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Study for Verification of Efficacy and Safety for Perampanel Monotherapy in Untreated Patients With Partial Onset Seizures (Including Secondarily Generalized Seizures) (FREEDOM Study)

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: NCT03201900
Recruitment Status : Active, not recruiting
First Posted : June 28, 2017
Results First Posted : February 25, 2020
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Partial Onset Seizures
Intervention Drug: E2007
Enrollment 91
Recruitment Details Participants took part in the study at 38 investigative sites in Japan and Korea. Results are reported based on the primary completion date of 28 Feb 2019. A total of 98 participants were screened, of which 07 were screen failures and 91 entered Treatment Phase. Of these, 89 participants received the study treatment.
Pre-assignment Details Study consisted of 2 main phases: Treatment Phase (consisted of 4 milligram [mg] Treatment Phase [the Titration Period {6 weeks} and the Maintenance Period {26 weeks}] and, for those participants who need a higher dose, the 8 mg Treatment Phase [the Titration Period {4 weeks} and the Maintenance Period {26 weeks}]) and Extension Phase.
Arm/Group Title Perampanel
Hide Arm/Group Description Participants received perampanel 2 mg tablets orally once daily (QD) for up to 2 weeks, then dose was up-titrated to 4 mg orally QD for 4 weeks in 4 mg Titration Period (6 Weeks) followed by perampanel 4 mg tablets orally QD in Maintenance Period (26 weeks). If participants experienced seizures during 4 mg Maintenance Period, investigator ended Maintenance Period and transitioned participants to 8 mg Titration Period based on participant’s safety and tolerability. In 8 mg Titration Period (4 weeks) participants received 6 mg perampanel tablets orally QD for 2 weeks and were up-titrated to 8 mg tablets orally QD for 2 weeks followed by perampanel 8 mg tablets orally QD in Maintenance Period (26 weeks). Participants who completed Treatment Phase and agreed to continue perampanel monotherapy entered Extension Phase and received perampanel until insufficient seizure control or lack of tolerability, or initiation of additional antiepileptic drugs (AEDs) (up to additional 124 weeks).
Period Title: Treatment Phase (Up to 62 Weeks)
Started 91
Treated 89
Completed 54
Not Completed 37
Reason Not Completed
Adverse Event             9
Subject Choice             1
Inadequate therapeutic effect             6
Lost to Follow-up             2
Withdrawal of consent             6
Other than specified             11
Not treated             2
Period Title: Extension Phase (Up to 124 Weeks)
Started 46 [1]
Completed 0
Not Completed 46
Reason Not Completed
Subject choice             1
Pregnancy             1
Inadequate therapeutic effect             1
Lost to Follow-up             1
Withdrawal of consent             1
Ongoing             41
[1]
Eligible participants who completed Treatment Phase and agreed to continue in the Extension Phase.
Arm/Group Title Perampanel
Hide Arm/Group Description Participants received perampanel 2 mg tablets orally QD for up to 2 weeks, then dose was up-titrated to 4 mg orally QD for 4 weeks in 4 mg Titration Period (6 Weeks) followed by perampanel 4 mg tablets orally QD in Maintenance Period (26 weeks). If participants experienced seizures during 4 mg Maintenance Period, investigator ended Maintenance Period and transitioned participants to 8 mg Titration Period based on participant’s safety and tolerability. In 8 mg Titration Period (4 weeks) participants received 6 mg perampanel tablets orally QD for 2 weeks and were up-titrated to 8 mg tablets orally QD for 2 weeks followed by perampanel 8 mg tablets orally QD in Maintenance Period (26 weeks). Participants who completed Treatment Phase and agreed to continue perampanel monotherapy entered Extension Phase and received perampanel until insufficient seizure control or lack of tolerability, or initiation of additional AEDs (up to additional 124 weeks).
Overall Number of Baseline Participants 89
Hide Baseline Analysis Population Description
The safety analysis set was the group of participants who signed informed consent, received at least 1 dose of study drug and had at least one post dose safety assessment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 89 participants
42.1  (18.19)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants
Female
44
  49.4%
Male
45
  50.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
89
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants
American Indian or Alaska Native
0
   0.0%
Asian
89
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Percentage of Participants With Partial-onset Seizures (POS) Who Achieved Seizure-free Status During the 26-week Maintenance Period of 4 mg Perampanel
Hide Description A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. POS was a seizure that starts in one area of the brain that may or may not associated with loss of awareness and consciousness. Seizure-free status was defined as no incidence of seizure during 26-week Maintenance Period of 4 mg perampanel.
Time Frame up to 26 weeks in Maintenance Period of 4 mg perampanel
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat (mITT) set: group of participants who signed informed consent, received at least 1 dose of study drug, had at least 1 postdose primary efficacy measurement and who entered 4 mg Maintenance Period with at least 1 postdose primary efficacy measurement in 26-week Maintenance Period.
Arm/Group Title Perampanel
Hide Arm/Group Description:
Participants received perampanel 2 mg tablets orally QD for up to 2 weeks, then dose was up-titrated to 4 mg orally QD for 4 weeks in 4 mg Titration Period (6 Weeks) followed by perampanel 4 mg tablets orally QD in Maintenance Period (26 weeks). If participants experienced seizures during 4 mg Maintenance Period, investigator ended Maintenance Period and transitioned participants to 8 mg Titration Period based on participant’s safety and tolerability. In 8 mg Titration Period (4 weeks) participants received 6 mg perampanel tablets orally QD for 2 weeks and were up-titrated to 8 mg tablets orally QD for 2 weeks followed by perampanel 8 mg tablets orally QD in Maintenance Period (26 weeks). Participants who completed Treatment Phase and agreed to continue perampanel monotherapy entered Extension Phase and received perampanel until insufficient seizure control or lack of tolerability, or initiation of additional AEDs (up to additional 124 weeks).
Overall Number of Participants Analyzed 73
Measure Type: Number
Unit of Measure: percentage of participants
63.0
2.Secondary Outcome
Title Percentage of Participants With POS Who Achieved Seizure-free Status During the 26-week Maintenance Period of Last Evaluated Dose of 4 or 8 mg Perampanel
Hide Description A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. POS was a seizure that starts in one area of the brain that may or may not associated with loss of awareness and consciousness. Seizure-free status was defined as no incidence of seizure during 26-week Maintenance Period of last evaluated dose of 4 or 8 mg perampanel.
Time Frame up to 26 weeks in Maintenance Period of last evaluated dose of 4 or 8 mg perampanel
Hide Outcome Measure Data
Hide Analysis Population Description
mITT set: group of participants who signed informed consent, received at least 1 dose of study drug, had at least 1 postdose primary efficacy measurement and who entered 4 mg Maintenance Period with at least 1 postdose primary efficacy measurement in 26-week Maintenance Period.
Arm/Group Title Perampanel
Hide Arm/Group Description:
Participants received perampanel 2 mg tablets orally QD for up to 2 weeks, then dose was up-titrated to 4 mg orally QD for 4 weeks in 4 mg Titration Period (6 Weeks) followed by perampanel 4 mg tablets orally QD in Maintenance Period (26 weeks). If participants experienced seizures during 4 mg Maintenance Period, investigator ended Maintenance Period and transitioned participants to 8 mg Titration Period based on participant’s safety and tolerability. In 8 mg Titration Period (4 weeks) participants received 6 mg perampanel tablets orally QD for 2 weeks and were up-titrated to 8 mg tablets orally QD for 2 weeks followed by perampanel 8 mg tablets orally QD in Maintenance Period (26 weeks). Participants who completed Treatment Phase and agreed to continue perampanel monotherapy entered Extension Phase and received perampanel until insufficient seizure control or lack of tolerability, or initiation of additional AEDs (up to additional 124 weeks).
Overall Number of Participants Analyzed 73
Measure Type: Number
Unit of Measure: percentage of participants
74.0
3.Secondary Outcome
Title Percentage of Participants With POS Who Achieved Seizure-free Status During 52-weeks of Treatment (26-week Maintenance Period Plus 26-weeks of 124 Week's Extension Phase) of 4 mg of Perampanel
Hide Description A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. POS was a seizure that starts in one area of the brain that may or may not associated with loss of awareness and consciousness. Seizure-free status was defined as no incidence of seizure during 52-weeks Treatment of 4 mg perampanel. Data for this outcome measure will be reported after study completion (which is planned for 2020).
Time Frame up to 52 weeks (Maintenance Period of 4 mg perampanel + Extension Phase of 4 mg perampanel)
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Percentage of Participants With POS Who Achieved Seizure-free Status During 52-weeks of Treatment (26-week Maintenance Period Plus 26-weeks of 124 Week's Extension Phase) of Last Evaluated Dose of 4 or 8 mg Perampanel
Hide Description A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. POS was a seizure that starts in one area of the brain that may or may not associated with loss of awareness and consciousness. Seizure-free status was defined as no incidence of seizure during 52-weeks Treatment of last evaluated dose of 4 or 8 mg perampanel. Data for this outcome measure will be reported after study completion (which is planned for 2020).
