A Study of Sativex® for Relief of Peripheral Neuropathic Pain Associated With Allodynia.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier:
NCT00711880
First received: July 7, 2008
Last updated: June 13, 2013
Last verified: June 2013
Results First Received: July 19, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions: Pain
Peripheral Neuropathy
Interventions: Drug: Sativex®
Drug: Placebo

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Sativex Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Placebo Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.

Participant Flow:   Overall Study
    Sativex     Placebo  
STARTED     63     62  
COMPLETED     50     55  
NOT COMPLETED     13     7  
Adverse Event                 11                 2  
Patient non-compliance                 1                 0  
Lack of Efficacy                 1                 5  



  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.
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Reporting Groups
  Description
Sativex Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Placebo Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Total Total of all reporting groups

Baseline Measures
    Sativex     Placebo     Total  
Number of Participants  
[units: participants]
  63     62     125  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     51     49     100  
>=65 years     12     13     25  
Age  
[units: years]
Mean ± Standard Deviation
  52.4  ± 15.8     54.3  ± 15.2     53.4  ± 15.4  
Gender  
[units: participants]
     
Female     35     39     74  
Male     28     23     51  
Region of Enrollment  
[units: participants]
     
United Kingdom     51     50     101  
Belgium     12     12     24  



  Outcome Measures
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1.  Primary:   Change From Baseline in the Mean Daily Peripheral Neuropathic Pain on a 0-10 Numerical Rating Scale Score During the Last Seven Days of Treatment (End of Treatment)   [ Time Frame: Day 0 to Day 42 ]

2.  Secondary:   Change From Baseline in Mean Neuropathic Pain Scale Score at the End of Treatment   [ Time Frame: Day 0 to Day 42 ]

3.  Secondary:   Change From Baseline in Mean Sleep Quality at the End of Treatment   [ Time Frame: Day 7 - Day 42 ]

4.  Secondary:   Change From Baseline in the Mean Pain Disability Index Score at the End of Treatment   [ Time Frame: Day 0 - Day 42 ]

5.  Secondary:   Change From Baseline in Mean Dynamic Allodynia Test Score at the End of Treatment   [ Time Frame: Day 7 and Day 42 ]

6.  Secondary:   Change From Baseline in Mean Static Allodynia Test Score at the End of Treatment   [ Time Frame: Day 0 - Day 42 ]

7.  Secondary:   Change From Baseline in Mean Total General Health Questionnaire Score at the End of Treatment   [ Time Frame: Day 7 and Day 42 ]

8.  Secondary:   Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Selective Reminding' at the End of Treatment   [ Time Frame: Day 7 and Day 42 ]

9.  Secondary:   Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for ‘10/36 Spatial Recall' at the End of Treatment   [ Time Frame: Day 7 and Day 42 ]

10.  Secondary:   Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Symbol Digit Modalities' at the End of Treatment   [ Time Frame: Day 7 and Day 42 ]

11.  Secondary:   Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Paced Auditory Serial Addition Task' at the End of Treatment   [ Time Frame: Day 7 and Day 42 ]

12.  Secondary:   Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Word List Generation' at the End of Treatment   [ Time Frame: Day 7 and Day 42 ]

13.  Secondary:   Subject Global Impression of Change in the Severity of Peripheral Neuropathic Pain at the End of Treatment   [ Time Frame: Day 42 ]

14.  Secondary:   Change From Pre-dose in Mean Intoxication 100 mm Visual Analogue Scale Score at the End of Treatment   [ Time Frame: Day 0 - Day 42 ]

15.  Secondary:   Subject Global Impression of Change in the Severity of Allodynia in Their Chosen Allodynic Area at the End of Treatment   [ Time Frame: Day 0 - 42 ]

16.  Secondary:   Incidence of Adverse Events as a Measure of Subject Safety   [ Time Frame: Day 0 - Day 42 ]


  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: NCT00711880     History of Changes
Other Study ID Numbers: GWNP0101
Study First Received: July 7, 2008
Results First Received: July 19, 2012
Last Updated: June 13, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment