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Intravenous Lacosamide Compared With Fosphenytoin in the Treatment of Patients With Frequent Nonconvulsive Seizures (TRENdS)

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ClinicalTrials.gov Identifier: NCT01458522
Recruitment Status : Completed
First Posted : October 25, 2011
Results First Posted : June 11, 2018
Last Update Posted : June 11, 2018
Sponsor:
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
Aatif Husain, Duke University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition: Nonconvulsive Seizures
Interventions: Drug: fPHT
Drug: LCM

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
173 participants consented. 74 participants were randomized.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
37 participants randomized to LCM, however 2 participants did not receive drug. 37 participants were randomized to fPHT and everyone received drug.

Reporting Groups
  Description
LCM First, Then fPHT

LCM bolus of 400 mg administered over 30 minutes. If further bolus is required, 200 mg is administered. Regardless of whether the subject received a rebolus, they will begin receiving a maintenance dose 12 hrs after initial dose. Daily maintenance dose will be the same as the total bolus (400 mg or 600 mg) divided into 2 doses.

If after initial treatment and any of the following occurs, subject will have reached end of 1st treatment arm and will crossover and receive the other drug. If any of the following did not occur the subject will be considered completed.

Subject has another seizure within 24 hrs following the 2-hr post-rebolus observation-only period.

Subject dose not receive a rebolus but has a seizure within 24 hrs following 2-hr post bolus observation-only period.

Subject experiences an AE that precludes further use of the 1st study drug. If crossover occurs, the subject will start over with the second drug, going through the same observation-only period.

fPHT First, Then LCM

fPHT treatment arm, a bolus of 20 mg PE/kg will be administered at a rate of no greater than 75 mg PE/minute. If a further bolus is required, 5 mg PE/kg will be administered. The daily maintenance dose for fPHT will be 5 mg PE/kg divided into 2 doses.

If after initial treatment and any of the following occurs, the subject will have reached the end of the first treatment arm and will "cross over" and begin receiving the other drug. If any of the following did NOT occur the subject will be considered completed.

Subject has another seizure within 24 hours following the 2-hour post-rebolus observation-only period.

Subject dose not receive a rebolus but has a seizure within 24 hours following 2-hour post bolus observation-only period.

Subject experiences an AE that precludes further use of the first study drug.

If crossover occurs, the subject will "start over" with the second drug, going through the same observation-only period, rebolusing (if necessary).


Participant Flow:   Overall Study
    LCM First, Then fPHT   fPHT First, Then LCM
STARTED   37   37 
Received First Drug   35   35 
Crossover to Second Drug   15   10 
COMPLETED [1]   34   26 
NOT COMPLETED   3   11 
Withdrawal by Subject                2                2 
Physician Decision                1                9 
[1] Completed all assigned intervention & observation. Not all subjects were assigned to crossover.



  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
LCM First, Then fPHT

LCM treatment arm, a bolus of 400 mg will be administered over 30 minutes. If a further bolus is required, 200 mg will be administered. Regardless of whether the subject received a rebolus, he or she will begin receiving a maintenance dose 12 hours after the initial dose. The daily maintenance dose will be the same as the total bolus (400 mg or 600 mg) divided into 2 doses.

If after initial treatment and any of the following occurs, subject will have reached the end of the first treatment arm and will “cross over” and begin receiving the other drug.

Subject has another seizure within 24 hours following the 2-hour post-rebolus observation-only period.

Subject dose not receive a rebolus but has a seizure within 24 hours following 2-hour post bolus observation-only period.

Subject experiences an AE that precludes further use of the first study drug.

If crossover occurs, the subject will "start over" with the second drug, going through the same observation-only period.

fPHT First, Then LCM

fPHT treatment arm, a bolus of 20 mg PE/kg will be administered at a rate of no greater than 75 mg PE/minute. If a further bolus is required, 5 mg PE/kg will be administered. The daily maintenance dose for fPHT will be 5 mg PE/kg divided into 2 doses.

