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

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Peripheral Nerve Disorders

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party:	GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier:	NCT00713817 History of Changes
Other Study ID Numbers:	GWCL0404 Part B
Study First Received:	July 10, 2008
Results First Received:	July 11, 2012
Last Updated:	July 11, 2012
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency Czech Republic: State Institute for Drug Control

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

ClinicalTrials.gov processed this record on May 22, 2013