NarcolepsyNARKOREXNCT00484757
Effect of Intranasal Administration of Orexine A on IL-6-System, Sleep-Wake-Regulation and Neurocognition
A study testing Orexine A in people with Narcolepsy, run by Zentrum für Integrative Psychiatrie at 1 site in Germany.
Trial summary
15 patients with narcolepsy and 15 healthy controls will be included in the study. According to a randomized, double-blind protocol they will receive intranasally at night first Orexine A and approximately two weeks later placebo or vice versa. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Narcolepsy
- What is being tested?
- Orexine A
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Jun 2007to Aug 2009
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Narcolepsy
- Age >18
- Informed consent
- GERMAN fluently spoken
Who cannot join
- Additional severe psychiatric or somatic disorders
- Pregnancy or nursing
- Anemia (Hb<10g/dl)
Trial locations and contacts
1 site in 1 country.
About this study
15 patients with narcolepsy and 15 healthy controls will be included in the study. According to a randomized, double-blind protocol they will receive intranasally at night first Orexine A and approximately two weeks later placebo or vice versa. Thereafter sleep will be recorded, the cytokine-system and neurocognition characterized.
- Conditions
- Narcolepsy
- Being tested
- Orexine A
- Keywords
- Narcolepsy, Orexines, sleep, cognition, cytokines
- Medical subject headings
- Narcolepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orexine ADrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of orexine A on sleep, neurocognition and immune-system
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionAug 2009 (estimated)
- Study completionAug 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NarcolepsyStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Zentrum für Integrative Psychiatrie
- Sponsor type
- University, hospital or other
- Investigators
- Dunja Hinze-Selch, MD, Principal investigator, Zentrum für Integrative Psychiatrie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00484757
- Sponsor's protocol ID
- Narkorex
- Other IDs
- DFG-SFB654/C5-Narkorex
- Acronym
- NARKOREX
- Status last verified
- Apr 2009
- First submitted
- 8 Jun 2007
- Last updated
- 3 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intranasal Administration of Orexine A on IL-6-System, Sleep-Wake-Regulation and Neurocognition
- ClinicalTrials.gov ID
- NCT00484757
- Acronym / sponsor ID
- NARKOREX / Narkorex
- Conditions
- Narcolepsy
- Keywords
- Narcolepsy, Orexines, sleep, cognition, cytokines
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Zentrum für Integrative PsychiatrieUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Aug 2009 (estimated)
- Study completion
- Aug 2009 (estimated)
- First posted
- 11 Jun 2007 (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.
15 patients with narcolepsy and 15 healthy controls will be included in the study. According to a randomized, double-blind protocol they will receive intranasally at night first Orexine A and approximately two weeks later placebo or vice versa. Thereafter sleep will be recorded, the cytokine-system and neurocognition characterized.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Narcolepsy
- Age >18
- Informed consent
- GERMAN fluently spoken
Key exclusion criteria (3 listed)
- Additional severe psychiatric or somatic disorders
- Pregnancy or nursing
- Anemia (Hb<10g/dl)
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 |
|---|---|---|
| Orexine A | Drug | – |
Primary outcome
Effect of orexine A on sleep, neurocognition and immune-system
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2009.
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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.
Dunja Hinze-Selch, MD principal investigator
Zentrum für Integrative Psychiatrie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orexine A in people with Narcolepsy, run by Zentrum für Integrative Psychiatrie 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 3 Apr 2009. 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.
Are results available for this study?
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?
Effect of orexine A on sleep, neurocognition and immune-system. 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 3 Apr 2009.