NCT00761137

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
5.4 years until next milestone

Results Posted

Study results publicly available

October 12, 2015

Completed
Last Updated

October 12, 2015

Status Verified

April 1, 2013

Enrollment Period

2.3 years

First QC Date

September 25, 2008

Results QC Date

August 5, 2011

Last Update Submit

September 22, 2015

Conditions

Sialorrhea Secondary to Parkinson's Disease

Keywords

sialorrheadroolingexcessive salivationparkinson's disease

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Percentage Change in Saliva Volume

    Before and 75 minutes after treatment administration

Study Arms (4)

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

Drug: 0.3 mg tropicamideDrug: 1 mg tropicamideDrug: 3 mg tropicamideDrug: 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

Drug: 0.3 mg tropicamideDrug: 1 mg tropicamideDrug: 3 mg tropicamideDrug: 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

Drug: 0.3 mg tropicamideDrug: 1 mg tropicamideDrug: 3 mg tropicamideDrug: 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

Drug: 0.3 mg tropicamideDrug: 1 mg tropicamideDrug: 3 mg tropicamideDrug: 0 mg tropicamide

Interventions

0.3 mg tropicamideDRUG

0.3 mg tropicamide in intra-oral thin film

Also known as: NH004
Tropicamide 0.3 mgTropicamide 1 mgTropicamide 3 mgTropicamide placebo
1 mg tropicamideDRUG

1 mg tropicamide in intra-oral thin film

Also known as: NH004
Tropicamide 0.3 mgTropicamide 1 mgTropicamide 3 mgTropicamide placebo
3 mg tropicamideDRUG

3 mg tropicamide in intra-oral thin film

Also known as: NH004
Tropicamide 0.3 mgTropicamide 1 mgTropicamide 3 mgTropicamide placebo
0 mg tropicamideDRUG

0 mg tropicamide (placebo) in intra-oral thin film

Also known as: NH004 (placebo)
Tropicamide 0.3 mgTropicamide 1 mgTropicamide 3 mgTropicamide placebo

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 with hypersensitivity to atropine or other anticholinergic drugs.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FLENI Hospital

Buenos Aires, Argentina

Location

Related Publications (1)

  • 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.

    PMID: 21636098RESULT

MeSH Terms

Conditions

SialorrheaParkinson Disease

Interventions

Tropicamide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Daniel Katzman
Organization
NeuroHealing Pharmaceuticals
info@neurohealing.com
617-965-0872

Study Officials

  • Elkan R Gamzu, PhD

    NeuroHealing Pharmaceuticals Inc.

    PRINCIPAL INVESTIGATOR

  • Marcelo Merello, MD, PhD

    FLENI Hospital, Argentina

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

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

September 25, 2008

First Posted

September 29, 2008

Study Start

March 1, 2008

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

October 12, 2015

Results First Posted

October 12, 2015

Record last verified: 2013-04

Locations

AR(1)