Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Institut fur Klinische Forschung, Germany
With
Weleda AG
Age
18–64
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Signed informed consent.
Diagnosis of MS according to McDonald criteria.
Current muscle stiffness ≥ 4 on a 11-point categorical rating scale.
On-going troublesome muscle stiffness for at least 3 months.
Stable disease for the previous 6 months.
Antispasticity medication and physiotherapy stabilised for the last 30 days.
Patients may be ambulatory or not.
Age 18-64.
You may not be if
Immunosuppressants which may affect spasticity (including corticosteroids and interferon but ex-cluding azathioprine) taken currently or in previous 30 days
Past or present history of psychotic illness.
Open/infected pressure sores or other source of chronic infection.
Significant fixed tendon contractures.
Severe cognitive impairment such that the patient is unable to provide informed consent.
History of clinically important renal, cardiovascular or neurol. diseases (apart from MS).
Malignancy within the past 2 years.
Cannabinoids taken currently or in previous 30 days.
Positive qualitative urinary test on cannabinoids at screening visit. (In this case a patient will be allowed to repeat the test at a second screening visit later.)
Known hypersensitivity to cannabinoids.
Current drug abuse, including alcohol abuse.
Laboratory parameters outside the following limits:
Creatinine \> 3x upper limit of normal Bilirubine \> 3x upper limit of normal Transaminases \> 5 x upper limit of normal
Anticipated immunisations within the 12 weeks of trial participation.
Other problems likely to make participation difficult at the discretion of the neurologist.
Women who are pregnant, lactating or not using adequate contraception.
Participation in other treatment studies currently or within the previous month.
