Status:
COMPLETED
Study of the Safety and Efficacy of Tropicamide Thin Films to Reduce Hypersalivation in Parkinson's Patients
Lead Sponsor:
NeuroHealing Pharmaceuticals Inc.
Collaborating Sponsors:
Michael J. Fox Foundation for Parkinson's Research
Conditions:
Sialorrhea (Excessive Drooling)
Eligibility:
All Genders
30+ years
Phase:
PHASE2
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.
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01844648
Start Date
April 1 2013
End Date
December 1 2015
Last Update
December 10 2015
Active Locations (3)
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1
Hôpital de la Salpêtrière
Paris, Cedrex 13, France, 75651
2
Hôpital Paul de Viguier
Toulouse, Cedrex 9, France, 31059
3
Hôpital Haut Lévêque
Bordeaux, Pessac, France, 33604