Safety and Efficacy Study of NH004 Films for Relief of Sialorrhea Symptoms in Parkinson's Disease Patients
Condition: Sialorrhea Secondary to Parkinson's Disease
MeSH terms: Sialorrhea; Parkinson Disease
Intervention: 0.3 mg tropicamide; 1 mg tropicamide; 3 mg tropicamide; 0 mg tropicamide
Intervention description: 0.3 mg tropicamide in intra-oral thin film; 1 mg tropicamide in intra-oral thin film; 3 mg tropicamide in intra-oral thin film; 0 mg tropicamide (placebo) in intra-oral thin film
Intervention MeSH terms: Tropicamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 19.0
Sex: All
Minimum age: 50 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: sialorrhea; drooling; excessive salivation; parkinson's disease

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with idiopathic Parkinson's disease, according to the United Kingdom Brain
             Bank criteria.

          2. Patients complaining of drooling, with a score of at least 3 in the FLENI Sialorrhea
             scale.

          3. Patient is between 50 and 80 years of age, inclusive.

          4. 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.

          5. 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.

          6. Patients who can reasonable be expected to be on "on-state" for the duration of the
             testing procedures.

          7. Patients who have a stable response to levodopa for PD.

        Exclusion Criteria:

          1. Pregnant women or women who may become pregnant.

          2. Patients with a diagnosis of depression, schizophrenia or with obvious symptoms of
             these diseases.

          3. Patients with Mini-Mental State Examination (MMSE) score equal to or lower than 26.

          4. Patients who are receiving the following drugs: tricyclic antidepressants, Monoamine
             Oxidase Inhibitors (MAOI's), neuroleptics (antipsychotics), or anticholinergics.

          5. Patients who have taken any of the drugs mentioned in exclusion criteria number 4
             within the last week.

          6. Patients with hypersensitivity to atropine or other anticholinergic drugs.

          7. Patients who have experienced adverse effects as a result of taking anticholinergic
             drugs.

          8. Patients taking hypnotic or other sleep inducing drugs.

          9. Patients with severe urinary or gastrointestinal symptoms.

         10. Patients with significant dental/oral pathology.

         11. Patients with severe dysautonomia.