A study comparing immediate-release oral Levodopa and L-dopa/carbidopa intestinal gel over cognition and mood in non-demented Parkinson?s disease (PD) patients

• Register: EUCTR
• Last refreshed on: 28 February 2019
• Main ID: EUCTR2015-002631-17-ES
• Date of registration: 03/11/2015
• Prospective Registration: Yes
• Primary sponsor: Institut de Recerca del Hospital de la Santa Creu i Sant Pau
• Public title: A study comparing immediate-release oral Levodopa and L-dopa/carbidopa intestinal gel over cognition and mood in non-demented Parkinson?s disease (PD) patients
• Scientific title: An intra-subject, randomized, double blind, crossover study comparing immediate-release oral LD (IR-LD) and L-dopa/carbidopa intestinal gel (LCIG) over cognition and mood in non-demented advanced Parkinson?s disease (PD) patients
• Date of first enrolment: 19/11/2015
• Target sample size: 18
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-002631-17
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Spain

Contacts

• Name: Unidad de Trastornos del Movimiento
• Affiliation: Institut de Recerca del Hospital de la Santa Creu i Sant Pau

• Name: Unidad de Trastornos del Movimiento
• Affiliation: Institut de Recerca del Hospital de la Santa Creu i Sant Pau

Key inclusion & exclusion criteria

Inclusion criteria:
1. Male or female patients aged 40 to 80 years old with diagnosis of Idiopathic Parkinson?s Disease according to the London Brain Bank Criteria. [44]
2. Patients must be able and willing to provide informed consent to participate in the study.
3. Patients must be receiving optimized treatment with a stable dose of LCIG for at least four weeks before entering the study.
4. Patients must be experiencing motor fluctuations with a minimum of two hours/of OFF time during the awake day
5. Patients must have a Hoehn & Yahr stage between II and III in the ON condition [45].
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 9
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 9

Exclusion criteria:
1. Any form of parkinsonism other than idiopathic Parkinson?s disease.
2. Patients with deep brain stimulation or history of neurosurgical procedure.
3. Untreated depressive disorder.
4. Patients with functional illiteracy or impossibility to perform any of the tests (i.e. cognitive, blood test) of the study.
5. Severe or ongoing unstable medical conditions (e.g. cardiac, hepatic, pulmonary, renal, metabolic or endocrine).
6. Imminent risk of self-harm based on Investigator?s clinical judgment, with a ?yes? answer on item 4 or 5 on the Columbia Suicide Severity Rating Scale (CSSRS)[50] at screening.
7. Parkinson?s Disease-Cognitive Rating Scale (PD-CRS) total score ? 64 and accomplishment of MDS criteria for dementia associated to PD at the time of screening [51, 52]. Patients with a PD-CRS total score ? 64, fulfilling diagnostic criteria for mild cognitive impairment in PD (PD-MCI) will be allowed to participate. [52, 53]
8. Patients with clinically significant apathetic symptoms as judged by both caregiver and neurologist and scoring > 14 on the Starkstein?s Apathy Evaluation Scale.[49]
9. Patients scoring ? 11 for anxiety and or depression on the Hospital Anxiety and Depression Scale (HADS). [37]
10. Previous history of any psychiatric condition as defined by the DSM-IV criteria based on the MINI International Neuropsychiatric Interview. [47, 54]
11. Patients with more than 30% of the day in off period and with dose failure episodes or unpredictable response to LD or severe dyskinesia that in opinion of the investigator could interfere with test performance or results.
12. Patients included in other clinical trial during the study period or 6 weeks before the study
13. Changes in psychotropic medication in the previous 4 weeks
14. Patients currently treated with: (i) Anticholinergic drugs; (ii) Typical neuroleptics, or any other drug which, in the opinion of the investigator, would interfere with the cognitive tests. Concomitant treatments with atypical neuroleptics (such as quetiapine, ziprasidone, or aripiprazole can be administered provided they remain at the lowest effective dose)
15. Permitted medications: anticholinesterase inhibitors and antidepressants initiated at least six weeks before study screening, or any other drug considered necessary for the safety and well-being of the patient are permitted during the study at the discretion of the investigator.


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

Health Condition(s) or Problem(s) studied

Parkinson disease

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

Intervention(s)

Trade Name: Duodopa
Product Name: Duodopa
Pharmaceutical Form: Intestinal gel

Trade Name: Sinemet Plus
Product Name: Sinemet Plus
Pharmaceutical Form: Tablet

Primary Outcome(s)

Secondary Objective: To compare at six consecutive time-points ( -1, +1, +2, +3, +4, +5 hour):
- Changes in LD plasma levels.
- Motor and dyskinesia scores.
- Changes on mood and anxiety levels.

Timepoint(s) of evaluation of this end point: Basal, +1 hour, +2 hours, +3 hours, +4 hours, +5 hours

Main Objective: To compare the acute cognitive and affective effects of immediate-release oral LD (IR-LD) and continuous delivery of LCIG in patients with PD measured at baseline (-1 hour) and at time-points +1, +3 and +5 hour. Thus, as showed in the flow-chart section (pag. 15), cognitive and affective effects measures considered as main variables for statistical purposes will be collected at - 1hour (pre-dosing) and at +1 hour after initiating either IR-LD or LCIG and one hour after receiving either IR-LD or oral placebo (+3, +5 hour).

Primary end point(s): Primary outcome measures will be the performance over time of different cognitive tasks: Wisconsin
Card Sorting Test, Sternberg Test, phonetic and alternating verbal fluency and a
reversal-learning task.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Basal, +1 hour, +2 hours, +3 hours, +4 hours, +5 hours

Secondary end point(s): Motor function, mood and anxiety

Secondary ID(s)

IIBSP-DUO-2015-46

Source(s) of Monetary Support

Abbvie Inc

Ethics review

Status: Approved
Approval date:
Contact: