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 range50 Years – 80 Years
SexALL
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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.
✕. 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.
What they're measuring
1
Sialorrhea Visual Analogue Scale (VAS)
Timeframe: Before and 120 min after treatment administration