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Trial record 2 of 5 for:    Sp848

An Open-Label Study to Determine Safety , Tolerability, and Efficacy of Oral Lacosamide in Children With Epilepsy

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: NCT00938912
Recruitment Status : Completed
First Posted : July 14, 2009
Results First Posted : January 18, 2022
Last Update Posted : January 18, 2022
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES, Inc. )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Epilepsy
Intervention Drug: Lacosamide
Enrollment 366
Recruitment Details The study started to enroll study participants in December 2009 and concluded in May 2021. Eligible study participants were allowed to roll over from study SP0847 (NCT00938431), SP0966 (NCT01969851) and EP0060 (NCT02710890) and eligible study participants were also allowed to directly enroll into the study.
Pre-assignment Details Total 366 participants were enrolled. Among 366, 365 participants received treatment. One participant was enrolled, but did not receive treatment prior to discontinuing due to ineligibility.
Arm/Group Title Lacosamide (All Participants)
Hide Arm/Group Description Participants aged greater than or equal to (≥1) month received either lacosamide (LCM) 2-12 milligrams/kilograms/day (mg/kg/day) (oral solution) or 100-600 mg/day (tablet) at a level to optimize tolerability and seizure control (maximum dose of 12 mg/kg/day or 600 mg/day based on body weight, whichever was lower) for approximately 2 years.
Period Title: Overall Study
Started 365
Completed 254
Not Completed 111
Reason Not Completed
Withdrawal by Subject             28
Lost to Follow-up             4
Lack of Efficacy             43
Adverse event, non-fatal             24
Adverse event, fatal             1
Participant self adjusted antiepileptic medication             1
Participant had a creatinine clearance less than 30 mL/min             1
Participant needed prohibit medication             1
Participant was scheduled for lobal resection             1
Did not meet Eligibility criteria             1
Participant relocated not related to AE             1
Participant moved to another city             1
Participant experienced break through seizures             1
No longer wished to participate in the study             1
Protocol Deviation             2
Arm/Group Title Lacosamide (All Participants)
Hide Arm/Group Description Participants aged ≥1 month received either LCM 2-12 mg/kg/day (oral solution) or 100-600 mg/day (tablet) at a level to optimize tolerability and seizure control (maximum dose of 12 mg/kg/day or 600 mg/day based on body weight, whichever was lower) for approximately 2 years.
Overall Number of Baseline Participants 365
Hide Baseline Analysis Population Description
Baseline Characteristics refer to the SS which consisted of all enrolled study participants who took at least 1 dose of LCM in this study.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 365 participants
<=18 years
365
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 365 participants
9.28  (4.55)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 365 participants
Female
173
  47.4%
Male
192
  52.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 365 participants
American Indian/Alaskan native
1
   0.3%
Asian
111
  30.4%
Black
26
   7.1%
White
201
  55.1%
Other/Mixed
26
   7.1%
1.Primary Outcome
Title Number of Participants With At Least One Treatment-Emergent Adverse Event (TEAE)
Hide Description An AE is any untoward medical occurrence in a participant or clinical investigation study participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Time Frame From Baseline to End of Safety Follow-Up (up to 4.3 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all enrolled study participants who took at least 1 dose of LCM in this study.
Arm/Group Title Lacosamide (All Participants) (SS)
Hide Arm/Group Description:
Participants aged ≥1 month received either LCM 2-12 mg/kg/day (oral solution) or 100-600 mg/day (tablet) at a level to optimize tolerability and seizure control (maximum dose of 12 mg/kg/day or 600 mg/day based on body weight, whichever was lower) for approximately 2 years. Participants formed the Safety Set (SS) which included all enrolled study participants who took at least 1 dose of LCM in this study.
Overall Number of Participants Analyzed 365
Measure Type: Count of Participants
Unit of Measure: Participants
336
  92.1%
2.Primary Outcome
Title Number of Participants With Serious Adverse Events (SAEs)
Hide Description SAE was any untoward medical occurrence that at any dose resulted in death, is life-threatening, required in participant hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect, is an infection that requires treatment with parenteral antibiotics, other important medical events which based on medical or scientific judgement may jeopardize the participants, or may require medical or surgical intervention to prevent any of the above.
Time Frame From Baseline to End of Safety Follow-Up (up to 4.3 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The SS consisted of all enrolled study participants who took at least 1 dose of LCM in this study.
Arm/Group Title Lacosamide (All Participants) (SS)
Hide Arm/Group Description:
Participants aged ≥1 month received either LCM 2-12 mg/kg/day (oral solution) or 100-600 mg/day (tablet) at a level to optimize tolerability and seizure control (maximum dose of 12 mg/kg/day or 600 mg/day based on body weight, whichever was lower) for approximately 2 years. Participants formed the SS which included all enrolled study participants who took at least 1 dose of LCM in this study.
