Clinical trial · Observational
An Observational Post-Marketing Safety Registry of Sativex®
An Observational Post-Marketing Safety Registry Of Patients Who Have Been Prescribed Sativex®
NCT02073474CI-TRIAL-00062785completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this registry is to monitor safety outcomes of patients who are receiving Sativex® for Multiple Sclerosis (MS) spasticity and for off-label indications in the United Kingdom (UK), Germany and Sweden.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Diabetes | — | UNRESOLVED | — |
| Multiple Sclerosis | — | UNRESOLVED | — |
| Neuropathic Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sativex® | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Sativex® users
- description
- UK: All patients and who are prescribed Sativex®. Germany and Sweden: Patients who are prescribed Sativex® from selected specialist neurology centres.
- interventionNames
- Drug: Sativex®
Primary outcomes (1)
- measure
- Incidence rates of adverse events.
- timeFrame
- Participants will be followed for the duration of Sativex treatment, an expected average of 2 years.
- description
- The number of treatment-emergent adverse events was recorded. The incidence rate (number of patients divided by the total patient-years exposure to Sativex®) for each adverse event is presented.
Secondary outcomes (9)
- measure
- Average daily number of sprays of Sativex® used.
- timeFrame
- Participants will be followed for the duration of Sativex treatment, an expected average of 2 years.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * All patients who are prescribed Sativex® in the UK * Patients who are prescribed Sativex® from selected specialist neurology centres in Germany and Sweden.
References
Publications (0)
Data not yet available
No reference posted for this study.