Sialorrhea Secondary to Parkinson's DiseasePhase 2NH004-2NCT00761137

Safety and Efficacy Study of NH004 Films for Relief of Sialorrhea Symptoms in Parkinson's Disease Patients

A Phase 2 study testing 0.3 mg tropicamide, 1 mg tropicamide and 3 mg tropicamide in people with Sialorrhea Secondary to Parkinson's Disease, run by NeuroHealing Pharmaceuticals Inc. at 1 site in Argentina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 50 to 80 years
Conditions the study is for: Sialorrhea Secondary to Parkinson's Disease
What is being tested?: 0.3 mg tropicamide, 1 mg tropicamide and 3 mg tropicamide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 1 siteArgentina
Study dates: Mar 2008to Jun 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with idiopathic Parkinson's disease, according to the United Kingdom Brain Bank criteria.
Patients complaining of drooling, with a score of at least 3 in the FLENI Sialorrhea scale.
Patient is between 50 and 80 years of age, inclusive.
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 medication and dose for PD for the last month. No changes in the medication for PD are expected during the study.
Patients who can reasonable be expected to be on "on-state" for the duration of the testing procedures.
Patients who have a stable response to levodopa for PD.

Who cannot join

Pregnant women or women who may become pregnant.
Patients with a diagnosis of depression, schizophrenia or with obvious symptoms of these diseases.
Patients with Mini-Mental State Examination (MMSE) score equal to or lower than 26.
Patients who are receiving the following drugs: tricyclic antidepressants, Monoamine Oxidase Inhibitors (MAOI's), neuroleptics (antipsychotics), or anticholinergics.
Patients who have taken any of the drugs mentioned in exclusion criteria number 4 within the last week.
Patients with hypersensitivity to atropine or other anticholinergic drugs.

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Patients who have experienced adverse effects as a result of taking anticholinergic drugs.
Patients taking hypnotic or other sleep inducing drugs.
Patients with severe urinary or gastrointestinal symptoms.
Patients with significant dental/oral pathology.
Patients with severe dysautonomia.

Trial locations and contacts

1 site in 1 country.

Argentina1 site

FLENI Hospital
Buenos Aires

Other trials in Argentina

About this study

Official title: A Two-Phase, Double Blind, Placebo-Controlled, Randomized, Crossover Study of the Safety and Efficacy of Intra-Oral NH004 Films for the Short-Term Relief of Sialorrhea Symptoms in Parkinson's Disease Patients

Read the detailed description

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.

Conditions: Sialorrhea Secondary to Parkinson's Disease
Being tested: 0.3 mg tropicamide, 1 mg tropicamide, 3 mg tropicamide, 0 mg tropicamide
Keywords: sialorrhea, drooling, excessive salivation, parkinson's disease
Medical subject headings: Sialorrhea, Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

0.3 mg tropicamideDrug
Also called NH004
0.3 mg tropicamide in intra-oral thin film
1 mg tropicamideDrug
Also called NH004
1 mg tropicamide in intra-oral thin film
3 mg tropicamideDrug
Also called NH004
3 mg tropicamide in intra-oral thin film
0 mg tropicamideDrug
Also called NH004 (placebo)
0 mg tropicamide (placebo) in intra-oral thin film

Study groups in NCT00761137
Study group	Role	What they receive
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 Receives: Drug: 0.3 mg tropicamide; Drug: 1 mg tropicamide; Drug: 3 mg tropicamide; Drug: 0 mg tropicamide
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 Receives: Drug: 0.3 mg tropicamide; Drug: 1 mg tropicamide; Drug: 3 mg tropicamide; Drug: 0 mg tropicamide
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 Receives: Drug: 0.3 mg tropicamide; Drug: 1 mg tropicamide; Drug: 3 mg tropicamide; Drug: 0 mg tropicamide
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 Receives: Drug: 0.3 mg tropicamide; Drug: 1 mg tropicamide; Drug: 3 mg tropicamide; Drug: 0 mg tropicamide

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Before and 120 min after treatment administration

Secondary outcomes (1)

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.
Measured: Before and 75 minutes after treatment administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2008Jun 2010

First posted29 Sep 2008 (estimated)
Study startMar 2008
Primary completionJun 2010
Study completionJun 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Sialorrhea Secondary to Parkinson's DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00761137
Sponsor's protocol ID: NH004-2
Acronym: NH004-2
Status last verified: Apr 2013
First submitted: 25 Sep 2008
Last updated: 12 Oct 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 21636098

Study at a glance

From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Two-Phase, Double Blind, Placebo-Controlled, Randomized, Crossover Study of the Safety and Efficacy of Intra-Oral NH004 Films for the Short-Term Relief of Sialorrhea Symptoms in Parkinson's Disease Patients
ClinicalTrials.gov ID: NCT00761137
Acronym / sponsor ID: NH004-2 / NH004-2
Conditions: Sialorrhea Secondary to Parkinson's Disease
Keywords: sialorrhea, drooling, excessive salivation, parkinson's disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: NeuroHealing Pharmaceuticals Inc.Industry (pharma, biotech, devices)
Collaborators: Michael J. Fox Foundation for Parkinson's Research
Study start: Mar 2008
Primary completion: Jun 2010 (actual)
Study completion: Jun 2010 (actual)
First posted: 29 Sep 2008 (estimated)
Results: Posted 12 Oct 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Tropicamide placebo	Experimental	Drug: 0.3 mg tropicamide, Drug: 1 mg tropicamide, Drug: 3 mg tropicamide, Drug: 0 mg tropicamidesubject received (blinded) each of the 4 drug doses at different visits - 0 mg tropicamide, 0.3 mg tropicamide, 1 mg tropicamide, 3 mg tropicamide
Tropicamide 0.3 mg	Experimental	Drug: 0.3 mg tropicamide, Drug: 1 mg tropicamide, Drug: 3 mg tropicamide, Drug: 0 mg tropicamidesubject received (blinded) each of the 4 drug doses at different visits - 0.3 mg tropicamide, 1 mg tropicamide, 3 mg tropicamide, 0 mg tropicamide
Tropicamide 1 mg	Experimental	Drug: 0.3 mg tropicamide, Drug: 1 mg tropicamide, Drug: 3 mg tropicamide, Drug: 0 mg tropicamidesubject received (blinded) each of the 4 drug doses at different visits - 1 mg tropicamide, 3 mg tropicamide, 0 mg tropicamide, 0.3 mg tropicamide
Tropicamide 3 mg	Experimental	Drug: 0.3 mg tropicamide, Drug: 1 mg tropicamide, Drug: 3 mg tropicamide, Drug: 0 mg tropicamidesubject received (blinded) each of the 4 drug doses at different visits - 3 mg tropicamide, 0 mg tropicamide, 0.3 mg tropicamide, 1 mg tropicamide

Who may qualify

Ages: 50 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Patients with idiopathic Parkinson's disease, according to the United Kingdom Brain Bank criteria.
Patients complaining of drooling, with a score of at least 3 in the FLENI Sialorrhea scale.
Patient is between 50 and 80 years of age, inclusive.
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 medication and dose for PD for the last month. No changes in the medication for PD are expected during the study.

Key exclusion criteria (11 listed)

Pregnant women or women who may become pregnant.
Patients with a diagnosis of depression, schizophrenia or with obvious symptoms of these diseases.
Patients with Mini-Mental State Examination (MMSE) score equal to or lower than 26.
Patients who are receiving the following drugs: tricyclic antidepressants, Monoamine Oxidase Inhibitors (MAOI's), neuroleptics (antipsychotics), or anticholinergics.
Patients who have taken any of the drugs mentioned in exclusion criteria number 4 within the last week.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
0.3 mg tropicamideAlso: NH0040.3 mg tropicamide in intra-oral thin film	Drug	Tropicamide 0.3 mg, Tropicamide 1 mg, Tropicamide 3 mg, Tropicamide placebo
1 mg tropicamideAlso: NH0041 mg tropicamide in intra-oral thin film	Drug	Tropicamide 0.3 mg, Tropicamide 1 mg, Tropicamide 3 mg, Tropicamide placebo
3 mg tropicamideAlso: NH0043 mg tropicamide in intra-oral thin film	Drug	Tropicamide 0.3 mg, Tropicamide 1 mg, Tropicamide 3 mg, Tropicamide placebo
0 mg tropicamideAlso: NH004 (placebo)0 mg tropicamide (placebo) in intra-oral thin film	Drug	Tropicamide 0.3 mg, Tropicamide 1 mg, Tropicamide 3 mg, Tropicamide placebo

Primary outcome

Sialorrhea Visual Analogue Scale (VAS)
Time frame: Before and 120 min after treatment administration
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.

1 secondary outcome

Percentage Change in Saliva Volume
Time frame: Before and 75 minutes after treatment administration

Results and safety

Results posted to the registry on 12 Oct 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	19	19

Primary outcome: Sialorrhea Visual Analogue Scale (VAS)

Time frame: Before and 120 min after treatment administration. Mean (Standard Deviation). Unit: cm on VAS

Measure	Tropicamide - Placebo n = 19	Tropicamide - 0.3 mg n = 19	Tropicamide - 1 mg n = 19	Tropicamide 3 mg n = 19
Value	-0.55 (0.54)	-1.08 (0.54)	-1.53 (0.52)	-0.81 (0.51)

Tropicamide - Placebo vs Tropicamide - 0.3 mg vs Tropicamide - 1 mg vs Tropicamide 3 mg: p = 0.6, ANOVA

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1 month. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	0 of 19 (0%)	0 of 19 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21636098Lloret 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Elkan R Gamzu, PhD principal investigator

NeuroHealing Pharmaceuticals Inc.

Marcelo Merello, MD, PhD principal investigator

FLENI Hospital, Argentina

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sialorrhea Visual Analogue Scale (VAS) (time frame: Before and 120 min after treatment administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00761137, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2015.