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Center for Global Research Data

The effects of systemic anti-infective concomitant medications on progression of neurological diseases

Lead Investigator: Chaim Singal, experiMind
Title of Proposal Research: The effects of systemic anti-infective concomitant medications on progression of neurological diseases
Vivli Data Request: 7143
Funding Source: None
Potential Conflicts of Interest: None

Summary of the Proposed Research:

Various evidence suggests neurological conditions may be induced or exacerbated by microbial infections. Furthermore, it has been shown that anti-infective medications may have neuroprotective properties. A retrospective cohort study was chosen for this research as this will enable me to examine many type of diseases, and many groups of medications, without the need to expose new patients for a new investigation by using existing data. The availability of clinical data from various randomized studies makes such data an attractive source for systematic research on many diseases and many groups of anti-infective medications. I will examine the effect of anti-infective agents on the progression of neurological diseases. Participants from the placebo group in neurological clinical trials who were administered anti-infective drugs for reasons unrelated to the clinical trial will be assessed for changes in their neurological condition and compared with placebo patients not given anti-infectives. These results will elucidate the potential risks and benefits of anti-infective medications for neurological diseases and will assist to better frame their clinical advantages for future clinical trials.

Requested Studies:

A Randomised, Double Blind, Placebo-controlled, Parallel Group Study to Investigate the Safety and Efficacy of Controlled-release Ropinirole (CR) (1-24 mg) Administered Once Daily for 12 Weeks in Subjects With Fibromyalgia
Data Contributor: GlaxoSmithKline
Study ID: NCT00256893
Sponsor ID: ROF102100

Duloxetine 60/120mg Versus Placebo in the Treatment of Fibromyalgia Syndrome
Data Contributor: Lilly
Study ID: NCT00233025
Sponsor ID: 9072

Flexible Dosed Duloxetine Versus Placebo in the Treatment of Fibromyalgia
Data Contributor: Lilly
Study ID: NCT00673452
Sponsor ID: 12220

A Randomized, Double-Blind Comparison of Duloxetine 30 mg QD and Placebo in Adult Patients With Fibromyalgia
Data Contributor: Lilly
Study ID: NCT00965081
Sponsor ID: 12873

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Episodic Migraine – the EVOLVE-2 Study
Data Contributor: Lilly
Study ID: NCT02614196
Sponsor ID: 15768

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Chronic Migraine – the REGAIN Study
Data Contributor: Lilly
Study ID: NCT02614261
Sponsor ID: 15769

A Double-blind, Double-dummy, Placebo-controlled, Randomized, Three Parallel Groups Study Comparing the Efficacy, Safety and Tolerability of Pramipexole ER Versus Placebo and Versus Pramipexole IR Administered Orally Over a 26-week Maintenance Phase in Patients With Early Parkinsons Disease (PD).
Data Contributor: Boehringer Ingelheim
Study ID: NCT00479401
Sponsor ID: 248.524

A Double-blind, Double-dummy, Placebo-controlled, Randomized, Three Parallel Groups Study Comparing the Efficacy, Safety and Tolerability of Pramipexole Extended Release (ER) Versus Placebo and Versus Pramipexole Immediate Release (IR) Administered Orally Over a 26-week Maintenance Phase in L-Dopa+ Treated Patients With Advanced Parkinsons Disease (PD).
Data Contributor: Boehringer Ingelheim
Study ID: NCT00466167
Sponsor ID: 248.525

A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment With Ropinirole CR as Adjunctive Therapy in Patients With Parkinson’s Disease Who Are Not Optimally Controlled on L-dopa
Data Contributor: GlaxoSmithKline
Study ID: NCT00381472
Sponsor ID: 101468/169

A Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Examine the Efficacy and Safety of Early Pramipexole (PPX) Treatment Versus Delayed Pramipexole Treatment in Patients With New Onset Parkinson’s Disease.
Data Contributor: Boehringer Ingelheim
Study ID: NCT00321854
Sponsor ID: 248.595

A Multi-centre, Multi-national, Phase 3, Randomized, Double-blind, Double-dummy, 3- Arm Parallel Group, Placebo- and Pramipexole- Controlled Trial of the Efficacy and Safety of Rotigotine Patch in Subjects With Advanced Stage, Idiopathic Parkinson’s Disease Who Are Not Well Controlled on Levodopa
Data Contributor: UCB
Study ID: NCT00244387
Sponsor ID: SP0515

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Four 12-week Treatment Cycles (48 Weeks Total) of Epratuzumab in Systemic Lupus Erythematosus Subjects With Moderate to Severe Disease
Data Contributor: UCB
Study ID: NCT01262365
Sponsor ID: SL0009

