Nabilone for Non-motor Symptoms in Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Intervention: Nabilone 0.25 mg
Intervention description: capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis
Intervention MeSH terms: Nabilone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: open-label
Masking: None (Open Label)
Masking description: None, open-label
Enrollment: 22.0
Sex: All
Minimum age: 30 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Parkinson´s Disease; cannabinoids; non-motor symptoms

Summary:

      This is an open-label extension study for participants of the randomized placebo-controlled,
      double-blind, parallel-group, enriched enrolment randomized withdrawal NMS-Nab Study,
      assessing the long-term safety and efficacy of nabilone for non-motor symptoms in patients
      with Parkinson´s Disease (PD). 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.

      Eligible patients will be re-tapered in an open-label nabilone dose optimization phase
      followed by an open-label period of 6 months on a stable nabilone dose.
    

Eligibility criteria:

        Inclusion Criteria:

        In order to be eligible for participation in the study, subjects must meet all inclusion
        criteria:

          1. In order to be eligible for the study, patients must have completed the double-blind
             phase of the NMS-Nab trial as responders within the last 2 months.

          2. For patients that completed NMS-Nab Study over 2 months prior to the Screening /
             Baseline Visit, and meet all other inclusion criteria, eligibility should be discussed
             on a case-by-case basis.

          3. Only patients without a drug-related serious adverse event (SAE) or (drug-related)
             moderate or severe AE during the NMS-Nab Study can be included in the study

          4. Patients must be able and willing to provide written informed consent prior to any
             study related procedure being performed. Patients with a legal guardian should be
             consented according to local requirements.

          5. Patients must be willing and able to take oral medication and able to comply with the
             study specific procedures.

          6. The patient is in good health as determined by medical examination and based on the
             investigator's judgement

        Exclusion Criteria:

        Patients with any of the following characteristics will be excluded from entering the
        study:

          1. Patients with PArkinson´s Disease (PD) who have not participated in the randomized
             double-blind phase of the previous NMS-Nab Study.

          2. Patients that experienced a drug-related SAE or had a (drug-related) moderate or
             severe AE during the NMS-Nab Study will be excluded in the study.

          3. Patients who are unable or unwilling to comply with the study procedures in the
             investigator´s opinion.

          4. Patients with any clinically significant or unstable medical or surgical condition at
             the Screening / Baseline Visit that may preclude safety and the completion of the
             study participation (based on the investigator's judgement).