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Study Title Principal Investigator
Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study)
Completed | Parkinson's Disease | Multisite
Clinical Director
Cochlear Implantation for Single-Sided Deafness
Active, not recruiting | deaf adult | Multisite
Robert Shannon
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CD Flex: An Open-Label, Non-Inferiority Study Evaluating the Efficacy and Safety of Two Injection Schedules of Xeomin (incobotulinumtoxinA) [Short Flex vs. Long Flex] in Subjects with Cervical Dystonia with < 10 Weeks of Benefit from OnabotulinumtoxinA Treatment MUS 60201 4073 1
Dystonia is a movement disorder characterized by sustained, involuntary muscle contractions which frequently causes twisting and repetitive movements or abnormal postures. Cervical dystonia (CD) is the most commonly described form of focal dystonia (abnormality involving a single area of the body). Xeomin (botulinum toxin type A), the study drug, has been shown to be effective and safe in the treatment of CD with two Phase III trials. Current practice in the treatment of CD with onabotulinumtoxinA (Botox) injection is to inject patients every 3 months. However, not all patients receive benefit from injections for the duration of 3 months. This study is designed to examine a shorter treatment interval with Xeomin injections and compare to the standard interval to determine if there is a difference from an efficacy standpoint (i.e., do the patients receive continuous benefit versus peaks and valleys) and if more frequent dosing leads to more development of botulinum toxin resistance. This study will evaluate if shorter dosing intervals is non-inferior to standard or longer dosing intervals by using the Toronto Western Spasmodic Torticollis Scale (TWSTRS) at control Visit 4 weeks post the the 8th injection. Secondary outcomes will evaluate efficacy, onset and offste of efficacy, safety and immunology. The primary efficacy variable will be defined as the change from study entry baseline in the TWSTRS-Severity score assessed at the 4-week control visti after the 8th injection (PPS sample). An analysis of covariance (ANCOVA) will be used for the primary efficacy analysis. All analysis of secondary endpoints for efficacy will be considered exploratory.
Active, not recruiting | Dystonia | Multisite
Jennifer Hui
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A Phase III, Open-Label, Extension Trial of ECU-MG-301 to Evaluate the Safety and Efficacy of Eculizumab in Subjects with Refractory Generalized Myasthenia Gravis (gMG).
This is a phase III, open label, extension trial of ECU-MG-301(HS-13-00805) to evaluate the safety and efficacy of Eculizumab in subjects with refractory generalized myasthenia gravis (gMG). Eculizumab is a humanized monoclonal antibody that was derived from the murine anti-human C5 antibody m5G1.1. Myasthenia Gravis is a rare, debilitating, acquired autoimmune disease of the neuromuscular junction (NMJ), clinically characterized by weakness and fatigability of skeletal muscle. Since complement activation plays a pivotal role in the pathophysiology of MG, eculizumab, a terminal complement inhibitor, as such may benefit patients who continue to have generalized weakness and bulbar signs and symptoms despite current standard of care. The primary objective of this trial is to evaluate the long-term safety of eculizumab in subjects with refractory gMG. Subjects who complete the 26-week treatment period (Visit 17) in the ECU-MG-301(HS-13-00805) trial may potentially enter this extension trial. There will be 3 periods in this study, Blind Induction Phase, Open-Label Maintenance Phase and Safety Follow-up Period. To preserve the blinded nature of the ECU-MG-301 trial, all subjects must undergo a blind induction phase and will receive blinded Investigational Product (IP) weekly for four (4) doses. Patients who were randomized to the placebo arm in the ECU-MG-301 trial will receive 4 vials IP (3 vials/900 mg eculizumab plus 1 vial placebo) at Visits 1 to 4. Patients who were randomized to the eculizumab arm in the ECU-MG-301 trial will continue to receive 4 vials IP (1200 mg eculizumab) every two weeks at Visits 1 and 3 and placebo at Visits 2 and 4. All subjects will receive open-label eculizumab (4 vials/1200 mg) every 2 weeks during the open level maintenance phase. On-Trial Rescue Therapy (high dose corticosteroid,plasmapheresis /plasma exchange (PE) or Intravenous Immunoglobulin,) will be allowed if a subject experiences clinical deterioration as defined in this protocol. For a subject who is discontinued from this trial, a follow-up visit for safety evaluation will be required. Primary efficacy endpoint is Safety and tolerability of eculizumab. Secondary Efficacy Endpoints will include the total change of QMG (Quantitative Myasthenia Gravis) score and total change of Myasthenia Gravis Composite (MGC) score. Safety analyses will be performed on the Safety Population and the Extension Safety Population includes all subjects who receive at least 1 dose of IP (eculizumab or Placebo). There is no interim analysis planned for this trial.