Time Frame up to 52 weeks (Maintenance Period of last evaluated dose of 4 or 8 mg perampanel + Extension Phase of 4 or 8 mg perampanel)
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Time to Onset of First Seizure From Study From the First Date of the Maintenance Period of 4 mg Perampanel
Hide Description Time to onset of first seizure was defined as the period from the first dose of study drug in the 4 mg Maintenance Period to the onset of first seizure. A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. Data for this outcome measure will be reported after study completion (which is planned for 2020).
Time Frame From the first date of the Maintenance Period (Week 6) up to the first seizure onset (up to 150 weeks)
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Time to First Seizure Onset From Study From the First Date of the Maintenance Period of Last Evaluated Dose of 4 or 8 mg Perampanel
Hide Description Time to onset of first seizure was defined as the period from the first dose of study drug in the 4 mg Maintenance Period to the onset of first seizure. A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. Data for this outcome measure will be reported after study completion (which is planned for 2020).
Time Frame From the first date of the Maintenance Period (Week 6) up to the first seizure onset (up to 150 weeks)
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Time to Withdrawal From Study From the First Date of the Maintenance Period of 4 mg Perampanel
Hide Description Time to withdrawal from the study was defined as the period from the first dose of study drug in the 4 mg Maintenance Period to the date of withdrawal from study, regardless of reason. A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. Data for this outcome measure will be reported after study completion (which is planned for 2020).
Time Frame From the first date of the Maintenance Period (Week 6) up to the date of first withdrawal, regardless of reason (up to 150 weeks)
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Time to Withdrawal From Study From the First Date of the Maintenance Period of Last Evaluated Dose of 4 or 8 mg Perampanel
Hide Description Time to withdrawal from the study was defined as the period from the first dose of study drug in the 4 mg Maintenance Period to the date of withdrawal from study, regardless of reason. A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. Data for this outcome measure will be reported after study completion (which is planned for 2020).
Time Frame From the first date of the Maintenance Period (Week 6) up to the date of first withdrawal, regardless of reason (up to 150 weeks)
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Number of Participants With Any Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Event (TESAEs), and TEAEs Leading to Discontinuation of the Study Drug
Hide Description [Not Specified]
Time Frame From baseline up to 28 days after last dose of study drug (up to 160 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set was the group of participants who signed informed consent, received at least one dose of study drug and had at least one postdose safety assessment.
Arm/Group Title Perampanel
Hide Arm/Group Description:
Participants received perampanel 2 mg tablets orally QD for up to 2 weeks, then dose was up-titrated to 4 mg orally QD for 4 weeks in 4 mg Titration Period (6 Weeks) followed by perampanel 4 mg tablets orally QD in Maintenance Period (26 weeks). If participants experienced seizures during 4 mg Maintenance Period, investigator ended Maintenance Period and transitioned participants to 8 mg Titration Period based on participant’s safety and tolerability. In 8 mg Titration Period (4 weeks) participants received 6 mg perampanel tablets orally QD for 2 weeks and were up-titrated to 8 mg tablets orally QD for 2 weeks followed by perampanel 8 mg tablets orally QD in Maintenance Period (26 weeks). Participants who completed Treatment Phase and agreed to continue perampanel monotherapy entered Extension Phase and received perampanel until insufficient seizure control or lack of tolerability, or initiation of additional AEDs (up to additional 124 weeks).
Overall Number of Participants Analyzed 89
Measure Type: Count of Participants
Unit of Measure: Participants
TEAEs
72
  80.9%
TESAEs
10
  11.2%
TEAEs leading to discontinuation of study drug
9
  10.1%
Time Frame From baseline up to 28 days after last dose of study drug (up to 160 weeks).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Perampanel
Hide Arm/Group Description Participants received perampanel 2 mg tablets orally QD for up to 2 weeks, then dose was up-titrated to 4 mg orally QD for 4 weeks in 4 mg Titration Period (6 Weeks) followed by perampanel 4 mg tablets orally QD in Maintenance Period (26 weeks). If participants experienced seizures during 4 mg Maintenance Period, investigator ended Maintenance Period and transitioned participants to 8 mg Titration Period based on participant’s safety and tolerability. In 8 mg Titration Period (4 weeks) participants received 6 mg perampanel tablets orally QD for 2 weeks and were up-titrated to 8 mg tablets orally QD for 2 weeks followed by perampanel 8 mg tablets orally QD in Maintenance Period (26 weeks). Participants who completed Treatment Phase and agreed to continue perampanel monotherapy entered Extension Phase and received perampanel until insufficient seizure control or lack of tolerability, or initiation of additional AEDs (up to additional 124 weeks).
