NCT00484757

Brief 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. Thereafter sleep will be recorded, the cytokine-system and neurocognition characterized.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 11, 2007

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

April 3, 2009

Status Verified

April 1, 2009

Enrollment Period

2.2 years

First QC Date

June 8, 2007

Last Update Submit

April 2, 2009

Conditions

Narcolepsy

Keywords

NarcolepsyOrexinessleepcognitioncytokines

Outcome Measures

Primary Outcomes (1)

  • Effect of orexine A on sleep, neurocognition and immune-system

Interventions

Orexine ADRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Additional severe psychiatric or somatic disorders
  • Pregnancy or nursing
  • Anemia (Hb\<10g/dl)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zentrum für Integrative Psychiatrie

Kiel, 24105, Germany

Location

MeSH Terms

Conditions

Narcolepsy

Condition Hierarchy (Ancestors)

Disorders of Excessive SomnolenceSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Dunja Hinze-Selch, MD

    Zentrum für Integrative Psychiatrie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 8, 2007

First Posted

June 11, 2007

Study Start

June 1, 2007

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

April 3, 2009

Record last verified: 2009-04

Locations

DE(1)