Clinical trials: Neurotoxicity Syndrome
Healthy
Study to Evaluate Safety and PK of a Single IM Dose of G03-52-01 vs Placebo in Adult Subjects
A Phase 1, randomized, double-blind, placebo-controlled dose escalation trial of four dose cohorts of 10 subjects (1: 10mg, 2: 25mg, 3: 50mg, 4: 100mg).
- Trial name
- NCT04171115
- Testing
- G03-52-01
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Alachua Government Services, Inc.
Metastases, Colorectal Neoplasms
XENOX - Evaluation of the Efficacy of Xaliproden in Reducing the Neurotoxicity of the Oxaliplatin + 5-FU/LV Chemotherapy
Purpose of the trial is to evaluate the efficacy of Xaliproden in reducing the neurotoxicity of the Oxaliplatin and 5-FU/LV chemotherapy, in patients with metastatic colorectal carcinomaPrimary objectives : Compare the risk of…
- Conditions
- Metastases, Colorectal Neoplasms, Colorectal Carcinoma
- Trial name
- NCT00272051
- Testing
- SR57746A
- Volunteers
- 620 people
- Sponsor
- Sanofi
Botulism
Phase 3, Randomized, Safety, Lot Consistency and Clinical Benefit Study of Recombinant Botulinum Vaccine A/B
This Phase 3 clinical trial is a double blind, placebo-controlled, randomized, multicenter investigation of rBV A/B in male and female healthy adults 18 to 55 years of age.
- Trial name
- rBV A/B (NCT01940315)
- Testing
- rBV A/B
- Volunteers
- healthy volunteers welcome
- Sponsor
- DynPort Vaccine Company LLC, A GDIT Company
NSCLC Adenocarcinoma, Solid Tumor
Atamparib in Patients With Advanced Solid Tumors
This is a multi-part, open-label, non-randomized phase Ib/II clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of atamparib, an investigational agent, in patients…
- Trial name
- PARP7 (NCT07374419)
- Testing
- atamparib escalation levels, atamparib RP2D
- Where
- China
- Volunteers
- 178 people
- Sponsor
- Nerviano Medical Sciences (Shanghai) Ltd.
Botulism
BT-011 Pharmacokinetics of Botulism Antitoxin Heptavalent in Pediatric Patients
The purpose of this study is to verify the pediatric dosing recommendations for BAT product in pediatric patients that are treated with BAT product due to a confirmed or suspected case of botulism.
- Trial name
- NCT02051062
- Testing
- Blood sample collection
- Volunteers
- 10 people
- Sponsor
- Emergent BioSolutions
Dyskinesia, Medication-induced
Levetiracetam in the Treatment of Neuroleptic-induced Tardive Dyskinesia
An 8-week study to examine safety and efficacy of levetiracetam in patients with neuroleptic-induced tardive dyskinesia
- Trial name
- NCT00175955
- Testing
- Levetiracetam
- Where
- 7 sites in Belgium, Bulgaria
- Volunteers
- 70 people
- Sponsor
- UCB Pharma
Akathisia, Drug-Induced, Antipsychotic Agents
Study of Preladenant for the Treatment of Neuroleptic Induced Akathisia (Study P05145)
This study is designed to evaluate the effectiveness of preladenant in the prevention (Part 1) or treatment (Part 2) of antipsychotic induced akathisia in participants with acute psychosis using the Barnes Akathisia Scale.
- Conditions
- Akathisia, Drug-Induced, Antipsychotic Agents, Movement Disorders
- Trial name
- NCT00693472
- Testing
- Preladenant, Anticholinergic agents or propanolol, Haloperidol
- Volunteers
- 46 people
- Sponsor
- Merck Sharp & Dohme LLC
Parkinson Disease, Dyskinesia, Medication-Induced
AV-101 (L-4-chlorokynurenine) in Parkinson's Disease Subjects With Levodopa-Induced Dyskinesia
This is a randomized, double-blind, placebo-controlled, crossover, proof-of-concept Phase 2 study to test efficacy and safety of AV-101 (L-4-chlorokynurenine) in Parkinson's Disease subjects with levodopa-induced dyskinesia.
- Conditions
- Parkinson Disease, Dyskinesia, Medication-Induced, L-Dopa Causing Adverse Effects in Therapeutic Use
- Trial name
- NCT04147949
- Testing
- AV-101
- Volunteers
- 20 people
- Sponsor
- VistaGen Therapeutics, Inc.
Colorectal Neoplasms
Oral Glutamine in the Prevention of Oxaliplatin-induced Neurotoxicity
Primary Objective: To assess the benefit of glutamine when added to calcium-magnesium on the occurrence of grade 2, 3 and 4 peripheral sensory neuropathy (PSN) related to oxaliplatin with the National Cancer Institute-Common…
- Trial name
- GLUTOX (NCT01087658)
- Testing
- Glutamine, Calcium and Magnesium
- Where
- 14 sites in Canada
- Volunteers
- 200 people
- Sponsor
- Sanofi
Cytokine Release Syndrome
A Study of Itacitinib for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy
"The purpose of this study is to assess the safety and efficacy of oral administration of itacitinib for the prevention of cytokine release syndrome (CRS) in male or female participants aged 12 years or older and who are planning…
- Trial name
- NCT04071366
- Testing
- Itacitinib, Immune effector cell therapy, Yescarta
- Where
- 10 sites in United States
- Volunteers
- 112 people
- Sponsor
- Incyte Corporation
Breast Neoplasms, Breast Diseases
Evaluation of BNP7787 for the Prevention of Neurotoxicity in Metastatic Breast Cancer Patients Receiving Weekly Paclitaxel
The purpose of this study is to determine whether BNP7787 is effective in preventing or reducing neurotoxicity (nerve damage) caused by paclitaxel (Taxol®).
