Trials Sponsors Conditions Drugs Pricing

Conditions

Sialorrhea (Excessive Drooling)

Keywords

Parkinson's diseaseSialorrheaTropicamideNon-motor symptomsThin 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 tropicamideDrug

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

NH004 tropicamide

NH004 PlaceboDrug

Intra-oral slow dissolving muco-adhesive thin film

NH004 placebo

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age30 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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.

Sponsors & Collaborators

NeuroHealing Pharmaceuticals Inc.
Industrylead
Michael J. Fox Foundation for Parkinson's Research
Othercollaborator

Study Sites (3)

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

MeSH Terms

Conditions

SialorrheaParkinson Disease

Condition Hierarchy (Ancestors)

Salivary Gland DiseasesMouth DiseasesStomatognathic DiseasesParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

Elkan R Gamzu, PhD
NeuroHealing Pharmaceuticals Inc.
STUDY DIRECTOR

Enrollment

30 participants (actual enrollment reported by the registry).

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 2013

Date type not reported

This date has not been verified as actual or estimated.

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.
+5 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

NH004 tropicamide

NH004 placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

NH004 tropicamide

NH004 placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations