on the ability of the participant to safely participate;
- Narrow angle glaucoma;
- (History of) pheochromocytoma;
- Use of noradrenergic agents;
- Use of CYP2D6 inhibitors (SSRIs, quinidine, terbinafine);
- Use of high dose salbutamol (or other beta2 agonists) that in the opinion of the Principal Investigator would impact on the ability of the participant to safely participate;
- Pregnancy and/or breastfeeding;
- Known hypersensitivity to atomoxetine.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Radboudumc
Nijmegen, Gelderland, 6525 GA
Franka Goossens, +31243668426, franka.goossens@radboudumc.nl
About this study
The goal of this clinical trial is to learn if the medication atomoxetine can reduce freezing of gait in people with Parkinson's disease. The main questions it aims to answer is:
Does atomoxetine reduce the frequency or severity of freezing of gait? What role does noradrenaline play in freezing of gait?
Researchers will compare atomoxetine to a placebo to see if atomoxetine can improve freezing of gait in people with Parkinson's disease.
Participants will:
Visit the study site for measurements Take atomoxetine or placebo Perform walking assessments and undergo MRI Complete questionnaires about anxiety, stress, and quality of life
- Conditions
- Parkinson's Disease (PD), Freezing of Gait, Freezing of Gait Symptoms in Parkinson Disease
- Being tested
- Atomoxetine, Placebo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtomoxetineDrug
Single dose, 40mg atomoxetine, capsule
PlaceboDrug
Single dose, placebo (microcrystalline cellulose), capsule
| Study group | Role | What they receive |
|---|---|---|
| Atomoxetine in visit 2 and placebo in visit 3 | Experimental | Not described Receives: Drug: Atomoxetine; Drug: Placebo |
| Placebo in visit 2 and atomoxetine in visit 3 | Experimental | Not described Receives: Drug: Atomoxetine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of time frozen in the dopaminergic OFF-state
Measured: Baseline, visit 2 (one week after baseline) and visit 3 (one week after visit 2).
Secondary outcomes (2)
The percentage of time frozen in the dopaminergic ON-state
Measured: Baseline, visit 2 (one week after baseline) and visit 3 (one week after visit 2).
The brain network integration-segregation coefficient
Measured: Visit 2 (one week after baseline) and visit 3 (one week after visit 2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start1 Jan 2026
- Primary completion1 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease (PD)Studies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Waterloo, Macquarie University, Australia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07316296
- Sponsor's protocol ID
- R0007688A
- Acronym
- AnTi-FREEZE
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacologically Modulating the Noradrenergic Arousal System to Reduce Freezing of Gait in Parkinson's Disease: a Multi-centre and Multi-modal Approach
- ClinicalTrials.gov ID
- NCT07316296
- Acronym / sponsor ID
- AnTi-FREEZE / R0007688A
- Conditions
- Parkinson's Disease (PD), Freezing of Gait, Freezing of Gait Symptoms in Parkinson Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- University of Waterloo, Macquarie University, Australia
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if the medication atomoxetine can reduce freezing of gait in people with Parkinson's disease. The main questions it aims to answer is:
Does atomoxetine reduce the frequency or severity of freezing of gait? What role does noradrenaline play in freezing of gait?
Researchers will compare atomoxetine to a placebo to see if atomoxetine can improve freezing of gait in people with Parkinson's disease.
Participants will:
Visit the study site for measurements Take atomoxetine or placebo Perform walking assessments and undergo MRI Complete questionnaires about anxiety, stress, and quality of life
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atomoxetine in visit 2 and placebo in visit 3 | Experimental | Drug: Atomoxetine, Drug: Placebo |
| Placebo in visit 2 and atomoxetine in visit 3 | Experimental | Drug: Atomoxetine, Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18 years or older;
- Diagnosis of idiopathic PD according to MDS Diagnostic Criteria;
- Stabilised on optimal dopaminergic PD treatment for a minimum of four weeks prior to the baseline visit (Visit 1) and for the duration of the trial;
- Presence of FOG symptoms on a daily basis;
- Ability to walk for 10-meters unaided in the dopaminergic ON-state;
Key exclusion criteria (15 listed)
- Current and/or previous (within 3 months) participation in a clinical trial;
- 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);
- Co-morbidity that significantly impacts ambulation (e.g. orthopaedic or rheumatological ailments);
- Severe cognitive impairment hampering the ability to comply with the study protocol;
- Active psychosis that would impact the ability to comply with the study protocol;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtomoxetineSingle dose, 40mg atomoxetine, capsule | Drug | Atomoxetine in visit 2 and placebo in visit 3, Placebo in visit 2 and atomoxetine in visit 3 |
| PlaceboSingle dose, placebo (microcrystalline cellulose), capsule | Drug | Atomoxetine in visit 2 and placebo in visit 3, Placebo in visit 2 and atomoxetine in visit 3 |
Primary outcome
The percentage of time frozen in the dopaminergic OFF-state
Time frame: Baseline, visit 2 (one week after baseline) and visit 3 (one week after visit 2).
2 secondary outcomes
The percentage of time frozen in the dopaminergic ON-state
Time frame: Baseline, visit 2 (one week after baseline) and visit 3 (one week after visit 2).
The brain network integration-segregation coefficient
Time frame: Visit 2 (one week after baseline) and visit 3 (one week after visit 2).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atomoxetine in people with Parkinson's Disease (PD) and Freezing of Gait, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of time frozen in the dopaminergic OFF-state (time frame: Baseline, visit 2 (one week after baseline) and visit 3 (one week after visit 2).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.