All-Cause Mortality
Perampanel
Affected / at Risk (%)
Total   0/89 (0.00%)    
Hide Serious Adverse Events
Perampanel
Affected / at Risk (%) # Events
Total   10/89 (11.24%)    
General disorders   
Malaise  1  1/89 (1.12%)  1
Infections and infestations   
Influenza  1  1/89 (1.12%)  1
Otitis media chronic  1  1/89 (1.12%)  1
Injury, poisoning and procedural complications   
Humerus fracture  1  1/89 (1.12%)  1
Musculoskeletal and connective tissue disorders   
Osteoarthritis  1  1/89 (1.12%)  1
Nervous system disorders   
Epilepsy  1  2/89 (2.25%)  4
Headache  1  1/89 (1.12%)  1
Intracranial aneurysm  1  1/89 (1.12%)  1
Partial seizures with secondary generalisation  1  1/89 (1.12%)  1
Postictal state  1  1/89 (1.12%)  1
Status epilepticus  1  1/89 (1.12%)  1
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Perampanel
Affected / at Risk (%) # Events
Total   71/89 (79.78%)    
Cardiac disorders   
Myocardial ischaemia  1  1/89 (1.12%)  1
Ear and labyrinth disorders   
Auditory disorder  1  1/89 (1.12%)  1
Hypoacusis  1  1/89 (1.12%)  1
Meniere's disease  1  1/89 (1.12%)  1
Vertigo  1  2/89 (2.25%)  2
Vestibular disorder  1  1/89 (1.12%)  1
Eye disorders   
Blepharitis  1  1/89 (1.12%)  1
Conjunctivitis allergic  1  1/89 (1.12%)  2
Gastrointestinal disorders   
Diarrhoea  1  3/89 (3.37%)  3
Stomatitis  1  3/89 (3.37%)  3
Toothache  1  3/89 (3.37%)  5
Abdominal discomfort  1  1/89 (1.12%)  1
Abdominal pain  1  2/89 (2.25%)  2
Constipation  1  2/89 (2.25%)  2
Dental caries  1  1/89 (1.12%)  1
Dyspepsia  1  1/89 (1.12%)  1
Gastric ulcer  1  1/89 (1.12%)  1
Gingival pain  1  1/89 (1.12%)  1
General disorders   
Feeling abnormal  1  4/89 (4.49%)  4
Chest discomfort  1  1/89 (1.12%)  1
Chest pain  1  2/89 (2.25%)  2
Fatigue  1  1/89 (1.12%)  1
Gait disturbance  1  1/89 (1.12%)  1
Malaise  1  1/89 (1.12%)  1
Oedema peripheral  1  1/89 (1.12%)  1
Pyrexia  1  1/89 (1.12%)  1
Hepatobiliary disorders   
Hepatic steatosis  1  1/89 (1.12%)  1
Immune system disorders   
Seasonal allergy  1  1/89 (1.12%)  1
Infections and infestations   
Nasopharyngitis  1  17/89 (19.10%)  29
Influenza  1  2/89 (2.25%)  2
Angular cheilitis  1  1/89 (1.12%)  1
Enterocolitis viral  1  1/89 (1.12%)  1
Gastroenteritis  1  1/89 (1.12%)  1
Gingivitis  1  1/89 (1.12%)  1
Hordeolum  1  1/89 (1.12%)  1
Otitis externa  1  1/89 (1.12%)  1
Otitis media chronic  1  1/89 (1.12%)  1
Pharyngitis  1  1/89 (1.12%)  1
Skin infection  1  1/89 (1.12%)  1
Tinea versicolour  1  1/89 (1.12%)  1
Trichophytosis  1  1/89 (1.12%)  1
Upper respiratory tract infection  1  1/89 (1.12%)  1
Tonsillitis  1  1/89 (1.12%)  1
Helicobacter infection  1  1/89 (1.12%)  1
Sinusitis  1  1/89 (1.12%)  1
Injury, poisoning and procedural complications   
Contusion  1  3/89 (3.37%)  3
Ankle fracture  1  1/89 (1.12%)  1
Fall  1  1/89 (1.12%)  1
Ligament sprain  1  2/89 (2.25%)  2
Procedural pain  1  1/89 (1.12%)  1
Tooth fracture  1  1/89 (1.12%)  1
