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NCT00484757 Clinical Trial

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

Narcolepsy Clinical Trial

— NARKOREX  

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00484757
Other study ID # Narkorex
Secondary ID DFG-SFB654/C5-Na
Status Active, not recruiting
Phase N/A
First received June 8, 2007
Last updated April 2, 2009
Start date June 2007
Est. completion date August 2009

Study information
Verified date April 2009
Source Zentrum für Integrative Psychiatrie
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 0
Est. completion date August 2009
Est. primary completion date August 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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)

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• Orexine A

Locations
Country Name City State
Germany Zentrum für Integrative Psychiatrie Kiel

Sponsors (1)
Lead Sponsor Collaborator
Zentrum für Integrative Psychiatrie

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Effect of orexine A on sleep, neurocognition and immune-system
See also
  Status Clinical Trial Phase
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Completed NCT02821715 - Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients Phase 2
Completed NCT01789398 - Patient Narcoleptic Treated With BF2.649 (Pitolisant) in add-on to Sodium Oxybate (HARMONY IV) Phase 3
Completed NCT01681121 - A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy Phase 2
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Completed NCT03173378 - Evaluation of Academic and Professional Trajectories of Narcoleptic Patients
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Completed NCT01067235 - Efficacy and Safety Study of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With Narcolespy Phase 3
Completed NCT00228566 - Study to Assess Patient Reported Outcomes With Armodafinil Treatment for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome Phase 3
Completed NCT00132873 - Trial of Xyrem® (Sodium Oxybate) for the Treatment of Narcolepsy Phase 3
Completed NCT00107848 - PROVIGIL® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome Phase 3
Completed NCT00107796 - Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy Phase 3
Enrolling by invitation NCT05113745 - A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy Phase 3
Suspended NCT04419792 - 'A Profile of Physical Performance Variables in an Out-patient Adult Population With Narcolepsy'