Status:
COMPLETED
Safety and Efficacy Study of NH004 Films for Relief of Sialorrhea Symptoms in Parkinson's Disease Patients
Lead Sponsor:
NeuroHealing Pharmaceuticals Inc.
Collaborating Sponsors:
Michael J. Fox Foundation for Parkinson's Research
Conditions:
Sialorrhea Secondary to Parkinson's Disease
Eligibility:
All Genders
50-80 years
Phase:
PHASE2
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00761137
Start Date
March 1 2008
End Date
June 1 2010
Last Update
October 12 2015
Active Locations (1)
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1
FLENI Hospital
Buenos Aires, Argentina