Enrolling by invitation | Myasthenia Gravis | Site Unknown
Said Beydoun
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Pilot Study Investigating the Utility of Epidural AlloGen-LI Injection for Treatment of Spinal Stenosis Symptoms
AlloGen-LI contains multiple factors that may serve to ameliorate the detrimental effects of osteorarthritis and degenerative disc disease. Anti-inflammatory components include inhibitors of matrix metalloproteins and pro-inflammatory cytokines, growth factors and interleukins. The product has low immunogenicity and is hypo-osmotic.2 Placental tissues, including amniotic fluid, amniotic membrane and chorion are regulated as human cell and tissue products (HCTP) by the FDA. This regulation allows clinicians to use the allograft materials for human injection. AlloGen-LI is derived from placental tissues obtained from carefully screened healthy mothers at the time of scheduled cesarean section. The mothers have agreed to donate the tissues, which would otherwise be discarded. The experimental treatment would entail an injection of one dose of AlloGen-LI and marcaine into the epidural space under CT guidance, in an identical manner to traditional epidural steroid /marcaine injections.
Enrolling by invitation | disc herniation | Not Multisite
Wende Gibbs
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A Phase 3, Randomized, Double Blind, Placebo And Active‑Controlled, Multicenter, Parallel‑Group Study Of The Analgesic Efficacy And Safety Of Tanezumab In Adult Subjects With Chronic Low Back Pain
This is a randomized, double blind, placebo and active controlled, multicenter, parallel group Phase 3 study of the efficacy and safety of tanezumab when administered by SC injection for up to 56 weeks in subjects with chronic low back pain. Approximately 1800 subjects will be randomized to 1 of 4 treatment groups in a 2:2:2:3 ratio (ie, 400 subjects per treatment group for the placebo, tanezumab 5 mg and tanezumab 10 mg treatment groups and 600 subjects in the tramadol PR treatment group). Treatment groups will include: 1.) Placebo administered SC at an 8 week interval plus placebo matching tramadol PR up to Week 16. At the Week 16 visit, subjects in this group who meet the efficacy responder criteria will be switched in a blinded fashion in a 1:1 ratio to either tanezumab 5 mg or tanezumab 10 mg administered SC at an 8 week interval plus placebo matching tramadol PR to Week 56; 2.)Tanezumab 5 mg SC administered at an 8 week interval plus placebo matching tramadol PR to Week 56; 3.) Tanezumab 10 mg SC administered at an 8 week interval plus placebo matching tramadol PR to Week 56; 4.) Oral tramadol PR plus placebo administered SC at an 8 week interval to Week 56. The study is designed with a total duration (post randomization) of up to 80 weeks and will consist of three periods: Screening (up to a maximum of 37 days; includes a Washout Period and an Initial Pain Assessment Period), a Double blind Treatment Period (comprised of a 16 week Primary Efficacy Phase and a 40 week Long Term Safety and Efficacy Phase), and a Follow up Period (24 weeks). The Screening Period (beginning up to 37 days prior to Randomization) includes a Washout Period (lasting 2 32 days), if required, and an Initial Pain Assessment Period (the 5 days prior to Randomization/Baseline). Prior to entering the study, subjects must have a documented history of previous inadequate treatment response to medications in 3 different categories of agents commonly used to treat and generally considered effective for the treatment of chronic low back pain.
Recruiting | Chronic low back pain | Multisite
Pfizer Center
A Study Of Pregabalin In The Treatment Of Subjects With Painful Diabetic Peripheral Neuropathy With Background Treatment Of Nsaid For Other Pain Conditions
Completed | Diabetes | Multisite
Pfizer Center
A Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Tolerability, and Safety of NXN-462 in Patients With Post-Herpetic Neuralgia (PHN)
NXN-462 is designed to target the nitric oxide synthase system (NOS), specifically the neuronal NOS (nNOS) isoform. By design, NXN-462 is a potent inhibitor of nNOS with good affinity, and has little or no affinity for a range of G protein-coupled receptors, ion channels, and enzymes. NXN-462 is being developed as an oral therapy for the treatment of neuropathic pain syndromes, including PHN. This drug design strategy provides a new therapeutic paradigm for the treatment of chronic neuropathic pain.
