A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures.

January 15, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

A Double-blind, Placebo-controlled, Parallel-group, Multicenter Study Of The Efficacy And Safety Of Pregabalin As Adjunctive Therapy In Children 1 Month Through <4 Years Of Age With Partial Onset Seizures

This study is designed to evaluate the effectiveness of 2 doses of pregabalin to reduce seizure frequency as an add on therapy in pediatric subjects 1 month to <4 years of age with refractory partial onset seizures. It is hypothesized that both doses of pregabalin will demonstrate superior efficacy when compared to placebo by reducing the partial onset seizure frequency and that pregabalin will be safe and well tolerated.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
175

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belarus
      • Minsk, Belarus, 220053
        • GU Republican Scientific and Practical Center Mother and Child
  • Belgium
    • Bruxelles Capitale
      • Brussels, Bruxelles Capitale, Belgium, 1090
        • UZ Brussel
  • Bosnia and Herzegovina
      • Banja Luka, Bosnia and Herzegovina, 78000
        • University Clinical Centre of the Republic of Srpska
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • UMHAT Dr. Georgi Stranski Ltd.
      • Plovdiv, Bulgaria, 4002
        • UMHAT "Sveti Georgi" Ltd.
  • China
      • Beijing, China, 100045
        • Beijing Children's Hospital
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Bethune Hospital of Jilin University
    • Shanghai
      • Shanghai, Shanghai, China, 201102
        • Children's Hospital of Fudan University
  • France
      • Garches, France, 92380
        • Hôpital Raymond Poincaré
  • Germany
    • Thueringen
      • Jena, Thueringen, Germany, 07747
        • Universitaetsklinikum Jena
  • Greece
      • Athens, Greece, 12462
        • University General Hospital Attikon
      • Thessaloniki, Greece, 54642
        • General Hospital of Thessaloniki Ippokratio
  • Hungary
      • Balassagyarmat, Hungary, H-2660
        • Dr. Kenessey Albert Korhaz es Rendelointezet
      • Budapest, Hungary, H-1032
        • Szent Margit Kórház
      • Budapest, Hungary, H-1146
        • Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaz, Gyermekneurologia
      • Budapest, Hungary, H-1083
        • Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika
      • Budapest, Hungary, H-1023
        • Szent Janos Korhaz es Eszak Budai Egyesitett Korhazak
      • Debrecen, Hungary, H-4032
        • Debreceni Egyetem Klinikai Kozpont
  • Israel
      • Holon, Israel, 5810001
        • Pharmacy of The E. Wolfson Medical Center
      • Holon, Israel, 5810001
        • The E. Wolfson Medical Center
      • Tel Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Center
      • Tel Aviv, Israel, 6423906
        • Pharmacy of Tel Aviv Sourasky Medical Center
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
  • Lebanon
      • Beirut, Lebanon
        • American University of Beirut Medical Center
      • Beirut, Lebanon
        • Saint George Hospital - University Medical Center
  • Malaysia
    • Kelantan
      • Kota Bharu, Kelantan, Malaysia, 15586
        • Hospital Raja Perempuan Zainab II
  • Philippines
      • Manila, Philippines, 1003
        • Metropolitan Medical Center
      • Manila, Philippines, 1008
        • University of Santo Tomas Hospital
      • Manila, Philippines, 1000
        • Manila Doctors Hospital
      • Quezon City, Philippines, 1102
        • St. Luke's Medical Center
      • Quezon City, Philippines, 1105
        • Philippine Children's Medical Center
    • Cebu
      • Cebu City, Cebu, Philippines, 6000
        • Cebu Doctors' University Hospital
      • Cebu City, Cebu, Philippines, 6000
        • Perpetual Succour Hospital
  • Romania
      • Bucuresti, Romania, 013766
        • Centrul Medical Unirea
      • Iasi, Romania, 700309
        • Spitalul Clinic de Urgente pentru Copii "Sf. Maria"
  • Russian Federation
      • Moscow, Russian Federation, 117997
        • FSFEI HE N.I. Pirogov RNRMU of Minzdrav of Russia
      • Moscow, Russian Federation, 125412
        • FSFEI HE N.I. Pirogov RNRMU of Minzdrav of Russia
      • Perm, Russian Federation, 614990
        • Perm State Medical University n. a. acad. E.A. Vagner
      • Saint Petersburg, Russian Federation, 194100
        • St. Petersburg State Pediatric Medical University
      • Saint Petersburg, Russian Federation, 194356
        • "Baltiyskaya Medicyna" LLC
      • Saint-Petersburg, Russian Federation, 191025
        • LLC Medical Technologies
      • Saint-Petersburg, Russian Federation, 192148
        • LLC Medical Technologies
      • Smolensk, Russian Federation, 214018
        • RSBHI Smolensk Regional Clinical Hospital
      • Ulyanovsk, Russian Federation, 432011
        • SHI Ulyanovsk Regional Children's Clinical Hospital n. a. Y.F.Goryachev
      • Ulyanovsk, Russian Federation, 432026
        • SHI Central Clinical Medical Unit
      • Ulyanovsk, Russian Federation, 432045
        • SHI Central Clinical Medical Unit
      • Yekaterinburg, Russian Federation, 620134
        • MAI Children's City Clinical Hospital 9
    • Nizhegorodskaya Oblast
      • Nizhniy Novgorod, Nizhegorodskaya Oblast, Russian Federation, 603159
        • Nizhmedklinika
    • Permskiy KRAY
      • Perm, Permskiy KRAY, Russian Federation, 614000
        • Perm State Medical University n. a. acad. E.A. Vagner
  • Serbia
      • Belgrade, Serbia, 11000
        • Mother and Child Healthcare Institute Dr Vukan Cupic
      • Belgrade, Serbia, 11000
        • University Children's Hospital Belgrade
    • Vojvodina
      • Novi Sad, Vojvodina, Serbia, 21000
        • Institute for Child and Youth Healthcare of Vojvodina
  • Spain
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet
  • Taiwan
      • Kaohsiung, Taiwan, 833
        • Chang Gung Memorial Hospital- Kaohsiung branch
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital
  • Thailand
    • Bangkok
      • Bangkoknoi, Bangkok, Thailand, 10700
        • Siriraj Hospital, Faculty of Medicine, Mahidol university
      • Ratchathevee, Bangkok, Thailand, 10400
        • Phramongkutklao Hospital
  • Turkey
      • Eskisehir, Turkey, 26480
        • Eskisehir Osmangazi Universitesi Tip Fakultesi
      • Trabzon, Turkey, 61080
        • Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi
    • Konak
      • Izmir, Konak, Turkey, 35120
        • Izmir Tepecik Training and Research Hospital
  • Ukraine
      • Dnipro, Ukraine, 49027
        • Komunalnyi zaklad "Dnipropetrovska dytiacha miska klinichna likarnia #5"
      • Dnipro, Ukraine, 49100
        • Komunalnyi zaklad "Dnipropetrovska oblasna dytiacha klinichna likarnia"
      • Ivano-Frankivsk, Ukraine, 76018
        • Ivano-Frankivska oblasna dytiacha klinichna likarnia
      • Kyiv, Ukraine, 04209
        • DZ "Ukrainskyi medychnyi tsentr reabilitatsii ditei z orhanichnym urazhenniam
      • Uzhgorod, Ukraine, 88018
        • Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii,viddilennia neirokhirurhii #2
  • United States
    • Florida
      • Orlando, Florida, United States, 32819
        • Pediatric Neurology, PA
      • Orlando, Florida, United States, 32819
        • Pediatric Epilepsy Center of Central Florida
      • Tampa, Florida, United States, 33609
        • Pediatric Epilepsy & Neurology Specialists, PA
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston
      • San Antonio, Texas, United States, 78249
        • Road Runner Research, Ltd.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 month to 3 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject must have 3 partial onset seizures in the month prior to screening.
  • Subject must have 2 partial onset seizures during the 48 hour baseline phase.
  • Signed Informed Consent.
  • On 1-3 stable anti-epileptic drugs at screening.

