Clinical trial NCT00244465: Observational Study to Evaluate Risks of Side Effects, Drug Abuse and Dependence in Patients Who Received Xyrem ® on Prescription
Official title: Post Marketing Non-interventional Surveillance Pharmacoepidemiology Study (PMSS) to Evaluate Long-term Safety, Tolerability and Compliance in Administration of Xyrem® (Sodium Oxybate) Oral Solution in Patients Who Receive Treatment With This Medication in Regular Clinical Practice.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Narcolepsy
Keywords: Narcolepsy
Cataplexy
Oxybate
Xyrem
Misuse
Safety
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-10-26
Enrollment: 750
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients being treated with Xyrem®.

Brief summary: Patients will be followed up for max 18 months. Information on the Adverse Events and potential misuse or abuse of Xyrem ® will be collected.


Eligibility criteria: Inclusion Criteria:

* Patients who received Xyrem ® on prescription

Exclusion Criteria:

* No limitations

Primary outcomes:
measure: Evaluation of risk for development adverse events, withdrawal syndrome and potential for dependence, abuse, overdose and misuse of Xyrem®. Obtaining information about adherence to Xyrem® prescribing information regarding indication and dosage.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: 9
city: Innsbruck
country: Austria
facility: 5
city: Antwerpen
country: Belgium
facility: 12
city: Brugge
country: Belgium
facility: 28
city: Brussels
country: Belgium
facility: 13
city: Gent
country: Belgium
facility: 34
city: Leuven
country: Belgium
facility: 35
city: Liege
country: Belgium
facility: 10
city: Praha 2
country: Czech Republic
facility: 16
city: Berlin
country: Germany
facility: 24
city: Berlin
country: Germany
facility: 25
city: Bremen
country: Germany
facility: 22
city: Hofheim/Taunus
country: Germany
facility: 19
city: Katzenelnbogen
country: Germany
facility: 42
city: Münster
country: Germany
facility: 23
city: Regensburg
country: Germany
facility: 20
city: Schwalmstadt
country: Germany
facility: 1
city: Ulm
country: Germany
facility: 31
city: Westerstede
country: Germany
facility: 21
city: Dublin 7
country: Ireland
facility: 4
city: Bologna
country: Italy
facility: 18
city: Baracaldo
country: Spain
facility: 40
city: Barcelona
country: Spain
facility: 11
city: Barcelona
country: Spain
facility: 7
city: Castellon
country: Spain
facility: 17
city: Granada
country: Spain
facility: 32
city: Madrid
country: Spain
facility: 15
city: Madrid
country: Spain
facility: 29
city: Palma de Mallorca
country: Spain
facility: 39
city: San Sebastian
country: Spain
facility: 36
city: Sevilla
country: Spain
facility: 14
city: Sevilla
country: Spain
facility: 37
city: Vigo
country: Spain
facility: 38
city: Vitoria
country: Spain
facility: 30
city: Vitoria
country: Spain
facility: 43
city: Barmelweid
country: Switzerland
facility: 41
city: Bern
country: Switzerland
facility: 33
city: Zürich
country: Switzerland
facility: 6
city: Cambridge
country: United Kingdom
facility: 2
city: Essex
country: United Kingdom
facility: 26
city: Leicester
country: United Kingdom
facility: 27
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References:
citation: Mayer G, Plazzi G, Iranzo A, Ortega-Albas J, Quinnell T, Pesch H, Serralheiro P, Schlit AF, Wuiame D, Bentz JWG. Long-term compliance, safety, and tolerability of sodium oxybate treatment in patients with narcolepsy type 1: a postauthorization, noninterventional surveillance study. Sleep. 2018 Sep 1;41(9). doi: 10.1093/sleep/zsy128.