ClinicalTrials.gov
ClinicalTrials.gov Menu

Assessing The Long-Term Safety And To Explore The Long-Term Efficacy Of Zonisamide As Monotherapy In Newly Diagnosed Partial Seizures

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: NCT00848549
Recruitment Status : Completed
First Posted : February 20, 2009
Results First Posted : January 15, 2013
Last Update Posted : December 24, 2015
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Epilepsy
Interventions Drug: Zonisamide
Drug: Carbamazepine
Enrollment 295

Recruitment Details E2090-E044-314 is a double-blind extension of E2090-E044-310 (NCT00477295) “base study.” Assessment of eligibility took place at the Study Entry Visit (SEV), which was the same day as their final visit of Study 310. Subjects remained on the same investigational product as they were randomized to in Study 310 until unblinding of that study.
Pre-assignment Details  
Arm/Group Title Zonisamide Carbamazepine
Hide Arm/Group Description Subjects received the same study drug to which they had been randomized in the core study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range. Subjects received the same study drug to which they had been randomized in the core study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
Period Title: E2090-E044-310 (Base Study) Disposition
Started 282 301
Completed 161 192
Not Completed 121 109
Reason Not Completed
Adverse Event             31             35
Withdrawal by Subject             35             24
Lack of Efficacy             23             23
Protocol Violation             3             8
Physician Decision             4             5
Lost to Follow-up             21             11
Not Specified             4             3
Period Title: E2090-E044-310 (Base Study) Transition
Started 161 192
Completed 137 158
Not Completed 24 34
Reason Not Completed
Chose not to enter 314 Extension study             24             34
Period Title: E2090-E044-314 (Extension Study)
Started 137 158
Completed 120 134
Not Completed 17 24
Reason Not Completed
Adverse Event             2             1
Protocol Violation             1             2
Withdrawal by Subject             8             12
Lack of Efficacy             1             1
Physician Decision             0             2
Not Specified             5             6
Arm/Group Title Zonisamide Carbamazepine Total
Hide Arm/Group Description Subjects received the same study drug to which they had been randomized in the core study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range. Subjects received the same study drug to which they had been randomized in the core study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range. Total of all reporting groups
Overall Number of Baseline Participants 282 301 583
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 282 participants 301 participants 583 participants
Base Study 310 (NCT00477295, n=583) 37.1  (16.33) 35.6  (15.50) 36.35  (15.92)
Extension Study 314 (NCT00848549, n=295) 37.8  (16.13) 34.4  (14.93) 36.1  (15.53)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 282 participants 301 participants 583 participants
Female (Base Study 310, NCT00477295) 107 128 235
Male (Base Study 310, NCT00477295) 174 172 346
Female (Extension Study 314, NCT00848549) 57 59 116
Male (Extension Study 314, NCT00848549) 80 99 179
1.Primary Outcome
Title Percentage of Participants Remaining in the Study at Each Visit
Hide Description The retention rate is defined as the percentage of subjects remaining on the study at each visit, starting from the first dose of study drug in the extension phase.
Time Frame At 3, 6, 9, 12, 15, 18, 21, 24, and 27 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) Population is defined as all subjects who received at least one dose of investigational product(IP)
Arm/Group Title Zonisamide Carbamazepine
Hide Arm/Group Description:
Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
Overall Number of Participants Analyzed 137 158
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
3 months
95.6
(92.2 to 99.1)
93.7
(89.8 to 97.5)
6 months
87.6
(82.0 to 93.2)
84.2
(78.4 to 89.9)
9 months
76.6
(69.5 to 83.8)
75.3
(68.5 to 82.1)
12 months
58.4
(50.1 to 66.7)
61.4
(53.7 to 69.0)
15 months
38.7
(30.5 to 46.9)
43.7
(35.9 to 51.5)
18 months
27.7
(20.2 to 35.3)
27.8
(20.8 to 34.9)
21 months
13.1
(7.4 to 18.8)
12.7
(7.4 to 17.9)
24 months
5.8
(1.9 to 9.8)
2.5
(0.1 to 5.0)
27 months
1.5
(0.0 to 3.5)
0.6
(0.0 to 1.9)
2.Secondary Outcome
Title Time to Drop-out Due to Lack of Efficacy
Hide Description Lack of efficacy was if the subject had poor seizure control (defined as experiencing a seizure despite being on the maximum dose for = 2 weeks). The subject could withdraw at any time due to lack of efficacy.
