MUltiple Sclerosis and Extract of Cannabis (MUSEC) Study
Ključne besede
Povzetek
Datumi
| Nazadnje preverjeno: | 02/28/2015 |
| Prvič predloženo: | 10/31/2007 |
| Predviden vpis oddan: | 10/31/2007 |
| Prvič objavljeno: | 11/01/2007 |
| Zadnja posodobitev oddana: | 03/23/2015 |
| Zadnja posodobitev objavljena: | 03/24/2015 |
| Dejanski datum začetka študija: | 05/31/2006 |
| Predvideni datum primarnega zaključka: | 10/31/2008 |
| Predvideni datum zaključka študije: | 10/31/2008 |
Stanje ali bolezen
Intervencija / zdravljenje
Drug: 1
Drug: 2
Faza
Skupine rok
| Roka | Intervencija / zdravljenje |
|---|---|
| Experimental: 1 Cannabis extract (delta-9-THC 2.5mg, CBD 1.25 mg per capsule), flexible dosing between 5 mg and 25 mg THC/d, administered twice daily | Drug: 1 Cannabis extract (delta-9-THC 2.5mg, CBD 1.25 mg per capsule), flexible dosing between 5 mg and 25 mg THC/d, administered twice daily |
| Placebo Comparator: 2 matching placebo capsules, twice daily | Drug: 2 Matching placebo capsules, twice daily |
Merila upravičenosti
| Starost, primerna za študij | 18 Years Za 18 Years |
| Spol, upravičen do študija | All |
| Sprejema zdrave prostovoljce | Da |
| Merila | 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. |
Izid
Primarni izidni ukrepi
1. Change in muscle stiffness: 11-point numerical Likert scale [12 weeks]
Ukrepi sekundarnega rezultata
1. Change in pain: 11-point numerical Likert scale [12 weeks]
