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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	19 March 2012
Main ID:	EUCTR2004-002505-74-IT
Date of registration:	07/12/2006
Prospective Registration:	No
Primary sponsor:	CEPHALON EUROPE
Public title:	A 6-Month Open Label, Flexible Dosage Study to Assess the Safety and Effectiveness of PROVIGIL Modafinil Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome
Scientific title:	A 6-Month Open Label, Flexible Dosage Study to Assess the Safety and Effectiveness of PROVIGIL Modafinil Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome
Date of first enrolment:	18/01/2005
Target sample size:	150
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-002505-74
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: Studio in aperto, a dose flessibile If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
Phase:

Countries of recruitment
Czech Republic	Finland	Italy	Spain	United Kingdom

Contacts

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Key inclusion & exclusion criteria

Inclusion criteria:
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome
MedDRA version: 6.1 Level: HLGT Classification code 10040998

Intervention(s)

Trade Name: PROVIGIL*30CPR 100MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Modafinil
CAS Number: 68693-11-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

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Secondary Outcome(s)

Secondary ID(s)

2004-002505-74-CZ

C1538/3034/ES/MN

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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