Laceration  1  1/89 (1.12%)  1
Foot Fracture  1  1/89 (1.12%)  1
Investigations   
Blood creatine phosphokinase increased  1  4/89 (4.49%)  4
Weight increased  1  2/89 (2.25%)  2
Blood cholesterol increased  1  1/89 (1.12%)  1
Blood lactate dehydrogenase increased  1  1/89 (1.12%)  1
Blood uric acid increased  1  1/89 (1.12%)  1
Electrocardiogram QT prolonged  1  1/89 (1.12%)  1
Hepatic enzyme increased  1  1/89 (1.12%)  1
Liver function test increased  1  1/89 (1.12%)  1
Metabolism and nutrition disorders   
Decreased appetite  1  1/89 (1.12%)  1
Hyperkalaemia  1  1/89 (1.12%)  1
Hyperlipidaemia  1  1/89 (1.12%)  1
Musculoskeletal and connective tissue disorders   
Back pain  1  2/89 (2.25%)  2
Intervertebral disc protrusion  1  1/89 (1.12%)  1
Muscle spasms  1  1/89 (1.12%)  1
Musculoskeletal pain  1  1/89 (1.12%)  1
Musculoskeletal stiffness  1  1/89 (1.12%)  1
Neck pain  1  1/89 (1.12%)  1
Spinal osteoarthritis  1  1/89 (1.12%)  1
Tenosynovitis  1  1/89 (1.12%)  1
Nervous system disorders   
Dizziness  1  32/89 (35.96%)  37
Somnolence  1  12/89 (13.48%)  13
Headache  1  10/89 (11.24%)  11
Epilepsy  1  4/89 (4.49%)  4
Amnesia  1  2/89 (2.25%)  2
Hypersomnia  1  2/89 (2.25%)  2
Aphasia  1  1/89 (1.12%)  1
Disturbance in attention  1  1/89 (1.12%)  2
Dysarthria  1  1/89 (1.12%)  1
Head discomfort  1  1/89 (1.12%)  1
Memory impairment  1  1/89 (1.12%)  1
Nervous system disorder  1  1/89 (1.12%)  1
Paraesthesia  1  1/89 (1.12%)  1
Postictal headache  1  1/89 (1.12%)  4
Syncope  1  1/89 (1.12%)  1
Tension headache  1  1/89 (1.12%)  1
seizure  1  1/89 (1.12%)  1
Psychiatric disorders   
Irritability  1  3/89 (3.37%)  3
Anxiety  1  2/89 (2.25%)  2
Affect lability  1  1/89 (1.12%)  1
Depressed mood  1  1/89 (1.12%)  1
Depression  1  1/89 (1.12%)  1
Emotional disorder  1  2/89 (2.25%)  2
Insomnia  1  1/89 (1.12%)  2
Reproductive system and breast disorders   
Dysmenorrhoea  1  1/89 (1.12%)  1
Respiratory, thoracic and mediastinal disorders   
Epistaxis  1  2/89 (2.25%)  3
Asthma  1  1/89 (1.12%)  1
Cough  1  1/89 (1.12%)  1
Dyspnoea  1  1/89 (1.12%)  1
Nasal congestion  1  1/89 (1.12%)  1
Rhinorrhoea  1  1/89 (1.12%)  2
Rhinitis allergic  1  1/89 (1.12%)  1
Skin and subcutaneous tissue disorders   
Acne  1  1/89 (1.12%)  1
Photosensitivity reaction  1  1/89 (1.12%)  1
Psoriasis  1  1/89 (1.12%)  1
Surgical and medical procedures   
Tooth extraction  1  1/89 (1.12%)  1
Vascular disorders   
Haemorrhage  1  1/89 (1.12%)  1
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Inquiry Service.
Organization: Eisai, Inc.
EMail: eisai-chiken_hotline@hhc.eisai.co.jp
Layout table for additonal information
Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT03201900    
Other Study ID Numbers: E2007-J000-342
First Submitted: June 27, 2017
First Posted: June 28, 2017
Results First Submitted: February 11, 2020
Results First Posted: February 25, 2020
Last Update Posted: May 12, 2020