Sativex Versus Placebo When Added to Existing Treatment for Central Neuropathic Pain in MS
This study has been completed.
Sponsor:
GW Pharmaceuticals Ltd.
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
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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
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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| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| No text entered. |
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
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 |
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Gender
[units: participants] |
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| 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'. |
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Outcome Measures
| 1. Primary: | Change in Mean Pain Due to MS NRS Score [ Time Frame: 14 weeks: Baseline - End of Treatment (last 7 days of treatment) ] |
| 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) ] |
| 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) ] |
| 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) ] |
| 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) ] |
| 6. Secondary: | Change in Subject Global Impression of Change (SGIC) [ Time Frame: Week 14 ] |
| 7. Secondary: | Change in Sleep Disruption NRS [ Time Frame: 14 weeks; Baseline to end of treatment (last 7 days) ] |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| 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:
|
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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| No text entered. |
Results Point of Contact:
Name/Title: Richard Potts Clinical Operations Director
Organization: GW Pharmaceuticals
phone: +44 1223 266800
e-mail: rp@gwpharm.com
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 |