Parkinson DiseasePhase 4DEPOPANCT00806468
Effect of Desmopressin on the Nocturnal Micturition Frequency in Patients With Parkinson Disease
A Phase 4 study testing Desmotabs in people with Parkinson Disease, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
This study will be conducted to study the effect of Desmopressin on the nocturnal micturition frequency in patients with idiopathic Parkinson syndrome. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Desmotabs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2009to Feb 2011
- Phase
- Phase 4
- 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 18 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients with idiopathic Parkinson Syndrome
- 18 to 85 years
- Nocturnal Pollakisuria > 2 mictions /night (documented in Screening phase )
- Na+ i.S > 135 mmol/l
- Patient is able to understand all aspects and individual consequences of the clinical trial
- An informed consent signed and dated by the patient is available prior to any study specific treatment
- The study is consistent with the patients´ request for an appropriate treatment
Who cannot join
- Intake of the following concomitant medication: Carbamazepin, Oxcarbazepine, diuretics (Furosemide, Torasemide), non steroidal antiphlogistics, Loperamide, antidiuretic hormone analoga (besides study medication), drugs for treatment of bladder disfunction, in particular anticholinergics
- Central Diabetes insipidus
- Known heart insufficiency (NYHA Stad. III und IV)
- clinical relevant kidney insufficiency
- Habitual and psychogenic Polydipsia
- Hypersensitivity or allergy against the trial medication or any other ingredient of the trial medication
Show all 9Show fewer
- Participation in another clinical trial during or within 6 months prior to this clinical trial
- Medical or psychological condition, which might endanger the proper conduction of the clinical trial
- Known drug or alcohol abuse
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinikum der Johannes Gutenberg-Universität Mainz, Studienzentrum Neurologie, Langenbeckstr. 1, 55131 Mainz
Mainz, 55131
About this study
Official title: A Double Blind, Placebo Controlled, Randomized, Monocentre Cross-over Study to Investigate the Effect of Desmopressin on the Nocturnal Micturition Frequency in Patients With Parkinson Disease
This study will be conducted to study the effect of Desmopressin on the nocturnal micturition frequency in patients with idiopathic Parkinson syndrome.
- Conditions
- Parkinson Disease
- Being tested
- Desmotabs
- Keywords
- nycturia, Parkinson syndrome, desmopressin, Nocturnal polyuria in patients with Parkinson syndrome
- Medical subject headings
- Parkinson Disease, Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesmotabsDrug
Desmotabs encapsulated, 0,2 mg once daily for one week, 0,2 mg bid for one week
| Study group | Role | What they receive |
|---|---|---|
| Desmopressin | Experimental | Desmopressin 0,2 mg once daily and Desmopressin 0,2 mg bid for one week each. Receives: Drug: Desmotabs |
What is being measured
The primary outcome is the main question the study is designed to answer.
average nocturnal micturition frequency within the 2 weeks treatment phase each
Measured: 6 weeks
Secondary outcomes (1)
safety and efficacy on nocturnal micturition frequency of Desmopressin in patients with Parkinson syndrome
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2008 (estimated)
- Study startFeb 2009
- Primary completionDec 2010 (estimated)
- Study completionFeb 2011 (estimated)
Why it stopped: lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Investigators
- Thomas Vogt, MD, Principal investigator, Johannes Gutenberg University Mainz, Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00806468
- Sponsor's protocol ID
- DEPOPA-2008
- Acronym
- DEPOPA
- Status last verified
- Jun 2010
- First submitted
- 9 Dec 2008
- Last updated
- 20 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Placebo Controlled, Randomized, Monocentre Cross-over Study to Investigate the Effect of Desmopressin on the Nocturnal Micturition Frequency in Patients With Parkinson Disease
- ClinicalTrials.gov ID
- NCT00806468
- Acronym / sponsor ID
- DEPOPA / DEPOPA-2008
- Conditions
- Parkinson Disease
- Keywords
- nycturia, Parkinson syndrome, desmopressin, Nocturnal polyuria in patients with Parkinson syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of recruitment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Feb 2011 (estimated)
- First posted
- 10 Dec 2008 (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.
This study will be conducted to study the effect of Desmopressin on the nocturnal micturition frequency in patients with idiopathic Parkinson syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Desmopressin | Experimental | Drug: DesmotabsDesmopressin 0,2 mg once daily and Desmopressin 0,2 mg bid for one week each. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male patients with idiopathic Parkinson Syndrome
- 18 to 85 years
- Nocturnal Pollakisuria > 2 mictions /night (documented in Screening phase )
- Na+ i.S > 135 mmol/l
- Patient is able to understand all aspects and individual consequences of the clinical trial
Key exclusion criteria (9 listed)
- Intake of the following concomitant medication: Carbamazepin, Oxcarbazepine, diuretics (Furosemide, Torasemide), non steroidal antiphlogistics, Loperamide, antidiuretic hormone analoga (besides study medication), drugs for treatment of bladder disfunction, in particular anticholinergics
- Central Diabetes insipidus
- Known heart insufficiency (NYHA Stad. III und IV)
- clinical relevant kidney insufficiency
- Habitual and psychogenic Polydipsia
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 |
|---|---|---|
| DesmotabsDesmotabs encapsulated, 0,2 mg once daily for one week, 0,2 mg bid for one week | Drug | Desmopressin |
Primary outcome
average nocturnal micturition frequency within the 2 weeks treatment phase each
Time frame: 6 weeks
1 secondary outcome
safety and efficacy on nocturnal micturition frequency of Desmopressin in patients with Parkinson syndrome
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2010.
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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.
Thomas Vogt, MD principal investigator
Johannes Gutenberg University Mainz, Department of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Desmotabs in people with Parkinson Disease, run by Johannes Gutenberg University Mainz at 1 site in Germany.
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 7 inclusion and 9 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: stopped early, as of the sponsor's last update on 20 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: lack of recruitment). Results are not available in the source record.
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?
average nocturnal micturition frequency within the 2 weeks treatment phase each (time frame: 6 weeks). 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 20 Dec 2010.