Parkinson DiseasePhase 1NCT03094156

Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics

A Phase 1 study testing BIA 6-512, Madopar® 250 and Comtan® in people with Parkinson Disease, run by Bial - Portela C S.A. at 1 site in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of the study was to To investigate whether the administration of BIA 6-512 (25 mg, 50 mg, 75 mg and 100 mg) at steady-state affects the pharmacokinetics of levodopa when administered in combination with a single-dose of immediate release levodopa/benserazide 200/50 mg or with a single-dose of immediate… Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Parkinson Disease
What is being tested?: BIA 6-512, Madopar® 250 and Comtan®
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 39 participants
Where: 1 sitePortugal
Study dates: 26 Apr 2006to 11 Jul 2006
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male or female subjects aged between 18 and 45 years, inclusive.
Subjects of body mass index (BMI) between 19 and 30 kg/m2, inclusive.
Subjects who were healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.
Subjects who had negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening
Subjects who had clinical laboratory test results clinically acceptable at screening and admission.
Subjects who had a negative screen for alcohol and drugs of abuse at screening and admission.

Show all 10Show fewer

Subjects who were non-smokers or who smoked ≤ 10 cigarettes or equivalent per day.
Subjects who were able and willing to gave written informed consent.
(If female) She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used one of the following methods of contraception: double barrier, intrauterine device or abstinence.
(If female) She had a negative urine pregnancy test at screening and admission.

Who cannot join

Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders.
Subjects who had a clinically relevant surgical history.
Subjects who had a clinically relevant family history.
Subjects who had a history of relevant atopy.
Subjects who had a history of relevant drug hypersensitivity.
Subjects who had a history of alcoholism or drug abuse.

Show all 20Show fewer

Subjects who consumed more than 14 units of alcohol a week.
Subjects who had a significant infection or known inflammatory process on screening or admission.
Subjects who had acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission.
Subjects who had used medicines within 2 weeks of admission that may affect the safety or other study assessments, in the investigator's opinion.
Subjects who had previously participated in a clinical trial with BIA 6-512.
Subjects who had used any investigational drug or participated in any clinical trial within 6 months prior to screening.
Subjects who had participated in more than 2 clinical trials within the 12 months prior to screening.
Subjects who had donated or received any blood or blood products within the 3 months prior to screening.
Subjects who were vegetarians, vegans or have medical dietary restrictions.
Subjects who cannot communicate reliably with the investigator.
Subjects who were unlikely to co-operate with the requirements of the study.
Subjects who were unwilling or unable to give written informed consent.
(If female) She was pregnant or breast-feeding.
(If female) She was of childbearing potential and she did not use an effective contraceptive method (double-barrier, intra-uterine device or abstinence) or she used oral contraceptives.

Trial locations and contacts

1 site in 1 country.

Portugal1 site

Human Pharmacology Unit (UFH) - BIAL - Portela & Cª, SA
S. Mamede Do Coronado, 4745-457

Other trials in Portugal

About this study

Official title: A Double-blind, Randomised, Placebo-controlled, Rising Multiple Dose Study in Healthy Volunteers to Investigate the Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics When Administered in Combination With a Single-dose of Levodopa/Benserazide 200/50 mg or With a Single-dose of Levodopa/Benserazide 200/50 mg Plus a Single-dose of Entacapone 200 mg

Read the detailed description

Single centre, double-blind, randomised, placebo-controlled, rising multiple-dose study in four sequential groups of healthy male and female subjects. Eligible subjects were admitted to the Human Pharmacology Unit (UFHBIAL - Portela \& Cª, SA) on the day prior to receiving the first study medication. Starting in the morning of Day 1 (first dose), subjects received BIA 6-512/Placebo thrice-daily until the morning of Day 5 (last dose). Concomitantly with the morning dose of BIA 6-512/Placebo, on Day 4 a levodopa/benserazide 200/50 mg (Madopar® 250) single-dose was administered. On Day 5, a Madopar® 250 single-dose and a entacapone 200 mg (Comtan®) single-dose were administered concomitantly with the morning dose of BIA 6-512/Placebo. In the morning of Day 4 and Day 5, products were administered in fasting of at least 8 hours and subjects remained fasted until 2 h post-dose. Subjects were resident in the UFH from admission (Day 0) until at least 24 h post last dose (Day 6); then, they were discharged and returned for the follow-up visit.

