Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2025-12-24 @ 9:12 PM
NCT ID:
NCT00552604
Eligibility Criteria:
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT00552604
Study Brief:
Protocol Section:
NCT00552604