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Status:

COMPLETED

Nabilone for Non-motor Symptoms in Parkinson's Disease

Lead Sponsor:

Medical University Innsbruck

Conditions:

Parkinson Disease

Eligibility:

All Genders

30-100 years

Phase:

PHASE3

Brief 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-te...

Detailed Description

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-te...

Eligibility Criteria

Inclusion

  • In order to be eligible for participation in the study, subjects must meet all inclusion criteria:
  • 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.
  • 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.
  • 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
  • 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.
  • Patients must be willing and able to take oral medication and able to comply with the study specific procedures.
  • The patient is in good health as determined by medical examination and based on the investigator's judgement

Exclusion

  • Patients with any of the following characteristics will be excluded from entering the study:
  • Patients with PArkinson´s Disease (PD) who have not participated in the randomized double-blind phase of the previous NMS-Nab Study.
  • 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.
  • Patients who are unable or unwilling to comply with the study procedures in the investigator´s opinion.
  • 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).

Key Trial Info

Start Date :

August 6 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 31 2020

Estimated Enrollment :

22 Patients enrolled

Trial Details

Trial ID

NCT03773796

Start Date

August 6 2018

End Date

January 31 2020

Last Update

March 2 2021

Active Locations (1)

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Department of Neurology - Medical University Innsbruck

Innsbruck, Tyrol, Austria, 6020