Sialorrhea (Excessive Drooling)Phase 2NCT01844648
Study of the Safety and Efficacy of Tropicamide Thin Films to Reduce Hypersalivation in Parkinson's Patients
A Phase 2 study testing NH004 tropicamide in people with Sialorrhea (Excessive Drooling), run by NeuroHealing Pharmaceuticals Inc. at 3 sites in France.
Trial summary
To study the safety and efficacy of tropicamide 1 mg intra-oral slow dissolving muco-adhesive thin films compared to placebo to reduce hypersalivation in PD patients manifesting sialorrhea complaints. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Sialorrhea (Excessive Drooling)
- What is being tested?
- NH004 tropicamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 3 sitesFrance
- Study dates
- Apr 2013to Dec 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with idiopathic Parkinson's disease, according to the UK Brain Bank criteria.
- Patients complaining of drooling, with a score of at least 6 points in the SCS-PD scale.
- Patients above 30 years old.
- Patients with Hoehn \& Yahr score between I-IV.
- 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 antiparkinsonian medications and at the same dose for the last month. No changes in the medication for PD are expected during the study.
Who cannot join
- Pregnant women.
- Patients with a secondary parkinsonian syndrome, parkinsonism-plus syndromes, heredodegenerative disorders or benign parkinsonism.
- Patients with a diagnosis of major depression or psychosis according to the DSM-IV.
- Patients with MMSE score equal to or lower than 24.
- Patients with a current diagnosis of substance abuse (DSM-IV) or history of alcohol or drug abuse in the past 3 months.
- Patients with hallucinations.
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- Patients with a current clinically significant gastrointestinal, renal, hepatic, endocrine, pulmonary or cardiovascular disease, including hypertension that is not well-controlled, asthma, chronic obstructive pulmonary disease (COPD) and Type I diabetes.
- Patients with a second- or third-degree atrioventricular block or sick sinus syndrome, uncontrolled atrial fibrillation, severe or unstable angina, congestive heart failure, myocardial infarction within 3 months of the screening visit, or significant ECG abnormality, including QTc ≥ 450 msec (males) or ≥ 470 msec (females), where QTc is based on Bazett's correction method.
- Patient with a neoplastic disorder, which is either currently active or has been in remission for less than one year.
- Patients with a history or a current diagnosis of HIV, or tests positive for Hepatitis B or C antibodies, or Hepatitis B surface antigen
- Patients who have participated in a previous clinical trial within 30 days of entry into the study (screening visit) or have received treatment with any investigational compound within 30 days.
- Patients with hypersensitivity to atropine or other anticholinergic drugs.
- Patients who have experienced adverse effects as a result of taking anticholinergic drugs.
- Patients who are receiving any anticholinergic drug or an anticholinesterase agent.
- Patients who started or changed the dose of any of the following medications in the previous week: tricyclic antidepressants, monoamine oxidase-A inhibitors, antipsychotics, benzodiazepines, opioids, antihistamines, carbamazepine, NSAIDs.
- Patients with significant dental/oral pathology.
- Patient with any abnormality that the investigator deems to be clinically relevant, either on medical history, physical examination, ECG or in a diagnostic laboratory test.
- Patients with closed-angle Glaucoma or those at high risk of suffering it after treatment with anticholinergic agents.
- Patients with Prostatic Adenoma.
- In the judgment of the Clinical Investigator, the patient is likely to be non-compliant or uncooperative during the study.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hôpital Haut Lévêque
Bordeaux, Pessac, 33604
Hôpital de la Salpêtrière
Paris, Cedrex 13, 75651
Hôpital Paul de Viguier
Toulouse, Cedrex 9, 31059
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Crossover Study of the Safety and Efficacy of Tropicamide 1 mg Intra-oral Slow Dissolving Muco-adhesive Thin Films to Reduce Hypersalivation in PD Patients Manifesting Sialorrhea Complaints
To study the safety and efficacy of tropicamide 1 mg intra-oral slow dissolving muco-adhesive thin films compared to placebo to reduce hypersalivation in PD patients manifesting sialorrhea complaints.
Read the detailed description
This is a double-blind, placebo-controlled, randomized, crossover, multicentre study comparing intra-oral slow dissolving muco-adhesive thin films containing tropicamide 1 mg or Placebo. Patients will receive each treatment twice daily (1 h after breakfast and 1 h after lunch) for 1-week.
Patients will be evaluated for eligibility during the 14-day screening period. Those patients meeting all entry criteria at baseline will be randomized (1:1) to receive first tropicamide followed by placebo films or vice versa. Patients will return for regularly scheduled visits at Weeks 1 and 3 or at early discontinuation.
- Conditions
- Sialorrhea (Excessive Drooling)
- Being tested
- NH004 tropicamide, NH004 Placebo
- Keywords
- Parkinson's disease, Sialorrhea, Tropicamide, Non-motor symptoms, Thin strip delivery
- 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.
NH004 tropicamideDrug
Intra-oral slow dissolving muco-adhesive thin film containing 1 mg tropicamide
NH004 PlaceboDrug
Intra-oral slow dissolving muco-adhesive thin film
| Study group | Role | What they receive |
|---|---|---|
| NH004 tropicamide | Experimental | tropicamide 1 mg thin film, twice daily for 7 days Receives: Drug: NH004 tropicamide |
| NH004 placebo | Placebo comparator | placebo thin film, twice daily for 7 days Receives: Drug: NH004 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Teachers Drooling Scale (% responding)
The primary endpoint for this trial is the difference in responder rate between tropicamide and placebo. Responders will be defined as subjects whose mean sialorrhea score improved by at least 30% as compared to baseline in the 9-point modified Teachers Drooling Scale (mTDS).
Measured: one week
Secondary outcomes (4)
modified Teachers Drooling Scale (mean)
Difference in the mean sialorrhea scores between placebo and tropicamide in the 9-point modified Teachers Drooling Scale (mTDS).
Measured: one week
Sialorrhea Clinical Scale for Parkinson's Disease (mean)
- Difference in the mean sialorrhea scores between placebo and tropicamide in the Sialorrhea Clinical Scale for Parkinson's Disease (SCS-PD).
Measured: one week
UPDRS Part II sialorrhea item (mean)
Difference in the mean sialorrhea scores between placebo and tropicamide in the UPDRS Part II sialorrhea item (#6).
Measured: one week
Visual Analg Scale
Saliva buccal content as measured by a Visual Analog Scale (VAS) score, evaluated before and during 3 hours after treatments administration.
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2013 (estimated)
- Study startApr 2013
- Primary completionOct 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sialorrhea (Excessive Drooling)Studies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuroHealing Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Responsible party
- Sponsor
- Investigators
- Elkan R Gamzu, PhD, Study director, NeuroHealing Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01844648
- Sponsor's protocol ID
- NH004-3
- Other IDs
- 2011-004212-36
- Status last verified
- Apr 2014
- First submitted
- 29 Apr 2013
- Last updated
- 10 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Crossover Study of the Safety and Efficacy of Tropicamide 1 mg Intra-oral Slow Dissolving Muco-adhesive Thin Films to Reduce Hypersalivation in PD Patients Manifesting Sialorrhea Complaints
- ClinicalTrials.gov ID
- NCT01844648
- Acronym / sponsor ID
- NH004-3
- Conditions
- Sialorrhea (Excessive Drooling)
- Keywords
- Parkinson's disease, Sialorrhea, Tropicamide, Non-motor symptoms, Thin strip delivery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- NeuroHealing Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Study start
- Apr 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 1 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study the safety and efficacy of tropicamide 1 mg intra-oral slow dissolving muco-adhesive thin films compared to placebo to reduce hypersalivation in PD patients manifesting sialorrhea complaints.
Detailed description
This is a double-blind, placebo-controlled, randomized, crossover, multicentre study comparing intra-oral slow dissolving muco-adhesive thin films containing tropicamide 1 mg or Placebo. Patients will receive each treatment twice daily (1 h after breakfast and 1 h after lunch) for 1-week.
Patients will be evaluated for eligibility during the 14-day screening period. Those patients meeting all entry criteria at baseline will be randomized (1:1) to receive first tropicamide followed by placebo films or vice versa. Patients will return for regularly scheduled visits at Weeks 1 and 3 or at early discontinuation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NH004 tropicamide | Experimental | Drug: NH004 tropicamidetropicamide 1 mg thin film, twice daily for 7 days |
| NH004 placebo | Placebo comparator | Drug: NH004 Placeboplacebo thin film, twice daily for 7 days |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with idiopathic Parkinson's disease, according to the UK Brain Bank criteria.
- Patients complaining of drooling, with a score of at least 6 points in the SCS-PD scale.
- Patients above 30 years old.
- Patients with Hoehn \& Yahr score between I-IV.
- 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.
Key exclusion criteria (20 listed)
- Pregnant women.
- Patients with a secondary parkinsonian syndrome, parkinsonism-plus syndromes, heredodegenerative disorders or benign parkinsonism.
- Patients with a diagnosis of major depression or psychosis according to the DSM-IV.
- Patients with MMSE score equal to or lower than 24.
- Patients with a current diagnosis of substance abuse (DSM-IV) or history of alcohol or drug abuse in the past 3 months.
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 |
|---|---|---|
| NH004 tropicamideIntra-oral slow dissolving muco-adhesive thin film containing 1 mg tropicamide | Drug | NH004 tropicamide |
| NH004 PlaceboIntra-oral slow dissolving muco-adhesive thin film | Drug | NH004 placebo |
Primary outcome
modified Teachers Drooling Scale (% responding)
Time frame: one week
The primary endpoint for this trial is the difference in responder rate between tropicamide and placebo. Responders will be defined as subjects whose mean sialorrhea score improved by at least 30% as compared to baseline in the 9-point modified Teachers Drooling Scale (mTDS).
4 secondary outcomes
modified Teachers Drooling Scale (mean)
Time frame: one week
Sialorrhea Clinical Scale for Parkinson's Disease (mean)
Time frame: one week
UPDRS Part II sialorrhea item (mean)
Time frame: one week
Visual Analg Scale
Time frame: one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2015.
Related trials for Sialorrhea (Excessive Drooling)
Not yet recruiting
Chewing Gum as a Therapeutic Intervention for the Management of Hypersalivation
Hypersialorrhea (Excessive Salivation), Psychiatric Disorders
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 study director
NeuroHealing Pharmaceuticals Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NH004 tropicamide in people with Sialorrhea (Excessive Drooling), run by NeuroHealing Pharmaceuticals Inc. at 3 sites in France.
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 6 inclusion and 20 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 10 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
modified Teachers Drooling Scale (% responding) (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2015.