Safety and Efficacy Study of NH004 Films for Relief of Sialorrhea Symptoms in Parkinson's Disease… (NCT00761137) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy Study of NH004 Films for Relief of Sialorrhea Symptoms in Parkinson's Disease Patients
Argentina19 participantsStarted 2008-03
Plain-language summary
The primary goal of the study is to evaluate the safety and potential efficacy of intra-oral dissolvable NH004 films to improve the short-term symptoms of sialorrhea (drooling) in Parkinson's disease (PD) patients.
Who can participate
Age range
50 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients with idiopathic Parkinson's disease, according to the United Kingdom Brain Bank criteria.
. Patients complaining of drooling, with a score of at least 3 in the FLENI Sialorrhea scale.
. Patient is between 50 and 80 years of age, inclusive.
. Male or non-pregnant female. Females of child-bearing potential will be required to have undergone a pregnancy test with negative results prior to entry to the study and agree to use contraceptive measures for the duration of the study.
. Patients must have used the same medication and dose for PD for the last month. No changes in the medication for PD are expected during the study.
. Patients who can reasonable be expected to be on "on-state" for the duration of the testing procedures.
. Patients who have a stable response to levodopa for PD.
Exclusion criteria
. Pregnant women or women who may become pregnant.
. Patients with a diagnosis of depression, schizophrenia or with obvious symptoms of these diseases.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sialorrhea Visual Analogue Scale (VAS)
Timeframe: Before and 120 min after treatment administration
. Patients with Mini-Mental State Examination (MMSE) score equal to or lower than 26.
. Patients who are receiving the following drugs: tricyclic antidepressants, Monoamine Oxidase Inhibitors (MAOI's), neuroleptics (antipsychotics), or anticholinergics.
. Patients who have taken any of the drugs mentioned in exclusion criteria number 4 within the last week.
. Patients with hypersensitivity to atropine or other anticholinergic drugs.
. Patients who have experienced adverse effects as a result of taking anticholinergic drugs.
. Patients taking hypnotic or other sleep inducing drugs.