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Effect of Intranasal Administration of Orexine A on IL-6-System, Sleep-Wake-Regulation and Neurocognition

NCT ID: NCT00484757

Last Updated: 2009-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2009-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Narcolepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Interventions

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Orexine A

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Narcolepsy
* Age \>18
* Informed consent
* GERMAN fluently spoken

Exclusion Criteria

* Additional severe psychiatric or somatic disorders
* Pregnancy or nursing
* Anemia (Hb\<10g/dl)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zentrum für Integrative Psychiatrie

OTHER

Sponsor Role lead

Principal Investigators

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Dunja Hinze-Selch, MD

Role: PRINCIPAL_INVESTIGATOR

Zentrum für Integrative Psychiatrie

Locations

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Zentrum für Integrative Psychiatrie

Kiel, , Germany

Site Status

Countries

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Germany

Other Identifiers

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DFG-SFB654/C5-Narkorex

Identifier Type: -

Identifier Source: secondary_id

Narkorex

Identifier Type: -

Identifier Source: org_study_id

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