Clinical trial NCT00761137: Safety and Efficacy Study of NH004 Films for Relief of Sialorrhea Symptoms in Parkinson's Disease Patients
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sialorrhea Secondary to Parkinson's Disease
Keywords: sialorrhea
drooling
excessive salivation
parkinson's disease
Lead sponsor: NeuroHealing Pharmaceuticals Inc.
Sponsor class: INDUSTRY
Collaborators: name: Michael J. Fox Foundation for Parkinson's Research
First posted: 2008-09-29
Enrollment: 19
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed description: NH004 contains the anticholinergic agent tropicamide and is delivered in a convenient product form (intra-oral dissolvable thin films) designed for the management of sialorrhea. This study is a double blind, placebo-controlled, crossover study of the safety and potential efficacy of three doses of of NH004 films for the short-term relief of the symptoms of sialorrhea in Parkinson's disease patients.

A total of up to 36 Parkinson's disease patients will be enrolled in the study in two Phases. Phase A will include 12 patients and Phase B up to 24 patients. There will be an interim analysis after conclusion of Phase A. In both phases patients will be randomized into one of four groups. Each group will have a distinctive sequence for receiving intra-oral dissolvable films of 0.3 mg, 1 mg, 3 mg of NH004, or placebo during four visits.

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.

Primary outcomes:
measure: Sialorrhea Visual Analogue Scale (VAS)
timeFrame: Before and 120 min after treatment administration
Secondary outcomes:
measure: Percentage Change in Saliva Volume
timeFrame: Before and 75 minutes after treatment administration
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: FLENI Hospital
Study officials:
affiliation: NeuroHealing Pharmaceuticals Inc.
name: Elkan R Gamzu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: FLENI Hospital, Argentina
name: Marcelo Merello, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 Parkinson's disease patients. J Neurol Sci. 2011 Nov 15;310(1-2):248-50. doi: 10.1016/j.jns.2011.05.021. Epub 2011 Jun 1.