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A Study to Determine the Maintenance of Effect After Long-term Treatment of Sativex® in Subjects With Neuropathic Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00713817
First Posted: July 11, 2008
Last Update Posted: August 16, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GW Pharmaceuticals Ltd.
  Purpose
The purpose of this study is to assess the maintenance of effect after long-term treatment of Sativex® in subjects with neuropathic pain.

Condition Intervention Phase
Pain Peripheral Neuropathy Drug: Sativex® Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Multicentre, Open Label, Follow on Study to Assess the Maintenance of Effect, Tolerance and Safety of Sativex® in the Treatment of Subjects With Neuropathic Pain. This Will be Followed by a Randomised-withdrawal Phase (Part B) for a Subset of Patients

Further study details as provided by GW Pharmaceuticals Ltd.:

Primary Outcome Measures:
  • Change From Baseline in Mean Daily Pain Severity on a 0-10 Numerical Rating Scale Score at the End of Treatment (Average of Last 7 Days Treatment) [ Time Frame: Day 0-35 ]
    The pain severity Numerical Rating Scale was complete at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate the number that best describes your pain severity in the last 24 hours" where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of neuropathic pain. A negative value indicates an improvement in pain score from baseline.


Secondary Outcome Measures:
  • Change From Baseline Neuropathic Pain Score at the End of Treatment [ Time Frame: Day 7 to 35 ]
    The Neuropathic Pain Scale score is the 0-100 sum of 10 individual pain scores (0-10 Numerical Rating Scale, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain.

  • Number of Subjects Who Failed Treatment at the End of the Treatment Period [ Time Frame: Day 7 to time of last dose ]

    Treatment failure was defined as follows:

    A. Premature termination of Part B (Randomised-Withdrawal) study medication. All subjects who did not complete at least 28 days on Part B (Randomised-Withdrawal) study medicationOr:

    B. An increase in pain, i.e. the mean pain 0-10 Numerical Rating Scale over seven consecutive days after Part B (Randomised-Withdrawal) randomisation had increased by at least 20% from the Part B (Randomised-Withdrawal) randomised treatment baseline.


  • Number of Subjects With More Than a 20% Loss of Response at the End of Treatment [ Time Frame: Day 0-35 ]
    The percentage change from baseline in mean 0-10 Numerical Rating Scale pain score was calculated. The percentage changes from baseline were classified and the number of subjects with 20% or greater loss of response to treatment (i.e. percent increase from baseline ≥ 20%) is presented.

  • Change From Baseline in Sleep Disruption 0-10 Numerical Rating Scale Score at the End of Treatment (Average of Last 7 Days Treatment) [ Time Frame: Day 0-35 ]
    The sleep disruption Numerical Rating Scale was completed at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night?" where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline.

  • Subject Global Impression of Change at the End of Treatment [ Time Frame: Day 7 to 35 ]
    A 7-point Likert-type scale was used, with the question: 'Please assess the status of your nerve pain since entry into the study using the scale below' with the markers "very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse". The number of subjects wo reported an improvement is presented.

  • Incidence of Adverse Events as a Measure of Subject Safety [ Time Frame: Day 0 -35 ]
    The number of subjects who experienced an adverse event during the course of the study is presented.


Enrollment: 19
Study Start Date: March 2007
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sativex Drug: Sativex®
Containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
Other Name: GW-1000-02
Placebo Comparator: Placebo Drug: Placebo
containing peppermint oil, 0.05% (v/v), quinoline yellow, 0.005% (w/v), sunset yellow, 0.0025% (w/v), in ethanol:propylene glycol (50:50) excipient
Other Name: GW-4001-01

Detailed Description:
A five week randomised-withdrawal phase (Part B) for a subset of subjects who took part in a 38 week, multicentre, open label (Part A) follow-on study to evaluate, the maintenance of effect of, the development of tolerance through exposure to, and safety of, Sativex® in the treatment of subjects with neuropathic pain. Subjects returned to the centre for an end of treatment visit at week 38 of Part A (Visit 5, Day 266), followed by Visits 5b (week 39), 5c (week 43) and an end of study visit took place 28 days after Visit 5c or withdrawal from the study.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Had participated in GWCL0404, was currently ongoing in the study (i.e. still receiving GW-1000-02 treatment) and had completed the study up to Visit 5
  • Had complied with all of the study requirements to-date, including the completion of the diary cards
  • Had shown tolerability to the study medication in this study
  • Ability (in the investigators opinion) and willingness to comply with all study requirements, including the completion of diary cards and study questionnaires

Exclusion Criteria:

  • Had experienced or was currently experiencing any adverse events or untoward medical occurrences which, in the opinion of the investigator, would prevent them from safely participating in this phase of the study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00713817


Locations
United Kingdom
Pain Management Research, Clinical Trials Unit, Netherwood House, Solihull Hospital
Solihull, West Midlands, United Kingdom, B91 2JL,
Sponsors and Collaborators
GW Pharmaceuticals Ltd.
Investigators
Principal Investigator: Barbara Hoggart, MBBS, FRCA Pain Management Research, Clinical Trials Unit, Netherwood House, Solihull Hospital
  More Information

Responsible Party: GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT00713817     History of Changes
Other Study ID Numbers: GWCL0404 Part B
First Submitted: July 10, 2008
First Posted: July 11, 2008
Results First Submitted: July 11, 2012
Results First Posted: August 16, 2012
Last Update Posted: August 16, 2012
Last Verified: July 2012

Keywords provided by GW Pharmaceuticals Ltd.:
Pain
Peripheral Neuropathy

Additional relevant MeSH terms:
Neuralgia
Peripheral Nervous System Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms


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