A Phase 2 interventional study of 0.3 mg tropicamide and 1 mg tropicamide in Sialorrhea Secondary to Parkinson's Disease, sponsored by NeuroHealing Pharmaceuticals Inc.. Completed at 1 site in Argentina. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-10-12.
Sponsored by NeuroHealing Pharmaceuticals Inc. · Phase 2, Interventional, and Treatment
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.
60 studies on the registry are indexed under Sialorrhea; 5 are open to participants now.
This study's enrollment of 19 is below the median of 31 across 44 interventional studies indexed under Sialorrhea.
Browse Sialorrhea studies →NeuroHealing Pharmaceuticals Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: 0.3 mg tropicamide · Drug: 1 mg tropicamide · Drug: 3 mg tropicamide · Drug: 0 mg tropicamide
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
Drug: 0.3 mg tropicamide · Drug: 1 mg tropicamide · Drug: 3 mg tropicamide · Drug: 0 mg tropicamide
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
Drug: 0.3 mg tropicamide · Drug: 1 mg tropicamide · Drug: 3 mg tropicamide · Drug: 0 mg tropicamide
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
Drug: 0.3 mg tropicamide · Drug: 1 mg tropicamide · Drug: 3 mg tropicamide · Drug: 0 mg tropicamide
0.3 mg tropicamide in intra-oral thin film
Also known as: NH004
1 mg tropicamide in intra-oral thin film
Also known as: NH004
3 mg tropicamide in intra-oral thin film
Also known as: NH004
0 mg tropicamide (placebo) in intra-oral thin film
Also known as: NH004 (placebo)
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.
Time frame: Before and 120 min after treatment administration
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.
Time frame: Before and 75 minutes after treatment administration
| Milestone | All Participants |
|---|---|
| Started | 19 |
| Placebo | 19 |
| 0.3 mg tropicamide | 19 |
| 1 mg tropicamide | 19 |
| 3 mg tropicamide | 19 |
| Completed | 19 |
| Not completed | 0 |
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.
| cm on VAS | Tropicamide - Placebo | Tropicamide - 0.3 mg | Tropicamide - 1 mg | Tropicamide 3 mg |
|---|---|---|---|---|
| Sialorrhea Visual Analogue Scale (VAS) | -0.55 ± 0.54 | -1.08 ± 0.54 | -1.53 ± 0.52 | -0.81 ± 0.51 |
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 change of saliva volume | Tropicamide - Placebo | Tropicamide - 0.3 mg | Tropicamide - 1 mg | Tropicamide 3 mg |
|---|---|---|---|---|
| Percentage Change in Saliva Volume | -5 (-27 to 17) | -27 (-48 to -6) | -33 (-60 to -7) | -20 (-33 to -7) |
Collected over 1 month. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Participants | — | 0/19 (0%) | 0/19 (0%) |
| Age, Continuous(years) | All Study Participants |
|---|---|
| Mean | 67 ± 12 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 4 |
| Male | 15 |
| Region of Enrollment(participants) | All Study Participants |
|---|---|
| Argentina | 19 |
This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tropicamide
NeuroHealing Pharmaceuticals Inc.