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

Information source: NeuroHealing Pharmaceuticals Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sialorrhea (Excessive Drooling)

Intervention: NH004 tropicamide (Drug); NH004 Placebo (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: NeuroHealing Pharmaceuticals Inc.

Official(s) and/or principal investigator(s):
Elkan R Gamzu, PhD, Study Director, Affiliation: NeuroHealing Pharmaceuticals Inc.

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: modified Teachers Drooling Scale (% responding)

Secondary outcome:

modified Teachers Drooling Scale (mean)

Sialorrhea Clinical Scale for Parkinson's Disease (mean)

UPDRS Part II sialorrhea item (mean)

Visual Analg Scale

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.

Eligibility

Minimum age: 30 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Hôpital de la Salpêtrière, Paris, Cedrex 13 75651, France

Hôpital Paul de Viguier, Toulouse, Cedrex 9 31059, France

Hôpital Haut Lévêque, Bordeaux, Pessac 33604, France

Additional Information

Starting date: April 2013
Last updated: August 6, 2015

Page last updated: August 23, 2015

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