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Trial record 8 of 104 for:    lewy dementia

A Double-blind Study of E2020 (Donepezil Hydrochloride) in Patients With Dementia With Lewy Bodies (DLB) (Study E2020-J081-431)

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: NCT00543855
Recruitment Status : Completed
First Posted : October 15, 2007
Results First Posted : February 18, 2013
Last Update Posted : March 8, 2013
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Dementia With Lewy Bodies (DLB)
Interventions Drug: 3 mg Donepezil hydrochloride
Drug: 5 mg Donepezil hydrochloride
Drug: 10 mg Donepezil hydrochloride
Drug: Placebo
Enrollment 167
Recruitment Details  
Pre-assignment Details 167 participants initiated the Observation period, 140 participants were enrolled in the treatment period, one participant did not receive treatment.
Arm/Group Title 3 mg Donepezil Hydrochloride 5 mg Donepezil Hydrochloride 10 mg Donepezil Hydrochloride Placebo
Hide Arm/Group Description

E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.

Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.

E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.

Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).

Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks).

E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.

Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).

Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).

Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43 - Day 84 (6 weeks).

Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.

Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.

Period Title: Overall Study
Started 35 33 37 34
Completed 31 31 31 30
Not Completed 4 2 6 4
Reason Not Completed
Adverse Event             3             1             3             4
Lost to Follow-up             0             0             1             0
Withdrawal by Subject             0             1             2             0
Protocol Violation             1             0             0             0
Arm/Group Title 3 mg Donepezil Hydrochloride 5 mg Donepezil Hydrochloride 10 mg Donepezil Hydrochloride Placebo Total
Hide Arm/Group Description

E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.

Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.

E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.

Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).

Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks).

E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.

Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).

Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).

Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43- Day 84 (6 weeks).

Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.

Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.

Total of all reporting groups
Overall Number of Baseline Participants 35 33 37 34 139
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants 33 participants 37 participants 34 participants 139 participants
79.6  (4.5) 77.9  (6.7) 78.4  (6.1) 78.7  (4.9) 78.7  (5.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 33 participants 37 participants 34 participants 139 participants
Female
18
  51.4%
16
  48.5%
33
  89.2%
23
  67.6%
90
  64.7%
Male
17
  48.6%
17
  51.5%
4
  10.8%
11
  32.4%
49
  35.3%
1.Primary Outcome
Title Cognitive Function: Change From Baseline in Mini-mental State Examination (MMSE) Total at Week 12 Last Observation Carried Forward (LOCF)
Hide Description MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, where a higher score indicated better cognitive state. Change: mean score at Week 12 LOCF minus mean score at baseline. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method.
Time Frame Baseline and every 4 weeks up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Set (PPS) was defined as those participants who complied with the study protocol.
Arm/Group Title 3 mg Donepezil Hydrochloride 5 mg Donepezil Hydrochloride 10 mg Donepezil Hydrochloride Placebo
Hide Arm/Group Description:

E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.

Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.

E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.

Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).

Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks).

E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.

Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).

Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).

Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43- Day 84 (6 weeks).

Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.

Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.

Overall Number of Participants Analyzed 33 31 33 30
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Baseline 20.1  (4.2) 19.7  (4.4) 19.7  (4.5) 18.2  (4.8)
Change from Baseline (LOCF) 1.2  (3.8) 3.5  (3.2) 2.3  (3.2) -0.6  (2.7)
2.Primary Outcome
Title Psychiatric Symptoms: Change From Baseline in Neuropsychiatric Inventory (NPI) Total at Week 12 Last Observation Carried Forward (LOCF)
Hide Description NPI measured 10 different domains of psychiatric symptoms including delusion and hallucination. Each domain is scored for: present or absent, frequency, and severity. The score derived from sub-scores; total ranged from "0" to "120," higher score indicated "worse neuropsychiatric outcomes." Change: mean score at Week 12 LOCF minus mean score at baseline. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method.
Time Frame Baseline and every 4 weeks up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Set (PPS) was defined as those participants who complied with the study protocol.
Arm/Group Title 3 mg Donepezil Hydrochloride 5 mg Donepezil Hydrochloride 10 mg Donepezil Hydrochloride Placebo
Hide Arm/Group Description:

E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.

Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.

E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.

Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).

Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks).

E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.

Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).

Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).

Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43- Day 84 (6 weeks).

Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.

Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.

Overall Number of Participants Analyzed 33 31 33 30
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Baseline 20.9  (13.1) 14.2  (8.4) 19.1  (11.8) 18.4  (8.9)
Change from Baseline (LOCF) -4.3  (21.5) -5.9  (6.5) -10.2  (12.0) -3.1  (10.9)
3.Primary Outcome
Title Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF)
Hide Description CIBIC plus is a clinician's interview-based impression of change plus the caregiver's input. It is a seven-point categorical assessment scale for evaluating global clinical function, ranging from "markedly improved” to “markedly worse”. Percentage of participants in each category were reported. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method.
Time Frame Baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Set (PPS) was defined as those participants who complied with the study protocol.
Arm/Group Title 3 mg Donepezil Hydrochloride 5 mg Donepezil Hydrochloride 10 mg Donepezil Hydrochloride Placebo
Hide Arm/Group Description:

E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.

Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.

E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.

Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).

Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks).

E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.

Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).

Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).

Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43- Day 84 (6 weeks).

Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.

Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.

Overall Number of Participants Analyzed 33 31 33 30
Measure Type: Number
Unit of Measure: Percentage of Participants
Marked improvement 3.6 17.9 3.8 0
Moderate Improvement 17.9 17.9 11.5 3.7
Minimal Improvement 50.0 35.7 50.0 29.6
No Change 21.4 14.3 30.8 18.5
Minimal Worsening 3.6 7.1 3.8 37.0
Moderate Worsening 0 7.1 0 11.1
Marked Worsening 3.6 0 0 0
4.Primary Outcome
Title Burden on Caregiver: Change From Baseline in J-ZBI (Japanese- Zarit Caregiver Burden Interview) Total at Week 12 Last Observation Carried Forward (LOCF)
Hide Description

J-ZBI is a Japanese version instrument to measure and assess the level of burden experienced by the principal caregivers of participants with dementia.

ZBI contains 22 items, in which each statement is scored by the caregiver using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). Total score derived from sub-scores; total ranged from 0-88. Higher scores indicate greater burden. Change: mean score at Week 12 LOCF minus mean score at baseline. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method.

Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Set (PPS) was defined as those participants who complied with the study protocol.
Arm/Group Title 3 mg Donepezil Hydrochloride 5 mg Donepezil Hydrochloride 10 mg Donepezil Hydrochloride Placebo
Hide Arm/Group Description:

E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.

Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.

E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.

Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).

Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks).

E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.

Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).

Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).

Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43- Day 84 (6 weeks).

Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.

Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.

Overall Number of Participants Analyzed 33 31 33 30
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Baseline 28.3  (14.4) 23.2  (11.6) 26.9  (16.3) 22.3  (9.8)
Change from Baseline (LOCF) -1.3  (11.1) -0.6  (16.4) -5.2  (13.8) 2.9  (9.1)
Time Frame [Not Specified]
Adverse Event Reporting Description Safety Analysis Set (SAS) was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety evaluation.
 
Arm/Group Title 3 mg Donepezil Hydrochloride 5 mg Donepezil Hydrochloride 10 mg Donepezil Hydrochloride Placebo
Hide Arm/Group Description

E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.

Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.

E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.

Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).

Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks).

E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.

Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).

Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).

Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43- Day 84 (6 weeks).

Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.

Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.

All-Cause Mortality
3 mg Donepezil Hydrochloride 5 mg Donepezil Hydrochloride 10 mg Donepezil Hydrochloride Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
3 mg Donepezil Hydrochloride 5 mg Donepezil Hydrochloride 10 mg Donepezil Hydrochloride Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/35 (5.71%)   2/33 (6.06%)   4/37 (10.81%)   2/34 (5.88%) 
Gastrointestinal disorders         
Inguinal Hernia  0/35 (0.00%)  1/33 (3.03%)  0/37 (0.00%)  0/34 (0.00%) 
Infections and infestations         
Pyelonephritis  0/35 (0.00%)  0/33 (0.00%)  1/37 (2.70%)  0/34 (0.00%) 
Injury, poisoning and procedural complications         
Femur Fracture  0/35 (0.00%)  0/33 (0.00%)  1/37 (2.70%)  0/34 (0.00%) 
Pelvic Fracture  0/35 (0.00%)  0/33 (0.00%)  0/37 (0.00%)  1/34 (2.94%) 
Musculoskeletal and connective tissue disorders         
Back Pain  0/35 (0.00%)  0/33 (0.00%)  1/37 (2.70%)  0/34 (0.00%) 
Nervous system disorders         
Cerebral Infarction  1/35 (2.86%)  0/33 (0.00%)  0/37 (0.00%)  0/34 (0.00%) 
Diabetic Neuropathy  0/35 (0.00%)  0/33 (0.00%)  0/37 (0.00%)  1/34 (2.94%) 
Paraparesis  0/35 (0.00%)  1/33 (3.03%)  0/37 (0.00%)  0/34 (0.00%) 
Subarachnoid Haemorrhage  1/35 (2.86%)  0/33 (0.00%)  0/37 (0.00%)  0/34 (0.00%) 
Psychiatric disorders         
Hallucination  1/35 (2.86%)  0/33 (0.00%)  1/37 (2.70%)  0/34 (0.00%) 
Restlessness  0/35 (0.00%)  0/33 (0.00%)  0/37 (0.00%)  1/34 (2.94%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
3 mg Donepezil Hydrochloride 5 mg Donepezil Hydrochloride 10 mg Donepezil Hydrochloride Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   24/35 (68.57%)   27/33 (81.82%)   32/37 (86.49%)   24/34 (70.59%) 
Gastrointestinal disorders         
Diarrhoea  0/35 (0.00%)  4/33 (12.12%)  3/37 (8.11%)  4/34 (11.76%) 
Constipation  0/35 (0.00%)  3/33 (9.09%)  1/37 (2.70%)  1/34 (2.94%) 
Dental Caries  1/35 (2.86%)  2/33 (6.06%)  0/37 (0.00%)  1/34 (2.94%) 
Abdominal Discomfort  0/35 (0.00%)  2/33 (6.06%)  0/37 (0.00%)  1/34 (2.94%) 
Nausea  0/35 (0.00%)  0/33 (0.00%)  2/37 (5.41%)  1/34 (2.94%) 
General disorders         
Malaise  0/35 (0.00%)  2/33 (6.06%)  0/37 (0.00%)  0/34 (0.00%) 
Infections and infestations         
Nasopharyngitis  3/35 (8.57%)  2/33 (6.06%)  4/37 (10.81%)  1/34 (2.94%) 
Gastroenteritis  0/35 (0.00%)  0/33 (0.00%)  3/37 (8.11%)  0/34 (0.00%) 
Injury, poisoning and procedural complications         
Contusion  2/35 (5.71%)  2/33 (6.06%)  1/37 (2.70%)  1/34 (2.94%) 
Fall  0/35 (0.00%)  1/33 (3.03%)  2/37 (5.41%)  0/34 (0.00%) 
Investigations         
Blood Creatine Phosphokinase Increased  5/35 (14.29%)  3/33 (9.09%)  5/37 (13.51%)  2/34 (5.88%) 
Blood Pressure Increased  5/35 (14.29%)  2/33 (6.06%)  2/37 (5.41%)  1/34 (2.94%) 
Blood Urine Present  0/35 (0.00%)  2/33 (6.06%)  4/37 (10.81%)  3/34 (8.82%) 
Blood Triglycerides Increased  2/35 (5.71%)  1/33 (3.03%)  0/37 (0.00%)  3/34 (8.82%) 
Glucose Urine Present  0/35 (0.00%)  1/33 (3.03%)  3/37 (8.11%)  1/34 (2.94%) 
White Blood Cell Count Decreased  0/35 (0.00%)  0/33 (0.00%)  4/37 (10.81%)  1/34 (2.94%) 
Blood Urea Increased  1/35 (2.86%)  0/33 (0.00%)  1/37 (2.70%)  2/34 (5.88%) 
Blood Alkaline Phosphatase Increased  0/35 (0.00%)  0/33 (0.00%)  1/37 (2.70%)  3/34 (8.82%) 
Electrocardiogram QT Prolonged  0/35 (0.00%)  1/33 (3.03%)  0/37 (0.00%)  2/34 (5.88%) 
Protein Urine Present  0/35 (0.00%)  2/33 (6.06%)  0/37 (0.00%)  0/34 (0.00%) 
Metabolism and nutrition disorders         
Diabetes Mellitus  0/35 (0.00%)  2/33 (6.06%)  1/37 (2.70%)  0/34 (0.00%) 
Decreased Appetite  1/35 (2.86%)  0/33 (0.00%)  2/37 (5.41%)  0/34 (0.00%) 
Musculoskeletal and connective tissue disorders         
Back Pain  2/35 (5.71%)  1/33 (3.03%)  2/37 (5.41%)  3/34 (8.82%) 
Arthralgia  0/35 (0.00%)  0/33 (0.00%)  0/37 (0.00%)  2/34 (5.88%) 
Nervous system disorders         
Parkinsonism  1/35 (2.86%)  2/33 (6.06%)  1/37 (2.70%)  0/34 (0.00%) 
Psychiatric disorders         
Poriomania  2/35 (5.71%)  0/33 (0.00%)  0/37 (0.00%)  0/34 (0.00%) 
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: Masaki Nakagawa, Study Director
Organization: Eisai Co., Ltd.
Phone: +81-3-3817-5245
Layout table for additonal information
Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT00543855     History of Changes
Other Study ID Numbers: E2020-J081-431
First Submitted: October 4, 2007
First Posted: October 15, 2007
Results First Submitted: January 16, 2013
Results First Posted: February 18, 2013
Last Update Posted: March 8, 2013