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Trial record 90 of 146 for:    epilepsy AND Bethesda

This Trial, Evaluating the Long-term Safety and Tolerability of Brivaracetam Will Provide Subjects Suffering From Epilepsy, Who May Have Benefited From Brivaracetam as Adjunctive Treatment, the Opportunity to Receive Open Label Brivaracetam Treatment

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: NCT00150800
Recruitment Status : Completed
First Posted : September 8, 2005
Results First Posted : December 5, 2018
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB PHARMA Inc. (US) )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Epilepsy
Intervention Drug: Brivaracetam
Enrollment 668
Recruitment Details The study started to enroll patients in January 2006 and concluded in September 2017. 668 subjects were included in the Enrolled Set but 1 subject from India lost to follow up and was excluded from the Safety Analysis Set due to lack of medical data.
Pre-assignment Details The Participant Flow refers to the Safety Analysis Set which included all subjects who took at least 1 dose of study drug.
Arm/Group Title Brivaracetam
Hide Arm/Group Description Brivaracetam (BRV) used as adjunctive treatment, flexible dosing up to 200 mg /day in b.i.d (twice daily) administration. Dose increase or decrease can be made in increments of maximum 50 mg /day on a weekly basis.
Period Title: Overall Study
Started 667
Completed 171
Not Completed 496
Reason Not Completed
Adverse Event             89
Death             18
Lack of Efficacy             166
Lost to Follow-up             58
Subject's choice             90
No compliance             18
IP misshandling             1
Site closure             24
Protocol non-adherence             2
Nobody to accompany patient             1
Distance too long for patient             1
Neurosurgery             2
BRV monotherapy             1
Visit refusal             3
Sponsor's request             2
Generalized Epilepsy             1
Moved from area/country             8
PI retiring             2
PI leaving site             2
Patient insurance             1
Surgical intervention             4
Pregnancy planned             1
PI discontinuation request             1
Arm/Group Title Brivaracetam
Hide Arm/Group Description Brivaracetam (BRV) used as adjunctive treatment, flexible dosing up to 200 mg /day in b.i.d (twice daily) administration. Dose increase or decrease can be made in increments of maximum 50 mg /day on a weekly basis.
Overall Number of Baseline Participants 667
Hide Baseline Analysis Population Description
The Baseline Characteristics refers to the Safety Analysis Set which included all subjects who took at least 1 dose of study drug.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 667 participants
<=18 years
30
   4.5%
Between 18 and 65 years
632
  94.8%
>=65 years
5
   0.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 667 participants
34.3  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 667 participants
Female
303
  45.4%
Male
364
  54.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 667 participants
American Indian/Alaskan Native
21
   3.1%
Asian
206
  30.9%
Black
18
   2.7%
Native Hawaiian Or Other Pacific Islander
1
   0.1%
White
361
  54.1%
Other/Mixed
60
   9.0%
1.Primary Outcome
Title Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) During the Study Period
Hide Description Treatment-Emergent Adverse Events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
Time Frame Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set consisted of all subjects who took at least 1 dose of study drug.
Arm/Group Title Brivaracetam (SS)
Hide Arm/Group Description:
Brivaracetam (BRV) used as adjunctive treatment, flexible dosing up to 200 mg /day in b.i.d (twice daily) administration. Dose increase or decrease can be made in increments of maximum 50 mg /day on a weekly basis.
Overall Number of Participants Analyzed 667
Measure Type: Number
Unit of Measure: percentage of participants
91.2
2.Primary Outcome
Title Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study Period
Hide Description Adverse Events (AE) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
Time Frame Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set consisted of all subjects who took at least 1 dose of study drug.
Arm/Group Title Brivaracetam (SS)
Hide Arm/Group Description:
Brivaracetam (BRV) used as adjunctive treatment, flexible dosing up to 200 mg /day in b.i.d (twice daily) administration. Dose increase or decrease can be made in increments of maximum 50 mg /day on a weekly basis.
Overall Number of Participants Analyzed 667
Measure Type: Number
Unit of Measure: percentage of participants
14.8
3.Primary Outcome
Title Percentage of Participants With a Serious Adverse Event (SAE) During the Study Period
Hide Description A Serious Adverse Event (SAE) is any untoward medical incidence that occurs at any dose.
Time Frame Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set consisted of all subjects who took at least 1 dose of study drug.
Arm/Group Title Brivaracetam (SS)
Hide Arm/Group Description:
Brivaracetam (BRV) used as adjunctive treatment, flexible dosing up to 200 mg /day in b.i.d (twice daily) administration. Dose increase or decrease can be made in increments of maximum 50 mg /day on a weekly basis.
Overall Number of Participants Analyzed 667
Measure Type: Number
Unit of Measure: percentage of participants
22.8
4.Secondary Outcome
Title Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period
Hide Description

Baseline is the Baseline from subject's previous study of enrollment period. N01193 [NCT00175825], N01252 [NCT00490035], N01253 [NCT00464269], N01254 [NCT00504881].

A 28 day Type 1 seizure frequency is the total number of Type 1 seizures divided by the total number of days evaluated multiplied by 28.

Time Frame From Baseline of the previous study to the Evaluation Period (up to 11 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Partial Onset Seizure (POS) Efficacy Analysis Set consisted of all subjects with POS who took at least 1 dose of study drug and had at least 1 seizure diary day during the Evaluation Period.
Arm/Group Title Brivaracetam (POS-ES)
Hide Arm/Group Description:
Brivaracetam (BRV) used as adjunctive treatment, flexible dosing up to 200 mg /day in b.i.d (twice daily) administration. Dose increase or decrease can be made in increments of maximum 50 mg /day on a weekly basis.
Overall Number of Participants Analyzed 648
Median (Inter-Quartile Range)
Unit of Measure: Seizures per 28 days
baseline
9.2
(5.5 to 20.2)
on treatment
4.2
(1.6 to 11.3)
5.Secondary Outcome
Title Percent Change in Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days From Baseline of the Previous Study to the Evaluation Period
Hide Description

The percent change from the previous study baselines, in Partial Onset Seizure (POS) (Type I) frequency per 28 days is defined as:

(the value at the previous study baselines) minus (the value at each time-points during the evaluation period) divided by the value at the previous study baselines.

Time Frame From Baseline of the previous study to the Evaluation Period (up to 11 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Partial Onset Seizures (POS) Efficacy Analysis Set consisted of all subjects with POS who took at least 1 dose of study drug and had at least 1 seizure diary day during the Evaluation Period.
Arm/Group Title Brivaracetam (POS-ES)
Hide Arm/Group Description:
Brivaracetam (BRV) used as adjunctive treatment, flexible dosing up to 200 mg /day in b.i.d (twice daily) administration. Dose increase or decrease can be made in increments of maximum 50 mg /day on a weekly basis.
Overall Number of Participants Analyzed 648
Median (Inter-Quartile Range)
Unit of Measure: percent change
57.3
(18.6 to 82.2)
6.Secondary Outcome
Title Percentage of Participants With Response for Partial Onset Seizure (POS) (Type I) Frequency Over the Evaluation Period
Hide Description A responder is defined as a subject with a higher than or equal to (>=) 50 % change in seizure frequency from Baseline period of the previous study.
Time Frame From Baseline of the previous study to the Evaluation Period (up to 11 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Partial Onset Seizures (POS) Efficacy Analysis Set consisted of all subjects with POS who took at least 1 dose of study drug and had at least 1 seizure diary day during the Evaluation Period.
Arm/Group Title Brivaracetam (POS-ES)
Hide Arm/Group Description:
Brivaracetam (BRV) used as adjunctive treatment, flexible dosing up to 200 mg /day in b.i.d (twice daily) administration. Dose increase or decrease can be made in increments of maximum 50 mg /day on a weekly basis.
Overall Number of Participants Analyzed 648
Measure Type: Number
Unit of Measure: percentage of participants
55.6
Time Frame Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Brivaracetam
Hide Arm/Group Description Brivaracetam (BRV) used as adjunctive treatment, flexible dosing up to 200 mg /day in b.i.d (twice daily) administration. Dose increase or decrease can be made in increments of maximum 50 mg /day on a weekly basis.
All-Cause Mortality
Brivaracetam
Affected / at Risk (%)
Total   18/667 (2.70%)    
Show Serious Adverse Events Hide Serious Adverse Events
Brivaracetam
Affected / at Risk (%) # Events
Total   152/667 (22.79%)    
Blood and lymphatic system disorders   
Anaemia * 1  1/667 (0.15%)  1
Lymphadenopathy * 1  1/667 (0.15%)  1
Cardiac disorders   
Angina unstable * 1  2/667 (0.30%)  2
Bradycardia * 1  1/667 (0.15%)  1
Myocardial infarction * 1  3/667 (0.45%)  3
Myocardial ischaemia * 1  1/667 (0.15%)  2
Supraventricular tachycardia * 1  1/667 (0.15%)  1
Ear and labyrinth disorders   
Vertigo * 1  1/667 (0.15%)  1
Gastrointestinal disorders   
Abdominal pain * 1  1/667 (0.15%)  1
Abdominal pain upper * 1  1/667 (0.15%)  1
Constipation * 1  1/667 (0.15%)  1
Gastric fistula * 1  1/667 (0.15%)  1
Gastrooesophageal reflux disease * 1  1/667 (0.15%)  1
Haemorrhoids * 1  2/667 (0.30%)  2
Intestinal obstruction * 1  1/667 (0.15%)  1
Intestinal perforation * 1  1/667 (0.15%)  1
Rectal haemorrhage * 1  1/667 (0.15%)  1
Splenic artery aneurysm * 1  1/667 (0.15%)  1
Vomiting * 1  2/667 (0.30%)  2
General disorders   
Chest pain * 1  2/667 (0.30%)  3
Drug ineffective * 1  1/667 (0.15%)  2
Multi-organ failure * 1  1/667 (0.15%)  1
Non-cardiac chest pain * 1  1/667 (0.15%)  2
Pyrexia * 1  2/667 (0.30%)  2
Sudden unexplained death in epilepsy * 1  2/667 (0.30%)  2
Unevaluable event * 1  3/667 (0.45%)  3
Hepatobiliary disorders   
Cholecystitis acute * 1  1/667 (0.15%)  1
Infections and infestations   
Appendicitis * 1  1/667 (0.15%)  1
Cellulitis * 1  2/667 (0.30%)  3
Cellulitis staphylococcal * 1  1/667 (0.15%)  1
Coccidioidomycosis * 1  1/667 (0.15%)  1
Dengue fever * 1  2/667 (0.30%)  2
Disseminated tuberculosis * 1  1/667 (0.15%)  1
Encephalitis herpes * 1  1/667 (0.15%)  1
Escherichia sepsis * 1  1/667 (0.15%)  1
Gastroenteritis * 1  1/667 (0.15%)  1
Gastroenteritis viral * 1  1/667 (0.15%)  1
Lobar pneumonia * 1  1/667 (0.15%)  1
Lung infection * 1  1/667 (0.15%)  1
Malaria * 1  1/667 (0.15%)  1
Mastoiditis * 1  1/667 (0.15%)  1
Meningitis tuberculous * 1  1/667 (0.15%)  3
Neurocysticercosis * 1  1/667 (0.15%)  1
Osteomyelitis * 1  1/667 (0.15%)  1
Pelvic inflammatory disease * 1  1/667 (0.15%)  1
Periorbital cellulitis * 1  1/667 (0.15%)  1
Pneumonia * 1  7/667 (1.05%)  9
Pyelonephritis * 1  1/667 (0.15%)  1
Rickettsiosis * 1  1/667 (0.15%)  1
Sepsis * 1  1/667 (0.15%)  1
Tooth abscess * 1  1/667 (0.15%)  1
Urinary tract infection * 1  3/667 (0.45%)  3
Viral infection * 1  1/667 (0.15%)  1
Injury, poisoning and procedural complications   
Abdominal injury * 1  1/667 (0.15%)  1
Accident * 1  1/667 (0.15%)  1
Anastomotic ulcer * 1  1/667 (0.15%)  1
Animal bite * 1  1/667 (0.15%)  1
Ankle fracture * 1  3/667 (0.45%)  3
Brain contusion * 1  1/667 (0.15%)  1
Burns third degree * 1  1/667 (0.15%)  1
Comminuted fracture * 1  1/667 (0.15%)  1
Craniocerebral injury * 1  3/667 (0.45%)  3
Fall * 1  3/667 (0.45%)  3
Femur fracture * 1  1/667 (0.15%)  1
Foot fracture * 1  1/667 (0.15%)  1
Hip fracture * 1  1/667 (0.15%)  2
Humerus fracture * 1  2/667 (0.30%)  2
Ligament sprain * 1  1/667 (0.15%)  1
Post procedural haematoma * 1  1/667 (0.15%)  1
Procedural hypotension * 1  1/667 (0.15%)  1
Radius fracture * 1  1/667 (0.15%)  1
Subdural haematoma * 1  1/667 (0.15%)  1
Subdural haemorrhage * 1  1/667 (0.15%)  1
Tendon rupture * 1  1/667 (0.15%)  1
Thermal burn * 1  2/667 (0.30%)  2
Toxicity to various agents * 1  4/667 (0.60%)  4
Ulna fracture * 1  2/667 (0.30%)  2
Upper limb fracture * 1  1/667 (0.15%)  2
Wrist fracture * 1  1/667 (0.15%)  1
Investigations   
Anticonvulsant drug level increased * 1  1/667 (0.15%)  1
Weight decreased * 1  1/667 (0.15%)  1
Weight increased * 1  1/667 (0.15%)  1
Metabolism and nutrition disorders   
Decreased appetite * 1  1/667 (0.15%)  1
Dehydration * 1  1/667 (0.15%)  1
Hyperammonaemia * 1  1/667 (0.15%)  1
Hypokalaemia * 1  1/667 (0.15%)  1
Hyponatraemia * 1  2/667 (0.30%)  3
Hypoproteinaemia * 1  1/667 (0.15%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  1/667 (0.15%)  1
Back pain * 1  1/667 (0.15%)  1
Intervertebral disc degeneration * 1  1/667 (0.15%)  1
Joint instability * 1  1/667 (0.15%)  1
Osteoarthritis * 1  1/667 (0.15%)  1
Osteonecrosis * 1  1/667 (0.15%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Brain cancer metastatic * 1  1/667 (0.15%)  1
Brain neoplasm * 1  1/667 (0.15%)  1
Colon cancer metastatic * 1  1/667 (0.15%)  1
Gastrointestinal tract adenoma * 1  1/667 (0.15%)  1
Lipoma * 1  1/667 (0.15%)  1
Lung adenocarcinoma metastatic * 1  1/667 (0.15%)  1
Malignant pleural effusion * 1  1/667 (0.15%)  1
Metastatic bronchial carcinoma * 1  1/667 (0.15%)  1
Non-small cell lung cancer * 1  1/667 (0.15%)  1
Ocular neoplasm * 1  1/667 (0.15%)  1
Oesophageal cancer metastatic * 1  1/667 (0.15%)  1
Ovarian epithelial cancer * 1  1/667 (0.15%)  1
Ovarian germ cell teratoma benign * 1  1/667 (0.15%)  1
Prostate cancer * 1  1/667 (0.15%)  1
Renal cell carcinoma * 1  1/667 (0.15%)  1
Small cell lung cancer stage unspecified * 1  1/667 (0.15%)  1
Small intestine carcinoma metastatic * 1  1/667 (0.15%)  1
Thyroid cancer * 1  1/667 (0.15%)  1
Uterine leiomyoma * 1  3/667 (0.45%)  3
Nervous system disorders   
Ataxia * 1  2/667 (0.30%)  2
Central nervous system lesion * 1  1/667 (0.15%)  1
Cerebral infarction * 1  2/667 (0.30%)  2
Cerebrovascular accident * 1  3/667 (0.45%)  3
Complicated migraine * 1  1/667 (0.15%)  1
Convulsion * 1  15/667 (2.25%)  20
Dizziness * 1  1/667 (0.15%)  1
Epilepsy * 1  1/667 (0.15%)  1
Grand mal convulsion * 1  2/667 (0.30%)  2
Headache * 1  1/667 (0.15%)  1
Hemiparesis * 1  1/667 (0.15%)  1
Metabolic encephalopathy * 1  1/667 (0.15%)  1
Partial seizures * 1  2/667 (0.30%)  2
Postictal state * 1  2/667 (0.30%)  2
Seizure cluster * 1  1/667 (0.15%)  2
Somnolence * 1  2/667 (0.30%)  2
Status epilepticus * 1  6/667 (0.90%)  7
Transient ischaemic attack * 1  4/667 (0.60%)  4
Pregnancy, puerperium and perinatal conditions   
Abortion * 1  1/667 (0.15%)  1
Abortion spontaneous * 1  2/667 (0.30%)  2
Foetal death * 1  2/667 (0.30%)  2
Pregnancy * 1  5/667 (0.75%)  5
Pregnancy on contraceptive * 1  2/667 (0.30%)  2
Pregnancy on oral contraceptive * 1  1/667 (0.15%)  1
Unintended pregnancy * 1  1/667 (0.15%)  1
Psychiatric disorders   
Abnormal behaviour * 1  1/667 (0.15%)  1
Aggression * 1  2/667 (0.30%)  2
Completed suicide * 1  2/667 (0.30%)  2
Depression * 1  1/667 (0.15%)  1
Hallucination * 1  1/667 (0.15%)  1
Major depression * 1  1/667 (0.15%)  1
Paranoia * 1  1/667 (0.15%)  1
Psychotic disorder * 1  1/667 (0.15%)  1
Schizophrenia * 1  1/667 (0.15%)  1
Self-injurious ideation * 1  1/667 (0.15%)  1
