| Eligibility |
Inclusion Criteria:
- Adult participants (aged 18 - 85 years inclusive)
Have been diagnosed with PD according to the UK Brain Bank Criteria
Participants must have demonstrated a positive response to oral DRTS have been treated with
oral DRTs for minimum of three years prior to the screening visit,
Report limitation to activities of daily living (must respond affirmatively to question 5
in section 1 of MANAGE-PD at study screen)
Participants must be able and willing to consent to participate in the study.
Participants must be willing and able to comply with study requirements.
Participants and investigators must expect that the participant will be able to remain on a
stable regimen of concomitant therapies used for the management of PD motor and non-motor
symptoms and not to introduce new medications used to treat motor or non-motor symptoms
associated with PD during the RCT or the first three months of the OLE. Details are
specified in the Concomitant Medication section below.
Participants must have at minimum a moderate burden of NMS (i.e. MDS-UPDRS part I scores =
11)65 at study screen to avoid floor effects for the primary endpoint (MDS-NMS).
The principal investigator or designee must have confidence in the participant's ability to
reliably use the TNM™ device, understand the assessments (provided in English only) and to
complete the assessment battery within a given on-state period. Expected duration of each
clinic visit can be found in the SOE.
Must have a study partner (defined as someone who sees the participant for more than one
hour a day, 3x per week) that is willing to consent and participate in the trial.
Participants must have capabilities to use and access smartphones and or tablets for the
collection of some study data. for the collection of some study data and/or computers for
access to telemedicine platforms.
Must be willing to answer questions related to sexual interest, arousal and performance in
an interview with study staff.
Exclusion Criteria:
Participant anticipates being unable to attend all visits and complete all study activities
in both the RCT and OLE.
Women of child-bearing potential who are pregnant or plan to become pregnant during the
course of the RCT or OLE
Women of child-bearing potential (i.e., are not yet 3 years removed from their first
menopausal symptom), who are not abstinent or exclusively in same sex relationships must:
- Test negative for pregnancy as indicated by a negative urine pregnancy test
- Agree to use an approved contraception method for the entirety of the RCT and OLE
Have a history or prior diagnosis of dementia or adjusted score = 20 on the Montreal
Cognitive Assessment (MoCA) at the screening visit
**This exclusion criterion has been set specifically to improve the validity of scores
assessed from the scaled questionnaires rather than reflecting a particular concern about
safety for this population
Have experienced a myocardial infarction, angina or stroke within the past 12 months
Are receiving deep brain stimulation therapy
Are treated with a pump for continuous delivery of dopamine replacement therapy
Use apomorphine rescue
Have received MRI guided high intensity focused ultrasound within the past 12 months
Experience frequent falls (defined by scores of 3 on question 19 from MANAGE-PD)
Work night shifts
Have any significant co-morbidity or illness which in the opinion of the investigator would
prevent safe participation in the study, compliance with protocol requirements or which
presents with symptoms that are also common in PD
demonstrate suicidality at screening (scores = 4 on the C-SSRS Baseline "In the past Month"
section)). Participants that respond affirmatively to this question should receive a
referral for mental health counseling according to local site regulations and standards.
Use a hearing aid that is implanted or that cannot be easily removed and replaced
Have a cochlear implant
Have chronic (>3 months) tinnitus
Have previously been diagnosed with traumatic brain injury with ongoing sequalae
Have been diagnosed with a co-morbid neurological disorder that may present with symptoms
overlapping with PD (e.g., stroke, brain tumor, epilepsy, Alzheimer's disease, multiple
sclerosis, amyotrophic lateral sclerosis, atypical Parkinsonism or aneurysm)
Have been previously diagnosed with vestibular dysfunction
Currently abuse alcohol, abuse drugs, including legal, illegal or prescribed drugs, or use
any drugs excluded as noted in the Excluded Medications List in section 5.3.2
Have unresolved complications from a previous surgical procedure at the baseline visits,
such as swelling or persistent pain, that requires medical intervention
Have active ear infections, perforated tympanic membrane or labyrinthitis, as identified by
a general ear examination performed by medically qualified Investigators
Have a recent history of frequent ear infections (= 1 per year over the past two years)
Are currently enrolled or have participated in another interventional clinical trial within
the last 30 days
Has a planned surgery scheduled to occur during the RCT or the first 90 days of the OLE
that requires sedation and/or would typically be followed with a prescription for pain
management
Have head eye surgery within the previous three months or ear surgery within the previous
six months
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