Completed | Neuralgia | Multisite
Thomas Lategan
A Randomized Double Blind Placebo Controlled Parallel Group Study Of The Efficacy And Safety Of Pregabalin (Bid) In Subjects With Post-traumatic Peripheral Neuropathic Pain
Completed | Neuralgia | Multisite
Pfizer Center
Randomized Phase III Clinical Trial of Adjuvant Radiation Versus Chemoradiation in Intermediate Risk, Stage I/IIA Cervical Cancer Treated With Initial Radical Hysterectomy and Pelvic Lymphadenectomy
PRIMARY OBJECTIVES: I. To determine if post-operative adjuvant chemo-radiation therapy (CRT) can significantly improve recurrence-free survival (RFS) when compared to radiation therapy (RT) alone in stage I-IIA cervical cancer patients with intermediate-risk factors after treatment with radical hysterectomy. SECONDARY OBJECTIVES: I. To determine whether post-operative adjuvant CRT can improve overall survival (OS) when compared to RT alone in stage I-IIA cervical cancer patients with intermediate risk factors after treatment with radical hysterectomy. II. To assess differences (across treatment arms) in incidence and severity of therapy-attributed adverse events utilizing the active version of Common Terminology Criteria for Adverse Events (CTCAE). III. To provide assessment of patient risk vs benefit (positive study only). IV. To determine whether post-operative adjuvant CRT improves the health-related quality-of-life (QOL) (compared to RT alone) as measured by Functional Assessment of Cancer Therapy-Cervix (FACT-Cx) Trial Outcome Index (TOI) and produce favorable toxicity profiles (with particular focus on treatment related genitourinary, gastrointestinal, neurological, pain and sexual adverse events). TERTIARY OBJECTIVES: I. To bank archival tumor tissue for research studies, including studies that evaluate the association between biomarkers, RFS, OS, and clinical-surgical-pathologic characteristics in patients randomized to post-operative adjuvant CRT compared to RT alone. II. To bank deoxyribonucleic acid (DNA) from whole blood for research studies, including studies that evaluate associations between single nucleotide polymorphisms (SNPs), and measures of clinical outcome, including RFS, OS, and adverse events in patients randomized to post-operative adjuvant CRT compared to RT alone. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients undergo pelvic external-beam radiation therapy (EBRT) or intensity-modulated radiation therapy (IMRT) 5 days a week for 5.5 weeks. ARM II: Patients receive cisplatin IV over 1-2 hours on day 1 and undergo radiotherapy as in Arm I. Treatment with cisplatin repeats every 7 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Recruiting | Gynecologic Cancers | Multisite
Sang Ryu
Pilot Study for Evaluation of Glatiramer Acetate in RRMS Patients With Comorbid Autoimmune Conditions
Multiple Sclerosis (MS) is an auto-immune neurodegenerative disease that affects more than 400,000 individuals in the United States, and 2.5 million worldwide (www.nationalmssociety.org). The main pathogenic mechanism in MS involves an inflammatory condition that damages the myelin of the central nervous system (CNS), resulting in axonal damage and neurological impairment, often leading to severe disability. MS is one of the most common causes of neurological disability in young and middle-aged adult individuals, and as such has a tremendous physical, psychological and social impact on patients' lives. MS is a complex disease diagnosed by McDonald criteria with different clinical and pathological phenotypes. Several forms of MS have been described: Relapsing-Remitting (RRMS), Secondary-Progressive MS (SPMS), Progressive-Relapsing MS (PRMS), and Primary-Progressive MS (PPMS). Glatiramer Acetate (GA) and Beta-Interferons (β-IFNs) are well established first-line immunomodulating treatment options for relapsing remitting multiple sclerosis (RRMS) with excellent safety profiles. The mechanisms of action of GA and IFNs are different. It is well known that in general Disease-Modifying Treatments (DMTs) reduce relapse rate in more than half of the multiple sclerosis (MS) patients who receive DMT, while having little if any effect on the rest. It has been speculated that the response to beta-interferons or GA may have genetic basis. As Axtell RC et al. indicated the experimental autoimmune encephalomyeilits (EAE) in mouse caused by TH1 cells generally respond well to interferon-beta, while EAE caused by TH17 cells get worse with interferon-beta. Autoimmune disease is an extreme situation where the autoimmune response overshoots and goes out of control. The other extreme is a degenerative disorder, where the autoimmune response is not strong enough for effective protection, and degeneration therefore continues. GA being an immunomodulator may provide both properly regulated immune suppression (in the case of autoimmune disease) and properly regulated immune activation (in the case of the neurodegenerative disease). Autoimmune conditions cluster in families with high risk for multiple sclerosis than in general population which suggests that the disease might arise on a background of a generalized susceptibility to autoimmunity. Occurrence of psoriasis, autoimmune thyroiditis, vasculitis, rheumatoid arthritis, scleroderma, lupus are seen more commonly in MS patients. Many of these patients initially get started on beta-IFNs, and usually do not do well on them. According to Investigator's and the USC MS Comprehensive Care Center experience, autoimmune co-morbidity associated with MS can serve as a biological marker predicting good response to GA and unfavorable response to the IFNs.
