Phase 2
N=19
Safety and Efficacy Study of NH004 Films for Relief of Sialorrhea Symptoms in Parkinson's Disease Patients
Sialorrhea Secondary to Parkinson's Disease
Bottom Line
View on ClinicalTrials.gov: NCT00761137 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Oct 2015
Primary outcome: Primary: Sialorrhea Visual Analogue Scale (VAS) — -0.55; -1.08; -1.53; -0.81 cm on VAS — p=0.6
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 0.3 mg tropicamide (Drug); 1 mg tropicamide (Drug); 3 mg tropicamide (Drug); 0 mg tropicamide (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- NeuroHealing Pharmaceuticals Inc.
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sialorrhea Visual Analogue Scale (VAS) |
-0.55; -1.08; -1.53; -0.81 | 0.6 |
| SECONDARY Percentage Change in Saliva Volume |
-5; -27; -33; -20 | — |
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
- 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.
- 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.
- Patients with severe urinary or gastrointestinal symptoms.
- Patients with significant dental/oral pathology.
- Patients with severe dysautonomia.
Data sourced from ClinicalTrials.gov (NCT00761137). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.