Table 1 Patients' characteristics in study phases

From: The treatment of spasticity with Δ9-tetrahydrocannabinol in persons with spinal cord injury

Phases Phase 1 open label Phase 2 open label Phase 3 parallel study randomized double-blind placebo-controlled
Medication Oral THC (Marinol™) capsules Rectal THC-HS suppositories Oral THC or placebo
N 22 8 13
   N 7 Placebo 6 Verum
Patients characteristics
Age: mean (range) 40.9 year (19–73) 48.8 year (32–66) 39.0 year (29–66) 42.8 year (36–48)
Sex: male/female 20/2 8/0 6/1 5/1
Paraplegiaa 11 3 4 4
Tetraplegiab 11 5 3 2
ASIAc (A/B/C/D) 6/4/4/8 1/3/2/2 3/1/0/3 2/0/2/2
Years postinjury 13.3 year (2–29) 15.5 year (5–28) 15.6 year (6–28) 13 year (3–29)
Drop outs 7 1 0 0
Completed phase 15 7 13
  1. aParaplegic patients: levels of injury T4–T11
  2. bTetraplegic patients: levels of injury C4–C6
  3. cASIA (American Spinal Injury Association) Impairment Scale: assessment for defining the extent of SCI of motor and sensory pathways