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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by FDA Office of Orphan Products Development.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Michael J. Fox Foundation for Parkinson's Research
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00761137
First received: September 25, 2008
Last updated: September 26, 2008
Last verified: September 2008
  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 patients.


Condition Intervention Phase
Sialorrhea Secondary to Parkinson's Disease
Drug: Crossover of placebo, 0.3, 1 or 3 mg of 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 FDA Office of Orphan Products Development:

Primary Outcome Measures:
  • Phase A (first 12 patients): subjective sialorrhea visual-analog scale. Phase B: sialorrhea visual-analog scale and objective saliva measurement (measured with a cotton roll). [ Time Frame: Phase A: every 15 minutes for 2 hours. Phase B: same as Phase A + one objective saliva measurement at a time point to be determined in the interim analysis. ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: March 2008
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Crossover Drug: Crossover of placebo, 0.3, 1 or 3 mg of tropicamide.
Mucoadhesive film containing placebo, 0.3, 1 or 3 mg of tropicamide.
Other Name: crossover

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 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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with idiopathic Parkinson's disease, according to the UK 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 MMSE score equal to or lower than 26.
  4. Patients who are receiving the following drugs: tricyclic antidepressants, 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

Contacts
Contact: Daniel Katzman 617.331.4111 daniel@neurohealing.com

Locations
Argentina
FLENI Hospital Recruiting
Buenos Aires, Argentina
Contact: Santiago Perez Lloret, MD    5777-3200 ext 2600    splloret@fleni.edu.ar   
Principal Investigator: Marcelo Merello, MD, PhD         
Sub-Investigator: Santiago Perez Lloret, MD         
Sub-Investigator: Gabriela Nano, MD         
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

No publications provided

Responsible Party: Elkan Gamzu, Interim Head of Clinical Trials, NeuroHealing Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00761137     History of Changes
Other Study ID Numbers: NH004-2
Study First Received: September 25, 2008
Last Updated: September 26, 2008
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Argentina: Human Research Bioethics Committee
United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:
sialorrhea
drooling
excessive salivation
parkinson's disease

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

ClinicalTrials.gov processed this record on November 25, 2014