If after initial treatment and any of the following occurs, the subject will have reached the end of the first treatment arm and will "cross over" and begin receiving the other drug.

Subject has another seizure within 24 hours following the 2-hour post-rebolus observation-only period.

Subject dose not receive a rebolus but has a seizure within 24 hours following 2-hour post bolus observation-only period.

Subject experiences an AE that precludes further use of the first study drug.

If crossover occurs, the subject will "start over" with the second drug, going through the same observation-only period, rebolusing (if necessary).

Total Total of all reporting groups

Baseline Measures
   LCM First, Then fPHT   fPHT First, Then LCM   Total 
Overall Participants Analyzed 
[Units: Participants]
 37   37   74 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.8  (12.1)   63.4  (20.4)   63.6  (16.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female   17   21   38 
Male   20   16   36 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
White   26   32   58 
Black or African American   9   3   12 
Asian   2   2   4 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   37   37   74 


  Outcome Measures

1.  Primary:   Percentage of Subjects Who Experience no Nonconvulsive Seizures (NCS) for 24 Hours Following Treatment With LCM vs. fPHT, as Measured by Continuous Electroencephalography (cEEG) Monitoring.   [ Time Frame: 24 hours ]

2.  Secondary:   Percentage of Subjects Who Require a Rebolus of the Initial Antiepileptic Drugs (AED) to Control Nonconvulsive Seizures (NCS) in the LCM vs fPHT Arms.   [ Time Frame: 24 hours ]

3.  Secondary:   Number of Subjects Who Required a Second Antiepileptic Drug (AED) to Control Nonconvulsive Seizures (NCS)   [ Time Frame: 24-26 hours ]

4.  Secondary:   Seizure Burden Change From Baseline to End of Initial Treatment   [ Time Frame: Baseline, 24 hours ]

5.  Secondary:   Seizure Burden Change From Baseline to End of Crossover, Excluding Initial Treatment Arm   [ Time Frame: baseline, 26-68 hours ]

6.  Secondary:   Time of First Bolus to End of Seizures After Initial Treatment Arm, Time From Crossover to End of Seizures in Crossover Treatment Arm   [ Time Frame: time of first bolus to end of seizures after initial treatment arm, time from crossover to end of seizures in crossover treatment arm ]

7.  Secondary:   Number of Predefined Adverse Events (AE) After Treatment Arm 1 Administration   [ Time Frame: 24 hours ]

8.  Secondary:   Percentage of Subjects in Whom Study Drug is Withdrawn Early After Treatment With Treatment Arm 1   [ Time Frame: baseline to end of treatment arm 1 ]

9.  Secondary:   Days in the Intensive Care Unit/Hospital   [ Time Frame: initial bolus to end of study ]

10.  Secondary:   Change in Functional Status as Measured by the Functional Disability Scale at Day 7 to 9 Postrandomization and Day 30 Post-randomization in the LCM vs fPHT Arms.   [ Time Frame: Baseline to day 7-9, baseline to day 30 ]

11.  Secondary:   Percentage of All Subjects Who Have Had a Seizure, Are on Antiepileptic Drug (AED) Therapy, and Are Alive/Dead at Day 30   [ Time Frame: both acute treatment periods to 30 days ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Aatif M. Husain, M.D.
Organization: Duke University
phone: 919-668-8700
e-mail: aatif.husain@duke.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Aatif Husain, Duke University
ClinicalTrials.gov Identifier: NCT01458522     History of Changes
Other Study ID Numbers: Pro00033295
Pro00037794 ( Other Identifier: Duke Site Protocol Number )
DCRI-CEMC101.01
First Submitted: October 20, 2011
First Posted: October 25, 2011
Results First Submitted: June 1, 2017
Results First Posted: June 11, 2018
Last Update Posted: June 11, 2018