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Safety and Efficacy Study of NH004 Films for Relief of Sialorrhea Symptoms in Parkinson's Disease Patients (NH004-2)

This study has been completed.
Sponsor:
Collaborator:
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
NeuroHealing Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00761137
First received: September 25, 2008
Last updated: September 22, 2015
Last verified: April 2013
  Purpose
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.

Condition Intervention Phase
Sialorrhea Secondary to Parkinson's Disease
Drug: 0.3 mg tropicamide
Drug: 1 mg tropicamide
Drug: 3 mg tropicamide
Drug: 0 mg tropicamide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by NeuroHealing Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Sialorrhea Visual Analogue Scale (VAS) [ Time Frame: Before and 120 min after treatment administration ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Percentage Change in Saliva Volume [ Time Frame: Before and 75 minutes after treatment administration ] [ Designated as safety issue: No ]
    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.


Enrollment: 19
Study Start Date: March 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tropicamide placebo
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
0.3 mg tropicamide in intra-oral thin film
Other Name: NH004
Drug: 1 mg tropicamide
1 mg tropicamide in intra-oral thin film
Other Name: NH004
Drug: 3 mg tropicamide
3 mg tropicamide in intra-oral thin film
Other Name: NH004
Drug: 0 mg tropicamide
0 mg tropicamide (placebo) in intra-oral thin film
Other Name: NH004 (placebo)
Experimental: Tropicamide 0.3 mg
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
0.3 mg tropicamide in intra-oral thin film
Other Name: NH004
Drug: 1 mg tropicamide
1 mg tropicamide in intra-oral thin film
Other Name: NH004
Drug: 3 mg tropicamide
3 mg tropicamide in intra-oral thin film
Other Name: NH004
Drug: 0 mg tropicamide
0 mg tropicamide (placebo) in intra-oral thin film
Other Name: NH004 (placebo)
Experimental: Tropicamide 1 mg
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
0.3 mg tropicamide in intra-oral thin film
Other Name: NH004
Drug: 1 mg tropicamide
1 mg tropicamide in intra-oral thin film
Other Name: NH004
Drug: 3 mg tropicamide
3 mg tropicamide in intra-oral thin film
Other Name: NH004
Drug: 0 mg tropicamide
0 mg tropicamide (placebo) in intra-oral thin film
Other Name: NH004 (placebo)
Experimental: Tropicamide 3 mg
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
0.3 mg tropicamide in intra-oral thin film
Other Name: NH004
Drug: 1 mg tropicamide
1 mg tropicamide in intra-oral thin film
Other Name: NH004
Drug: 3 mg tropicamide
3 mg tropicamide in intra-oral thin film
Other Name: NH004
Drug: 0 mg tropicamide
0 mg tropicamide (placebo) in intra-oral thin film
Other Name: NH004 (placebo)

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.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with idiopathic Parkinson's disease, according to the United Kingdom Brain Bank criteria.
  2. Patients complaining of drooling, with a score of at least 3 in the FLENI Sialorrhea scale.
  3. Patient is between 50 and 80 years of age, inclusive.
  4. 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.
  5. 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.
  6. Patients who can reasonable be expected to be on "on-state" for the duration of the testing procedures.
  7. Patients who have a stable response to levodopa for PD.

Exclusion Criteria:

  1. Pregnant women or women who may become pregnant.
  2. Patients with a diagnosis of depression, schizophrenia or with obvious symptoms of these diseases.
  3. Patients with Mini-Mental State Examination (MMSE) score equal to or lower than 26.
  4. Patients who are receiving the following drugs: tricyclic antidepressants, Monoamine Oxidase Inhibitors (MAOI's), neuroleptics (antipsychotics), or anticholinergics.
  5. Patients who have taken any of the drugs mentioned in exclusion criteria number 4 within the last week.
  6. Patients with hypersensitivity to atropine or other anticholinergic drugs.
  7. Patients who have experienced adverse effects as a result of taking anticholinergic drugs.
  8. Patients taking hypnotic or other sleep inducing drugs.
  9. Patients with severe urinary or gastrointestinal symptoms.
  10. Patients with significant dental/oral pathology.
  11. Patients with severe dysautonomia.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00761137

Locations
Argentina
FLENI Hospital
Buenos Aires, Argentina
Sponsors and Collaborators
NeuroHealing Pharmaceuticals Inc.
Michael J. Fox Foundation for Parkinson's Research
Investigators
Principal Investigator: Elkan R Gamzu, PhD NeuroHealing Pharmaceuticals Inc.
Principal Investigator: Marcelo Merello, MD, PhD FLENI Hospital, Argentina
  More Information

Publications:
Responsible Party: NeuroHealing Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00761137     History of Changes
Other Study ID Numbers: NH004-2 
Study First Received: September 25, 2008
Results First Received: August 5, 2011
Last Updated: September 22, 2015
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Argentina: Human Research Bioethics Committee
United States: Federal Government

Keywords provided by NeuroHealing Pharmaceuticals Inc.:
sialorrhea
drooling
excessive salivation
parkinson's disease

Additional relevant MeSH terms:
Parkinson Disease
Sialorrhea
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Tropicamide
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 05, 2016