Overall Number of Participants Analyzed 365
Measure Type: Count of Participants
Unit of Measure: Participants
82
  22.5%
3.Primary Outcome
Title Number of Participants That Withdraw Due to a Treatment-Emergent Adverse Event
Hide Description TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
Time Frame From Baseline to End of Safety Follow-Up (up to 4.3 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The SS consisted of all enrolled study participants who took at least 1 dose of LCM in this study.
Arm/Group Title Lacosamide (All Participants) (SS)
Hide Arm/Group Description:
Participants aged ≥1 month received either LCM 2-12 mg/kg/day (oral solution) or 100-600 mg/day (tablet) at a level to optimize tolerability and seizure control (maximum dose of 12 mg/kg/day or 600 mg/day based on body weight, whichever was lower) for approximately 2 years. Participants formed the SS which included all enrolled study participants who took at least 1 dose of LCM in this study.
Overall Number of Participants Analyzed 365
Measure Type: Count of Participants
Unit of Measure: Participants
27
   7.4%
4.Secondary Outcome
Title Percent Change From Baseline in 28 Day Partial-onset Seizure Frequency to the End of the Treatment Period
Hide Description Percent change in seizure frequency per 28 days (PCH) from the Baseline value (B) to Treatment Period interval (T) was defined as:PCH = [(SFT - SFB)/SFB] x 100 where, SFT corresponded to seizure frequency during Treatment Period for relative interval in open-label study and SFB corresponded to Baseline seizure frequency. For both periods, the frequency was standardized to the number of seizures per 28 days. For rollover participants, the Baseline values from the previous pediatric studies were designated as Baseline values in SP848. The Baseline value for seizure counts for directly enrolled participants were taken from the historical seizure count case report form/electronic case report form (CRF/eCRF) module in combination with the seizure diary data collected from the date of the Screening Visit to the day prior to the date of first dose of LCM. Participants from EP0060 RxL enrollment group had no baseline data due to taking oral LCM prior to EP0060.
Time Frame From Baseline to End of Treatment Period (up to 4.2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all study participants in the SS who had at least 1 completed post-Baseline seizure diary. Here, number of participants analyzed included those participants who were evaluable for the assessment.
Arm/Group Title Lacosamide (All Participants) (FAS)
Hide Arm/Group Description:
Participants aged ≥1 month received either LCM 2-12 mg/kg/day (oral solution) or 100-600 mg/day (tablet) at a level to optimize tolerability and seizure control (maximum dose of 12 mg/kg/day or 600 mg/day based on body weight, whichever was lower) for approximately 2 years. Participants formed the Full Analysis Set (FAS) which included all study participants in the SS who had at least 1 completed post-Baseline seizure diary.
Overall Number of Participants Analyzed 308
Mean (Standard Deviation)
Unit of Measure: percent change
-24.13  (112.08)
5.Secondary Outcome
Title Percentage of Participants With ≥50% Reduction in 28-day Partial-onset Seizure Frequency
Hide Description A 50% responder is a participant experiencing a ≥50% reduction in partial-onset seizure frequency per 28 days from Baseline to end of the specified time interval, otherwise a participant is a non-responder. For rollover participants, the Baseline values from the previous pediatric studies were designated as Baseline values in SP848. The Baseline value for seizure counts for directly enrolled participants were taken from the historical seizure count CRF/eCRF module in combination with the seizure diary data collected from the date of the Screening Visit to the day prior to the date of first dose of LCM. Participants from EP0060 RxL enrollment group had no baseline data due to taking oral LCM prior to EP0060.
Time Frame From Baseline to End of Treatment Period (up to 4.2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all study participants in the SS who had at least 1 completed post-Baseline seizure diary. Here, number of participants analyzed included those participants who were evaluable for the assessment.
Arm/Group Title Lacosamide (All Participants) (FAS)
Hide Arm/Group Description:
Participants aged ≥1 month received either LCM 2-12 mg/kg/day (oral solution) or 100-600 mg/day (tablet) at a level to optimize tolerability and seizure control (maximum dose of 12 mg/kg/day or 600 mg/day based on body weight, whichever was lower) for approximately 2 years. Participants formed the FAS which included all study participants in the SS who had at least 1 completed post-Baseline seizure diary.
