12-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's disease.

• Register: EUCTR
• Last refreshed on: 4 April 2022
• Main ID: EUCTR2016-001403-23-IT
• Date of registration: 06/09/2021
• Prospective Registration: No
• Primary sponsor: ABBVIE DEUTSCHLAND GMBH & CO. KG
• Public title: 12-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's disease.
• Scientific title: An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparative interventional trial on Duodopa VERsus oral medication) - DYSCOVER Study
• Date of first enrolment: 13/09/2016
• Target sample size: 60
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-001403-23
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Optimized medical treatment Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

European Union, Finland, Greece, Hungary, Italy, Slovakia, Spain, United States

Contacts

• Name: EU Clinical Trials Helpdesk
• Affiliation: AbbVie Ltd.

• Name: EU Clinical Trials Helpdesk
• Affiliation: AbbVie Ltd.

Key inclusion & exclusion criteria

Inclusion criteria:
1. Male or female subjects of at least 30 years old at the time of Visit 3.
2. Subject must have a diagnosis of idiopathic Parkinson's disease according to the United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria
3. Patients with advanced levodopa-responsive Parkinson's disease and persistent motor fluctuations who have not been controlled with optimized medical treatment. "Optimized medical 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.
4. UDysRS Total score = 30 at Visit 3 based on Central Blinded Rater's score.
5. Subject (or subject's proxy/caregiver) must be able to complete both the Subject Dosing Diary and the PD Diary and must be able to demonstrate the ability to operate, manipulate, and care for the pump and tubing.
6. Subject must demonstrate at least 75% concordance with the Investigator's or qualified designee's assessment of symptoms on the Parkinson's Disease Diary following training at Screening Visit 1 with concordance on at least 1 time interval of "Off," concordance on at least 1 time interval of "ON regardless of dyskinesia" and at least 1 time
interval of "ON with dyskinesia" irrespective of whether the dyskinesia are troublesome or not troublesome.
7. Subject is eligible to transfer to commercial treatment of Duodopa after completing the study based on local country requirements.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion criteria:
1. Predominantly di-phasic dyskinesia, as per Investigator discretion.
2. Patients who were treated with LCIG before
3. Patients who have had previous surgery for PD including, but not limited to deep brain stimulation (DBS) or cell transplantation.
4. A Mini-Mental State Examination (MMSE) score of < 24 at Visit 1 or significant cognitive impairment that, in the opinion of the Investigator, could impact the subject's ability to participate in the trial
5. Current primary psychiatric diagnosis of uncontrolled acute psychotic disorder or primary psychiatric diagnoses of bipolar disorder, schizophrenia, obsessive compulsive disorder or currently experiencing a major depressive episode with psychotic features per Diagnostic and
Statistical Manual of Mental Disorders Fifth Edition, Text Revision (DSM-V-TR).
6. Subject 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 Investigator.
7. Current diagnosis or history of drug or alcohol abuse (DSM-V-TR criteria) within 12 months prior to screening visit.
8. Participation in a concurrent interventional or observational study.
9. Lack of motivation or insufficient language skills to complete the study questionnaires.
10. Subject'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), atypical Parkinson Syndrome (e.g., Multiple System Atrophy, Progressive supranuclear Palsy, Diffuse Lewy Body
disease) or other neurodegenerative disease that might mimic the symptoms of PD.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Dyskinesia in advanced Parkinson's disease
MedDRA version: 21.1 Level: LLT Classification code 10013113 Term: Disease Parkinson's System Organ Class: 100000004852

Intervention(s)

Trade Name: Duodopa
Product Name: na
Product Code: [na]
Pharmaceutical Form: Gel
INN or Proposed INN: LEVODOPA
CAS Number: 59-92-7
Current Sponsor code: N.D.
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
INN or Proposed INN: CARBIDOPA
CAS Number: 38821-49-7
Current Sponsor code: N.D.
Other descriptive name: CARBIDOPA MONOHYDRATE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-

Primary Outcome(s)

Main Objective: The primary objective of this interventional study is to examine the effect of LCIG treatment relative to that of Optimized Medical Treatment (OMT) on dyskinesia as measured by the Unified Dyskinesia Rating Scale (UDysRS) Total Score.

Timepoint(s) of evaluation of this end point: Baseline, Week 2, Week 4, Week 8, Week 12/Early termination visit

Primary end point(s): Change from baseline to week 12 in Unified Dyskinesia Rating Scale (UDysRS) Total Score

Secondary Objective: The Secondary objective is to assess the effect of LCIG treatment relative to that of OMT on dyskinesia as measured by PD Diaries, motor symptoms, motor complications, safety, tolerability and health-related outcome measures.

Secondary Outcome(s)

Secondary end point(s): Secondary endpoints (with hierarchical analysis)
• ON time without troublesome dyskinesia as measured by the PD Diary
• PDQ-8 Summary Index
• CGI-C
• UPDRS Part II Score
• OFF time as measured by PD Diary
• UPDRS Part III Score
Additional Efficacy Endpoints are:
¿ UDysRS Historical Score, Objective Score and Parts 1 through 4 Scores
¿ ON time with troublesome dyskinesia and ON time without dyskinesia
as measured by PD Diary
¿ mAIMS
Additional Health Outcome Endpoints:
¿ King's PD Pain Scale

Timepoint(s) of evaluation of this end point: 1. Baseline, Week 2, Week 4, Week 8, Week 12/Early termination visit
2. Baseline, Week 8, Week 12/Early termination visit
3. Week 2, Week 4, Week 8, Week 12/Early termination visit
4. Screening, Baseline, Week 2, Week 4, Week 8, Week 12/Early termination visit
5. Baseline, Week 2, Week 4, Week 8, Week 12/Early termination visit
6. Screening, Baseline, Week 2, Week 4, Week 8, Week 12/Early termination visit
7. Baseline, Week 2, Week 4, Week 8, Week 12/Early termination visit
8. Baseline, Week 2, Week 4, Week 8, Week 12/Early termination visit
9. Baseline, Week 2, Week 4, Week 8, Week 12/Early termination visit
10. Baseline, Week 4, Week 8, Week 12/Early termination visit

Secondary ID(s)

M15-535

2016-001403-23-FI

Source(s) of Monetary Support

AbbVie Inc.

Ethics review

Status: Approved
Approval date: 13/09/2016
Contact:

Results

• Results available: Yes
• Date Posted: 03/09/2020
• Date Completed: 19/09/2019
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-001403-23/results