Nabilone for Non-motor Symptoms in Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized placebo-controlled, double-blind, parallel-group, enriched enrollment
      randomized withdrawal study assessing the efficacy and safety of nabilone for non-motor
      symptoms in patients with Parkinson´s Disease. Nabilone is an analogue of
      tetrahydrocannabinol (THC), the psychoactive component of cannabis. Nabilone acts as a
      partial agonist on both Cannabinoid 1 (CB1) and Cannabinoid 2 (CB2) receptor in humans and
      therefore mimics the effect of THC but with more predictable side effects and less euphoria.

      Part 1 is an open-label dose adjustment phase of the study. In eligible patients, a screening
      period is followed by an open-label nabilone dose optimization phase and a stable phase for
      at least 1 week. Treatment responders will be included in Part 2 of the study (randomized
      placebo-controlled, double-blind, parallel-grouped).

      Part 2 is the placebo-controlled, double-blind, parallel-group randomized withdrawal phase of
      the study.
    

Detailed description: 
      This is a randomized placebo-controlled, double-blind, parallel-group, enriched enrollment
      randomized withdrawal study assessing the efficacy and safety of nabilone for non-motor
      symptoms in patients with Parkinson´s Disease. Nabilone is an analogue of
      tetrahydrocannabinol (THC), the psychoactive component of cannabis. Nabilone acts as a
      partial agonist on both Cannabinoid 1 (CB1) and Cannabinoid 2 (CB2) receptor in humans and
      therefore mimics the effect of THC but with more predictable side effects and less euphoria.

      Part 1 is the open-label dose adjustment phase of the study. In Part 1, eligible subjects,
      who have signed the informed consent form at the screening visit, will receive open-label
      nabilone starting with a dosage of 0.25 mg in the evening. During dose titration and
      optimization, nabilone will be titrated in 0.25 mg increments (increase by 0.25 mg/ every one
      to four days) up to a maximum dose of 1 mg twice daily. Patients should be on a stable
      nabilone dose for at least 1 week afterwards until Baseline Visit (V 0).

      Part 2 is the placebo-controlled, double-blind, parallel-group randomized withdrawal phase of
      the study. At Baseline Visit, treatment responders will be included in Part 2 of the study
      (randomized placebo-controlled, double-blind, parallel-grouped). Responders are randomized in
      a 1:1 ratio at Baseline Visit to receive either nabilone or matching placebo for 4 weeks + 2
      days. The placebo-controlled, double-blind, randomized withdrawal phase will end with a
      clinic visit (Termination Visit V 1). Following this, the study medication will be tapered in
      all patients. During this period the patients will receive phone calls every other day. A
      Safety Telephone Call and a Safety Follow-Up Visit will be performed.
    

Intervention name(s): Nabilone 0.25 mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis; capsule, corn starch, daily basis
Intervention MeSH terms: Nabilone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized placebo-controlled, double-blind, parallel-group, enriched enrolment randomized withdrawal study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson´s Disease; cannabinoids; non-motor symptoms