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An Observational Post-Marketing Safety Registry of Sativex®

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ClinicalTrials.gov Identifier: NCT02073474
Recruitment Status : Completed
First Posted : February 27, 2014
Last Update Posted : October 11, 2017
Sponsor:
Information provided by (Responsible Party):
GW Pharmaceuticals Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment
Multiple Sclerosis Diabetes Cancer Neuropathic Pain Drug: Sativex®

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Actual Enrollment : 978 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: An Observational Post-Marketing Safety Registry Of Patients Who Have Been Prescribed Sativex®
Actual Study Start Date : February 2011
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Sativex® users
UK: All patients and who are prescribed Sativex®. Germany and Sweden: Patients who are prescribed Sativex® from selected specialist neurology centres.
Drug: Sativex®
Contains delta-9-tetrahydrocannabinol (THC), 27 mg/mL; cannabidiol (CBD), 25 mg/mL; in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Each actuation delivers THC 2.7 mg and CBD 2.5 mg.
Other Names:
  • Nabiximols
  • GWP42001
  • THC/CBD spray




Primary Outcome Measures :
  1. Incidence rates of adverse events. [ Time Frame: Participants will be followed for the duration of Sativex treatment, an expected average of 2 years. ]
    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 Outcome Measures :
  1. Average daily number of sprays of Sativex® used. [ Time Frame: Participants will be followed for the duration of Sativex treatment, an expected average of 2 years. ]
    The average daily dose of Sativex® was recorded and is presented.

  2. Number of patients experiencing fall-related injuries requiring medical attention. [ Time Frame: Participants will be followed for the duration of Sativex treatment, an expected average of 2 years. ]
    Patients were asked if they had sought medical attention because of a fall-related injury; since they started taking Sativex® (initial record); during this period (follow-up records). The number of patients answering 'yes' is presented.

  3. Number of patients experiencing a change in driving ability. [ Time Frame: Participants will be followed for the duration of Sativex treatment, an expected average of 2 years. ]
    Patients were asked to report any change in their driving ability; since they started taking Sativex® (initial record); during this period (follow-up records). The markers were: Improved, No change, Deteriorated, Not appropriate. The number of patients for each marker is presented.

  4. Number of patients experiencing suicidal thoughts or attempts. [ Time Frame: Participants will be followed for the duration of Sativex treatment, an expected average of 2 years. ]
    Patients were asked if they had experienced any suicidal thoughts or attempted suicide; since they started taking Sativex® (initial record); during this period (follow-up records). The number of patients answering 'yes' is presented.

  5. Number of patients experiencing significant psychiatric or psychotic events other than suicidality. [ Time Frame: Participants will be followed for the duration of Sativex treatment, an expected average of 2 years. ]
    Patients were asked if they had experienced any significant psychiatric or psychotic events other than suicidality; since they started taking Sativex® (initial record); during this period (follow-up records). The number of patients answering 'yes' is presented.

  6. Incidence of patient deaths. [ Time Frame: Participants will be followed for the duration of Sativex treatment, an expected average of 2 years. ]
    The incidence of treatment-emergent deaths was recorded and the number of patient deaths is presented.

  7. Number of patients receiving worthwhile benefit from Sativex®. [ Time Frame: Participants will be followed for the duration of Sativex treatment, an expected average of 2 years. ]
    Patients were asked if Sativex® was providing worthwhile benefit. The number of patients answering 'yes' at one or more time points is presented.

  8. Number of MS patients discontinuing anti-spasticity medications. [ Time Frame: Participants will be followed for the duration of Sativex treatment, an expected average of 2 years. ]
    MS patients were asked what other anti-spasticity medications that have previously been used are now stopped permanently; since they started taking Sativex® (initial record); during this period (follow-up records). The number of patients for each discontinued medication is presented.

  9. Number of MS patients discontinuing medications for MS symptoms other than anti-spasticity medications. [ Time Frame: Participants will be followed for the duration of Sativex treatment, an expected average of 2 years. ]
    MS patients were asked what medications for MS symptom other than anti-spasticity medications that have previously been used are now stopped permanently; since they started taking Sativex® (initial record); during this period (follow-up records). The number of patients for each discontinued medication is presented.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients who are prescribed Sativex® in the UK and patients who are prescribed Sativex® from selected specialist neurology centres in Germany and Sweden.
Criteria

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.

Additional Information:

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Responsible Party: GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT02073474     History of Changes
Other Study ID Numbers: GWSR10128
First Posted: February 27, 2014    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017

Keywords provided by GW Pharmaceuticals Ltd.:
cannabinoids
Sativex
THC
delta-9-tetrahydrocannabinol
cannabidiol
CBD
Registry
Safety
MS

Additional relevant MeSH terms:
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Multiple Sclerosis
Neuralgia
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Nabiximols
Dronabinol
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Hallucinogens
Psychotropic Drugs
Analgesics, Non-Narcotic
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists