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| Name | Class |
|---|---|
| Michael J. Fox Foundation for Parkinson's Research | OTHER |
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The primary goal of the study is to evaluate the safety and potential efficacy of intra-oral dissolvable NH004 films to improve the short-term symptoms of sialorrhea (drooling) in Parkinson's disease (PD) patients.
NH004 contains the anticholinergic agent tropicamide and is delivered in a convenient product form (intra-oral dissolvable thin films) designed for the management of sialorrhea. This study is a double blind, placebo-controlled, crossover study of the safety and potential efficacy of three doses of of NH004 films for the short-term relief of the symptoms of sialorrhea in Parkinson's disease patients.
A total of up to 36 Parkinson's disease patients will be enrolled in the study in two Phases. Phase A will include 12 patients and Phase B up to 24 patients. There will be an interim analysis after conclusion of Phase A. In both phases patients will be randomized into one of four groups. Each group will have a distinctive sequence for receiving intra-oral dissolvable films of 0.3 mg, 1 mg, 3 mg of NH004, or placebo during four visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tropicamide placebo | Experimental | subject received (blinded) each of the 4 drug doses at different visits - 0 mg tropicamide, 0.3 mg tropicamide, 1 mg tropicamide, 3 mg tropicamide |
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| Tropicamide 0.3 mg | Experimental | subject received (blinded) each of the 4 drug doses at different visits - 0.3 mg tropicamide, 1 mg tropicamide, 3 mg tropicamide, 0 mg tropicamide |
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| Tropicamide 1 mg | Experimental | subject received (blinded) each of the 4 drug doses at different visits - 1 mg tropicamide, 3 mg tropicamide, 0 mg tropicamide, 0.3 mg tropicamide |
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| Tropicamide 3 mg | Experimental | subject received (blinded) each of the 4 drug doses at different visits - 3 mg tropicamide, 0 mg tropicamide, 0.3 mg tropicamide, 1 mg tropicamide |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.3 mg tropicamide | Drug | 0.3 mg tropicamide in intra-oral thin film |
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| Measure | Description | Time Frame |
|---|---|---|
| Sialorrhea Visual Analogue Scale (VAS) | Saliva buccal assessment was evaluated by an VAS scale before, and 15, 30, 45, 60, 90, and 120 min after treatment administration. Subjects were asked to rate how much saliva they perceived in their buccal cavity on an unmarked 0 to 10 cm line, higher scores meaning greater perceived buccal saliva levels. | Before and 120 min after treatment administration |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in Saliva Volume | Saliva volume was measured at baseline and 75 minutes after treatment administration. Volumes were measured by using cotton rolls placed near each Stenton duct and below the tongue for 5 minutes; cotton rolls were centrifuged and the volume of saliva determined. | Before and 75 minutes after treatment administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elkan R Gamzu, PhD | NeuroHealing Pharmaceuticals Inc. | Principal Investigator |
| Marcelo Merello, MD, PhD | FLENI Hospital, Argentina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FLENI Hospital | Buenos Aires | Argentina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21636098 | Result | Lloret SP, Nano G, Carrosella A, Gamzu E, Merello M. A double-blind, placebo-controlled, randomized, crossover pilot study of the safety and efficacy of multiple doses of intra-oral tropicamide films for the short-term relief of sialorrhea symptoms in Parkinson's disease patients. J Neurol Sci. 2011 Nov 15;310(1-2):248-50. doi: 10.1016/j.jns.2011.05.021. Epub 2011 Jun 1. |
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Four interventions, subjects were randomly assigned to one of 16 sequences.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | subjects randomly received (blinded) each of the 4 doses at different visits - 0 mg, 0.3 mg, 1mg, 3 mg Drug: Tropicamide |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 1 mg tropicamide | Drug | 1 mg tropicamide in intra-oral thin film |
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| 3 mg tropicamide | Drug | 3 mg tropicamide in intra-oral thin film |
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| 0 mg tropicamide | Drug | 0 mg tropicamide (placebo) in intra-oral thin film |
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| Placebo |
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| 0.3 mg Tropicamide |
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| 1 mg Tropicamide |
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| 3 mg Tropicamide |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | This study was a double-blind, randomized, placebo controlled, two-phased, Latin-square crossover study. Subjects received three single-doses of tropicamide or placebo in random order, with a 7-day washout period. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Sialorrhea Visual Analogue Scale (VAS) | Saliva buccal assessment was evaluated by an VAS scale before, and 15, 30, 45, 60, 90, and 120 min after treatment administration. Subjects were asked to rate how much saliva they perceived in their buccal cavity on an unmarked 0 to 10 cm line, higher scores meaning greater perceived buccal saliva levels. | Posted | Mean | Standard Deviation | cm on VAS | Before and 120 min after treatment administration |
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| Secondary | Percentage Change in Saliva Volume | Saliva volume was measured at baseline and 75 minutes after treatment administration. Volumes were measured by using cotton rolls placed near each Stenton duct and below the tongue for 5 minutes; cotton rolls were centrifuged and the volume of saliva determined. | Percentage saliva volume change was determined in the last seven (7) patients enrolled. | Posted | Median | 95% Confidence Interval | percentage change of saliva volume | Before and 75 minutes after treatment administration |
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1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | subjects received (blinded) each of the 4 doses at different visits - 0 mg, 0.3 mg, 1mg, 3 mg Drug: Tropicamide | 0 | 19 | 0 | 19 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Katzman | NeuroHealing Pharmaceuticals | 617-965-0872 | info@neurohealing.com |
| ID | Term |
|---|---|
| D012798 | Sialorrhea |
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| D014331 | Tropicamide |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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