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

September 22, 2015 updated by: NeuroHealing Pharmaceuticals Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • FLENI Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tropicamide placebo
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
Drug: 0.3 mg tropicamide
0.3 mg tropicamide in intra-oral thin film
Other Names:
  • NH004
Drug: 1 mg tropicamide
1 mg tropicamide in intra-oral thin film
Other Names:
  • NH004
Drug: 3 mg tropicamide
3 mg tropicamide in intra-oral thin film
Other Names:
  • NH004
Drug: 0 mg tropicamide
0 mg tropicamide (placebo) in intra-oral thin film
Other Names:
  • NH004 (placebo)
Experimental: Tropicamide 0.3 mg
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
Drug: 0.3 mg tropicamide
0.3 mg tropicamide in intra-oral thin film
Other Names:
  • NH004
Drug: 1 mg tropicamide
1 mg tropicamide in intra-oral thin film
Other Names:
  • NH004
Drug: 3 mg tropicamide
3 mg tropicamide in intra-oral thin film
Other Names:
  • NH004
Drug: 0 mg tropicamide
0 mg tropicamide (placebo) in intra-oral thin film
Other Names:
  • NH004 (placebo)
Experimental: Tropicamide 1 mg
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
Drug: 0.3 mg tropicamide
0.3 mg tropicamide in intra-oral thin film
Other Names:
  • NH004
Drug: 1 mg tropicamide
1 mg tropicamide in intra-oral thin film
Other Names:
  • NH004
Drug: 3 mg tropicamide
3 mg tropicamide in intra-oral thin film
Other Names:
  • NH004
Drug: 0 mg tropicamide
0 mg tropicamide (placebo) in intra-oral thin film
Other Names:
  • NH004 (placebo)
Experimental: Tropicamide 3 mg
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
Drug: 0.3 mg tropicamide
0.3 mg tropicamide in intra-oral thin film
Other Names:
  • NH004
Drug: 1 mg tropicamide
1 mg tropicamide in intra-oral thin film
Other Names:
  • NH004
Drug: 3 mg tropicamide
3 mg tropicamide in intra-oral thin film
Other Names:
  • NH004
Drug: 0 mg tropicamide
0 mg tropicamide (placebo) in intra-oral thin film
Other Names:
  • NH004 (placebo)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sialorrhea Visual Analogue Scale (VAS)
Time Frame: Before and 120 min after treatment administration
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage Change in Saliva Volume
Time Frame: Before and 75 minutes after treatment administration
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NeuroHealing Pharmaceuticals Inc.

Collaborators

Michael J. Fox Foundation for Parkinson's Research

Investigators

  • Principal Investigator: Elkan R Gamzu, PhD, NeuroHealing Pharmaceuticals Inc.
  • Principal Investigator: Marcelo Merello, MD, PhD, FLENI Hospital, Argentina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

September 25, 2008

First Submitted That Met QC Criteria

September 26, 2008

First Posted (Estimate)

September 29, 2008

Study Record Updates

Last Update Posted (Estimate)

October 12, 2015

Last Update Submitted That Met QC Criteria

September 22, 2015

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NH004-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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