Use of Cannabinoids in Patients With Multiple Sclerosis
关键词
抽象
描述
Baseline assessment will be followed by randomisation and dose introduction. Patients will be randomly assigned to two counterbalanced groups starting either with Sativex or with placebo as the first drug. They will be dispensed sufficient study medication for two weeks together with a diary. During the two-week treatment period all the patients will have to be reached the optimal, individualised dosage to subjectively relief spasticity.Patient will return after three weeks and they will undergo the fMRI and neurophysiological evaluations.Then patients will perform a two-week washout period and they will be requested to intake the alternative medicine. After two weeks patients will perform a second fMRI/neurophysiological study. Two weeks later, after a second washout period, a last visit will be performed to conclude the study.
日期
| 最后验证: | 08/31/2005 |
| 首次提交: | 09/11/2005 |
| 提交的预估入学人数: | 09/11/2005 |
| 首次发布: | 09/19/2005 |
| 上次提交的更新: | 11/27/2005 |
| 最近更新发布: | 11/28/2005 |
| 实际学习开始日期: | 06/30/2005 |
状况或疾病
干预/治疗
Drug: Sativex
相
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: 1. Male or female subjects between 18 and 60 years of age (inclusive) 2. Have definite Multiple Sclerosis as per Poser Criteria 3. Have either relapsing remitting or secondary progressive course 4. Baseline EDSS score from 3.0 to 6.5 (inclusive) 5. Stable disease for at least 30 days prior to study entry 6. Be right-handed with normal right hand function 7. Female patients of child bearing potential and male patients whose partner is of child bearing potential who are willing to ensure that they or their partner use effective contraception during the study and for three months thereafter 8. If female, be neither pregnant nor breast-feeding. Confirmation that the subjects not pregnant must be established by a negative serum hCG pregnancy test at baseline. 9. No cannabinoids use (cannabis, Marinol, Nabilone) for at least three months prior to entry into the study and willing to abstain from any use of cannabis during the study 10. Significant spasticity in at least two muscle groups defined as a score of 2 or more on the Ashworth scale for each muscle group 11. Antispastic/antiepileptic treatments (dosage, frequency and route of administration) stable for at least one month prior the study entry - Exclusion Criteria: 1. Have a primary progressive MS 2. Patients under disease modifying therapies prescribed in the 6 months prior the study entry 3. Patients who have participated in another research study in the past 6 months 4. Changes in antispastic/antiepileptic treatments (dosage, frequency and route of administration) within one month prior the study entry 5. Have a psychiatric disorders or cognitive impairment that preclude safe participation in the study 6. Known history of alcohol or substance abuse 7. Concurrent clinically important immunologic, pulmonary, renal, liver, active thyroid, and/or other major disease other than MS 8. Severe cardiovascular, disorders, such as ischaemic heart disease, arrhythmias, poorly controlled hypertension or severe heart failure 9. Patients suffering from acute or chronic pain 10. History of epilepsy 11. Female patient who is pregnant, lactating or planning pregnancy during the course of the study 12. Scheduled elective surgery or other procedures requiring general anaesthesia during the study 13. Patient who is terminally ill or is inappropriate for placebo medication 14. Systemic corticosteroid therapy within 4 weeks of randomization or exacerbation of MS within 30 days 15. Regular levodopa therapy within 7 days of the study entry 16. Male patient currently receiving sildenafil (Viagra) and unwilling to stop medication for the duration of the study 17. Patients who are currently taking antiarrhythmic medications 18. Known or suspected adverse reaction to cannabinoids 19. Travel outside the Italy planned during the study 20. Donation of blood during the study 21. Contraindications to MRI scans - |
结果
主要结果指标
1. To evaluate the effect of Sativex on: a)patterns of brain activation associated with movement(fMRI); b) changes in level of spasticity (H-reflex); c)changes in intracortical excitability and on synaptic intracortical network of the motor areas(TMS). [undefined]
