A Study of the Long-term Safety of Sativex Use

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier:
NCT01606137
First received: May 21, 2012
Last updated: June 13, 2013
Last verified: June 2013
Results First Received: July 19, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Multiple Sclerosis
Spasticity
Pain
Intervention: Drug: GW-1000-02

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
GW-1000-02 Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). The maximum permitted dose of was eight actuations in any three hour period, and 48 actuations in any 24 hour period (THC 130 mg : CBD 120 mg).

Participant Flow:   Overall Study
    GW-1000-02  
STARTED     507  
COMPLETED     245  
NOT COMPLETED     262  
Adverse Event                 85  
Withdrawal by Subject                 74  
Lack of Efficacy                 56  
Lost to Follow-up                 15  
Protocol Violation                 1  
Patient non-compliance                 9  
Death                 1  
Decreased/no pain                 4  
Issues with driving                 4  
multiple sclerosis less stable                 1  
Increased bilirubin                 1  
Spray causes nausea                 1  
Not enough improvement                 4  
Wanted to try another treatment                 1  
Patient leaving country                 1  
Personal reasons                 1  
Unable to tolerate study med. taste                 1  
Patient moving                 1  
Unable to collect consistent data                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
GW-1000-02 Active treatment

Baseline Measures
    GW-1000-02  
Number of Participants  
[units: participants]
  507  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     458  
>=65 years     49  
Age  
[units: years]
Mean ± Standard Deviation
  50  ± 12.3  
Gender  
[units: participants]
 
Female     288  
Male     219  
Region of Enrollment  
[units: participants]
 
United Kingdom     507  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Incidence of Adverse Events as a Measure of Subject Safety.   [ Time Frame: Up to 1051 days ]

2.  Secondary:   Change From Parent Study Baseline in Spasticity 0-10 Numerical Rating Scale Score After 52 Weeks of Treatment.   [ Time Frame: 0 - 52 weeks ]

3.  Secondary:   Change From Parent Study Baseline in Central Neuropathic Pain 0-10 Numerical Rating Scale Score at 52 Weeks of Treatment.   [ Time Frame: 0 - 52 weeks. ]

4.  Secondary:   Change From Parent Study Baseline in Neuropathic Pain 0-10 Numerical Rating Scale Score at 52 Weeks of Treatment in Multiple Sclerosis Subjects.   [ Time Frame: 0 - 52 weeks. ]

5.  Secondary:   Change From Parent Study Baseline in Pain 0-10 Numerical Rating Scale Score at 52 Weeks of Treatment.   [ Time Frame: 0 - 52 weeks. ]

6.  Secondary:   Subject Assessment of Benefit at the Last Study Visit in Those Experiencing Neuropathic Pain Due to Multiple Sclerosis.   [ Time Frame: Up to 1051 days ]

7.  Secondary:   Investigator Assessment of Benefit at the Last Study Visit in Those Experiencing Neuropathic Pain Due to Multiple Sclerosis.   [ Time Frame: Up to 1051 days ]

8.  Secondary:   Subject Assessment of Benefit at the Last Study Visit in Those Experiencing Central Neuropathic Pain.   [ Time Frame: Up to 1051 days ]

9.  Secondary:   Investigator Assessment of Benefit at the Last Study Visit in Those Experiencing Central Neuropathic Pain.   [ Time Frame: Up to 1051days ]

10.  Secondary:   Subject Assessment of Benefit at the Last Study Visit in Those Experiencing Pain.   [ Time Frame: Up to 1051 ]

11.  Secondary:   Investigator Assessment of Benefit at the Last Study Visit in Those Experiencing Pain.   [ Time Frame: Up to 1051 days ]

12.  Secondary:   Subject Assessment of Benefit at the Last Study Visit in All Multiple Sclerosis Subjects.   [ Time Frame: Up to 1051 days ]

13.  Secondary:   Investigator Assessment of Benefit at the Last Study Visit in All Multiple Sclerosis Subjects.   [ Time Frame: Up to 1051 days. ]

14.  Secondary:   Investigator Global Assessment at the Last Study Visit in Subjects With Neuropathic Pain Due to Multiple Sclerosis.   [ Time Frame: Up to 1051 days ]

15.  Secondary:   Investigator Global Assessment at the Last Study Visit in Subjects With Central Neuropathic Pain.   [ Time Frame: Up to 1051 days. ]

16.  Secondary:   Investigator Global Assessment at the Last Study Visit in Subjects With Pain.   [ Time Frame: Up to 1051 days. ]

17.  Secondary:   Investigator Global Assessment at the Last Study Visit in Subjects With Multiple Sclerosis.   [ Time Frame: Up to 1051 days. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Mr Richard Potts, Clinical Operations Director
Organization: GW Pharma Ltd.
phone: 0044 1223 266800
e-mail: rp@gwpharm.com


Publications of Results:

Responsible Party: GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT01606137     History of Changes
Other Study ID Numbers: GWEXT0102
Study First Received: May 21, 2012
Results First Received: July 19, 2012
Last Updated: June 13, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency