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

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ClinicalTrials.gov Identifier: NCT01844648
Recruitment Status : Completed
First Posted : May 1, 2013
Last Update Posted : December 10, 2015
Sponsor:
Collaborator:
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
NeuroHealing Pharmaceuticals Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Sialorrhea (Excessive Drooling) Drug: NH004 tropicamide Drug: NH004 Placebo Phase 2

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  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Tropicamide

Arm Intervention/treatment
Experimental: NH004 tropicamide
tropicamide 1 mg thin film, twice daily for 7 days
Drug: NH004 tropicamide
Intra-oral slow dissolving muco-adhesive thin film containing 1 mg tropicamide

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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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.



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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01844648


Locations
France
Hôpital de la Salpêtrière
Paris, Cedrex 13, France, 75651
Hôpital Paul de Viguier
Toulouse, Cedrex 9, France, 31059
Hôpital Haut Lévêque
Bordeaux, Pessac, France, 33604
Sponsors and Collaborators
NeuroHealing Pharmaceuticals Inc.
Michael J. Fox Foundation for Parkinson's Research
Investigators
Study Director: Elkan R Gamzu, PhD NeuroHealing Pharmaceuticals Inc.

Responsible Party: NeuroHealing Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01844648     History of Changes
Other Study ID Numbers: NH004-3
2011-004212-36 ( EudraCT Number )
First Posted: May 1, 2013    Key Record Dates
Last Update Posted: December 10, 2015
Last Verified: April 2014

Keywords provided by NeuroHealing Pharmaceuticals Inc.:
Parkinson's disease
Sialorrhea
Tropicamide
Non-motor symptoms
Thin strip delivery

Additional relevant MeSH terms:
Sialorrhea
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Tropicamide
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action