Completed | Multiple Sclerosis | Not Multisite
Regina Berkovich
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A Randomized, Double-Blind, Placebo-Controlled Study of SD-809 (Deutetrabenazine) for the Treatment of Moderate to Severe Tardive Dyskinesia
Completed | Dyskinesias | Multisite
Michael Huang
A PHASE IIIb, MULTICENTRE, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF DYSPORT USING 2 mL DILUTION IN ADULTS WITH CERVICAL DYSTONIA A-TL-52120-169
A multicentre, randomised, double blind, placebo controlled study where at study entry, subjects will be randomised in a ratio of 2:1 to receive either Dysport or placebo. The primary objective of the study is to evaluate the efficacy and safety of Dysport 500 units (U)/vial using 2 mL dilution compared with placebo for the treatment of cervical dystonia (CD). All subjects are planned to have a single treatment in this study. Following study treatment, follow up visits will be performed at Week 2, Week 4 and Week 12 (+28 days/4 weeks) or early withdrawal due to any reason. All subjects who complete the Week 12 visit will be considered to have completed the study and will be offered entry into an open label extension (OLE) study, which consists of up to three treatment cycles of Dysport using the 2 mL dilution scheme. Between Weeks 4 and 8, subjects may be deemed eligible for early entry into the OLE study, i.e. before they reach the planned Week 12 study visit if rescue treatment is needed. Approximately 132 male and female subjects with CD will be enrolled. The primary efficacy endpoint is the change from baseline in TWSTRS total score at Week 4. Clinical Trial Rationale:The current USPI allows for only one dilution of Dysport: 500 U in 1 mL volume. Feedback obtained from scientific experts and Investigators at medical advisory boards and in market research data has pointed to the lack of scientific data supporting a 2 mL dilution as an obstacle to providing appropriate, safe and effective Dysport utilisation in the USA for subjects suffering from CD. Despite the lack of labelled information, the 2 mL dilution with Dysport reflects real world clinical practice in the USA.The addition of data in the USPI supporting the safety and efficacy of a 2 mL dilution with Dysport will provide the clinician more flexibility in injection volume range to better equip them to meet the needs of a broader spectrum of subjects with CD. Therefore, in this clinical study the majority of enrolled subjects will be previously treated with Botox to reflect the real world clinical scenario in the USA.Statistical analyses will be performed by an external CRO. Statistical evaluation will be performed by using SAS. Exploratory analysis will be performed for each of the tertiary secondary efficacy endpoints using appropriate methods.
Active, not recruiting | Dystonia | Multisite
Jennifer Hui
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A Phase 3b, Prospective, Multicenter, Open-Label Extension Study to Assess Long Term Safety and Efficacy of DYSPORT Using 2mL Dilution in Adults with Cervical Dystonia
A phase 3b, prospective, multicenter, open-label extension study to assess the long term safety and effectiveness of Dysport using 2 mL dilution in adults with cervical dystonia. This study is open to subjects who have completed the Dysport double-blind study protocol A-TL-52120-169 or are eligible for early entry, from enrollment into the 169 study.Clinical Trial Rationale:The current USPI allows for only one dilution of Dysport: 500 U in 1 mL volume. Feedback obtained from scientific experts and Investigators at medical advisory boards and in market research data has pointed to the lack of scientific data supporting a 2 mL dilution as an obstacle to providing appropriate, safe and effective Dysport utilisation in the USA for subjects suffering from CD. Despite the lack of labelled information, the 2 mL dilution with Dysport reflects real world clinical practice in the USA.The addition of data in the USPI supporting the safety and efficacy of a 2 mL dilution with Dysport will provide the clinician more flexibility in injection volume range to better equip them to meet the needs of a broader spectrum of subjects with CD. The primary objective of the study is to assess long term safety of repeat treatment cycles of Dysport 500 units (U)/vial using 2 mL dilution scheme for the treatment of cervical dystonia (CD). Secondary objective is to assess long term efficacy of repeat treatment cycles of Dysport 500 units (U)/vial using 2 mL dilution scheme for the treatment of cervical dystonia (CD). The study consists of up to three treatment cycles of Dysport using the 2 mL dilution scheme. Approximately 132 male and female subjects with CD will be enrolled. The primary efficacy endpoint is the change from treatment cycle baseline (defined as Day 1 in each cycle) in TWSTRS total score at Week 4 and Week 12 visits, in Treatment Cycles 1, 2, and 3. Statistical analyses will be performed by an external CRO. Statistical evaluation will be performed by using SAS.
Enrolling by invitation | Dystonia | Multisite
Jennifer Hui
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