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Trial record 1 of 1 for:    NCT00552305
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To Determine Tolerability and Efficacy of Long-term Oral Lacosamide in Patients With 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: NCT00552305
Recruitment Status : Completed
First Posted : November 1, 2007
Results First Posted : September 2, 2011
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Partial Epilepsies
Intervention Drug: lacosamide
Enrollment 370
Recruitment Details The study was started in August of 2001 with recruitment occurring in the United States, Germany, Hungary, Lithuania, Poland, Sweden, Switzerland, and the United Kingdom. The study had last patient last visit in February of 2010.
Pre-assignment Details  
Arm/Group Title Lacosamide
Hide Arm/Group Description 50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
Period Title: Overall Study
Started 370
Completed 120
Not Completed 250
Reason Not Completed
Adverse Event             43
Lack of Efficacy             120
Lost to Follow-up             4
Protocol Violation             3
Withdrawal by Subject             44
Lack of efficacy/withdrew consent             1
Lack of efficacy (LoE)/adverse event             3
Adverse event (AE)/withdrew (WD) consent             2
Unsatisfactory compliance             11
Poor compliance/lost to follow-up             1
AE/Other: prohibited drug required             1
LoE/WD consent/Other: cannot make visits             1
Other: Site closed             4
Other: Personal problems             1
Other: Unable to attend visits             1
Other: Subject underwent surgery             4
Other: Subject became pregnant             1
Other: Health problems, not drug related             1
Other: Subject moved from area             2
Other: Subject incarcerated             1
Other: Subject went to rehab             1
Arm/Group Title Lacosamide
Hide Arm/Group Description 50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
Overall Number of Baseline Participants 370
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 370 participants
<=18 years
3
   0.8%
Between 18 and 65 years
364
  98.4%
>=65 years
3
   0.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 370 participants
40.8  (11.01)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 370 participants
Female
192
  51.9%
Male
178
  48.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 370 participants
United States 248
Hungary 13
Poland 4
Lithuania 46
Germany 21
United Kingdom 12
Switzerland 2
Sweden 24
1.Primary Outcome
Title Number of Subjects Reporting at Least 1 Treat-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 Years)
Hide Description Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Time Frame During the Treatment Period (up to 8 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 370 subjects who entered the study, 370 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.
Arm/Group Title Lacosamide
Hide Arm/Group Description:
50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
Overall Number of Participants Analyzed 370
Measure Type: Number
Unit of Measure: subjects
343
2.Primary Outcome
Title Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 Years)
Hide Description Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Time Frame During the Treatment Period (up to 8 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 370 subjects who entered the study, 370 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.
Arm/Group Title Lacosamide
Hide Arm/Group Description:
50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
Overall Number of Participants Analyzed 370
Measure Type: Number
Unit of Measure: subjects
47
3.Primary Outcome
Title Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (up to 8 Years)
Hide Description A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention.
Time Frame During the Treatment Period (up to 8 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 370 subjects who entered the study, 370 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.
Arm/Group Title Lacosamide
Hide Arm/Group Description:
50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
Overall Number of Participants Analyzed 370
Measure Type: Number
Unit of Measure: subjects
125
4.Secondary Outcome
Title Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (up to 8 Years)
Hide Description

Median percentage change is the median value with respect to the percent change from Baseline across the population of subjects. Percentage change is calculated as 100 times the difference of the seizure frequency for the treatment period and the Baseline seizure frequency divided by the baseline seizure frequency.

Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency.

Time Frame Baseline, End of Treatment Period (up to 8 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 370 subjects who were enrolled/treated in the study, 369 are included in this summary based on the Full Analysis Set (FAS). FAS population: number of subjects treated with at least 1 post-baseline seizure diary day with available data during the SP615 study.
Arm/Group Title Lacosamide
Hide Arm/Group Description:
50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
Overall Number of Participants Analyzed 369
Median (Full Range)
Unit of Measure: percentage change
-50.8
(-100.0 to 408.9)
5.Secondary Outcome
Title Percentage of at Least 50% Responders During the Treatment Period (up to 8 Years)
Hide Description At least 50 percent response is based on the percentage reduction in 28-day seizure frequency during the Treatment Period of the open-label extension relative to the Baseline Phase of the prior study. This endpoint reflects the percentage of subjects with at least 50% reduction (ie, at least 50% change) in 28-day partial onset seizure frequency
Time Frame Treatment Period (up to 8 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 370 subjects who were enrolled/treated in the study, 369 are included in this summary based on the Full Analysis Set (FAS). FAS population: number of subjects treated with at least 1 post-baseline seizure diary day with available data during the SP615 study.
Arm/Group Title Lacosamide
Hide Arm/Group Description:
50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
Overall Number of Participants Analyzed 369
Measure Type: Number
Unit of Measure: percentage of subjects
51.2
Time Frame The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lacosamide
Hide Arm/Group Description 50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
All-Cause Mortality
Lacosamide
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Lacosamide
Affected / at Risk (%) # Events
Total   125/370 (33.78%)    
Blood and lymphatic system disorders   
LEUKOPENIA * 1  1/370 (0.27%)  1
Cardiac disorders   
SINUS BRADYCARDIA * 1  3/370 (0.81%)  3
ANGINA PECTORIS * 1  3/370 (0.81%)  3
ATRIAL FIBRILLATION * 1  1/370 (0.27%)  1
ATRIOVENTRICULAR BLOCK FIRST DEGREE * 1  1/370 (0.27%)  1
ACUTE CORONARY SYNDROME * 1  1/370 (0.27%)  1
BRADYCARDIA * 1  1/370 (0.27%)  1
CARDIAC FIBRILLATION * 1  1/370 (0.27%)  1
CARDIOMYOPATHY * 1  1/370 (0.27%)  1
CORONARY ARTERY STENOSIS * 1  1/370 (0.27%)  1
CORONARY ARTERY DISEASE * 1  1/370 (0.27%)  1
MYOCARDIAL INFARCTION * 1  1/370 (0.27%)  1
Ear and labyrinth disorders   
VERTIGO * 1  1/370 (0.27%)  1
Eye disorders   
VISION BLURRED * 1  1/370 (0.27%)  1
Gastrointestinal disorders   
VOMITING * 1  2/370 (0.54%)  3
COLITIS * 1  1/370 (0.27%)  1
INGUINAL HERNIA * 1  1/370 (0.27%)  1
HAEMORRHOIDS * 1  1/370 (0.27%)  1
IRRITABLE BOWEL SYNDROME * 1  1/370 (0.27%)  1
NAUSEA * 1  1/370 (0.27%)  1
RECTAL HAEMORRHAGE * 1  1/370 (0.27%)  1
COLONIC POLYP * 1  1/370 (0.27%)  1
ABDOMINAL PAIN * 1  1/370 (0.27%)  1
DIARRHOEA * 1  1/370 (0.27%)  1
ILEUS * 1  1/370 (0.27%)  2
ENTEROCELE * 1  1/370 (0.27%)  1
General disorders   
CHEST PAIN * 1  5/370 (1.35%)  6
NON-CARDIAC CHEST PAIN * 1  4/370 (1.08%)  4
OEDEMA PERIPHERAL * 1  1/370 (0.27%)  1
IRRITABILITY * 1  1/370 (0.27%)  1
Hepatobiliary disorders   
CHOLELITHIASIS * 1  1/370 (0.27%)  1
Infections and infestations   
PNEUMONIA * 1  2/370 (0.54%)  2
BRONCHITIS * 1  1/370 (0.27%)  1
APPENDICITIS * 1  1/370 (0.27%)  1
BACTERIAL INFECTION * 1  1/370 (0.27%)  1
GASTROINTESTINAL INFECTION * 1  1/370 (0.27%)  1
URINARY TRACT INFECTION * 1  1/370 (0.27%)  1
Injury, poisoning and procedural complications   
HAND FRACTURE * 1  3/370 (0.81%)  3
DRUG TOXICITY * 1  3/370 (0.81%)  3
ANKLE FRACTURE * 1  2/370 (0.54%)  2
INJURY * 1  2/370 (0.54%)  2
HEAD INJURY * 1  2/370 (0.54%)  2
INTENTIONAL OVERDOSE * 1  2/370 (0.54%)  2
CEREBRAL HAEMORRHAGE TRAUMATIC * 1  1/370 (0.27%)  1
FALL * 1  1/370 (0.27%)  1
PELVIC FRACTURE * 1  1/370 (0.27%)  1
POST-TRAUMATIC PAIN * 1  1/370 (0.27%)  1
TREATMENT NONCOMPLIANCE * 1  1/370 (0.27%)  1
UPPER LIMB FRACTURE * 1  1/370 (0.27%)  1
CERVICAL VERTEBRAL FRACTURE * 1  1/370 (0.27%)  1
LOWER LIMB FRACTURE * 1  1/370 (0.27%)  1
OVERDOSE * 1  1/370 (0.27%)  1
PNEUMOTHORAX TRAUMATIC * 1  1/370 (0.27%)  1
RIB FRACTURE * 1  1/370 (0.27%)  1
ROAD TRAFFIC ACCIDENT * 1  1/370 (0.27%)  1
THORACIC VERTEBRAL FRACTURE * 1  1/370 (0.27%)  1
TIBIA FRACTURE * 1  1/370 (0.27%)  1
HIP FRACTURE * 1  1/370 (0.27%)  2
MEDICAL DEVICE COMPLICATION * 1  1/370 (0.27%)  1
SPINAL FRACTURE * 1  1/370 (0.27%)  1
THERMAL BURN * 1  1/370 (0.27%)  1
JOINT INJURY * 1  1/370 (0.27%)  1
THERAPEUTIC AGENT TOXICITY * 1  1/370 (0.27%)  1
Investigations   
ELECTROENCEPHALOGRAM * 1  4/370 (1.08%)  4
ELECTROCARDIOGRAM QRS COMPLEX PROLONGED * 1  2/370 (0.54%)  2
BIOPSY * 1  1/370 (0.27%)  1
INVESTIGATION * 1  1/370 (0.27%)  1
ELECTROCARDIOGRAM ST SEGMENT ABNORMAL * 1  1/370 (0.27%)  1
SINGLE PHOTON EMISSION COMPUTERISED TOMOGRAM * 1  1/370 (0.27%)  1
BLOOD CREATINE PHOSPHOKINASE INCREASED * 1  1/370 (0.27%)  1
ELECTROCARDIOGRAM CHANGE * 1  1/370 (0.27%)  1
HEART RATE INCREASED * 1  1/370 (0.27%)  1
URINARY CASTS * 1  1/370 (0.27%)  1
Metabolism and nutrition disorders   
DEHYDRATION * 1  2/370 (0.54%)  3
HYPONATRAEMIA * 1  2/370 (0.54%)  2
HYPOCALCAEMIA * 1  1/370 (0.27%)  1
HYPERCALCAEMIA * 1  1/370 (0.27%)  1
Musculoskeletal and connective tissue disorders   
INTERVERTEBRAL DISC PROTRUSION * 1  3/370 (0.81%)  4
FLANK PAIN * 1  2/370 (0.54%)  3
OSTEOARTHRITIS * 1  2/370 (0.54%)  3
MUSCULOSKELETAL PAIN * 1  1/370 (0.27%)  1
MUSCULAR WEAKNESS * 1  1/370 (0.27%)  1
ARTHRITIS * 1  1/370 (0.27%)  1
SPINAL COLUMN STENOSIS * 1  1/370 (0.27%)  1
LUMBAR SPINAL STENOSIS * 1  1/370 (0.27%)  1
ARTHRALGIA * 1  1/370 (0.27%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
CHRONIC LYMPHOCYTIC LEUKAEMIA * 1  1/370 (0.27%)  1
HEPATIC NEOPLASM * 1  1/370 (0.27%)  1
HAEMANGIOMA * 1  1/370 (0.27%)  1
NEOPLASM * 1  1/370 (0.27%)  1
SQUAMOUS CELL CARCINOMA * 1  1/370 (0.27%)  1
GLIOBLASTOMA MULTIFORME * 1  1/370 (0.27%)  1
THYROID NEOPLASM * 1  1/370 (0.27%)  1
BREAST CANCER * 1  1/370 (0.27%)  1
OVARIAN CANCER * 1  1/370 (0.27%)  1
COLON NEOPLASM * 1  1/370 (0.27%)  1
Nervous system disorders   
CONVULSION * 1  23/370 (6.22%)  26
STATUS EPILEPTICUS * 1  7/370 (1.89%)  7
TRANSIENT ISCHAEMIC ATTACK * 1  4/370 (1.08%)  5
HEADACHE * 1  3/370 (0.81%)  3
HEMIPARESIS * 1  2/370 (0.54%)  2
DIZZINESS * 1  2/370 (0.54%)  2
GRAND MAL CONVULSION * 1  2/370 (0.54%)  2
CEREBRAL INFARCTION * 1  2/370 (0.54%)  2
EPILEPSY * 1  2/370 (0.54%)  2
ENCEPHALOPATHY * 1  1/370 (0.27%)  1
PARTIAL SEIZURES WITH SECONDARY GENERALISATION * 1  1/370 (0.27%)  1
CEREBRAL HAEMORRHAGE * 1  1/370 (0.27%)  1
METABOLIC ENCEPHALOPATHY * 1  1/370 (0.27%)  1
MYASTHENIA GRAVIS * 1  1/370 (0.27%)  1
MYASTHENIA GRAVIS CRISIS * 1  1/370 (0.27%)  1
SYNCOPE * 1  1/370 (0.27%)  1
COGNITIVE DISORDER * 1  1/370 (0.27%)  1
CEREBROVASCULAR ACCIDENT * 1  1/370 (0.27%)  1
COORDINATION ABNORMAL * 1  1/370 (0.27%)  1
BALANCE DISORDER * 1  1/370 (0.27%)  2
PSYCHOMOTOR HYPERACTIVITY * 1  1/370 (0.27%)  1
OPTIC NEURITIS RETROBULBAR * 1  1/370 (0.27%)  1
COMPLEX PARTIAL SEIZURES * 1  1/370 (0.27%)  1
Pregnancy, puerperium and perinatal conditions   
PREGNANCY * 1  1/370 (0.27%)  1
Psychiatric disorders   
CONFUSIONAL STATE * 1  4/370 (1.08%)  4
DEPRESSION * 1  3/370 (0.81%)  3
MAJOR DEPRESSION * 1  2/370 (0.54%)  2
AGGRESSION * 1  2/370 (0.54%)  2
SUICIDAL IDEATION * 1  2/370 (0.54%)  2
EPILEPTIC PSYCHOSIS * 1  1/370 (0.27%)  2
HALLUCINATION * 1  1/370 (0.27%)  1
PARANOIA * 1  1/370 (0.27%)  1
SUICIDE ATTEMPT * 1  1/370 (0.27%)  1
ACUTE PSYCHOSIS * 1  1/370 (0.27%)  2
HALLUCINATION, AUDITORY * 1  1/370 (0.27%)  1
NIGHTMARE * 1  1/370 (0.27%)  1
Renal and urinary disorders   
NEPHROLITHIASIS * 1  2/370 (0.54%)  2
RENAL FAILURE ACUTE * 1  1/370 (0.27%)  1
HAEMATURIA * 1  1/370 (0.27%)  1
PROTEINURIA * 1  1/370 (0.27%)  1
Reproductive system and breast disorders   
DYSFUNCTIONAL UTERINE BLEEDING * 1  1/370 (0.27%)  1
UTERINE HAEMORRHAGE * 1  1/370 (0.27%)  1
Respiratory, thoracic and mediastinal disorders   
DYSPNOEA * 1  2/370 (0.54%)  2
PULMONARY FIBROSIS * 1  1/370 (0.27%)  1
RESPIRATORY FAILURE * 1  1/370 (0.27%)  1
ASPHYXIA * 1  1/370 (0.27%)  1
ASTHMA * 1  1/370 (0.27%)  8
PNEUMOTHORAX * 1  1/370 (0.27%)  1
ACUTE RESPIRATORY FAILURE * 1  1/370 (0.27%)  1
Skin and subcutaneous tissue disorders   
RASH * 1  1/370 (0.27%)  1
Surgical and medical procedures   
ABORTION INDUCED * 1  2/370 (0.54%)  2
THERAPY REGIMEN CHANGED * 1  1/370 (0.27%)  1
BRAIN OPERATION * 1  1/370 (0.27%)  1
HYSTERECTOMY * 1  1/370 (0.27%)  1
SURGERY * 1  1/370 (0.27%)  1
BRAIN LOBECTOMY * 1  1/370 (0.27%)  1
STENT PLACEMENT * 1  1/370 (0.27%)  1
VAGAL NERVE STIMULATOR REMOVAL * 1  1/370 (0.27%)  1
NASAL SEPTAL OPERATION * 1  1/370 (0.27%)  1
Vascular disorders   
DEEP VEIN THROMBOSIS * 1  2/370 (0.54%)  2
CIRCULATORY COLLAPSE * 1  1/370 (0.27%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lacosamide
Affected / at Risk (%) # Events
Total   307/370 (82.97%)    
Eye disorders   
DIPLOPIA * 1  63/370 (17.03%)  92
VISION BLURRED * 1  47/370 (12.70%)  60
Gastrointestinal disorders   
NAUSEA * 1  64/370 (17.30%)  89
VOMITING * 1  49/370 (13.24%)  71
DIARRHOEA * 1  29/370 (7.84%)  40
CONSTIPATION * 1  20/370 (5.41%)  21
General disorders   
FATIGUE * 1  61/370 (16.49%)  77
Infections and infestations   
UPPER RESPIRATORY TRACT INFECTION * 1  61/370 (16.49%)  108
NASOPHARYNGITIS * 1  60/370 (16.22%)  111
SINUSITIS * 1  43/370 (11.62%)  62
INFLUENZA * 1  32/370 (8.65%)  42
URINARY TRACT INFECTION * 1  31/370 (8.38%)  48
BRONCHITIS * 1  28/370 (7.57%)  34
Injury, poisoning and procedural complications   
CONTUSION * 1  57/370 (15.41%)  129
SKIN LACERATION * 1  50/370 (13.51%)  117
EXCORIATION * 1  27/370 (7.30%)  50
JOINT SPRAIN * 1  19/370 (5.14%)  23
Investigations   
WEIGHT INCREASED * 1  21/370 (5.68%)  22
Musculoskeletal and connective tissue disorders   
BACK PAIN * 1  43/370 (11.62%)  63
PAIN IN EXTREMITY * 1  33/370 (8.92%)  49
ARTHRALGIA * 1  31/370 (8.38%)  42
MUSCULOSKELETAL PAIN * 1  21/370 (5.68%)  30
MUSCULAR WEAKNESS * 1  20/370 (5.41%)  24
Nervous system disorders   
DIZZINESS * 1  147/370 (39.73%)  254
HEADACHE * 1  77/370 (20.81%)  145
COORDINATION ABNORMAL * 1  53/370 (14.32%)  69
SOMNOLENCE * 1  41/370 (11.08%)  50
TREMOR * 1  39/370 (10.54%)  55
MEMORY IMPAIRMENT * 1  27/370 (7.30%)  29
CONVULSION * 1  27/370 (7.30%)  32
BALANCE DISORDER * 1  26/370 (7.03%)  34
NYSTAGMUS * 1  24/370 (6.49%)  28
HYPOAESTHESIA * 1  20/370 (5.41%)  26
Psychiatric disorders   
INSOMNIA * 1  33/370 (8.92%)  35
DEPRESSION * 1  33/370 (8.92%)  36
ANXIETY * 1  19/370 (5.14%)  20
Respiratory, thoracic and mediastinal disorders   
COUGH * 1  29/370 (7.84%)  33
PHARYNGOLARYNGEAL PAIN * 1  26/370 (7.03%)  34
Skin and subcutaneous tissue disorders   
RASH * 1  28/370 (7.57%)  33
Vascular disorders   
HYPERTENSION * 1  19/370 (5.14%)  19
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.1)
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.
UCB has > 60 but <= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that the results shall be published regardless of outcome.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB (Study Director)
Organization: UCB Clinical Trial Call Center
Phone: +1 887 822 9493
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00552305    
Other Study ID Numbers: SP0615
First Submitted: October 30, 2007
First Posted: November 1, 2007
Results First Submitted: February 23, 2011
Results First Posted: September 2, 2011
Last Update Posted: July 17, 2018