A double-blind, randomised, placebo-controlled study to investigate the tolerability and the effect of three multiple-dose regimens of BIA 9-1067 on the levodopa pharmacokinetics, catechol-0-methyltransferase activity and motor response in parkinson´s disease patients treated with levodopa/dopa-decarboxylaseinhibitor

• Conditions: Parkinson’s Disease; MedDRA version: 17.1Level: LLTClassification code 10013113Term: Disease Parkinson'sSystem Organ Class: 100000004852

• Registration Number: EUCTR2009-012897-12-RO
• Lead Sponsor: BIAL-Portela & Ca, SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-30
• Last Update Posted: 7 April 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

At screening (admission to the baseline period):
- Male or female of non-childbearing potential (by reason of surgery or postmenopausal);
- Age = 30 years;
- A diagnosis of PD according to the UK PDS Brain Bank diagnostic criteria (bradykinesia and at least one of the
following: muscular rigidity, rest tremor and postural instability);
- Predictable signs of end-of-dose deterioration despite optimal” levodopa/carbidopa or levodopa/benserazide
therapy;
- Modified Hoehn and Yahr stage of less than 5 in the off” state; mean duration of off” state =1.5 h during
waking hours (based on historical information);
- Results of clinical laboratory tests acceptable by the investigator (not clinically significant for the well-being of
the patient or for the purpose of the study);
- Able and willing to give written informed consent.
At randomisation (completion of the baseline period):
- Been treated with a stable regimen of 3 to 8 doses per day of standard-release levodopa/carbidopa 100/25 mg
(Sinemet®) or levodopa/benserazide 100/25 mg (Madopar®/Restex®) for at least 1 week prior to randomisation;
- Mean duration of off” state =1.5 h during waking hours (average of recordings of last 3 evaluable days on
patient’s diary);
- Concomitant anti-Parkinsonian medication (other than apomorphine, entacapone or tolcapone) in stable doses
for at least 4 weeks prior to admission;

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

At screening (admission to the baseline period):
- Non-idiopathic parkinsonism (atypical parkinsonism, symptomatic parkinsonism, Parkinson-plus syndrome);
- Treated with entacapone, tolcapone, neuroleptics, antidepressants (except serotonin-specific reuptake inhibitors
or imipraminics [desipramine, imipramine, clomipramine and amitriptyline]), monoamine oxidase inhibitors
(except selegiline up to 10 mg/day in oral formulation or 1.25 mg/day in buccal absorption formulation or
rasagiline up to 1 mg/day) or antiemetics (except domperidone) within 2 weeks prior to admission;
- Treated with any investigational product within 1 month prior to admission (or within 5 half-lives, whichever is
longer);
- A psychiatric or any medical condition that might place him/her at increased risk or interfere with assessments;
- Known hypersensitivity to any of the ingredients of the investigational products;
- A history of abuse of alcohol, drugs or medications within the last 2 years;
- A clinically relevant ECG abnormality;
- A history or current evidence of heart disease, including but not limited to myocardial infarction, angina,
congestive heart failure and cardiac arrhythmia;
- Unstable concomitant disease being treated with changing doses of medication;
- A history or current evidence of any relevant disease in the context of this study, i.e., with respect to the safety
of the patient (e.g., hepatic impairment) or related to the study conditions;
- A test positive for the HIV-1 or HIV-2 antibodies, or hepatitis B surface antigen (HbsAg), or hepatitis C
antibody (HCVAb);
- Donated blood or received blood or blood products within the 6 months prior to admission;
- Pregnant, breast-feeding or of childbearing potential;
- Other condition or circumstance that, in the opinion of the investigator, may
compromise the patient’s ability to comply with the study protocol.
At randomisation (completion of the baseline period):
- Treated with levodopa/DDCI in a 10:1 ratio or in a controlled-release formulation during the baseline period;
- Treated with apomorphine during the baseline period;
- A clinically relevant ECG abnormality.
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Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified