NCT01610713已完成3 期
Double Blind, Randomised, Parallel Group, Placebo Controlled Trial of a Combination of THC and CBD in Patients With Multiple Sclerosis, Followed by an Open Label Assessment and Study Extension
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Change From Mean Part A Primary Impairment Visual Analogue Scale Score (After 6 Weeks) at the End of Four Weeks of Open-label Treatment (10 Weeks Total)
研究概览
简要总结
An open-label extension study in which patients with multiple sclerosis received GW-1000-02 [named Sativex® in Canada and also named Sativex® Oromucosal Spray] for four weeks in an open-label manner.
详细描述
Subjects who took part in GWMS0001 Part A were invited to continue to receive GW-1000-02 in this four-week open-label part of the study. Subjects received open-label cannabinoid extract (GW-1000-02) for four weeks, either with or without peppermint flavouring, according to their study centre. Subjects who completed the study could choose to continue receiving GW-1000-02 by entering the long-term safety extension follow-on study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged at least 18 years.
- •Multiple Sclerosis of any type.
- •Stable Multiple Sclerosis symptomatology during the four weeks before study entry.
- •Symptoms of the required severity (>50 mm on a 100 mm Visual Analogue Scale severity scale) in least one of the specified impairment categories; spasticity, muscle spasms, disturbed bladder control, neuropathic pain, limb tremor.
- •A stable medication regime during the four weeks before study entry.
- •Willing to abstain from cannabis or cannabinoids for at least seven days before study entry, and during the study.
- •Agreed either to use effective contraception during the study and for three months thereafter, or had been surgically sterilised or, if female, were post-menopausal.
- •Clinically acceptable laboratory results for pre-study screening.
- •Willing and able to undertake and comply with all study requirements.
- •Willing and able to read, consider and understand the subject information and consent form and give written informed consent. Subjects unable to read or to sign the document procedures were treated as detailed in the Declaration of Helsinki.
- •Willing for their general practitioner, and consultant if appropriate, to be informed of study participation.
- •Willing for their name to be notified to Home Office for participation in the study.
排除标准
- •Known or strongly suspected to be abusing drugs, including alcohol.
- •Not prepared to abstain from cannabis or cannabinoids during the study.
- •Current or past addiction to cannabis.
- •Known or suspected to have had an adverse reaction to cannabinoids causing psychosis or other severe psychiatric illness.
- •History of any type of schizophrenia, any other psychotic illness, or other significant psychiatric illness or personality disorder other than depression associated with chronic illness.
- •Received any drug containing levodopa (Sinemet®, Sinemet plus®, Levodopa®, L-dopa®, Madopar®, Benserazide®).
- •Serious cardiovascular disorder including angina, uncontrolled hypertension, or an uncontrolled symptomatic cardiac arrhythmia.
- •Significant renal or hepatic impairment as shown in medical history or indicated by laboratory results.
- •History of epilepsy.
- •Terminal illness or other condition in which placebo medication would be inappropriate.
- •Pregnant, lactating or at risk of pregnancy.
- •Participated in any other clinical research study during the 12 weeks before study entry.
- •Planned hospital admission between study entry and Visit
- •Planned travel outside the UK between study entry and Visit 6.
研究组 & 干预措施
GW-1000-02
Experimental
Active treatment.
干预措施: GW-1000-02 (Drug)
结局指标
主要结局
Change From Mean Part A Primary Impairment Visual Analogue Scale Score (After 6 Weeks) at the End of Four Weeks of Open-label Treatment (10 Weeks Total)
时间窗: End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
This was achieved by measuring the change in the Part A study score (mean of all scores during the last two weeks of six weeks of double-blind therapy) in the severity of the primary impairment (mean of all scores during the last two weeks of four weeks of open-label therapy), a composite score from one of five multiple sclerosis symptom categories that subjects nominated as their most severe symptom. The severity scores were recorded using a 100 mm Visual Analogue Scale, where 0 = no problem and 100 = very bad. As such, a decrease in score indicates an improvement and a negative value indicates an improvement in score from baseline.
次要结局
- Change From Mean Part A Short Orientation Memory Concentration Score at the End of Open-label Treatment(End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment]))
- Change From Mean Part A Guy's Neurological Disability Scale Score at the End of Open-label Treatment(End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment]))
- Change From Mean Part A Care-Giver Strain Index Score at the End of Open-label Treatment(End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment]))
- Change From Mean Part A Ashworth Scale Score at the End of Open-label Treatment(End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment]))
- Change From Part A Mean Muscle Spasm Visual Analogue Scale Score at the End of Open-Label Treatment(End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment]))
- Change From Part A Mean Tremor Visual Analogue Scale Score at the End of Open-Label Treatment(End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment]))
- Change From Mean Part A Total Adult Memory and Information Processing Battery Score at the End of Open-label Treatment(End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment]))
- Change From Mean Part A Beck's Depression Inventory (BDI-II) Score at the End of Open-label Treatment(End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment]))
- Change From Mean Part A Fatigue Severity Scale Questionnaire Score at the End of Open-label Treatment(End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment]))
- Change From Mean Part A Total Bladder Control Questionnaire Score at the End of Open-label Treatment(End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment]))
- Change From Mean Part A Reading Visual Acuity Test Score at the End of Open-label Treatment(End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment]))
- Change From Mean Part A Tremor Activities of Daily Living Score at the End of Open-label Treatment(End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment]))
- Change From Mean Part A Rivermead Mobility Index Score at the End of Open-label Treatment(End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment]))
- Change From Mean Part A Nine Hole Peg Test Score at the End of Open-label Treatment(End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment]))
- Incidence of Adverse Events as a Measure of Patient Safety(End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment]))
- Change From Mean Part A Barthel Activities for Daily Living Score at the End of Open-label Treatment(End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment]))
- Change From Mean Part A Total 28-item General Health Questionnaire Score at the End of Open-label Treatment(End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment]))
- Change From Mean Part A Sleep Quality 100 mm Visual Analogue Scale Score at the End of Open-label Treatment(End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment]))
- Change From Part A Mean Sleep Amount 100 mm Visual Analogue Scale Score at the End of Open-label Treatment(End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment]))
- Change From Part A Mean Feeling Upon Wakening 100 mm Visual Analogue Scale Score at the End of Open-Label Treatment(End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment]))
- Change From Part A Mean Spasticity Visual Analogue Scale Score at the End of Open-Label Treatment(End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment]))
- Change From Part A Mean Pain Visual Analogue Scale Score at the End of Open-Label Treatment(End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment]))
- Change From Part A Mean Bladder Problems Visual Analogue Scale Score at the End of Open-Label Treatment(End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment]))
- Change From Part A Mean Ten-metre Mobility Score at the End of Open-Label Treatment(End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment]))
- Subject Global Opinion of Effect on Multiple Sclerosis at the End of Open-label Treatment(End of Part B (week 10))
研究者
研究点 (1)
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