NCT01568047 is a Phase 2 clinical trial of BIA 9-1067 in Parkinson's Disease, sponsored by Bial - Portela C S.A..

Who is sponsoring NCT01568047?

NCT01568047 is sponsored by Bial - Portela C S.A..

What drugs are being tested in NCT01568047?

Interventions in NCT01568047: Placebo, BIA 9-1067, BIA 9-1067, BIA 9-1067, Levodopa/Carbidopa, Levodopa/Benzerazide.

What condition does NCT01568047 study?

NCT01568047 studies Parkinson's Disease.

Is NCT01568047 still recruiting?

NCT01568047 is currently completed. Last updated 23 November 2015.

Are results published for NCT01568047?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2015-11-23 · How we verify

NCT01568047

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Multicentre, Double-blind, Randomised, Placebo-controlled Study in Four Parallel Groups of PD Patients Treated With Standard-release Levodopa/Carbidopa 100/25 mg (Sinemet®) or Levodopa/Benserazide 100/25 mg (Madopar®/Restex®) and With Motor Fluctuations ("Wearing-off" Phenomenon)

Completed Phase 2 Results posted Last updated 23 November 2015

What this trial tests

Phase 2 trial testing Placebo in Parkinson's Disease in 40 participants. Completed in 1 June 2010.

Timeline

1 February 2010

Primary endpoint
1 June 2010

1 June 2010

Quick facts

Lead sponsor	Bial - Portela C S.A.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	40
Start date	1 February 2010
Primary completion	1 June 2010
Estimated completion	1 June 2010
Sites	7 locations across Romania, Ukraine

Drugs / interventions tested

Placebo
BIA 9-1067 (BIA 9-1067) — full drug profile →
BIA 9-1067 (BIA 9-1067) — full drug profile →
BIA 9-1067 (BIA 9-1067) — full drug profile →
Levodopa/Carbidopa
Levodopa/Benzerazide — full drug profile →

Conditions studied

Parkinson's Disease — all drugs for Parkinson's Disease →

Sponsor

Bial - Portela C S.A. — full company profile →

Who can join

30 and older, any sex, with Parkinson's Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Cmax - Observed Maximum Concentration
Time frame: 28 days
Baseline period - to be switched respectively to standard-release levodopa/carbidopa 100/25 mg (Sinemet®) or levodopa/benserazide 100/25 mg (Madopar®/Restex®) and to adjust the number of daily doses. Test Period - After the baseline period during the 21 to 28 days
Tmax - Time to Observed Maximum Concentration
Time frame: 28 days
Baseline period - to be switched respectively to standard-release levodopa/carbidopa 100/25 mg (Sinemet®) or levodopa/benserazide 100/25 mg (Madopar®/Restex®) and to adjust the number of daily doses. Test Period - After the baseline period during the 21 to 28 days

Sponsor's own description

The purpose of this study is to investigate the tolerability and the effect of BIA 9-1067 at steady-state on the levodopa pharmacokinetics in Parkinson's Disease (PD) patients treated with levodopa/dopa-decarboxylase inhibitor.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of BIA 9-1067

Trials testing the same drug.

NCT02847442 — Efficacy and Safety of Opicapone in Clinical Practice · Phase 4 · completed

Other recruiting trials for Parkinson's Disease

Currently open trials in the same condition.

NCT07371338 — Phase 1 Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of IPS101A in Parkinson's Disease Patients · Phase 1 · recruiting
NCT07330258 — A US Study That Observes How Parkinson's Disease Changes Over Time in Patients Who Still Have Movement Symptoms Despite · recruiting
NCT07384429 — Effects of Lemborexant on Motor-sleep Comorbidity in Parkinson's Disease · Phase 4 · recruiting
NCT07384442 — Effects of Targeted Temporal Interference Stimulation of Cerebellar Nuclei on Tremor and Gait Disturbance in Parkinson's · NA · recruiting
NCT06562569 — Non-invasive VNS for PD Gait · NA · recruiting

Other Bial - Portela C S.A. trials

Trials by the same sponsor.

NCT07403799 — REal-life ON PARKinson's - ITaly (REONPARK-IT) · recruiting
NCT04990284 — eArly levoDopa With Opicapone in Parkinson's paTients wIth motOr fluctuatioNs. · Phase 4 · completed
NCT04986995 — OpicApone Sleep dISorder · Phase 4 · completed
NCT04978597 — Early ParkinSon wIth L-DOPA/DDCI and OpicapoNe (EPSILON Study) · Phase 3 · completed
NCT04986982 — OpiCapone Effect on Motor Fluctuations and pAiN · Phase 4 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01568047 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bial - Portela C S.A.
Last refreshed: 23 November 2015

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01568047.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing