Pain Clinical Trial
Official title:
Efficacy and Safety of Delta-9-tetrahydrocannabinol (∆9-THC) in Behavioural Disturbances and Pain in Dementia
This is a phase II, randomized, placebo-controlled, double-blind, parallel-group,
multicentre study to the efficacy and safety of low dose delta-9-THC in behavioural
disturbances and pain in patients with mild to severe dementia, when added to an analgesic
treatment with acetaminophen.
It is hypothesized that Namisol® will lead to more behavioural disturbances than placebo,
when added to an analgesic treatment with acetaminophen, and as measured by a change in
Neuropsychiatric Inventory (NPI) score, after a three week treatment period.
It is expected that this will be due, primarily, to psychoactive effects of Namisol® and
secondary to a reduction in pain sensation (as measured with VRS and PACSLAC-D). It is
expected that a reduction in NPS will positively affect quality of life and lead to better
functioning in daily living.
There is a high prevalence of behavioural disturbances (NPS) in persons with dementia.
Persistent pain complaints can be a cause of NPS. Unfortunately, there is a lack of
appropriate drugs for treating both these problems. This and positive suggestions from
preliminary clinical studies with THC on NPS and directly fuel the study presented here.
This will be a phase II study in which the efficacy and safety of Namisol® (a tablet with
THC) on behavioural disturbances, such as agitation, aggression and motor disturbances in
dementia patients will be evaluated.
Secondary study objectives are :
2. To evaluate the efficacy of Namisol® on other secondary outcome measures, such as quality
of life and functioning in daily activities.
3. To evaluate safety of Namisol® as assessed with physical examination, effects on
cognitive functioning and adverse event monitoring.
4. For the subgroup of subjects suffering from pain: to evaluate the efficacy of Namisol®
pain intensity
It is hypothesized that Namisol® will lead to more reduction in behavioural disturbances
than placebo, when added to an analgesic treatment with acetaminophen, and as measured by a
change in Neuropsychiatric Inventory (NPI) score, after a three week treatment period. It is
expected that this will be due, primarily, to psychoactive effects of Namisol® and secondary
to a reduction in pain sensation (as measured with VRS and PACSLAC-D). It is expected that a
reduction in NPS will positively affect quality of life and lead to better functioning in
daily living
This is a randomized placebo-controlled double-blind parallel-group multicentre study.
Subjects who appear to fulfill the eligibility criteria are informed about the study. After
signing informed consent by the subject and/or caregiver, a screening visit will take place.
Subjects who are eligible for participation enter a wash-out period, for discontinuation of
their own analgesic medication (if applicable). Subjects will be randomly allocated to
receive one of the two interventions (Namisol® 1.5 mg + acetaminophen 1000 mg three times
daily, or placebo + acetaminophen 1000 mg three times daily) for a double-blind intervention
period of three weeks. After two weeks the primary outcome measure (NPI) is assessed by a
telephone interview with the caregiver. Subjects visit the site twice (at baseline and after
three weeks treatment) for assessments of the outcome parameters, including the NPI. For the
purpose of compliance and safety, there will be a weekly phone call, performed by the
researcher. After completion of this period subject's own analgesic treatment will be
restarted (if applicable). After a follow up phase of two weeks, the subject is contacted by
telephone for assessment of adverse events.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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