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Study Evaluating LAMICTAL Extended-Release Therapy Added To Current Seizure Treatments In Patients With Partial Seizures

NCT ID: NCT00113165

Last Updated: 2016-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

244 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2007-07-31

Brief Summary

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This study is being conducted to compare the efficacy and safety of LAMICTAL (lamotrigine) extended-release with placebo in the treatment of partial seizures. LAMICTAL extended-release is an investigational drug. Placebo tablets look like LAMICTAL extended-release tablets but do not contain active medication. In this study, LAMICTAL extended-release or placebo tablets will be added to current seizure treatments.

Detailed Description

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Conditions

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Epilepsy Epilepsy, Partial

Keywords

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partial seizures Epilepsy antiepileptic drugs anticonvulsants LAMICTAL seizures lamotrigine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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LAMICTAL extended-release

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of epilepsy with partial seizures for more than 24 weeks.
* Must experience at least 8 partial seizures during an 8-week Baseline Phase.
* Must currently be receiving treatment with a stable regimen of one or two antiepileptic drugs for at least four weeks.
* Patient or parent/caregiver must be willing and able to maintain a written daily seizure diary.

Exclusion Criteria

* Previous treatment with lamotrigine.
* Exhibits any primary generalized seizures.
* Receiving treatment with felbamate or currently following the ketogenic diet.
* Pregnant, breastfeeding, or planning to become pregnant.
Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Anniston, Alabama, United States

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Birmingham, Alabama, United States

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Northport, Alabama, United States

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Tuscaloosa, Alabama, United States

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Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Scottsdale, Arizona, United States

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Sun City, Arizona, United States

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Newport Beach, California, United States

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Santa Monica, California, United States

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Sepuldeva, California, United States

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Washington D.C., District of Columbia, United States

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Washington D.C., District of Columbia, United States

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Hollywood, Florida, United States

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Maitland, Florida, United States

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Ocala, Florida, United States

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Tallahassee, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Austell, Georgia, United States

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Savannah, Georgia, United States

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Chicago, Illinois, United States

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Flossmoor, Illinois, United States

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Springfield, Illinois, United States

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Des Moines, Iowa, United States

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Wichita, Kansas, United States

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Crestview Hills, Kentucky, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Detroit, Michigan, United States

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Grand Rapids, Michigan, United States

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Traverse City, Michigan, United States

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Minneapolis, Minnesota, United States

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Minneapolis, Minnesota, United States

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Chesterfield, Missouri, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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Edison, New Jersey, United States

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West Orange, New Jersey, United States

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New York, New York, United States

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Plainview, New York, United States

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Asheville, North Carolina, United States

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Chapel Hill, North Carolina, United States

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Greenville, North Carolina, United States

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Raleigh, North Carolina, United States

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Columbus, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Cheswick, Pennsylvania, United States

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Greensburg, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Galveston, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Wichita Falls, Texas, United States

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Salt Lake City, Utah, United States

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Richmond, Virginia, United States

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Seattle, Washington, United States

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Milwaukee, Wisconsin, United States

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Capital Federal, Buenos Aires, Argentina

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Curitiba, Paraná, Brazil

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Campinas, São Paulo, Brazil

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Santiago, Región Metro de Santiago, Chile

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Santiago, Región Metro de Santiago, Chile

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Singen, Baden-Wurttemberg, Germany

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Ulm, Baden-Wurttemberg, Germany

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Alzenau in Unterfranken, Bavaria, Germany

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Bamberg, Bavaria, Germany

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Fürth, Bavaria, Germany

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Munich, Bavaria, Germany

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Neuötting, Bavaria, Germany

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Straubing, Bavaria, Germany

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Unterhaching, Bavaria, Germany

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Würzburg, Bavaria, Germany

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Bernau bei Berlin, Brandenburg, Germany

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Ludwigsfelde, Brandenburg, Germany

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Hamburg, City state of Hamburg, Germany

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Hamburg, City state of Hamburg, Germany

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Hamburg, City state of Hamburg, Germany

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Hamburg, City state of Hamburg, Germany

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Hamburg, City state of Hamburg, Germany

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Bad Homburg, Hesse, Germany

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Frankfurt am Main, Hesse, Germany

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Giessen, Hesse, Germany

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Bückeburg, Lower Saxony, Germany

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Göttingen, Lower Saxony, Germany

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Osnabrück, Lower Saxony, Germany

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Wismar, Mecklenburg-Vorpommern, Germany

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Wismar, Mecklenburg-Vorpommern, Germany

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Baesweiler, North Rhine-Westphalia, Germany

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Bochum, North Rhine-Westphalia, Germany

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Bochum, North Rhine-Westphalia, Germany

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Cologne, North Rhine-Westphalia, Germany

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Cologne, North Rhine-Westphalia, Germany

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Essen, North Rhine-Westphalia, Germany

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Essen, North Rhine-Westphalia, Germany

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Hattingen, North Rhine-Westphalia, Germany

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Mönchengladbach, North Rhine-Westphalia, Germany

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Münster, North Rhine-Westphalia, Germany

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Limburgerhof, Rhineland-Palatinate, Germany

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Chemnitz, Saxony, Germany

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Flöha, Saxony, Germany

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Leipzig, Saxony, Germany

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Radeberg, Saxony, Germany

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Bernburg, Saxony-Anhalt, Germany

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Halle, Saxony-Anhalt, Germany

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Magdeburg, Saxony-Anhalt, Germany

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Magdeburg, Saxony-Anhalt, Germany

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Naumburg, Saxony-Anhalt, Germany

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Kiel, Schleswig-Holstein, Germany

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Berlin, State of Berlin, Germany

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Berlin, State of Berlin, Germany

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Berlin, State of Berlin, Germany

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Jena, Thuringia, Germany

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Jena-Lobeda, Thuringia, Germany

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Hyderabad, Andhra Pradesh, , India

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Lucknow, , India

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New Delhi, , India

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San Germán, Puerto Rico, Puerto Rico

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San Juan, Puerto Rico, Puerto Rico

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San Juan, Puerto Rico, Puerto Rico

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Yekaterinburg, , Russia

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Kharkiv, , Ukraine

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Kyiv, , Ukraine

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Lviv, , Ukraine

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Countries

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United States Argentina Brazil Chile Germany India Puerto Rico Russia South Korea Ukraine

References

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Naritoku DK, Warnock CR, Messenheimer JA, Borgohain R, Evers S, Guekht AB, Karlov VA, Lee BI, Pohl LR. Lamotrigine extended-release as adjunctive therapy for partial seizures. Neurology. 2007 Oct 16;69(16):1610-8. doi: 10.1212/01.wnl.0000277698.33743.8b.

Reference Type BACKGROUND
PMID: 17938371 (View on PubMed)

van Dijkman SC, de Jager NCB, Rauwe WM, Danhof M, Della Pasqua O. Effect of Age-Related Factors on the Pharmacokinetics of Lamotrigine and Potential Implications for Maintenance Dose Optimisation in Future Clinical Trials. Clin Pharmacokinet. 2018 Aug;57(8):1039-1053. doi: 10.1007/s40262-017-0614-5.

Reference Type DERIVED
PMID: 29363050 (View on PubMed)

Study Documents

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Document Type: Dataset Specification

View Document

Document Type: Clinical Study Report

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Document Type: Annotated Case Report Form

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Informed Consent Form

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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LAM100034

Identifier Type: -

Identifier Source: org_study_id