- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01844648
Study of the Safety and Efficacy of Tropicamide Thin Films to Reduce Hypersalivation in Parkinson's Patients
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 Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Collaborators
Investigators
- Study Director: Elkan R Gamzu, PhD, NeuroHealing Pharmaceuticals Inc.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Stomatognathic Diseases
- Mouth Diseases
- Salivary Gland Diseases
- Sialorrhea
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Mydriatics
- Tropicamide
Other Study ID Numbers
- NH004-3
- 2011-004212-36 (EudraCT Number)
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.
Clinical Trials on Sialorrhea (Excessive Drooling)
-
Maharishi Markendeswar University (Deemed to be...Completed
-
Hadassah Medical OrganizationUnknown
-
Hospices Civils de LyonCompletedCerebral Palsy | Pathological Drooling
-
Isra UniversityUnknown
-
Cairo UniversityCompletedCerebral Palsy | Drooling | KinesiotapeEgypt
-
Hospices Civils de LyonRecruiting
-
National Taiwan University HospitalNational Science Council, TaiwanUnknownCerebral Palsy | DroolingTaiwan
-
Centre Médico-Chirurgical de Réadaptation des Massues...CompletedCerebral Palsy | DroolingFrance
-
Hacettepe UniversityCompleted
-
Solstice NeurosciencesCompleted
Clinical Trials on NH004 tropicamide
-
NeuroHealing Pharmaceuticals Inc.Michael J. Fox Foundation for Parkinson's ResearchCompletedSialorrhea Secondary to Parkinson's DiseaseArgentina
-
URAL Telekomunikasyon San. Trade Inc.RecruitingGlaucoma | Eye Diseases | Age-Related Macular Degeneration | Diabetic Retinopathy | Diabetic Macular Edema | Retinal Vein OcclusionTurkey
-
Semnan University of Medical SciencesCompletedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusIran, Islamic Republic of
-
URAL Telekomunikasyon San. Trade Inc.Akdeniz UniversityRecruitingDiabetic Retinopathy | Diabetic Macular Edema | Diabetic Eye ProblemsTurkey
-
LENZ Therapeutics, IncCompleted
-
Bulent Ecevit UniversityCompletedRetinopathy of Prematurity
-
University of the PhilippinesCompleted
-
Eyenovia Inc.Completed
-
Aristotle University Of ThessalonikiNational and Kapodistrian University of AthensCompletedRetinopathy of PrematurityGreece
-
Min-Sheng General HospitalUnknown