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Trial record 25 of 104 for:    PHENYTOIN

Open-label Drug Interaction Study Between Eslicarbazepine Acetate and Phenytoin.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02283827
Recruitment Status : Completed
First Posted : November 5, 2014
Results First Posted : December 18, 2014
Last Update Posted : December 18, 2014
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Epilepsy
Interventions: Drug: BIA 2-093
Drug: Phenytoin

  Participant Flow

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 A BIA 2-093 + Phenytoin (PHT) Day 1 to 2: Pre-treatment 1: ESL 600 mg Day 3 to 8: Treatment 1:1200 mg ESL Day 9 to 10: Treatment 1 + Pre-treatment 2: 1200 mg ESL+ PHT 100 mg Day 11 to 27: Treatment 1 + Treatment 2: 1200 mg ESL + PHT 300 mg
Group B BIA 2-093 + Phenytoin (PHT)

Day 1 to 2: Pre-treatment 2: PHT 100 mg Day 3 to 8: Treatment 2: PHT 300 mg Day 9 to 10: Treatment 2 + Pre-treatment 1: PHT 300 mg

+ ESL 600 mg Day 11 to 27: Treatment 1 + Treatment 2: 1200 mg ESL + PHT 300 mg


Participant Flow:   Overall Study
    Group A BIA 2-093 + Phenytoin (PHT)   Group B BIA 2-093 + Phenytoin (PHT)
STARTED   16   16 
COMPLETED   15   13 
NOT COMPLETED   1   3 



  Baseline Characteristics

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 A BIA 2-093 + Phenytoin (PHT) Pre-treatment: 600 mg ESL, 2 days; Treatment 1: 1200 mg ESL 6 days Treatment 2: 1200 mg ESL and PHT 100 mg for 2 days Treatment 3: 1200 mg ESL and PHT 300 mg for17 days
Group B BIA 2-093 + Phenytoin (PHT) Pre-treatment: 100 mg PHT for 2 days; Treatment 1: 300 mg PHT 6 days; Treatment 2: 600 mg ESL + PHT 300 mg for 2 days; Treatment 3: 1200 mg ESL and PHT 300 mg for 17 days
Total Total of all reporting groups

Baseline Measures
   Group A BIA 2-093 + Phenytoin (PHT)   Group B BIA 2-093 + Phenytoin (PHT)   Total 
Overall Participants Analyzed 
[Units: Participants]
 16   16   32 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   16   16   32 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   0   0   0 
Male   16   16   32 


  Outcome Measures

1.  Primary:   Cmax - the Maximum Plasma Concentration   [ Time Frame: Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration ]

2.  Secondary:   AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time   [ Time Frame: Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration ]

3.  Secondary:   Tmax - the Time of Occurrence of Cmax   [ Time Frame: Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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: NCT02283827     History of Changes
Other Study ID Numbers: BIA-2093-121
First Submitted: November 3, 2014
First Posted: November 5, 2014
Results First Submitted: December 1, 2014
Results First Posted: December 18, 2014
Last Update Posted: December 18, 2014