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Safety and Efficacy Study of NH004 Films for Relief of Sialorrhea Symptoms in Parkinson's Disease Patients (NH004-2)

Primary Purpose

Sialorrhea Secondary to Parkinson's Disease

Status
Completed
Phase
Phase 2
Locations
Argentina
Study Type
Interventional
Intervention
0.3 mg tropicamide
1 mg tropicamide
3 mg tropicamide
0 mg tropicamide
Sponsored by
NeuroHealing Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sialorrhea Secondary to Parkinson's Disease focused on measuring sialorrhea, drooling, excessive salivation, parkinson's disease

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • FLENI Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Tropicamide placebo

Tropicamide 0.3 mg

Tropicamide 1 mg

Tropicamide 3 mg

Arm Description

subject received (blinded) each of the 4 drug doses at different visits - 0 mg tropicamide, 0.3 mg tropicamide, 1 mg tropicamide, 3 mg tropicamide

subject received (blinded) each of the 4 drug doses at different visits - 0.3 mg tropicamide, 1 mg tropicamide, 3 mg tropicamide, 0 mg tropicamide

subject received (blinded) each of the 4 drug doses at different visits - 1 mg tropicamide, 3 mg tropicamide, 0 mg tropicamide, 0.3 mg tropicamide

subject received (blinded) each of the 4 drug doses at different visits - 3 mg tropicamide, 0 mg tropicamide, 0.3 mg tropicamide, 1 mg tropicamide

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 25, 2008
Last Updated
September 22, 2015
Sponsor
NeuroHealing Pharmaceuticals Inc.
Collaborators
Michael J. Fox Foundation for Parkinson's Research
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1. Study Identification

Unique Protocol Identification Number
NCT00761137
Brief Title
Safety and Efficacy Study of NH004 Films for Relief of Sialorrhea Symptoms in Parkinson's Disease Patients
Acronym
NH004-2
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

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NeuroHealing Pharmaceuticals Inc.
Collaborators
Michael J. Fox Foundation for Parkinson's Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sialorrhea Secondary to Parkinson's Disease
Keywords
sialorrhea, drooling, excessive salivation, parkinson's disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tropicamide placebo
Arm Type
Experimental
Arm Description
subject received (blinded) each of the 4 drug doses at different visits - 0 mg tropicamide, 0.3 mg tropicamide, 1 mg tropicamide, 3 mg tropicamide
Arm Title
Tropicamide 0.3 mg
Arm Type
Experimental
Arm Description
subject received (blinded) each of the 4 drug doses at different visits - 0.3 mg tropicamide, 1 mg tropicamide, 3 mg tropicamide, 0 mg tropicamide
Arm Title
Tropicamide 1 mg
Arm Type
Experimental
Arm Description
subject received (blinded) each of the 4 drug doses at different visits - 1 mg tropicamide, 3 mg tropicamide, 0 mg tropicamide, 0.3 mg tropicamide
Arm Title
Tropicamide 3 mg
Arm Type
Experimental
Arm Description
subject received (blinded) each of the 4 drug doses at different visits - 3 mg tropicamide, 0 mg tropicamide, 0.3 mg tropicamide, 1 mg tropicamide
Intervention Type
Drug
Intervention Name(s)
0.3 mg tropicamide
Other Intervention Name(s)
NH004
Intervention Description
0.3 mg tropicamide in intra-oral thin film
Intervention Type
Drug
Intervention Name(s)
1 mg tropicamide
Other Intervention Name(s)
NH004
Intervention Description
1 mg tropicamide in intra-oral thin film
Intervention Type
Drug
Intervention Name(s)
3 mg tropicamide
Other Intervention Name(s)
NH004
Intervention Description
3 mg tropicamide in intra-oral thin film
Intervention Type
Drug
Intervention Name(s)
0 mg tropicamide
Other Intervention Name(s)
NH004 (placebo)
Intervention Description
0 mg tropicamide (placebo) in intra-oral thin film
Primary Outcome Measure Information:
Title
Sialorrhea Visual Analogue Scale (VAS)
Description
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.
Time Frame
Before and 120 min after treatment administration
Secondary Outcome Measure Information:
Title
Percentage Change in Saliva Volume
Description
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.
Time Frame
Before and 75 minutes after treatment administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elkan R Gamzu, PhD
Organizational Affiliation
NeuroHealing Pharmaceuticals Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marcelo Merello, MD, PhD
Organizational Affiliation
FLENI Hospital, Argentina
Official's Role
Principal Investigator
Facility Information:
Facility Name
FLENI Hospital
City
Buenos Aires
Country
Argentina

12. IPD Sharing Statement

Citations:
PubMed Identifier
21636098
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.
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Safety and Efficacy Study of NH004 Films for Relief of Sialorrhea Symptoms in Parkinson's Disease Patients

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