Overall Number of Participants Analyzed 308
Measure Type: Number
Unit of Measure: percentage of participants
53.6
6.Secondary Outcome
Title Percentage of Participants With ≥75% Reduction in 28-day Partial-onset Seizure Frequency
Hide Description A 75% responder is a participant experiencing a ≥75% reduction in partial-onset seizure frequency per 28 days from Baseline to end of the specified time interval, otherwise a participant is a non-responder. For rollover participants, the Baseline values from the previous pediatric studies were designated as Baseline values in SP848. The Baseline value for seizure counts for directly enrolled participants were taken from the historical seizure count CRF/eCRF module in combination with the seizure diary data collected from the date of the Screening Visit to the day prior to the date of first dose of LCM. Participants from EP0060 RxL enrollment group had no baseline data due to taking oral LCM prior to EP0060.
Time Frame From Baseline to End of Treatment Period (up to 4.2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all study participants in the SS who had at least 1 completed post-Baseline seizure diary. Here, number of participants analyzed included those participants who were evaluable for the assessment.
Arm/Group Title Lacosamide (All Participants) (FAS)
Hide Arm/Group Description:
Participants aged ≥1 month received either LCM 2-12 mg/kg/day (oral solution) or 100-600 mg/day (tablet) at a level to optimize tolerability and seizure control (maximum dose of 12 mg/kg/day or 600 mg/day based on body weight, whichever was lower) for approximately 2 years. Participants formed the FAS which included all study participants in the SS who had at least 1 completed post-Baseline seizure diary.
Overall Number of Participants Analyzed 308
Measure Type: Number
Unit of Measure: percentage of participants
40.3
7.Secondary Outcome
Title Number of Seizure Days Per 28 Days for Participants With Generalized Seizures
Hide Description A seizure day was defined as a day where any type of seizure was reported in the seizure diary and seizures were assessed. Days in the seizure diary which were marked as "not done" on the CRF/eCRF were not counted as seizure-free days.
Time Frame Weeks 4, 8, 12, 20, 28, 36, 44, 52, 60, 72, 84 and 96
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all study participants in the SS who had at least 1 completed post-Baseline seizure diary. Here, number of participants analyzed included those participants who were evaluable for the assessment and number analyzed signifies participants who were evaluable at specified time points.
Arm/Group Title Lacosamide (All Participants) (FAS)
Hide Arm/Group Description:
Participants aged ≥1 month received either LCM 2-12 mg/kg/day (oral solution) or 100-600 mg/day (tablet) at a level to optimize tolerability and seizure control (maximum dose of 12 mg/kg/day or 600 mg/day based on body weight, whichever was lower) for approximately 2 years. Participants formed the FAS which included all study participants in the SS who had at least 1 completed post-Baseline seizure diary.
Overall Number of Participants Analyzed 47
Mean (Standard Deviation)
Unit of Measure: seizure days per 28 days
Week 4 Number Analyzed 47 participants
14.59  (11.94)
Week 8 Number Analyzed 46 participants
14.83  (12.24)
Week 12 Number Analyzed 46 participants
13.68  (12.62)
Week 20 Number Analyzed 46 participants
12.57  (12.58)
Week 28 Number Analyzed 43 participants
13.10  (12.63)
Week 36 Number Analyzed 43 participants
11.43  (11.93)
Week 44 Number Analyzed 40 participants
9.24  (11.23)
Week 52 Number Analyzed 41 participants
10.48  (11.68)
Week 60 Number Analyzed 39 participants
10.31  (11.84)
Week 72 Number Analyzed 39 participants
11.15  (12.10)
Week 84 Number Analyzed 38 participants
11.87  (12.45)
Week 96 Number Analyzed 37 participants
10.73  (11.77)
8.Secondary Outcome
Title Percentage of Participants Who Achieved a Seizure-free Status
Hide Description Study participants were considered seizure-free for a given period if they completed the period, reported zero seizures during the period, and had no more than 10% of days in the period for which seizure data were not available (ie, "not done" was noted on the Seizure Frequency CRF/eCRF module).
Time Frame From Baseline to End of Treatment Period (up to 4.2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all study participants in the SS who had at least 1 completed post-Baseline seizure diary. Here, number of participants analyzed included those participants who were evaluable for the assessment.
Arm/Group Title Lacosamide (All Participants) (FAS)
Hide Arm/Group Description:
Participants aged ≥1 month received either LCM 2-12 mg/kg/day (oral solution) or 100-600 mg/day (tablet) at a level to optimize tolerability and seizure control (maximum dose of 12 mg/kg/day or 600 mg/day based on body weight, whichever was lower) for approximately 2 years. Participants formed the FAS which included all study participants in the SS who had at least 1 completed post-Baseline seizure diary.
