Sativex Versus Placebo When Added to Existing Treatment for Central Neuropathic Pain in MS

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GW Pharmaceuticals Ltd.

ClinicalTrials.gov Identifier:

NCT00391079

First received: October 20, 2006

Last updated: July 25, 2012

Last verified: July 2012

History of Changes

Results First Received: May 30, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Multiple Sclerosis
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	Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
Placebo	Range of 8-12 sprays per day of placebo spray.

Participant Flow: Overall Study

	Sativex	Placebo
STARTED	167	172
COMPLETED	141	156
NOT COMPLETED	26	16

Baseline Characteristics

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Reporting Groups

	Description
Sativex	Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
Placebo	Range of 8-12 sprays per day of placebo spray.
Total	Total of all reporting groups

Baseline Measures

	Sativex	Placebo	Total
Number of Participants [units: participants]	167	172	339
Age [units: years] Mean ± Standard Deviation	48.42 ± 10.43	49.51 ± 10.50	48.97 ± 10.47
Gender [units: participants]
Female	113	117	230
Male	54	55	109
Duration of Multiple Sclerosis (MS) [units: years] Mean ± Standard Deviation	11.42 ± 8.00	12.53 ± 8.50	11.99 ± 8.26
Duration of Central Neuropathic Pain (CNP) [units: years] Mean ± Standard Deviation	5.59 ± 6.12	5.33 ± 4.80	5.46 ± 5.49
Baseline Pain Numerical Rating Scale (NRS) score ^[1] [units: Points on a scale] Mean ± Standard Deviation	6.55 ± 1.35	6.61 ± 1.29	6.58 ± 1.32

[1]	Pain severity NRS was completed daily by answering the following question: 'On a scale of '0 to 10' please indicate the average level of your nerve pain at your chosen site over the last day', with the anchors: 0='no pain' and 10= 'worst possible pain'.

Outcome Measures

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1. Primary:

Change in Mean Pain Due to MS NRS Score [ Time Frame: 14 weeks: Baseline - End of Treatment (last 7 days of treatment) ]

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2. Primary:

Number of Patients With at Least 30% Improvement in Numerical Rating Scale (NRS) Pain Score From Baseline [ Time Frame: 14 weeks: Baseline - end of treatment (last 7 days) ]

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3. Secondary:

Change in Pain From Baseline to End of the Treatment Using the NPS (Neuropathic Pain Scale) [ Time Frame: 14 weeks: Baseline - End of treatment (Week 14) ]

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4. Secondary:

Change From Baseline to End of Treatment in Break-through Analgesia Usage [ Time Frame: 14 weeks: baseline - end of treatment (last 7 days) ]

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5. Secondary:

Change From Baseline to End of Treatment in BPI (Brief Pain Inventory) Short Form [ Time Frame: 14 weeks: Baseline to end of treatment (last 7 days of treatment) ]

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6. Secondary:

Change in Subject Global Impression of Change (SGIC) [ Time Frame: Week 14 ]

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7. Secondary:

Change in Sleep Disruption NRS [ Time Frame: 14 weeks; Baseline to end of treatment (last 7 days) ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: GW will coordinate the dissemination of data from this study and may solicit input and assistance from the principal investigator. All publications for example, manuscripts, abstracts, oral/slide presentations or book chapters based on this study, must be submitted to GW for corporate review before release.

Limitations and Caveats

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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Results Point of Contact:

Name/Title: Richard Potts Clinical Operations Director
Organization: GW Pharmaceuticals
phone: +44 1223 266800
e-mail: rp@gwpharm.com

No publications provided

Responsible Party:	GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier:	NCT00391079 History of Changes
Other Study ID Numbers:	GWMS0501
Study First Received:	October 20, 2006
Results First Received:	May 30, 2012
Last Updated:	July 25, 2012
Health Authority:	Canada: Health Canada United Kingdom: Medicines and Healthcare Products Regulatory Agency Czech Republic: State Institute for Drug Control

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