Narcolepsy Clinical Trial
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.
| Verified date | September 2016 |
| Source | UCB Pharma |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | European Union: European Medicines Agency |
| Study type | Observational |
Patients will be followed up for max 18 months. Information on the Adverse Events and potential misuse or abuse of Xyrem ® will be collected.
| Status | Completed |
| Enrollment | 750 |
| Est. completion date | September 2016 |
| Est. primary completion date | September 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Patients who received Xyrem ® on prescription Exclusion Criteria: - No limitations |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Austria | 9 | Graz | |
| Austria | 5 | Innsbruck | |
| Belgium | 12 | Antwerpen | |
| Belgium | 28 | Brugge | |
| Belgium | 13 | Brussels | |
| Belgium | 34 | Gent | |
| Belgium | 35 | Leuven | |
| Belgium | 10 | Liege | |
| Czech Republic | 16 | Praha 2 | |
| Germany | 24 | Berlin | |
| Germany | 25 | Berlin | |
| Germany | 22 | Bremen | |
| Germany | 19 | Hofheim/Taunus | |
| Germany | 42 | Katzenelnbogen | |
| Germany | 23 | Münster | |
| Germany | 20 | Regensburg | |
| Germany | 1 | Schwalmstadt | |
| Germany | 31 | Ulm | |
| Germany | 21 | Westerstede | |
| Ireland | 4 | Dublin 7 | |
| Italy | 18 | Bologna | |
| Spain | 40 | Baracaldo | |
| Spain | 11 | Barcelona | |
| Spain | 7 | Barcelona | |
| Spain | 17 | Castellon | |
| Spain | 32 | Granada | |
| Spain | 15 | Madrid | |
| Spain | 29 | Madrid | |
| Spain | 39 | Palma de Mallorca | |
| Spain | 36 | San Sebastian | |
| Spain | 14 | Sevilla | |
| Spain | 37 | Sevilla | |
| Spain | 38 | Vigo | |
| Spain | 30 | Vitoria | |
| Spain | 43 | Vitoria | |
| Switzerland | 41 | Barmelweid | |
| Switzerland | 33 | Bern | |
| Switzerland | 6 | Zürich | |
| United Kingdom | 2 | Cambridge | |
| United Kingdom | 26 | Essex | |
| United Kingdom | 27 | Leicester |
| Lead Sponsor | Collaborator |
|---|---|
| UCB Pharma |
Austria, Belgium, Czech Republic, Germany, Ireland, Italy, Spain, Switzerland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 12 months | Yes |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04072380 -
A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy
|
Phase 2 | |
| Withdrawn |
NCT03626727 -
Evaluation of the Efficacy of Sodium Oxybate (Xyrem®) in Treatment of Post-traumatic Narcolepsy and Post-traumatic Hypersomnia
|
Early Phase 1 | |
| Completed |
NCT02821715 -
Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients
|
Phase 2 | |
| Completed |
NCT01681121 -
A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy
|
Phase 2 | |
| Completed |
NCT01789398 -
Patient Narcoleptic Treated With BF2.649 (Pitolisant) in add-on to Sodium Oxybate (HARMONY IV)
|
Phase 3 | |
| Completed |
NCT00174174 -
Provigil (Modafinil) Study by Taiwan Biotech Co.
|
N/A | |
| Completed |
NCT05059223 -
A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy
|
Phase 3 | |
| Completed |
NCT04923594 -
Four-week Study of the Safety and Efficacy of NLS-2 (Mazindol Extended Release) in the Treatment of Narcolepsy
|
Phase 2 | |
| Recruiting |
NCT06279247 -
Proteomics and Metabolomics of Body Fluid in Patients With Narcolepsy
|
||
| Completed |
NCT04647903 -
Study to Evaluate the Abuse Liability, Pharmacokinetics, Safety and Tolerability of an Abuse-Deterrent d-Amphetamine Sulfate Immediate Release Formulation (ADAIR)
|
Phase 1 | |
| Completed |
NCT03267303 -
A Study to Evaluate the Safety and Efficacy of TS-091 in Patients With Narcolepsy
|
Phase 2 | |
| Completed |
NCT03173378 -
Evaluation of Academic and Professional Trajectories of Narcoleptic Patients
|
||
| Completed |
NCT05055024 -
An Open Label Study of NLS-2 (Mazindol Extended Release) in Subjects With Narcolepsy
|
Phase 2 | |
| 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'
|