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Four 12-week Treatment Cycles (48 Weeks Total) of Epratuzumab in Systemic Lupus Erythematosus Subjects With Moderate to Severe Disease
Data Contributor: UCB
Study ID: NCT01261793
Sponsor ID: SL0010

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 76-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE)
Data Contributor: GlaxoSmithKline
Study ID: NCT00410384
Sponsor ID: HGS1006-C1056

A 54-week, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Effects of Rosiglitazone (Extended Release Tablets) as Adjunctive Therapy to Donepezil on Cognition and Overall Clinical Response in APOE ε4-stratified Subjects With Mild to Moderate Alzheimer’s Disease.
Data Contributor: GlaxoSmithKline
Study ID: NCT00348309
Sponsor ID: AVA102672

Effect of γ-Secretase Inhibition on the Progression of Alzheimer’s Disease: LY450139 Versus Placebo
Data Contributor: Lilly
Study ID: NCT00594568
Sponsor ID: 7666

A Multi-centre, Double-blind, Parallel-group, Randomised Controlled Study to Investigate Efficacy, Safety and Tolerability of Orally Administered BI 409306 During a 12-week Treatment Period Compared to Placebo in Patients With Cognitive Impairment Due to Alzheimer’s Disease
Data Contributor: Boehringer Ingelheim
Study ID: NCT02337907
Sponsor ID: 1289.7

A Randomized, Double-Blind, Placebo- and Active-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy
Data Contributor: Lilly
Study ID: NCT01710358
Sponsor ID: 13978

A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate for Inducing and Sustaining Clinical Response in the Treatment of DMARD-Naïve Adults With Early Active Rheumatoid Arthritis
Data Contributor: UCB
Study ID: NCT01521923
Sponsor ID: RA0055 Period 2

A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate for Inducing and Sustaining Clinical Response in the Treatment of DMARD-Naïve Adults With Early Active Rheumatoid Arthritis
Data Contributor: UCB
Study ID: NCT01519791
Sponsor ID: RA0055 Period 1

A 24-week, Double-blind, Double-dummy, Randomized, Parallel-group Study to Investigate the Effects of Rosiglitazone (Extended Release Tablets), Donepezil, and Placebo as Monotherapy on Cognition and Overall Clinical Response in APOE ε4-stratified Subjects With Mild to Moderate Alzheimer’s Disease. (REFLECT-1)
Data Contributor: GlaxoSmithKline
Study ID: NCT00428090
Sponsor ID: 105640

A Randomized, Double-blind, Multi-center, Placebo-controlled, Cross-over Study to Determine the Consistency of Response for Trexima (Sumatriptan 85mg/Naproxen Sodium 500mg) Administered During the Mild Pain Phase for the Acute Treatment of Multiple Migraine Attacks
Data Contributor: GlaxoSmithKline
Study ID: NCT00240630
Sponsor ID: TRX103632

A Randomized, Double-blind, Multi-center, Placebo-controlled, Cross-over Study to Determine the Consistency of Response for Trexima* (Sumatriptan 85mg/Naproxen Sodium 500mg) Administered During the Mild Pain Phase for the Acute Treatment of Multiple Migraine Attacks (*Treximet)
Data Contributor: GlaxoSmithKline
Study ID: NCT00240617
Sponsor ID: TRX103635

TXA107979: A Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of a Combination Product Containing Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine in Adolescents
Data Contributor: GlaxoSmithKline
Study ID: NCT00843024
Sponsor ID: TXA107979

A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™)a Fully Human Monoclonal Anti-BLyS Antibody in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057
Data Contributor: GlaxoSmithKline
Study ID: NCT00712933
Sponsor ID: 112234

A Randomized, Double-Blind, Placebo-Controlled 52-Week Study to Assess Adverse Events of Special Interest in Adults With Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab
Data Contributor: GlaxoSmithKline
Study ID: NCT01705977
Sponsor ID: 115467

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects With Systemic Lupus Erythematosus (SLE)
Data Contributor: GlaxoSmithKline
Study ID: NCT01484496
Sponsor ID: 112341

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Wk Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE)
Data Contributor: GlaxoSmithKline
Study ID: NCT00424476
Sponsor ID: HGS1006-C1057

A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 24-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Biologic Disease-Modifying Antirheumatic Drug-Naive Patients With Active Psoriatic Arthritis
Data Contributor: Lilly
Study ID: NCT01695239
Sponsor ID: 13731

Phase 3, Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Subjects With Adult-Onset Active and Progressive Psoriatic Arthritis (PsA)
Data Contributor: UCB
Study ID: NCT01087788
Sponsor ID: PsA001

Update: This data request was withdrawn on 7-Apr-2022 by the researcher.