Overall Number of Participants Analyzed 323
Measure Type: Number
Unit of Measure: percentage of participants
7.4
Time Frame From Baseline to End of Safety Follow-Up (up to 4.3 years)
Adverse Event Reporting Description TEAEs were defined as those events which started on or after the date of first SP848 LCM administration and occurred within 30 days after last dose of LCM, or whose severity worsened on or after the date of first SP848 LCM administration.
 
Arm/Group Title Lacosamide (All Participants) (SS)
Hide Arm/Group Description Participants aged ≥1 month received either LCM 2-12 mg/kg/day (oral solution) or 100-600 mg/day (tablet) at a level to optimize tolerability and seizure control (maximum dose of 12 mg/kg/day or 600 mg/day based on body weight, whichever was lower) for approximately 2 years. Participants formed the SS which included all enrolled study participants who took at least 1 dose of LCM in this study.
All-Cause Mortality
Lacosamide (All Participants) (SS)
Affected / at Risk (%)
Total   1/365 (0.27%)    
Hide Serious Adverse Events
Lacosamide (All Participants) (SS)
Affected / at Risk (%) # Events
Total   82/365 (22.47%)    
Blood and lymphatic system disorders   
Coagulopathy * 1  1/365 (0.27%)  1
Cardiac disorders   
Bradycardia * 1  1/365 (0.27%)  1
Cyanosis * 1  1/365 (0.27%)  1
Gastrointestinal disorders   
Vomiting * 1  8/365 (2.19%)  19
Constipation * 1  3/365 (0.82%)  3
Diarrhoea * 1  3/365 (0.82%)  3
Abdominal pain * 1  2/365 (0.55%)  2
Haematemesis * 1  2/365 (0.55%)  2
Gastritis * 1  1/365 (0.27%)  1
Intussusception * 1  1/365 (0.27%)  1
Mallory-Weiss syndrome * 1  1/365 (0.27%)  1
Pancreatitis * 1  1/365 (0.27%)  1
Traumatic tooth displacement * 1  1/365 (0.27%)  1
General disorders   
Pyrexia * 1  4/365 (1.10%)  5
Adverse drug reaction * 1  1/365 (0.27%)  1
Chest pain * 1  1/365 (0.27%)  1
Hypothermia * 1  1/365 (0.27%)  1
Sudden death * 1  1/365 (0.27%)  1
Infections and infestations   
Pneumonia * 1  6/365 (1.64%)  6
Bronchitis * 1  4/365 (1.10%)  4
Bronchopneumonia * 1  3/365 (0.82%)  3
Gastroenteritis * 1  3/365 (0.82%)  3
Sepsis * 1  3/365 (0.82%)  3
Upper respiratory tract infection * 1  3/365 (0.82%)  3
Urinary tract infection * 1  3/365 (0.82%)  3
Otitis media * 1  2/365 (0.55%)  2
Tonsillitis * 1  2/365 (0.55%)  3
Acute tonsillitis * 1  1/365 (0.27%)  1
Bronchiolitis * 1  1/365 (0.27%)  1
Erythema infectiosum * 1  1/365 (0.27%)  1
Pneumonia mycoplasmal * 1  1/365 (0.27%)  1
Pneumonia viral * 1  1/365 (0.27%)  1
Urinary tract infection fungal * 1  1/365 (0.27%)  1
Viral infection * 1  1/365 (0.27%)  2
Injury, poisoning and procedural complications   
Endotracheal intubation complication * 1  1/365 (0.27%)  1
Foreign body aspiration * 1  1/365 (0.27%)  1
Head injury * 1  1/365 (0.27%)  1
Limb traumatic amputation * 1  1/365 (0.27%)  1
Skull fracture * 1  1/365 (0.27%)  1
Investigations   
Weight decreased * 1  1/365 (0.27%)  1
Metabolism and nutrition disorders   
Dehydration * 1  4/365 (1.10%)  4
Decreased appetite * 1  2/365 (0.55%)  2
Hyperammonaemia * 1  1/365 (0.27%)  1
Malnutrition * 1  1/365 (0.27%)  1
Musculoskeletal and connective tissue disorders   
Atlantoaxial instability * 1  1/365 (0.27%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Astrocytoma, low grade * 1  1/365 (0.27%)  1
Nervous system disorders   
Convulsion * 1  21/365 (5.75%)  29
Status epilepticus * 1  11/365 (3.01%)  16
Epilepsy * 1  6/365 (1.64%)  6
Complex partial seizures * 1  5/365 (1.37%)  6
Partial seizures with secondary generalisation * 1  4/365 (1.10%)  12
Partial seizures * 1  3/365 (0.82%)  3
Seizure cluster * 1  3/365 (0.82%)  5
Headache * 1  2/365 (0.55%)  2
Altered state of consciousness * 1  1/365 (0.27%)  1
Clonic convulsion * 1  1/365 (0.27%)  1
Encephalitis autoimmune * 1  1/365 (0.27%)  1
Grand mal convulsion * 1  1/365 (0.27%)  1
Haemorrhage intracranial * 1  1/365 (0.27%)  1
Lethargy * 1  1/365 (0.27%)  1
Neurotoxicity * 1  1/365 (0.27%)  1
Paraesthesia * 1  1/365 (0.27%)  1
Psychomotor skills impaired * 1  1/365 (0.27%)  1
Psychomotor hyperactivity * 1  1/365 (0.27%)  1
Simple partial seizures * 1  1/365 (0.27%)  2
Somnolence * 1  1/365 (0.27%)  1
VIIth nerve paralysis * 1  1/365 (0.27%)  1
Psychiatric disorders   
Mental status changes * 1  3/365 (0.82%)  5
Affective disorder * 1  1/365 (0.27%)  2
Agitation * 1  1/365 (0.27%)  1
Anxiety disorder * 1  1/365 (0.27%)  2
Hallucination, visual * 1  1/365 (0.27%)  1
Hallucination, auditory * 1  1/365 (0.27%)  1
Nightmare * 1  1/365 (0.27%)  1
Sleep disorder * 1  1/365 (0.27%)  1
Substance-induced psychotic disorder * 1  1/365 (0.27%)  1
Suicidal ideation * 1  1/365 (0.27%)  1
Renal and urinary disorders   
Haematuria * 1  1/365 (0.27%)  1
Nephrolithiasis * 1  1/365 (0.27%)  1
Nephrotic syndrome * 1  1/365 (0.27%)  1
Respiratory, thoracic and mediastinal disorders   
Respiratory distress * 1  2/365 (0.55%)  2
Hypoxia * 1  1/365 (0.27%)  1
Pneumonia aspiration * 1  1/365 (0.27%)  1
Sleep apnoea syndrome * 1  1/365 (0.27%)  1
Skin and subcutaneous tissue disorders   
Drug eruption * 1  1/365 (0.27%)  1
Rash * 1  1/365 (0.27%)  1
Vascular disorders   
Haematoma * 1  1/365 (0.27%)  1
1
Term from vocabulary, MedDRA v16.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lacosamide (All Participants) (SS)
Affected / at Risk (%) # Events
Total   291/365 (79.73%)    
Gastrointestinal disorders   
Vomiting * 1  77/365 (21.10%)  149
Diarrhoea * 1  40/365 (10.96%)  52
Constipation * 1  25/365 (6.85%)  34
Nausea * 1  25/365 (6.85%)  35
Abdominal pain * 1  21/365 (5.75%)  32
Abdominal pain upper * 1  19/365 (5.21%)  29
General disorders   
Pyrexia * 1  80/365 (21.92%)  126
Fatigue * 1  21/365 (5.75%)  31
Infections and infestations   
Nasopharyngitis * 1  91/365 (24.93%)  253
Upper respiratory tract infection * 1  86/365 (23.56%)  167
Pharyngitis * 1  37/365 (10.14%)  48
Gastroenteritis * 1  29/365 (7.95%)  35
Influenza * 1  29/365 (7.95%)  38
Bronchitis * 1  26/365 (7.12%)  40
Viral infection * 1  21/365 (5.75%)  36
Sinusitis * 1  20/365 (5.48%)  29
Urinary tract infection * 1  20/365 (5.48%)  24
Ear infection * 1  19/365 (5.21%)  27
Injury, poisoning and procedural complications   
Contusion * 1  25/365 (6.85%)  55
Metabolism and nutrition disorders   
Decreased appetite * 1  26/365 (7.12%)  28
Nervous system disorders   
Somnolence * 1  74/365 (20.27%)  100
Dizziness * 1  69/365 (18.90%)  114
Headache * 1  45/365 (12.33%)  97
Tremor * 1  21/365 (5.75%)  23
Respiratory, thoracic and mediastinal disorders   
Cough * 1  36/365 (9.86%)  43
1
Term from vocabulary, MedDRA v16.1
*
Indicates events were collected by non-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: 001-844-599-2273
EMail: UCBCares@ucb.com
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB BIOSCIENCES, Inc. )
ClinicalTrials.gov Identifier: NCT00938912    
Other Study ID Numbers: SP848
2011-001559-35 ( EudraCT Number )
First Submitted: July 10, 2009
First Posted: July 14, 2009
Results First Submitted: December 17, 2021
Results First Posted: January 18, 2022
Last Update Posted: January 18, 2022