Parkinson's DiseasePhase 1NCT02772627
Study to Investigate the Tolerability, Steady-state Pharmacokinetics and Erythrocyte COMT Inhibition of BIA 3-202
A Phase 1 study testing Nebicapone in people with Parkinson's Disease, run by Bial - Portela C S.A. at 1 site in Portugal.
Trial summary
The purpose of this study is to investigate the tolerability and safety of three multiple dose regimens of nebicapone (BIA 3-202 100 mg, 200 mg, and 300 mg 6 times daily) in healthy volunteers. To characterise the steady-state pharmacokinetic and erythrocyte COMT inhibition profiles of nebicapone in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Nebicapone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 sitePortugal
- Study dates
- Sep 2001to Dec 2001
- 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 and female subjects aged between 18 and 45 years, inclusive.
- Subjects of body mass index (BMI) between 19 and 28 kg/m2, inclusive.
- Subjects who were healthy as determined by pre study medical history, physical examination, and 12- lead ECG.
- Subjects who had clinical laboratory tests acceptable to the investigator.
- Subjects who were negative for HBsAg, anti-HCV Ab and HIV-1 and HIV-2 Ab tests at screening.
- Subjects who were negative for drugs of abuse and alcohol at screening and admission.
Show all 9Show fewer
- Subjects who were non-smokers or who smoke less than 10 cigarettes or equivalent per day.
- Subjects who were able and willing to give 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.
Who cannot join
- Subjects who did not conform to the above inclusion criteria, or
- Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, 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.
Show all 22Show fewer
- Subjects who had a history of alcoholism or drug abuse.
- Subjects who consumed more than 21 units of alcohol a week.
- Subjects who had a significant infection or known inflammatory process on screening and/or admission.
- Subjects who had acute gastrointestinal symptoms at the time of screening and/or admission (e.g., nausea, vomiting, diarrhoea, heartburn).
- Subjects who had an acute infection such as influenza at the time of screening and/or admission.
- Subjects who had used prescription drugs within 4 weeks of first dosing.
- Subjects who had used oral contraceptives or over the counter medication excluding oral routine vitamins but including mega dose vitamin therapy within one week of first dosing.
- Subjects who had used any investigational drug and/or participated in any clinical trial within 3 months of their first admission to this study.
- Subjects who had previously received BIA 3-202.
- Subjects who had donated and/or received any blood or blood products within the previous 2 months prior to screening.
- Subjects who were vegetarians, vegans and/or have medical dietary restrictions.
- Subjects who could not communicate reliably with the investigator.
- Subjects who were unlikely to co-operate with the requirements of the study.
- (If female) She was pregnant or breast-feeding.
- (If female) She was of childbearing potential and she did not use an approved effective contraceptive method or she used oral contraceptives.
- Subjects who were unwilling or unable to give written informed consent.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Human Pharmacology Unit - BIAL - Portela & Ca, S.A.
S. Mamede Do Coronado, S. Mamede Do Coronado, 4745-457
About this study
Official title: A Double-blind, Randomised, Placebo-controlled, Rising Multiple Dose Study to Investigate the Tolerability, Steady-state Pharmacokinetics and Erythrocyte COMT Inhibition of BIA 3-202 in Healthy Volunteers.
The purpose of this study is to investigate the tolerability and safety of three multiple dose regimens of nebicapone (BIA 3-202 100 mg, 200 mg, and 300 mg 6 times daily) in healthy volunteers. To characterise the steady-state pharmacokinetic and erythrocyte COMT inhibition profiles of nebicapone in healthy volunteers.
Read the detailed description
Study design and methodology:
This was a single centre, human pharmacology (phase I), double-blind, randomised, placebo-controlled study of three multiple rising doses in three sequential groups of healthy volunteers. Subjects were screened for eligibility within 28 days of admission.
Screening:
Screening consisted of review of medical history, physical examination, neurological examination, vital signs, 12-lead ECG, clinical laboratory safety tests (haematology, coagulation, plasma biochemistry, urinalysis, HBsAg, anti-HCV Ab, anti-HIV-1 and anti-HIV-2 Ab), drugs of abuse and alcohol screen, and written informed consent. A pregnancy test was performed in all female subjects. The investigator was informed of the screening results prior to the subject's admission.
Treatment period:
Eligible subjects were admitted to the UFH for one treatment period on the morning of the day prior to receiving the first dose of trial medication and remained in the UFH until at least 48 hours after receiving their final dose of trial medication (final dose: Day 8; leaving the UFH: Day 10). Then, they were to leave and to return on the Days 15, 22 and 29 for the 168 h, 336 h, and 504 h post final dose blood samples and clinical evaluations. Trial medication was administered at 4-h intervals (Group 1: Nebicapone 100 mg/Placebo, 6 times/day; Group 2: Nebicapone 200 mg/Placebo, 6 times/day; Group 3: Nebicapone 300 mg/Placebo, 6 times/day).
On admission (Day -1), subjects had a physical examination, medical history update, vital signs (blood pressure and heart rate), neurological examination, 12-lead ECG, clinical laboratory tests (haematology, coagulation, plasma biochemistry, urinalysis), pregnancy test, screen for drugs of abuse and alcohol, and 24-h urine collection for the assay of urinary electrolytes and creatinine.
On Day 1, Nebicapone /Placebo started being administered at 4 hourly intervals, until the final dose on Day 8.
The following assessments were performed as described: vital signs (blood pressure and heart rate) at Days 1 to 7 pre and 1 hour post 08, 12, 16, 20 and 24 h doses, and Day 8 pre-dose and 1, 24, 48, 168, 336 hours post final dose, and at Day 29; physical examination: admission, at Day 10 and Day 29; neurological examination at on admission, pre-dose and 2 hours post 08, 12, 16, 20 and 24 h doses on Day 1, 2 hours post 08h00 and 20h00 doses on Days 2 to 7, and 2 hours post 08h00 dose on Day 8; 12-lead ECG at 1 hour post 08h00 dose on Days 1, 2, 3, 5 and 8, and 48 h post final dose, and Day 29; continuous lead-II ECG monitoring at 0-6 hours post first dose on Day 1, and 0-4 hours post 08h00 dose on Day 8; blood samples (7 ml) for the assay of plasma nebicapone and its metabolites, and for the assay of the erythrocyte soluble COMT (S-COMT) activity were taken at Day 1, pre-dose, ½, 1, 1½, 2, 3, 4, 8, 12 and 16 hours post first dose (08h00), at Day 8, pre final dose (08h00), ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 168*, 336*, and 504* hours post final dose (*only for the assay of plasma nebicapone metabolites), and at Days 2, 3, 4, 5, 6, and 7, pre 08h00 and 20h00 doses; urine and blood collection for urinalysis, coagulation, haematology and plasma biochemistry at admission, and on Days 2, 10 and 29; and 24-h urine collection for the assay of urinary electrolytes and creatinine at admission, and on Days 1 and 9.
Adverse events were monitored throughout.
Follow-up:
The end-of-study assessments took place after the last blood sample (504 h) and included: medical history review, physical examination, vital signs, 12-lead ECG, clinical laboratory safety tests, adverse events; pregnancy test (if female).
- Conditions
- Parkinson's Disease
- Being tested
- Nebicapone, Placebo
- Keywords
- Parkinson's disease, Nebicapone
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NebicaponeDrug
Also called BIA 3-202
Nebicapone 100 mg tablets; oral route.
PlaceboDrug
Placebo tablets; oral route.
| Study group | Role | What they receive |
|---|---|---|
| Nebicapone 100 mg / Placebo | Experimental | Treatment consisted of nebicapone/placebo repeated administration: one dose at 4-h intervals, for 7 full days: first dose at approximately 08 h (±1 h) on Day 1 and final dose at approximately 08 h (±1 h) on Day 8. Within each group (n=8), 2 volunteers were be randomised to receive placebo and the remaining 6 volunteers to receive nebicapone. Receives: Drug: Nebicapone; Drug: Placebo |
| Nebicapone 200 mg / Placebo | Experimental | Treatment consisted of nebicapone/placebo repeated administration: one dose at 4-h intervals, for 7 full days: first dose at approximately 08 h (±1 h) on Day 1 and final dose at approximately 08 h (±1 h) on Day 8. Within each group (n=8), 2 volunteers were be randomised to receive placebo and the remaining 6 volunteers to receive nebicapone. Receives: Drug: Nebicapone; Drug: Placebo |
| Nebicapone 300 mg / Placebo | Experimental | Treatment consisted of nebicapone/placebo repeated administration: one dose at 4-h intervals, for 7 full days: first dose at approximately 08 h (±1 h) on Day 1 and final dose at approximately 08 h (±1 h) on Day 8. Within each group (n=8), 2 volunteers were be randomised to receive placebo and the remaining 6 volunteers to receive nebicapone. Receives: Drug: Nebicapone; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) - Nebicapone
Mean nebicapone plasma concentration-time profiles following the last dose (Day 8) of a multiple-dose oral administration of nebicapone (100 mg, 200 mg or 300 mg, at 4-h intervals)
Measured: Day 8
Time of maximum observed concentration (tmax) - Nebicapone
Mean nebicapone plasma concentration-time profiles following the last dose (Day 8) of a multiple-dose oral administration of nebicapone (100 mg, 200 mg or 300 mg, at 4-h intervals)
Measured: Day 8
Area under the plasma concentration time curve extrapolated to infinity (AUC0-∞) - Nebicapone
Mean nebicapone plasma concentration-time profiles following the last dose (Day 8) of a multiple-dose oral administration of nebicapone (100 mg, 200 mg or 300 mg, at 4-h intervals)
Measured: Day 8
Apparent terminal elimination half-life (t1/2) - Nebicapone
Mean nebicapone plasma concentration-time profiles following the last dose (Day 8) of a multiple-dose oral administration of nebicapone (100 mg, 200 mg or 300 mg, at 4-h intervals)
Measured: Day 8
Maximum observed plasma concentration (Cmax) - 3-O-methylnebicapone (BIA 3-270)
Mean 3-O-methylnebicapone (BIA 3-270) plasma concentration-time profiles following the last dose (Day 8) of a multiple-dose oral administration of nebicapone (100 mg, 200 mg or 300 mg, at 4-h intervals)
Measured: Day 8
Time of maximum observed concentration (tmax) - 3-O-methylnebicapone (BIA 3-270)
Mean 3-O-methylnebicapone (BIA 3-270) plasma concentration-time profiles following the last dose (Day 8) of a multiple-dose oral administration of nebicapone (100 mg, 200 mg or 300 mg, at 4-h intervals)
Measured: Day 8
Area under the plasma concentration time curve extrapolated to infinity (AUC0-∞) - 3-O-methylnebicapone (BIA 3-270)
Mean 3-O-methylnebicapone (BIA 3-270) plasma concentration-time profiles following the last dose (Day 8) of a multiple-dose oral administration of nebicapone (100 mg, 200 mg or 300 mg, at 4-h intervals)
Measured: Day 8
Apparent terminal elimination half-life (t1/2) - 3-O-methylnebicapone (BIA 3-270)
Mean 3-O-methylnebicapone (BIA 3-270) plasma concentration-time profiles following the last dose (Day 8) of a multiple-dose oral administration of nebicapone (100 mg, 200 mg or 300 mg, at 4-h intervals)
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startSep 2001
- Primary completionDec 2001
- Study completionDec 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bial - Portela C S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02772627
- Sponsor's protocol ID
- BIA-3202-105
- Status last verified
- May 2016
- First submitted
- 12 May 2016
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. 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 to Investigate the Tolerability, Steady-state Pharmacokinetics and Erythrocyte COMT Inhibition of BIA 3-202 in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT02772627
- Acronym / sponsor ID
- BIA-3202-105
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, Nebicapone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Bial - Portela C S.A.Industry (pharma, biotech, devices)
- Study start
- Sep 2001
- Primary completion
- Dec 2001 (actual)
- Study completion
- Dec 2001 (actual)
- First posted
- 13 May 2016 (estimated)
- 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.
The purpose of this study is to investigate the tolerability and safety of three multiple dose regimens of nebicapone (BIA 3-202 100 mg, 200 mg, and 300 mg 6 times daily) in healthy volunteers. To characterise the steady-state pharmacokinetic and erythrocyte COMT inhibition profiles of nebicapone in healthy volunteers.
Detailed description
Study design and methodology:
This was a single centre, human pharmacology (phase I), double-blind, randomised, placebo-controlled study of three multiple rising doses in three sequential groups of healthy volunteers. Subjects were screened for eligibility within 28 days of admission.
Screening:
Screening consisted of review of medical history, physical examination, neurological examination, vital signs, 12-lead ECG, clinical laboratory safety tests (haematology, coagulation, plasma biochemistry, urinalysis, HBsAg, anti-HCV Ab, anti-HIV-1 and anti-HIV-2 Ab), drugs of abuse and alcohol screen, and written informed consent. A pregnancy test was performed in all female subjects. The investigator was informed of the screening results prior to the subject's admission.
Treatment period:
Eligible subjects were admitted to the UFH for one treatment period on the morning of the day prior to receiving the first dose of trial medication and remained in the UFH until at least 48 hours after receiving their final dose of trial medication (final dose: Day 8; leaving the UFH: Day 10). Then, they were to leave and to return on the Days 15, 22 and 29 for the 168 h, 336 h, and 504 h post final dose blood samples and clinical evaluations. Trial medication was administered at 4-h intervals (Group 1: Nebicapone 100 mg/Placebo, 6 times/day; Group 2: Nebicapone 200 mg/Placebo, 6 times/day; Group 3: Nebicapone 300 mg/Placebo, 6 times/day).
On admission (Day -1), subjects had a physical examination, medical history update, vital signs (blood pressure and heart rate), neurological examination, 12-lead ECG, clinical laboratory tests (haematology, coagulation, plasma biochemistry, urinalysis), pregnancy test, screen for drugs of abuse and alcohol, and 24-h urine collection for the assay of urinary electrolytes and creatinine.
On Day 1, Nebicapone /Placebo started being administered at 4 hourly intervals, until the final dose on Day 8.
The following assessments were performed as described: vital signs (blood pressure and heart rate) at Days 1 to 7 pre and 1 hour post 08, 12, 16, 20 and 24 h doses, and Day 8 pre-dose and 1, 24, 48, 168, 336 hours post final dose, and at Day 29; physical examination: admission, at Day 10 and Day 29; neurological examination at on admission, pre-dose and 2 hours post 08, 12, 16, 20 and 24 h doses on Day 1, 2 hours post 08h00 and 20h00 doses on Days 2 to 7, and 2 hours post 08h00 dose on Day 8; 12-lead ECG at 1 hour post 08h00 dose on Days 1, 2, 3, 5 and 8, and 48 h post final dose, and Day 29; continuous lead-II ECG monitoring at 0-6 hours post first dose on Day 1, and 0-4 hours post 08h00 dose on Day 8; blood samples (7 ml) for the assay of plasma nebicapone and its metabolites, and for the assay of the erythrocyte soluble COMT (S-COMT) activity were taken at Day 1, pre-dose, ½, 1, 1½, 2, 3, 4, 8, 12 and 16 hours post first dose (08h00), at Day 8, pre final dose (08h00), ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 168*, 336*, and 504* hours post final dose (*only for the assay of plasma nebicapone metabolites), and at Days 2, 3, 4, 5, 6, and 7, pre 08h00 and 20h00 doses; urine and blood collection for urinalysis, coagulation, haematology and plasma biochemistry at admission, and on Days 2, 10 and 29; and 24-h urine collection for the assay of urinary electrolytes and creatinine at admission, and on Days 1 and 9.
Adverse events were monitored throughout.
Follow-up:
The end-of-study assessments took place after the last blood sample (504 h) and included: medical history review, physical examination, vital signs, 12-lead ECG, clinical laboratory safety tests, adverse events; pregnancy test (if female).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nebicapone 100 mg / Placebo | Experimental | Drug: Nebicapone, Drug: PlaceboTreatment consisted of nebicapone/placebo repeated administration: one dose at 4-h intervals, for 7 full days: first dose at approximately 08 h (±1 h) on Day 1 and final dose at approximately 08 h (±1 h) on Day 8. Within each group (n=8), 2 volunteers were be randomised to receive placebo and the remaining 6 volunteers to receive nebicapone. |
| Nebicapone 200 mg / Placebo | Experimental | Drug: Nebicapone, Drug: PlaceboTreatment consisted of nebicapone/placebo repeated administration: one dose at 4-h intervals, for 7 full days: first dose at approximately 08 h (±1 h) on Day 1 and final dose at approximately 08 h (±1 h) on Day 8. Within each group (n=8), 2 volunteers were be randomised to receive placebo and the remaining 6 volunteers to receive nebicapone. |
| Nebicapone 300 mg / Placebo | Experimental | Drug: Nebicapone, Drug: PlaceboTreatment consisted of nebicapone/placebo repeated administration: one dose at 4-h intervals, for 7 full days: first dose at approximately 08 h (±1 h) on Day 1 and final dose at approximately 08 h (±1 h) on Day 8. Within each group (n=8), 2 volunteers were be randomised to receive placebo and the remaining 6 volunteers to receive nebicapone. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male and female subjects aged between 18 and 45 years, inclusive.
- Subjects of body mass index (BMI) between 19 and 28 kg/m2, inclusive.
- Subjects who were healthy as determined by pre study medical history, physical examination, and 12- lead ECG.
- Subjects who had clinical laboratory tests acceptable to the investigator.
- Subjects who were negative for HBsAg, anti-HCV Ab and HIV-1 and HIV-2 Ab tests at screening.
Key exclusion criteria (22 listed)
- Subjects who did not conform to the above inclusion criteria, or
- Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, 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.
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 |
|---|---|---|
| NebicaponeAlso: BIA 3-202Nebicapone 100 mg tablets; oral route. | Drug | Nebicapone 100 mg / Placebo, Nebicapone 200 mg / Placebo, Nebicapone 300 mg / Placebo |
| PlaceboPlacebo tablets; oral route. | Drug | Nebicapone 100 mg / Placebo, Nebicapone 200 mg / Placebo, Nebicapone 300 mg / Placebo |
Primary outcome
Maximum observed plasma concentration (Cmax) - Nebicapone
Time frame: Day 8
Mean nebicapone plasma concentration-time profiles following the last dose (Day 8) of a multiple-dose oral administration of nebicapone (100 mg, 200 mg or 300 mg, at 4-h intervals)
Time of maximum observed concentration (tmax) - Nebicapone
Time frame: Day 8
Mean nebicapone plasma concentration-time profiles following the last dose (Day 8) of a multiple-dose oral administration of nebicapone (100 mg, 200 mg or 300 mg, at 4-h intervals)
Area under the plasma concentration time curve extrapolated to infinity (AUC0-∞) - Nebicapone
Time frame: Day 8
Mean nebicapone plasma concentration-time profiles following the last dose (Day 8) of a multiple-dose oral administration of nebicapone (100 mg, 200 mg or 300 mg, at 4-h intervals)
Apparent terminal elimination half-life (t1/2) - Nebicapone
Time frame: Day 8
Mean nebicapone plasma concentration-time profiles following the last dose (Day 8) of a multiple-dose oral administration of nebicapone (100 mg, 200 mg or 300 mg, at 4-h intervals)
Maximum observed plasma concentration (Cmax) - 3-O-methylnebicapone (BIA 3-270)
Time frame: Day 8
Mean 3-O-methylnebicapone (BIA 3-270) plasma concentration-time profiles following the last dose (Day 8) of a multiple-dose oral administration of nebicapone (100 mg, 200 mg or 300 mg, at 4-h intervals)
Time of maximum observed concentration (tmax) - 3-O-methylnebicapone (BIA 3-270)
Time frame: Day 8
Mean 3-O-methylnebicapone (BIA 3-270) plasma concentration-time profiles following the last dose (Day 8) of a multiple-dose oral administration of nebicapone (100 mg, 200 mg or 300 mg, at 4-h intervals)
Area under the plasma concentration time curve extrapolated to infinity (AUC0-∞) - 3-O-methylnebicapone (BIA 3-270)
Time frame: Day 8
Mean 3-O-methylnebicapone (BIA 3-270) plasma concentration-time profiles following the last dose (Day 8) of a multiple-dose oral administration of nebicapone (100 mg, 200 mg or 300 mg, at 4-h intervals)
Apparent terminal elimination half-life (t1/2) - 3-O-methylnebicapone (BIA 3-270)
Time frame: Day 8
Mean 3-O-methylnebicapone (BIA 3-270) plasma concentration-time profiles following the last dose (Day 8) of a multiple-dose oral administration of nebicapone (100 mg, 200 mg or 300 mg, at 4-h intervals)
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 13 May 2016.
- Individual participant dataSharing planned: No
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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 Nebicapone in people with Parkinson's 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 9 inclusion and 22 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 13 May 2016. 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?
Maximum observed plasma concentration (Cmax) - Nebicapone (time frame: Day 8). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2016.