Conditions: Parkinson Disease
Being tested: Placebo, BIA 6-512, Madopar® 250, Comtan®
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
1 capsule of placebo [to be taken orally, with 240 mL of potable water]
BIA 6-512Drug
Also called Trans-resveratrol
1 capsule of BIA 6-512 25mg or 1 capsule of BIA 6-512 50 mg or 1 capsule of BIA 6-512 75 mg or 1 capsule of BIA 6-512 100 mg [to be taken orally, with 240 mL of potable water]
Madopar® 250Drug
Levodopa/benserazide immediate release tablets 200mg/50mg [to be taken orally, with 240 mL of potable water]
Comtan®Drug
Entacapone 200 mg tablets [to be taken orally, with 240 mL of potable water]

Study groups in NCT03094156
Study group	Role	What they receive
Placebo	Experimental	Subjects were administered with those investigational products at approximately 8-h intervals, starting in the morning (approximately at 8h00) of Day 1 and finishing in the morning of Day 5 (last dose). On Day 4, concomitantly with the Placebo morning dose, one tablet of Madopar® 250 was administered. On Day 5, concomitantly with the Placebo morning dose, one tablet of Madopar® 250 and one tablet of Comtan® were administered. Receives: Drug: Placebo; Drug: Madopar® 250; Drug: Comtan®
BIA 6-512 25 mg	Experimental	Subjects were administered with those investigational products at approximately 8-h intervals, starting in the morning (approximately at 8h00) of Day 1 and finishing in the morning of Day 5 (last dose). On Day 4, concomitantly with the BIA 6-512 25 mg morning dose, one tablet of Madopar® 250 was administered. On Day 5, concomitantly with the BIA 6-512 25 mg morning dose, one tablet of Madopar® 250 and one tablet of Comtan® were administered. Receives: Drug: BIA 6-512; Drug: Madopar® 250; Drug: Comtan®
BIA 6-512 50 mg	Experimental	Subjects were administered with those investigational products at approximately 8-h intervals, starting in the morning (approximately at 8h00) of Day 1 and finishing in the morning of Day 5 (last dose). On Day 4, concomitantly with the BIA 6-512 50 mg morning dose, one tablet of Madopar® 250 was administered. On Day 5, concomitantly with the BIA 6-512 50 mg morning dose, one tablet of Madopar® 250 and one tablet of Comtan® were administered. Receives: Drug: BIA 6-512; Drug: Madopar® 250; Drug: Comtan®
BIA 6-512 75 mg	Experimental	Subjects were administered with those investigational products at approximately 8-h intervals, starting in the morning (approximately at 8h00) of Day 1 and finishing in the morning of Day 5 (last dose). On Day 4, concomitantly with the BIA 6-512 75 mg morning dose, one tablet of Madopar® 250 was administered. On Day 5, concomitantly with the BIA 6-512 75 mg morning dose, one tablet of Madopar® 250 and one tablet of Comtan® were administered. Receives: Drug: BIA 6-512; Drug: Madopar® 250; Drug: Comtan®
BIA 6-512 100 mg	Experimental	Subjects were administered with those investigational products at approximately 8-h intervals, starting in the morning (approximately at 8h00) of Day 1 and finishing in the morning of Day 5 (last dose). On Day 4, concomitantly with the BIA 6-512 100 mg morning dose, one tablet of Madopar® 250 was administered. On Day 5, concomitantly with the BIA 6-512 100 mg morning dose, one tablet of Madopar® 250 and one tablet of Comtan® were administered. Receives: Drug: BIA 6-512; Drug: Madopar® 250; Drug: Comtan®

What is being measured

The primary outcome is the main question the study is designed to answer.

Day 4 - Maximum observed plasma drug concentration (Cmax)
BIA 6-512, levodopa, 3-OMD and entacapone pharmacokinetic parameters on day 4
Measured: pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8 and 16 hours post-dose
Day 4 - Time of occurrence of Cmax (tmax)
BIA 6-512, levodopa, 3-OMD and entacapone pharmacokinetic parameters on day 4
Measured: pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8 and 16 hours post-dose
Day 4 - Area under the plasma concentration-time curve (AUC) from time zero to the last sampling time at which concentrations were at or above the limit of quantification (AUC0-t)
BIA 6-512, levodopa, 3-OMD and entacapone pharmacokinetic parameters on day 4
Measured: pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8 and 16 hours post-dose
Day 4 - AUC from time zero to 8 h post-dose (AUC0-τ)
BIA 6-512, levodopa, 3-OMD and entacapone pharmacokinetic parameters on day 4
Measured: pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8 and 16 hours post-dose
Day 4 - Apparent terminal elimination half-life, calculated from ln 2/λz (t1/2)
BIA 6-512, levodopa, 3-OMD and entacapone pharmacokinetic parameters on day 4
Measured: pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8 and 16 hours post-dose
Day 4 - Area under the plasma concentration versus time curve from time zero to infinity (AUC0-∞)
BIA 6-512, levodopa, 3-OMD and entacapone pharmacokinetic parameters on day 4
Measured: pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8 and 16 hours post-dose
Day 5 - Maximum observed plasma drug concentration (Cmax)
Measured: pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 16 and 24 hours post-dose
Day 5 - Time of occurrence of Cmax (tmax)
BIA 6-512, levodopa, 3-OMD and entacapone pharmacokinetic parameters on day 5
Measured: pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 16 and 24 hours post-dose
Day 5 - Area under the plasma concentration-time curve (AUC) from time zero to the last sampling time at which concentrations were at or above the limit of quantification (AUC0-t)
BIA 6-512, levodopa, 3-OMD and entacapone pharmacokinetic parameters on day 5
Measured: pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 16 and 24 hours post-dose
Day 5 - AUC from time zero to 8 h post-dose (AUC0-τ)
BIA 6-512, levodopa, 3-OMD and entacapone pharmacokinetic parameters on day 5
Measured: pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 16 and 24 hours post-dose
Day 5 - Apparent terminal elimination half-life, calculated from ln 2/λz (t1/2)
BIA 6-512, levodopa, 3-OMD and entacapone pharmacokinetic parameters on day 5
Measured: pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 16 and 24 hours post-dose
Day 5 - Area under the plasma concentration versus time curve from time zero to infinity (AUC0-∞)
BIA 6-512, levodopa, 3-OMD and entacapone pharmacokinetic parameters on day 5
Measured: pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 16 and 24 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Apr 200611 Jul 2006

First posted29 Mar 2017
Study start26 Apr 2006
Primary completion11 Jul 2006
Study completion11 Jul 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03094156
Sponsor's protocol ID: BIA-6512-106
Status last verified: Mar 2017
First submitted: 23 Mar 2017
Last updated: 30 Mar 2017
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Randomised, Placebo-controlled, Rising Multiple Dose Study in Healthy Volunteers to Investigate the Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics When Administered in Combination With a Single-dose of Levodopa/Benserazide 200/50 mg or With a Single-dose of Levodopa/Benserazide 200/50 mg Plus a Single-dose of Entacapone 200 mg
ClinicalTrials.gov ID: NCT03094156
Acronym / sponsor ID: BIA-6512-106
Conditions: Parkinson Disease
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: Bial - Portela C S.A.Industry (pharma, biotech, devices)
Study start: 26 Apr 2006 (actual)
Primary completion: 11 Jul 2006 (actual)
Study completion: 11 Jul 2006 (actual)
First posted: 29 Mar 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
Placebo	Experimental	Drug: Placebo, Drug: Madopar® 250, Drug: Comtan®Subjects were administered with those investigational products at approximately 8-h intervals, starting in the morning (approximately at 8h00) of Day 1 and finishing in the morning of Day 5 (last dose). On Day 4, concomitantly with the Placebo morning dose, one tablet of Madopar® 250 was administered. On Day 5, concomitantly with the Placebo morning dose, one tablet of Madopar® 250 and one tablet of Comtan® were administered.
BIA 6-512 25 mg	Experimental	Drug: BIA 6-512, Drug: Madopar® 250, Drug: Comtan®Subjects were administered with those investigational products at approximately 8-h intervals, starting in the morning (approximately at 8h00) of Day 1 and finishing in the morning of Day 5 (last dose). On Day 4, concomitantly with the BIA 6-512 25 mg morning dose, one tablet of Madopar® 250 was administered. On Day 5, concomitantly with the BIA 6-512 25 mg morning dose, one tablet of Madopar® 250 and one tablet of Comtan® were administered.
BIA 6-512 50 mg	Experimental	Drug: BIA 6-512, Drug: Madopar® 250, Drug: Comtan®Subjects were administered with those investigational products at approximately 8-h intervals, starting in the morning (approximately at 8h00) of Day 1 and finishing in the morning of Day 5 (last dose). On Day 4, concomitantly with the BIA 6-512 50 mg morning dose, one tablet of Madopar® 250 was administered. On Day 5, concomitantly with the BIA 6-512 50 mg morning dose, one tablet of Madopar® 250 and one tablet of Comtan® were administered.
BIA 6-512 75 mg	Experimental	Drug: BIA 6-512, Drug: Madopar® 250, Drug: Comtan®Subjects were administered with those investigational products at approximately 8-h intervals, starting in the morning (approximately at 8h00) of Day 1 and finishing in the morning of Day 5 (last dose). On Day 4, concomitantly with the BIA 6-512 75 mg morning dose, one tablet of Madopar® 250 was administered. On Day 5, concomitantly with the BIA 6-512 75 mg morning dose, one tablet of Madopar® 250 and one tablet of Comtan® were administered.
BIA 6-512 100 mg	Experimental	Drug: BIA 6-512, Drug: Madopar® 250, Drug: Comtan®Subjects were administered with those investigational products at approximately 8-h intervals, starting in the morning (approximately at 8h00) of Day 1 and finishing in the morning of Day 5 (last dose). On Day 4, concomitantly with the BIA 6-512 100 mg morning dose, one tablet of Madopar® 250 was administered. On Day 5, concomitantly with the BIA 6-512 100 mg morning dose, one tablet of Madopar® 250 and one tablet of Comtan® were administered.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Male or female subjects aged between 18 and 45 years, inclusive.
Subjects of body mass index (BMI) between 19 and 30 kg/m2, inclusive.
Subjects who were healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.
Subjects who had negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening
Subjects who had clinical laboratory test results clinically acceptable at screening and admission.

Key exclusion criteria (20 listed)

Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders.
Subjects who had a clinically relevant surgical history.
Subjects who had a clinically relevant family history.
Subjects who had a history of relevant atopy.
Subjects who had a history of relevant drug hypersensitivity.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Placebo1 capsule of placebo [to be taken orally, with 240 mL of potable water]	Drug	Placebo
BIA 6-512Also: Trans-resveratrol1 capsule of BIA 6-512 25mg or 1 capsule of BIA 6-512 50 mg or 1 capsule of BIA 6-512 75 mg or 1 capsule of BIA 6-512 100 mg [to be taken orally, with 240 mL of potable water]	Drug	BIA 6-512 100 mg, BIA 6-512 25 mg, BIA 6-512 50 mg, BIA 6-512 75 mg
Madopar® 250Levodopa/benserazide immediate release tablets 200mg/50mg [to be taken orally, with 240 mL of potable water]	Drug	BIA 6-512 100 mg, BIA 6-512 25 mg, BIA 6-512 50 mg, BIA 6-512 75 mg, Placebo
Comtan®Entacapone 200 mg tablets [to be taken orally, with 240 mL of potable water]	Drug	BIA 6-512 100 mg, BIA 6-512 25 mg, BIA 6-512 50 mg, BIA 6-512 75 mg, Placebo

Primary outcome

Day 4 - Maximum observed plasma drug concentration (Cmax)
Time frame: pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8 and 16 hours post-dose
BIA 6-512, levodopa, 3-OMD and entacapone pharmacokinetic parameters on day 4
Day 4 - Time of occurrence of Cmax (tmax)
Time frame: pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8 and 16 hours post-dose
BIA 6-512, levodopa, 3-OMD and entacapone pharmacokinetic parameters on day 4
Day 4 - Area under the plasma concentration-time curve (AUC) from time zero to the last sampling time at which concentrations were at or above the limit of quantification (AUC0-t)
Time frame: pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8 and 16 hours post-dose
BIA 6-512, levodopa, 3-OMD and entacapone pharmacokinetic parameters on day 4
Day 4 - AUC from time zero to 8 h post-dose (AUC0-τ)
Time frame: pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8 and 16 hours post-dose
BIA 6-512, levodopa, 3-OMD and entacapone pharmacokinetic parameters on day 4
Day 4 - Apparent terminal elimination half-life, calculated from ln 2/λz (t1/2)
Time frame: pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8 and 16 hours post-dose
BIA 6-512, levodopa, 3-OMD and entacapone pharmacokinetic parameters on day 4
Day 4 - Area under the plasma concentration versus time curve from time zero to infinity (AUC0-∞)
Time frame: pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8 and 16 hours post-dose
BIA 6-512, levodopa, 3-OMD and entacapone pharmacokinetic parameters on day 4
Day 5 - Maximum observed plasma drug concentration (Cmax)
Time frame: pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 16 and 24 hours post-dose
Day 5 - Time of occurrence of Cmax (tmax)
Time frame: pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 16 and 24 hours post-dose
BIA 6-512, levodopa, 3-OMD and entacapone pharmacokinetic parameters on day 5
Day 5 - Area under the plasma concentration-time curve (AUC) from time zero to the last sampling time at which concentrations were at or above the limit of quantification (AUC0-t)
Time frame: pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 16 and 24 hours post-dose
BIA 6-512, levodopa, 3-OMD and entacapone pharmacokinetic parameters on day 5
Day 5 - AUC from time zero to 8 h post-dose (AUC0-τ)
Time frame: pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 16 and 24 hours post-dose
BIA 6-512, levodopa, 3-OMD and entacapone pharmacokinetic parameters on day 5
Day 5 - Apparent terminal elimination half-life, calculated from ln 2/λz (t1/2)
Time frame: pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 16 and 24 hours post-dose
BIA 6-512, levodopa, 3-OMD and entacapone pharmacokinetic parameters on day 5
Day 5 - Area under the plasma concentration versus time curve from time zero to infinity (AUC0-∞)
Time frame: pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 16 and 24 hours post-dose
BIA 6-512, levodopa, 3-OMD and entacapone pharmacokinetic parameters on day 5

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BIA 6-512, Madopar® 250 and Comtan® in people with Parkinson Disease, run by Bial - Portela C S.A. at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Day 4 - Maximum observed plasma drug concentration (Cmax) (time frame: pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8 and 16 hours post-dose). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03094156.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2017.