Primary Outcome Measures:
- Incidence of study treatment-related adverse events (AE) [ Time Frame: during 71 days from screening ] [ Designated as safety issue: Yes ]
- Change in sNRS scores from randomization to end of placebo-controlled treatment phase [ Time Frame: during the12 week treatment period ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Incidence of all AEs [ Time Frame: during the 12 week treatment period ] [ Designated as safety issue: No ]
- Percent change in walking velocity [ Time Frame: during 71 days from screening ] [ Designated as safety issue: No ]
- Global impression of improvement in patient’s clinical condition [ Time Frame: during the 12 week treatment period ] [ Designated as safety issue: No ]
A Phase II, double-blind, randomized, placebocontrolled, parallel-group study. Spasticity is one of the most common and most disabling symptoms of MS, Cannabinoids reduce pain and spasticity in MS patients.
PTL201 capsules contain 5 mg THC and 5 mg cannabidiol (CBD). PTL201 doses will be titrated over a one-week period until reaching maximum tolerated dose (MTD )for each patient (patients will be told they may receive placebo or active treatment, although all treatments will be active). The MTD will be self administered for three weeks thereafter. Patients demonstrating response to treatment will continue self administering daily PTL201 treatment, or placebo, for an additional four weeks.Patients will keep a daily diary.