Sialorrhea Secondary to Parkinson's Disease Clinical Trial
— NH004-2Official title:
A Two-Phase, Double Blind, Placebo-Controlled, Randomized, Crossover Study of the Safety and Efficacy of Intra-Oral NH004 Films for the Short-Term Relief of Sialorrhea Symptoms in Parkinson's Disease Patients
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.
| Status | Completed |
| Enrollment | 19 |
| Est. completion date | June 2010 |
| Est. primary completion date | June 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 50 Years to 80 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | FLENI Hospital | Buenos Aires |
| Lead Sponsor | Collaborator |
|---|---|
| NeuroHealing Pharmaceuticals Inc. | Michael J. Fox Foundation for Parkinson's Research |
Argentina,
Lloret SP, Nano G, Carrosella A, Gamzu E, Merello M. A double-blind, placebo-controlled, randomized, crossover pilot study of the safety and efficacy of multiple doses of intra-oral tropicamide films for the short-term relief of sialorrhea symptoms in Par — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Sialorrhea Visual Analogue Scale (VAS) | Saliva buccal assessment was evaluated by an VAS scale before, and 15, 30, 45, 60, 90, and 120 min after treatment administration. Subjects were asked to rate how much saliva they perceived in their buccal cavity on an unmarked 0 to 10 cm line, higher scores meaning greater perceived buccal saliva levels. | Before and 120 min after treatment administration | No |
| Secondary | Percentage Change in Saliva Volume | Saliva volume was measured at baseline and 75 minutes after treatment administration. Volumes were measured by using cotton rolls placed near each Stenton duct and below the tongue for 5 minutes; cotton rolls were centrifuged and the volume of saliva determined. | Before and 75 minutes after treatment administration | No |