Time Frame Week 1 to Week 109 (in core study) and Month 1 to Month 27 (in extension study)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
310 ITT Population (combined ITT Population from basecore study and extension phase). 24 participants were discontinued in each arm due to lack of efficacy; these were the participants that were evaluated in this outcome.
Arm/Group Title Zonisamide Carbamazepine
Hide Arm/Group Description:
Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: Days
297.9  (170.03) 289.0  (108.93)
3.Secondary Outcome
Title Time to Drop-out Due to Adverse Event (AE)
Hide Description

Adverse events in study subjects included any change in the subject’s condition.

This includes symptoms, physical findings, or clinical syndromes. All AEs that occurred after signing of informed consent through the last visit and for 15 days following study drug discontinuation were captured on the AE Case Report Form (CRF).

Time Frame Week 1 to Week 109 (in base study) and Month 1 to Month 27 (in extension study)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
310 ITT Population (33 participants were discontinued in the Zonisamide arm and 35 were discontinued in the Carbamazepine arm; these were the participants evaluated for this outcome)
Arm/Group Title Zonisamide Carbamazepine
Hide Arm/Group Description:
Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
Overall Number of Participants Analyzed 33 35
Mean (Standard Deviation)
Unit of Measure: Days
131.9  (166.90) 97.2  (114.47)
4.Secondary Outcome
Title Percentage of Participants That Are Seizure Free for at Least 24 Month Consecutive Period in the Base Study and Extension Phase
Hide Description The number of participants that have remained seizure free for at least a 24 month consecutive period from the start of the Flexible Dosing Period (FDP: the period following the Titration Period and leading into the Maintenance Period) in the base study through the treatment period of this study. Seizure freedom was defined as the absence of all seizure regardless of seizure type.
Time Frame Week 5 to Week 109 (in base study) and Month 1 to Month 27 (in extension phase)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
310 ITT Population
Arm/Group Title Zonisamide Carbamazepine
Hide Arm/Group Description:
Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
Overall Number of Participants Analyzed 281 300
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
32.3
(26.5 to 38.0)
35.2
(29.5 to 40.9)
5.Secondary Outcome
Title Change From Baseline in Quality of Life Assessed by Quality of Life in Epilepsy-Problems Questionnaire (QOLIE-31-P) Overall Score at Each Visit
Hide Description The QOLIE-31-P is a 31-item questionnaire evaluating a participant's QOL perception in 7 domains: seizure worry,emotional well being,energy/fatigue, cognitive functioning, medication effects, social functioning,overall QOL. The overall score is derived by weighing and then summing the 7 domain scores. Precoded numeric values for some domains are such that a higher number reflects a more favorable health state; others are such that a higher number reflects a less favorable state. Precoded values are converted to 0-100 point scores; higher converted scores always reflect better QOL.
Time Frame Weeks 0, 26, 52, 78 and 117
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Zonisamide Carbamazepine
Hide Arm/Group Description:
Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
Overall Number of Participants Analyzed 137 158
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Week 0 4.697  (16.254) 7.101  (13.781)
Week 26 6.101  (16.566) 10.956  (14.940)
Week 52 8.602  (14.326) 11.687  (13.653)
Week 78 4.287  (15.566) 1.902  (13.495)
Week 117 -0.292  (17.332) 15.849  (12.302)
Time Frame From the time the subject signed the informed consent form through the Final Visit/Early Termination Visit and for 15 days following study drug discontinuation.
