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Pharmacologically Modulating the Noradrenergic Arousal System to Reduce Freezing of Gait in Parkinson's Disease: a Multi-centre and Multi-modal Approach

ConditionsParkinson's Disease (PD)Freezing of GaitFreezing of Gait Symptoms in Parkinson Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorRadboud University Medical Center

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Crossover

Treatments tested in this trial

  • Atomoxetine

    Drug

    Single dose, 40mg atomoxetine, capsule

  • Placebo

    Drug

    Single dose, placebo (microcrystalline cellulose), capsule

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Atomoxetine in visit 2 and placebo in visit 3Experimental treatment 2 interventions
Group B: Placebo in visit 2 and atomoxetine in visit 3Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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).

Secondary outcomes

1

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).
2

The brain network integration-segregation coefficient

Time frame
Visit 2 (one week after baseline) and visit 3 (one week after visit 2).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Radboud University Medical Center

Lead sponsor

University of Waterloo

Collaborator

Macquarie University, Australia

Collaborator

Source ClinicalTrials.gov
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