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A Study to Investigate the Tolerability and Effect of Three Single-dose Regimens of BIA 9-1067 | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study to Investigate the Tolerability and Effect of Three Single-dose Regimens of BIA 9-1067

A Double-blind, Randomised, Placebo-controlled, Cross-over Study to Investigate the Tolerability and Effect of Three Single-dose Regimens of BIA 9-1067 on the Levodopa Pharmacokinetics, Motor Response, and Erythrocyte Soluble Catechol-O-methyltransferase Activity in Parkinson's Disease Patients Concomitantly Treated With Levodopa/Dopa-decarboxylase Inhibitor

NCT01568034•Bial - Portela C S.A.

View on ClinicalTrials.gov

Summary

The purpose of this study is to investigate the effect of BIA 9-1067 on the levodopa pharmacokinetics when administered in combination with immediate release levodopa/carbidopa or levodopa/benserazide in Parkinson's Disease (PD) patients.

Detailed Description

This was a three-centre, double-blind, randomised, placebo-controlled, crossover study with four consecutive single-dose treatment periods in PD patients treated with immediate release 100 mg/25 mg levodopa/carbidopa or 100 mg/25 mg levodopa/benserazide

Eligibility

Age

30 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female of non-childbearing potential (by reason of surgery or postmenopausal);
•Aged between 30 and 75 years, inclusive;
•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;
•Been treated with a stable regimen of 3 to 8 doses of standard release 100 mg/25 mg levodopa/carbidopa or 100 mg/25 mg levodopa/benserazide per day within at least 1 week prior to randomisation;
•Modified Hoehn and Yahr stage of less than 5 in the off-state;
•Mean duration of OFF stage ≥ 1.5 h during waking hours (based on historical information);
•Concomitant anti-Parkinsonian medication (other than apomorphine, entacapone or tolcapone) in stable doses for at least 4 weeks prior to randomisation;
•Results of clinical laboratory tests acceptable by the investigator (not clinically significant for the well-being of the subject or for the purpose of the study);
•Able and willing to give written informed consent.

Exclusion Criteria

•Non-idiopathic parkinsonism (atypical parkinsonism, symptomatic parkinsonism, Parkinson-plus syndrome);
•Treated with levodopa/carbidopa or levodopa/benserazide in a 10:1 ratio, or with levodopa/carbidopa in a controlled-release formulation;
•Treated with entacapone, tolcapone, neuroleptics, antidepressants (except serotonin-specific reuptake inhibitors or imipramines \[desipramine, imipramine, clomipramine and amitriptyline\]), 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 4 weeks prior to randomisation;
•Treated with apomorphine within 7 days prior to randomisation;
•Treated with any investigational product within 2 months prior to randomisation (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;
+6 more criteria

Locations (3)

Department of Neurology-Hospital de Santa Maria-Faculty of Medicine, University of Lisbon

Lisbon, Portugal

Spitalul Clinic Colentina - Clinica de Neurologie

Bucharest, Romania

Department of Neurology- Hospital of the department of medical care of Ministry Internal Affairs of Ukraine

Kyiv, Ukraine

Key Dates

Start Date

April 1, 2009

Primary Completion Date

February 1, 2010

Completion Date

February 1, 2010

Last Updated

January 12, 2015

Enrollment

ACTUAL participants

Conditions

Parkinson's Disease

Interventions

BIA 9-1067

DRUG

BIA 9-1067

DRUG

BIA 9-1067

DRUG

Placebo

DRUG

Levodopa/Carbidopa

DRUG

Levodopa/Benzerazide

DRUG

Deep Brain Stimulation Therapy in Movement Disorders

NCT02119611

Parkinson's Disease

View study

RECRUITINGPHASE1

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

NCT07310264

Healthy Volunteers (HV)Parkinson's Disease (PD)

View study

RECRUITINGNA

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 12, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Investigate the Tolerability and Effect of Three Single-dose Regimens of BIA 9-1067

Inclusion Criteria

Exclusion Criteria

Deep Brain Stimulation Therapy in Movement Disorders

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease

Effect of Striatal Temporal Interference Stimulation on Language Processing in Neurodegenerative Diseases

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations