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Study of BIA 9-1067 to Investigate Its Effect on Levodopa Pharmacokinetic

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.
ClinicalTrials.gov Identifier:
NCT01519284
First received: January 23, 2012
Last updated: July 22, 2015
Last verified: July 2015
Results First Received: July 22, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Parkinson Disease
Interventions: Drug: BIA 9-1067 5 mg
Drug: Entacapone
Drug: Placebo
Drug: levodopa/carbidopa
Drug: BIA 9-1067 15 mg
Drug: BIA 9-1067 30 mg

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Group 1 Placebo at all the dosing times
Group 2

Day 1 to 7:

BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose

Day 8:

BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose

Group 3

Day 1 to 7:

BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose

Day 8:

BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose

Group 4

Day 1 to 7:

BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose

Day 8:

BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose

Group 5

Day 1 to 7:

Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose

Day 8:

Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose


Participant Flow:   Overall Study
    Group 1   Group 2   Group 3   Group 4   Group 5
STARTED   16   16   18   16   16 
COMPLETED   16   16   16   16   16 
NOT COMPLETED   0   0   2   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Group 1

Placebo at all the dosing times

Placebo: placebo (four times a day)

Group 2

Day 1 to 7:

BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose

Day 8:

BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose

BIA 9-1067 5 mg: BIA 9-1067 OPC, Opicapone 5 mg

Placebo: placebo (four times a day)

levodopa/carbidopa: standard release levodopa/carbidopa 100/25 mg (single-dose)

Group 3

Day 1 to 7:

BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose

Day 8:

BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose

Placebo: placebo (four times a day)

levodopa/carbidopa: standard release levodopa/carbidopa 100/25 mg (single-dose)

BIA 9-1067 15 mg: BIA 9-1067 OPC, Opicapone 15 mg

Group 4

Day 1 to 7:

BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose

Day 8:

BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose

Placebo: placebo (four times a day)

levodopa/carbidopa: standard release levodopa/carbidopa 100/25 mg (single-dose)

BIA 9-1067 30 mg: BIA 9-1067 OPC, Opicapone 30 mg

Group 5

Day 1 to 7:

Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose

Day 8:

Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose

Entacapone: Entacapone 200 mg

Placebo: placebo (four times a day)

levodopa/carbidopa: standard release levodopa/carbidopa 100/25 mg (single-dose)

Total Total of all reporting groups

Baseline Measures
   Group 1   Group 2   Group 3   Group 4   Group 5   Total 
Overall Participants Analyzed 
[Units: Participants]
 16   16   18   16   16   82 
Age 
[Units: Participants]
           
<=18 years   0   0   0   0   0   0 
Between 18 and 65 years   16   16   18   16   16   82 
>=65 years   0   0   0   0   0   0 
Gender 
[Units: Participants]
           
Female   8   8   9   8   8   41 
Male   8   8   9   8   8   41 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Cmax - Maximum Plasma Concentration of Levodopa   [ Time Frame: 8 days ]

2.  Secondary:   Tmax - Time to Reach Maximum Plasma Concentration of Levodopa   [ Time Frame: 8 days ]

3.  Secondary:   AUC0-t - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to the Last Sampling Time at Which the Drug Concentration Was at or Above the Lower Limit of Quantification.   [ Time Frame: 8 days ]

4.  Secondary:   AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to Infinity   [ Time Frame: 8 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Head of Clinical Research
Organization: Bial – Portela & Cª, S.A.
phone: +351 229 866 100
e-mail: jose.rocha@bial.com



Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT01519284     History of Changes
Other Study ID Numbers: BIA-91067-114
Study First Received: January 23, 2012
Results First Received: July 22, 2015
Last Updated: July 22, 2015
Health Authority: Portugal: National Pharmacy and Medicines Institute