Exclusion Criteria:

  • Primary generalized seizures including clonic, tonic, clonic-tonic, absence, febrile seizures, and infantile spasms.
  • Lennox-Gasteau, BECTS, and Dravet's syndrome.
  • Status epliepticus within 1 year of screening.
  • Any change in AED regimen with 7 days of screening.
  • Progressive structural central nervous system (CNS) lesion or a progressive encephalopathy.
  • Progressive errors of metabolism.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
Placebo Liquid dosed three times daily beginning at Randomization through Taper Phase
EXPERIMENTAL: Study Drug Level 1
Drug: Pregabalin Dose Level 1
Pregabalin liquid dosed daily three times a day in equally divided doses escalated to 7.0 mg/kg/day beginning at Randomization through Taper Phase then tapered to 3.5 mg/kg/day during 1 week Taper Phase
EXPERIMENTAL: Study Drug Level 2
Drug: Pregabalin Dose Level 2
Pregabalin liquid dosed daily three times a day in equally divided doses escalated to 14.0 mg/kg/day beginning at Randomization through Taper Phase then tapered to 3.5 mg/kg/day during 1 week Taper Phase

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Log Transformed 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase
Time Frame: Day 1 up to Day 14
All partial onset seizures experienced during treatment phase were recorded by central reader during the 48 to 72 hour video-electroencephalogram (EEG). Double Blind 24 hour EEG seizure rate for all partial onset seizures = ([Number of seizures in double blind 48 to 72 hour EEG assessment] divided by [number of hours of video-EEG monitoring])*24. The EEG assessment was done at the end of the fixed dose treatment. For log-transformation, the quantity 1 was added to the double blind 24 hour EEG seizure rate for all participants to account for any possible "0" seizure incidence. This resulted in final calculation as: log transformed (double-blind 24-hour EEG seizure rate + 1).
Day 1 up to Day 14

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Responder Rate: Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase
Time Frame: Day 1 up to Day 14
Responder Rate was defined as percentage of participants who had a 50% or greater reduction from baseline in 24-hour seizure rate during the double-blind treatment phase. Double Blind 24 hour EEG seizure rate for all partial onset seizures = ([Number of seizures in double blind 48 to 72 hour EEG assessment] divided by [number of hours of video-EEG monitoring])*24. The EEG assessment was done at the end of the fixed dose treatment.
Day 1 up to Day 14

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Day 1 up to End of study (EOS) (maximum Day 25)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were events which occurred between first dose of study drug and up to end of study (up to Day 25) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events.
Day 1 up to End of study (EOS) (maximum Day 25)
Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Day 1 up to EOS (maximum Day 25)
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were events which occurred between first dose of study drug and up to end of study (up to Day 25) that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to drug was assessed by the investigator. AEs included both serious and non-serious adverse events.
Day 1 up to EOS (maximum Day 25)
Number of Adverse Events by Severity
Time Frame: Day 1 up to EOS (maximum Day 25)
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified according to the severity in 3 categories a) mild: AEs does not interfere with participant's usual function b) moderate: AEs interferes to some extent with participant's usual function c) severe: AEs interferes significantly with participant's usual function.
Day 1 up to EOS (maximum Day 25)
Number of Participants With Laboratory Test Abnormalities
Time Frame: From Baseline up to EOS (maximum Day 25)
Abnormality Criteria: hemoglobin,hematocrit,red blood cells(RBC)count:<0.8*lower limit of normal[LLN],platelets:<0.5*LLN/>1.75*upper limit of normal[ULN]; leukocytes:<0.6*LLN/>1.5*ULN; lymphocytes,neutrophils, total protein,albumin, tetraiodothyronine,thyroid stimulating hormone:<0.8*LLN/>1.2*ULN; basophils,eosinophils,monocytes:>1.2*ULN; prothrombin [PT],PT international ratio:>1.1*ULN; aspartate aminotransferase,alanine aminotransferase,alkaline phosphatase,gamma glutamyl transferase:>0.3*ULN; bilirubin:>1.5*ULN; blood urea nitrogen,creatinine, cholesterol,triglycerides:>1.3*ULN; sodium: <0.95*LLN/>1.05*ULN; potassium,chloride,calcium,bicarbonate:<0.9*LLN/>1.1*ULN; glucose fasting:<0.6*LLN/>1.5*ULN; creatine kinase:>2*ULN;urine glucose,ketone,protein:>=1;urine WBC,RBC:>= 20/High Power Field[HPF]; urine casts,hyaline casts:>1/Low Power Field; urine bacteria:>20/HPF.
From Baseline up to EOS (maximum Day 25)
Number of Participants With Vital Signs Abnormalities
Time Frame: From Baseline (BL) up to EOS (maximum Day 25)
Criteria for abnormalities in vital signs included: sitting/supine systolic blood pressure (SBP) values: maximum increase and decrease of greater than or equal to (>=) 30 millimeter of mercury (mmHg) from baseline; sitting/supine diastolic blood pressure (DBP) value: maximum increase and decrease of >=20 mmHg from baseline.
From Baseline (BL) up to EOS (maximum Day 25)
Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study
Time Frame: Screening and EOS (maximum Day 25)
Physical examinations evaluated the following body systems/organs: abdomen; ears; extremities; eyes; general appearance; head; heart; lungs; lymph nodes; mouth; musculoskeletal; nose; skin and throat. Abnormalities in physical examination were based on investigator's discretion.
Screening and EOS (maximum Day 25)
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Time Frame: Baseline (BL) and EOS (maximum Day 25)
Neurological examinations included: coordination; cranial nerve function (CNF); gait and station; level of consciousness (LOC); lower and upper extremity sensation; muscle strength; muscle tone; nystagmus; reflexes and speech. Abnormalities in neurological examination were based on investigator's discretion and also, some components of the neurological examination were not done for certain participants due to participant age or significant developmental impairment. Only those categories of neurological examination in which at least 10% of participants had an abnormality in any treatment group at any time point were reported in this outcome measure.
Baseline (BL) and EOS (maximum Day 25)
Number of Participants With Electrocardiogram (ECG) Abnormalities
Time Frame: From screening up to EOS (maximum Day 25)
Criteria for abnormalities in ECG findings: 1) Time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS complex): >=140 milliseconds (msec); 2) The interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval): >=200 msec; 3) Time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate using Fridericia's formula (QTCF interval): absolute value 450 to <480 msec, 480 to <500 msec, >=500 msec; 4) Maximum QT interval: >=500 msec; 5) Maximum QTCB interval (Bazett's correction): 450 to< 480 msec, 480 to <500 msec, >=500 msec. Only those categories of ECG abnormalities in which participants were found abnormal (maximum QTCB interval 450-<480 msec), were reported in this outcome measure.
From screening up to EOS (maximum Day 25)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 16, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 13, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 13, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2014

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 20, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A0081042
  • 2013-003420-37 (EUDRACT_NUMBER)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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