A Multi-Centre, 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.
- Conditions
- europathic pain
- Registration Number
- EUCTR2004-004395-36-CZ
- Lead Sponsor
- GW Pharma Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 383
1. Subject is willing and able to give informed consent for participation in the study (see Section 15.2)
2. Male or female, aged 18 years or above
3. Subject has participated in a GW clinical study to investigate the effects of Sativex on their neuropathic pain and has completed the study. This must have been within the last seven days
4. Subject has complied with all of the study requirements in the preceding GW parent study, including the completion of diary cards and study questionnaires
5. Subject has shown tolerability to the study medication in a preceding GW study
6. Subject is expected, in the opinion of the investigator, to gain clinical benefit from receiving Sativex therapy
7. Subject is willing and able (in the investigators opinion) to comply with all study requirements, including the completion of diary cards and study questionnaires
8. Subject is willing for his or her name to be notified to the responsible authorities for participation in this study, according to local laws and regulations
9. Subject is willing to allow his or her primary care physician and consultant, if appropriate, to be notified of participation in the study
For inclusion in Part B (Randomised withdrawal phase) of this study, subjects must fulfill ALL of the following criteria:
1. Subject has participated in GWCL0404, is currently ongoing in the study (i.e., subject is still receiving Sativex treatment) and who has completed the study up to Visit 5.
2. Subject has complied with all of the study requirements to-date, including the completion of the diary cards.
3. Subject has shown tolerability to the study medication in this study.
4. Subject is willing and able (in the investigators opinion) to comply with all study requirements, including the completion of diary cards.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Any history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying disease
2. Any know or suspected history of alcohol or substance abuse
3. Any history of epilepsy or recurrent seizures
4. Any known or suspected hypersensitivity to cannabinoids or any of the excipients of the study medication
5. Subject has evidence of cardiomyopathy
6. Subject has experienced myocardial infarction or clinically relevant cardiac dysfunction within the last 12 months or has a cardiac disorder that, in the opinion of the investigator would put the subject at risk of a clinically relevant arrhythmia or myocardial infarction
7. Subject has a QT interval; of > 450 ms (male) or > 470 ms (females) at Visit 1
8. Subject has a secondary or tertiary AV block or sinus bradycardia (HR < 50 bpm unless physiological) or sinus tachycardia (HR >110 bpm) at Visit 1
9. Subject has a diastolic blood pressure of < 50 mmHg or > 105 mmHg in a sitting position at rest for 5 minutes prior at Visit 1
10. Subject has impaired renal function e.g. creatinine clearance is lower than 50 ml/min at Visit 1 and indicative of renal impairment.
11. Subject has significantly impaired hepatic function, at Visit 1, in the investigator's opinion
12. Female subjects of child bearing potential and male subjects whose partner is of child bearing potential, unless willing to ensure that they or their partner use effective contraception during the study and for three months thereafter
13. Female subject who is pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter
14. Subjects who have received an IMP within the 12 weeks before Visit 1 (except the prerequisite study medication from the GW parent study
15. Any other significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, may influence the result of the study, or the subject's ability to participate in the study
16. Following a physical exam, the subject has any abnormalities that, in the opinion of the investigator, would prevent the subject from safely participating in the study
17. Unwilling to abstain form donation of blood during the study
18. Subjects previously entered into this study
For Part B (Randomised withdrawal phase) of this study, subjects may not enter if ANY of the following apply:
1. The subject has experienced or is currently experiencing any adverse events or untoward medical occurences which, in the opinion of the investigator, would prevent them from safely participating in this amendment to the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the maintenance of effect of and development of tolerance of exposure to, open label Sativex therapy in subjects with neuropathic pain.<br><br>To assess the safety of Sativex.<br><br>Phase B (randomised withdrawal phase) -<br>To investigate the maintenance of efficacy after long term treatment with Sativex.<br>Assesment of the abscence or occurence of withdrawal symptoms.;Secondary Objective: To evaluate the effects of long-term, open label Sativex therapy in subjects with painful neuropathy on:<br><br>- secondary measure of pain<br>- sleep quality<br>- quality of life<br>;Primary end point(s): Investigational medical product (IMP) dosing, and average pain severity evaluated from weekly diaries and measured on a pain severity numerical rating scale (NRS)<br><br>Adverse events (AEs) collected throughout the study.<br><br>Part B (Randomised withdrawal phase)<br><br>The primary endpoint is the average daily pain severity on a pain severity NRS.
- Secondary Outcome Measures
Name Time Method