NCT02549092

A Study to Examine the Effect of an Active Drug Intestinal Gel Therapy Relative to That of Optimized Medical Treatment (OMT) on Non-motor Symptoms (NMS) Associated With Advanced Parkinson's Disease (PD)

Brief summary

The primary objective of this study is to examine the effect of an active drug relative to that of OMT on non-motor symptoms associated with Parkinson's disease (PD).

Interventional study

Status:
Active, not recruiting
Conditions:
Advanced Parkinson's Disease
Enrollment:
89 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M12-927
Allocation:
Randomized
Intervention model:
Parallel Assignment
Masking:
None (Open Label)
Purpose:
Treatment

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Eligibility criteria

Participant attributes:
Male and Female

Age:

30 Years and older.

Inclusion Criteria:

1. Participant(s) must have a diagnosis of idiopathic Parkinson's disease according to
the United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria.

2. Participant(s) demonstrates persistent motor fluctuations in spite of individually
optimized treatment.

3. The participant's Parkinson's disease is levodopa-responsive.

4. Participant(s) has had optimized treatment with available anti-PD medication and their
motor symptoms are judged inadequately controlled on this optimized treatment.
Optimized treatment is defined as the maximum therapeutic effect obtained with
pharmacological antiparkinsonian therapies when no further improvement is expected
regardless of any additional manipulations of levodopa and/or other antiparkinsonian
medication. This will be based on the Investigator's clinical judgment.

5. Male or female participant(s) must be at least 30 years of age.

6. Minimum Parkinson's Disease Sleep Scale 2 (PDSS-2) total score of 18 at Baseline
assessment.

Exclusion Criteria:

1. Participant's PD diagnosis is unclear or there is a suspicion that the subject has a
parkinsonian syndrome such as secondary parkinsonism (e.g. caused by drugs, toxins,
infectious agents, vascular disease, trauma, brain neoplasm), parkinson-plus syndrome
(e.g. Multiple System Atrophy, Progressive supranuclear Palsy, Diffuse Lewy Body
disease) or other neurodegenerative disease that might mimic the symptoms of PD.

2. Participant(s) has undergone neurosurgery for the treatment of Parkinson's disease.

3. Known hypersensitivity to levodopa, carbidopa or radiopaque material.

4. Participant(s) has contraindications to levodopa (e.g. narrow angle glaucoma,
malignant melanoma).

5. Participant(s) experiencing clinically significant sleep attacks or clinically
significant impulsive behavior (e.g. pathological gambling, hypersexuality) at any
point during the three months prior to the Screening evaluation as judged by the
Principal Investigator.

All the cities where the clinical studies are located

Edmonton - T6G 2X8
Ottawa - K1H 8L6
Toronto - M5T 2S8

Alberta