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

NCT01844648 | Completed Phase 2

• 2 other identifiers: NH004-32011-004212-36
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

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.

Conditions

Sialorrhea (Excessive Drooling)

Keywords

Parkinson's disease; Sialorrhea; Tropicamide; Non-motor symptoms; Thin strip delivery

Outcome Measures

Primary Outcomes (1)

• modified Teachers Drooling Scale (% responding)

  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 Outcomes (4)

• modified Teachers Drooling Scale (mean)

  one week

• Sialorrhea Clinical Scale for Parkinson's Disease (mean)

  one week

• UPDRS Part II sialorrhea item (mean)

  one week

• Visual Analg Scale

  one week

Study Arms (2)

NH004 tropicamide

EXPERIMENTAL

tropicamide 1 mg thin film, twice daily for 7 days

Drug: NH004 tropicamide

NH004 placebo

PLACEBO COMPARATOR

placebo thin film, twice daily for 7 days

Drug: NH004 Placebo

Interventions

NH004 tropicamide DRUG

Intra-oral slow dissolving muco-adhesive thin film containing 1 mg tropicamide

NH004 tropicamide

NH004 Placebo DRUG

Intra-oral slow dissolving muco-adhesive thin film

NH004 placebo

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NeuroHealing Pharmaceuticals Inc.: lead
• Michael J. Fox Foundation for Parkinson's Research: collaborator

Study Sites (3)

Hôpital de la Salpêtrière

Paris, Cedrex 13, 75651, France

Location

Hôpital Paul de Viguier

Toulouse, Cedrex 9, 31059, France

Location

Hôpital Haut Lévêque

Bordeaux, Pessac, 33604, France

Location

MeSH Terms

Conditions

Sialorrhea; Parkinson Disease

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Elkan R Gamzu, PhD

  NeuroHealing Pharmaceuticals Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2013
• First Posted: May 1, 2013
• Study Start: April 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 10, 2015

Record last verified: 2014-04

Locations

FR (3)