Adverse Event Reporting Description Adverse events were assessed at clinical visits based on the subject's diary, vitals, weight, physical examination, neurological exam, and laboratory evaluations.
 
Arm/Group Title Zonisamide (Extension Study 314, NCT00848549) Carbamazepine (Extension Study 314, NCT00848549) Zonisamide (Base Study 310, NCT00477295) Carbamazepine (Base Study 310, NCT00477295)
Hide Arm/Group Description Subjects received the same study drug to which they had been randomized in the core study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range. Subjects received the same study drug to which they had been randomized in the core study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range. The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP. The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
All-Cause Mortality
Zonisamide (Extension Study 314, NCT00848549) Carbamazepine (Extension Study 314, NCT00848549) Zonisamide (Base Study 310, NCT00477295) Carbamazepine (Base Study 310, NCT00477295)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Zonisamide (Extension Study 314, NCT00848549) Carbamazepine (Extension Study 314, NCT00848549) Zonisamide (Base Study 310, NCT00477295) Carbamazepine (Base Study 310, NCT00477295)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/137 (5.11%)   7/158 (4.43%)   15/281 (5.34%)   17/300 (5.67%) 
Cardiac disorders         
Myocardial ischaemia * 1  1/137 (0.73%)  0/158 (0.00%)  0/281 (0.00%)  0/300 (0.00%) 
Bradycardia * 1  0/137 (0.00%)  0/158 (0.00%)  0/281 (0.00%)  1/300 (0.33%) 
Myocardial infarction * 1  0/137 (0.00%)  0/158 (0.00%)  1/281 (0.36%)  0/300 (0.00%) 
Ear and labyrinth disorders         
Vertigo * 1  0/137 (0.00%)  0/158 (0.00%)  1/281 (0.36%)  0/300 (0.00%) 
Gastrointestinal disorders         
Abdominal pain * 1  1/137 (0.73%)  0/158 (0.00%)  0/281 (0.00%)  0/300 (0.00%) 
Duodenal ulcer haemorrhage * 1  1/137 (0.73%)  0/158 (0.00%)  0/281 (0.00%)  0/300 (0.00%) 
Peptic ulcer haemorrhage * 1  1/137 (0.73%)  0/158 (0.00%)  0/281 (0.00%)  0/300 (0.00%) 
Gastric ulcer * 1  0/137 (0.00%)  0/158 (0.00%)  0/281 (0.00%)  1/300 (0.33%) 
General disorders         
Death * 1  0/137 (0.00%)  0/158 (0.00%)  1/281 (0.36%)  0/300 (0.00%) 
Pyrexia * 1  0/137 (0.00%)  0/158 (0.00%)  1/281 (0.36%)  0/300 (0.00%) 
Hepatobiliary disorders         
Cholecystitis * 1  0/137 (0.00%)  1/158 (0.63%)  0/281 (0.00%)  0/300 (0.00%) 
Cholelithiasis * 1  0/137 (0.00%)  0/158 (0.00%)  0/281 (0.00%)  1/300 (0.33%) 
Infections and infestations         
Upper respiratory tract infection * 1  0/137 (0.00%)  1/158 (0.63%)  0/281 (0.00%)  0/300 (0.00%) 
Viral infection * 1  0/137 (0.00%)  1/158 (0.63%)  0/281 (0.00%)  0/300 (0.00%) 
Appendicitis * 1  0/137 (0.00%)  0/158 (0.00%)  1/281 (0.36%)  0/300 (0.00%) 
Chronic sinusitis * 1  0/137 (0.00%)  0/158 (0.00%)  0/281 (0.00%)  1/300 (0.33%) 
Sinusitis bacterial * 1  0/137 (0.00%)  0/158 (0.00%)  0/281 (0.00%)  1/300 (0.33%) 
Typhoid fever * 1  0/137 (0.00%)  0/158 (0.00%)  1/281 (0.36%)  0/300 (0.00%) 
Injury, poisoning and procedural complications         
Clavicle fracture * 1  0/137 (0.00%)  1/158 (0.63%)  0/281 (0.00%)  0/300 (0.00%) 
Subarachnoid haemorrhage * 1  0/137 (0.00%)  0/158 (0.00%)  0/281 (0.00%)  1/300 (0.33%) 
Facial bones fracture * 1  0/137 (0.00%)  0/158 (0.00%)  0/281 (0.00%)  2/300 (0.67%) 
Femur fracture * 1  0/137 (0.00%)  0/158 (0.00%)  0/281 (0.00%)  1/300 (0.33%) 
Head injury * 1  0/137 (0.00%)  0/158 (0.00%)  0/281 (0.00%)  1/300 (0.33%) 
Humerus fracture * 1  0/137 (0.00%)  0/158 (0.00%)  0/281 (0.00%)  1/300 (0.33%) 
Joint dislocation * 1  0/137 (0.00%)  0/158 (0.00%)  1/281 (0.36%)  0/300 (0.00%) 
Muscle strain * 1  0/137 (0.00%)  0/158 (0.00%)  0/281 (0.00%)  1/300 (0.33%) 
Radius fracture * 1  0/137 (0.00%)  0/158 (0.00%)  0/281 (0.00%)  1/300 (0.33%) 
Skull fracture * 1  0/137 (0.00%)  0/158 (0.00%)  0/281 (0.00%)  1/300 (0.33%) 
Investigations         
Electrocardiogram abnormal * 1  1/137 (0.73%)  0/158 (0.00%)  0/281 (0.00%)  0/300 (0.00%) 
Hepatic enzyme increased * 1  0/137 (0.00%)  0/158 (0.00%)  0/281 (0.00%)  1/300 (0.33%) 
Metabolism and nutrition disorders         
Hyponatraemia * 1  0/137 (0.00%)  1/158 (0.63%)  0/281 (0.00%)  0/300 (0.00%) 
Hypokalaemia * 1  0/137 (0.00%)  0/158 (0.00%)  1/281 (0.36%)  0/300 (0.00%) 
Musculoskeletal and connective tissue disorders         
Osteoarthritis * 1  0/137 (0.00%)  1/158 (0.63%)  0/281 (0.00%)  0/300 (0.00%) 
Bone pain * 1  0/137 (0.00%)  0/158 (0.00%)  1/281 (0.36%)  0/300 (0.00%) 
Musculoskeletal pain * 1  0/137 (0.00%)  0/158 (0.00%)  0/281 (0.00%)  1/300 (0.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Prostatic adenoma * 1  1/137 (0.73%)  0/158 (0.00%)  0/281 (0.00%)  0/300 (0.00%) 
Brain neoplasm * 1  0/137 (0.00%)  0/158 (0.00%)  1/281 (0.36%)  0/300 (0.00%) 
Prostate cancer * 1  0/137 (0.00%)  0/158 (0.00%)  0/281 (0.00%)  1/300 (0.33%) 
Nervous system disorders         
Ataxia * 1  0/137 (0.00%)  1/158 (0.63%)  0/281 (0.00%)  0/300 (0.00%) 
Carotid artery stenosis * 1  1/137 (0.73%)  0/158 (0.00%)  0/281 (0.00%)  0/300 (0.00%) 
Somnolence * 1  0/137 (0.00%)  1/158 (0.63%)  0/281 (0.00%)  0/300 (0.00%) 
Transient ischaemic attack * 1  1/137 (0.73%)  0/158 (0.00%)  0/281 (0.00%)  0/300 (0.00%) 
Partial seizures with secondary generalization * 1  0/137 (0.00%)  0/158 (0.00%)  0/281 (0.00%)  4/300 (1.33%) 
Complex partial seizures * 1  0/137 (0.00%)  0/158 (0.00%)  1/281 (0.36%)  0/300 (0.00%) 
Convulsion * 1  0/137 (0.00%)  0/158 (0.00%)  1/281 (0.36%)  0/300 (0.00%) 
Epilepsy * 1  0/137 (0.00%)  0/158 (0.00%)  0/281 (0.00%)  1/300 (0.33%) 
Ischaemic stroke * 1  0/137 (0.00%)  0/158 (0.00%)  0/281 (0.00%)  1/300 (0.33%) 
Partial seizures * 1  0/137 (0.00%)  0/158 (0.00%)  1/281 (0.36%)  0/300 (0.00%) 
Pregnancy, puerperium and perinatal conditions         
Unwanted pregnancy * 1  0/137 (0.00%)  1/158 (0.63%)  0/281 (0.00%)  0/300 (0.00%) 
Psychiatric disorders         
Acute psychosis * 1  0/137 (0.00%)  0/158 (0.00%)  1/281 (0.36%)  0/300 (0.00%) 
Suicidal ideation * 1  0/137 (0.00%)  0/158 (0.00%)  0/281 (0.00%)  1/300 (0.33%) 
Suicide attempt * 1  0/137 (0.00%)  0/158 (0.00%)  0/281 (0.00%)  1/300 (0.33%) 
Respiratory, thoracic and mediastinal disorders         
Nasal septum deviation * 1  0/137 (0.00%)  0/158 (0.00%)  0/281 (0.00%)  1/300 (0.33%) 
Respiratory disorder * 1  0/137 (0.00%)  0/158 (0.00%)  1/281 (0.36%)  0/300 (0.00%) 
Rhinitis hypertrophic * 1  0/137 (0.00%)  0/158 (0.00%)  0/281 (0.00%)  1/300 (0.33%) 
Skin and subcutaneous tissue disorders         
Rash * 1  0/137 (0.00%)  0/158 (0.00%)  0/281 (0.00%)  2/300 (0.67%) 
Purpura * 1  0/137 (0.00%)  0/158 (0.00%)  1/281 (0.36%)  0/300 (0.00%) 
Vascular disorders         
Hypertension * 1  1/137 (0.73%)  0/158 (0.00%)  0/281 (0.00%)  0/300 (0.00%) 
Hypotension * 1  0/137 (0.00%)  0/158 (0.00%)  0/281 (0.00%)  1/300 (0.33%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA V. 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Zonisamide (Extension Study 314, NCT00848549) Carbamazepine (Extension Study 314, NCT00848549) Zonisamide (Base Study 310, NCT00477295) Carbamazepine (Base Study 310, NCT00477295)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   12/137 (8.76%)   10/158 (6.33%)   72/281 (25.62%)   69/300 (23.00%) 
Investigations         
Weight Decreased * 1  8/137 (5.84%)  0/158 (0.00%)  19/281 (6.76%)  0/300 (0.00%) 
Metabolism and nutrition disorders         
Decreased appetite * 1  0/137 (0.00%)  0/158 (0.00%)  22/281 (7.83%)  5/300 (1.67%) 
Nervous system disorders         
Headache * 1  6/137 (4.38%)  10/158 (6.33%)  29/281 (10.32%)  37/300 (12.33%) 
Somnolence * 1  0/137 (0.00%)  0/158 (0.00%)  17/281 (6.05%)  23/300 (7.67%) 
Dizziness * 1  0/137 (0.00%)  0/158 (0.00%)  11/281 (3.91%)  23/300 (7.67%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA V. 13.0
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: Eisai Inc.
Organization: Eisai Call Center
Phone: 888-422-4743
Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00848549     History of Changes
Other Study ID Numbers: E2090-E044-314
2008-001159-23 ( EudraCT Number )
First Submitted: February 19, 2009
First Posted: February 20, 2009
Results First Submitted: November 12, 2012
Results First Posted: January 15, 2013
Last Update Posted: December 24, 2015