Suicidal ideation * 1  2/667 (0.30%)  2
Suicide attempt * 1  7/667 (1.05%)  8
Renal and urinary disorders   
Calculus ureteric * 1  1/667 (0.15%)  1
Calculus urinary * 1  1/667 (0.15%)  1
Hydronephrosis * 1  1/667 (0.15%)  1
Renal failure * 1  1/667 (0.15%)  1
Renal failure acute * 1  1/667 (0.15%)  1
Reproductive system and breast disorders   
Benign prostatic hyperplasia * 1  1/667 (0.15%)  1
Dysfunctional uterine bleeding * 1  1/667 (0.15%)  1
Menorrhagia * 1  2/667 (0.30%)  2
Ovarian cyst * 1  1/667 (0.15%)  1
Scrotal disorder * 1  1/667 (0.15%)  1
Respiratory, thoracic and mediastinal disorders   
Asphyxia * 1  1/667 (0.15%)  1
Asthma * 1  1/667 (0.15%)  1
Dyspnoea * 1  2/667 (0.30%)  2
Dyspnoea exertional * 1  1/667 (0.15%)  1
Hypoxia * 1  1/667 (0.15%)  1
Lung infiltration * 1  1/667 (0.15%)  1
Pneumonia aspiration * 1  3/667 (0.45%)  3
Pneumothorax * 1  1/667 (0.15%)  1
Pulmonary congestion * 1  1/667 (0.15%)  1
Pulmonary embolism * 1  2/667 (0.30%)  2
Respiratory failure * 1  2/667 (0.30%)  2
Surgical and medical procedures   
Abortion induced * 1  2/667 (0.30%)  2
Vascular disorders   
Hypertension * 1  2/667 (0.30%)  2
1
Term from vocabulary, MedDRA15.0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Brivaracetam
Affected / at Risk (%) # Events
Total   521/667 (78.11%)    
Gastrointestinal disorders   
Nausea * 1  67/667 (10.04%)  93
Diarrhoea * 1  65/667 (9.75%)  86
Vomiting * 1  58/667 (8.70%)  109
Toothache * 1  42/667 (6.30%)  66
Abdominal pain * 1  39/667 (5.85%)  55
Constipation * 1  38/667 (5.70%)  48
General disorders   
Pyrexia * 1  69/667 (10.34%)  132
Fatigue * 1  51/667 (7.65%)  63
Irritability * 1  42/667 (6.30%)  50
Infections and infestations   
Nasopharyngitis * 1  94/667 (14.09%)  154
Influenza * 1  84/667 (12.59%)  177
Upper respiratory tract infection * 1  76/667 (11.39%)  137
Urinary tract infection * 1  64/667 (9.60%)  150
Injury, poisoning and procedural complications   
Fall * 1  40/667 (6.00%)  72
Contusion * 1  34/667 (5.10%)  68
Laceration * 1  34/667 (5.10%)  65
Metabolism and nutrition disorders   
Decreased appetite * 1  36/667 (5.40%)  41
Musculoskeletal and connective tissue disorders   
Back pain * 1  64/667 (9.60%)  88
Arthralgia * 1  52/667 (7.80%)  66
Pain in extremity  1  44/667 (6.60%)  63
Nervous system disorders   
Headache * 1  165/667 (24.74%)  420
Dizziness * 1  142/667 (21.29%)  254
Somnolence * 1  91/667 (13.64%)  116
Convulsion * 1  70/667 (10.49%)  99
Tremor * 1  38/667 (5.70%)  48
Psychiatric disorders   
Depression * 1  70/667 (10.49%)  85
Insomnia * 1  49/667 (7.35%)  65
Anxiety * 1  45/667 (6.75%)  65
Respiratory, thoracic and mediastinal disorders   
Cough * 1  46/667 (6.90%)  69
Skin and subcutaneous tissue disorders   
Rash * 1  34/667 (5.10%)  56
Vascular disorders   
Hypertension * 1  46/667 (6.90%)  55
1
Term from vocabulary, MedDRA15.0
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB
Organization: Cares
Phone: +1844 599 ext 2273
EMail: UCBCares@ucb.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB PHARMA Inc. (US) )
ClinicalTrials.gov Identifier: NCT00150800     History of Changes
Other Study ID Numbers: N01199
First Submitted: September 6, 2005
First Posted: September 8, 2005
Results First Submitted: September 18, 2018
Results First Posted: December 5, 2018
Last Update Posted: December 5, 2018