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
Recruitment status was Recruiting
Sponsor:
NeuroHealing Pharmaceuticals Inc.
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
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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:
MedlinePlus related topics:
Parkinson's Disease
Drug Information available for:
Tropicamide
U.S. FDA Resources
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:
- Patients with idiopathic Parkinson's disease, according to the UK 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.
Exclusion Criteria:
- Pregnant women or women who may become pregnant.
- Patients with a diagnosis of depression, schizophrenia or with obvious symptoms of these diseases.
- Patients with MMSE score equal to or lower than 26.
- Patients who are receiving the following drugs: tricyclic antidepressants, 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.
- 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.
Contacts and Locations
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 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 Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Mydriatics Autonomic Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on May 21, 2013