Study of the Safety and Efficacy of Tropicamide Thin Films to Reduce Hypersalivation in Parkinson's Patients

December 8, 2015 updated by: NeuroHealing Pharmaceuticals Inc.

A Randomized, Double-blind, Placebo-controlled, Crossover Study of the Safety and Efficacy of Tropicamide 1 mg Intra-oral Slow Dissolving Muco-adhesive Thin Films to Reduce Hypersalivation in PD Patients Manifesting Sialorrhea Complaints

To study the safety and efficacy of tropicamide 1 mg intra-oral slow dissolving muco-adhesive thin films compared to placebo to reduce hypersalivation in PD patients manifesting sialorrhea complaints.

Study Overview

Status

Completed

Detailed Description

This is a double-blind, placebo-controlled, randomized, crossover, multicentre study comparing intra-oral slow dissolving muco-adhesive thin films containing tropicamide 1 mg or Placebo. Patients will receive each treatment twice daily (1 h after breakfast and 1 h after lunch) for 1-week.

Patients will be evaluated for eligibility during the 14-day screening period. Those patients meeting all entry criteria at baseline will be randomized (1:1) to receive first tropicamide followed by placebo films or vice versa. Patients will return for regularly scheduled visits at Weeks 1 and 3 or at early discontinuation.

Study Type

Interventional

Enrollment (Actual)

30

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

    • Cedrex 13
      • Paris, Cedrex 13, France, 75651
        • Hôpital de la Salpêtrière
    • Cedrex 9
      • Toulouse, Cedrex 9, France, 31059
        • Hôpital Paul de Viguier
    • Pessac
      • Bordeaux, Pessac, France, 33604
        • Hôpital Haut Lévêque

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

28 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Patients with idiopathic Parkinson's disease, according to the UK Brain Bank criteria.
  • Patients complaining of drooling, with a score of at least 6 points in the SCS-PD scale.
  • Patients above 30 years old.
  • Patients with Hoehn & Yahr score between I-IV.
  • 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 antiparkinsonian medications and at the same dose for the last month. No changes in the medication for PD are expected during the study.

Exclusion criteria:

  • Pregnant women.
  • Patients with a secondary parkinsonian syndrome, parkinsonism-plus syndromes, heredodegenerative disorders or benign parkinsonism.
  • Patients with a diagnosis of major depression or psychosis according to the DSM-IV.
  • Patients with MMSE score equal to or lower than 24.
  • Patients with a current diagnosis of substance abuse (DSM-IV) or history of alcohol or drug abuse in the past 3 months.
  • Patients with hallucinations.
  • Patients with a current clinically significant gastrointestinal, renal, hepatic, endocrine, pulmonary or cardiovascular disease, including hypertension that is not well-controlled, asthma, chronic obstructive pulmonary disease (COPD) and Type I diabetes.
  • Patients with a second- or third-degree atrioventricular block or sick sinus syndrome, uncontrolled atrial fibrillation, severe or unstable angina, congestive heart failure, myocardial infarction within 3 months of the screening visit, or significant ECG abnormality, including QTc ≥ 450 msec (males) or ≥ 470 msec (females), where QTc is based on Bazett's correction method.
  • Patient with a neoplastic disorder, which is either currently active or has been in remission for less than one year.
  • Patients with a history or a current diagnosis of HIV, or tests positive for Hepatitis B or C antibodies, or Hepatitis B surface antigen
  • Patients who have participated in a previous clinical trial within 30 days of entry into the study (screening visit) or have received treatment with any investigational compound within 30 days.
  • Patients with hypersensitivity to atropine or other anticholinergic drugs.
  • Patients who have experienced adverse effects as a result of taking anticholinergic drugs.
  • Patients who are receiving any anticholinergic drug or an anticholinesterase agent.
  • Patients who started or changed the dose of any of the following medications in the previous week: tricyclic antidepressants, monoamine oxidase-A inhibitors, antipsychotics, benzodiazepines, opioids, antihistamines, carbamazepine, NSAIDs.
  • Patients with significant dental/oral pathology.
  • Patient with any abnormality that the investigator deems to be clinically relevant, either on medical history, physical examination, ECG or in a diagnostic laboratory test.
  • Patients with closed-angle Glaucoma or those at high risk of suffering it after treatment with anticholinergic agents.
  • Patients with Prostatic Adenoma.
  • In the judgment of the Clinical Investigator, the patient is likely to be non-compliant or uncooperative during the study.

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: NH004 tropicamide
tropicamide 1 mg thin film, twice daily for 7 days
Intra-oral slow dissolving muco-adhesive thin film containing 1 mg tropicamide
Placebo Comparator: NH004 placebo
placebo thin film, twice daily for 7 days
Intra-oral slow dissolving muco-adhesive thin film

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
modified Teachers Drooling Scale (% responding)
Time Frame: one week
The primary endpoint for this trial is the difference in responder rate between tropicamide and placebo. Responders will be defined as subjects whose mean sialorrhea score improved by at least 30% as compared to baseline in the 9-point modified Teachers Drooling Scale (mTDS).
one week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
modified Teachers Drooling Scale (mean)
Time Frame: one week
Difference in the mean sialorrhea scores between placebo and tropicamide in the 9-point modified Teachers Drooling Scale (mTDS).
one week
Sialorrhea Clinical Scale for Parkinson's Disease (mean)
Time Frame: one week
- Difference in the mean sialorrhea scores between placebo and tropicamide in the Sialorrhea Clinical Scale for Parkinson's Disease (SCS-PD).
one week
UPDRS Part II sialorrhea item (mean)
Time Frame: one week
Difference in the mean sialorrhea scores between placebo and tropicamide in the UPDRS Part II sialorrhea item (#6).
one week
Visual Analg Scale
Time Frame: one week
Saliva buccal content as measured by a Visual Analog Scale (VAS) score, evaluated before and during 3 hours after treatments administration.
one week

Collaborators and Investigators

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

Investigators

  • Study Director: Elkan R Gamzu, PhD, NeuroHealing Pharmaceuticals Inc.

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

April 1, 2013

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

April 29, 2013

First Submitted That Met QC Criteria

April 29, 2013

First Posted (Estimate)

May 1, 2013

Study Record Updates

Last Update Posted (Estimate)

December 10, 2015

Last Update Submitted That Met QC Criteria

December 8, 2015

Last Verified

April 1, 2014

More Information

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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