- Conditions
- Breast Neoplasms, Breast Diseases, Metastases, Neoplasm
- Trial name
- NCT00039780
- Testing
- BNP7787
- Volunteers
- 764 people
- Sponsor
- BioNumerik Pharmaceuticals, Inc.
Cytokine Release Syndrome, Immune Effector Cell-Associated Neurotoxicity Syndrome
RPM Signals in Outpatient CAR T Therapy
The goal of this observational study is to learn how patients' vital signs and symptoms change during outpatient CAR T-cell therapy with lisocabtagene maraleucel (liso-cel), a type of cancer treatment.
- Conditions
- Cytokine Release Syndrome, Immune Effector Cell-Associated Neurotoxicity Syndrome, B-Cell Lymphoma, Chronic Lymphocytic Leukemia
- Trial name
- NCT07882732
- Volunteers
- 125 people
- Sponsor
- Current Health
Parkinson Disease, Dyskinesia, Drug-Induced
Dipraglurant (ADX48621) for the Treatment of Patients With Parkinson's Disease Receiving Levodopa-based Therapy
This study is designed to evaluate the safety and efficacy of dipraglurant in PD patients with dyskinesia (randomized 1:1 to receive active or placebo) for 12 weeks (1 week at 150 mg per day and 11 weeks at 300 mg per day).
- Conditions
- Parkinson Disease, Dyskinesia, Drug-Induced, Dyskinesias
- Trial name
- NCT04857359
- Testing
- Dipraglurant
- Where
- 41 sites in United States
- Volunteers
- 25 people
- Sponsor
- Addex Pharma S.A.
Botulism
BT-010 Registry for the Evaluation of Safety and Clinical Outcomes in Patients Treated With Botulinum Antitoxin
The purpose of the Registry was to evaluate patient safety following Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine) (BAT®) administration in adult and pediatric patients with a confirmed or suspected exposure to…
- Trial name
- NCT02055183
- Testing
- BAT
- Volunteers
- 162 people
- Sponsor
- Emergent BioSolutions
Medication-Induced Dyskinesia
Study to Assess the Safety, Tolerability and Preliminary Efficacy of NLX-112 Versus Placebo in L-dopa-induced Dyskinesia
This is a double-blind, randomized, placebo-controlled Phase 2a study evaluating the safety, tolerability, and preliminary efficacy of up to 2 mg/day (1 mg BID) of NLX-112 versus placebo in patients with moderate to severe L-DOPA…
- Trial name
- NCT05148884
- Testing
- NLX-112
- Where
- 5 sites in Sweden
- Volunteers
- 27 people
- Sponsor
- Neurolixis SAS
Parkinson Disease, Dyskinesia, Drug-Induced
Open Label, Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias
The purpose of this study is to generate long-term safety, tolerability and efficacy data for AFQ056 in patients who have participated in and completed any AFQ056 phase II study in PD-LID (Parkinson's disease, L-dopa induced…
- Conditions
- Parkinson Disease, Dyskinesia, Drug-Induced, Levodopa
- Trial name
- NCT01173731
- Testing
- AFQ056
- Where
- 22 sites in United States, Australia and 4 more
- Volunteers
- 66 people
- Sponsor
- Novartis Pharmaceuticals
Akathisia, Drug-Induced, Dyskinesia, Drug-Induced
Study of Preladenant for the Treatment of Antipsychotic Induced Movement Disorders in Participants With Schizophrenia (Study P04628)
This study was designed to determine if preladenant (SCH 420814, MK-3814) can reduce drug-induced involuntary movements in participants with schizophrenia or schizoaffective disorder.
- Conditions
- Akathisia, Drug-Induced, Dyskinesia, Drug-Induced, Parkinsonian Disorders
- Trial name
- NCT00686699
- Testing
- Preladenant
- Volunteers
- 11 people
- Sponsor
- Merck Sharp & Dohme LLC
Dyskinesia, Drug-Induced, Parkinson Disease
Safinamide for Levodopa-induced Dyskinesia (PD-LID)
This will be a prospective, multi-center, randomized, double-blind, parallel group, placebo-controlled study, in participants with PD who are on a stable regimen of dopaminergic medication and have at least mild levodopa-induced…
- Trial name
- NCT03987750
- Testing
- Safinamide Methanesulfonate 150mg, Safinamide Methanesulfonate 100mg
- Sponsor
- Zambon SpA
Schizophrenia
Transcutaneous Non-invasive Vagus Nerve Stimulation (t-VNS) in the Treatment of Schizophrenia
Randomized, controlled, double-blind, two-armed clinical investigation to show the efficacy and safety of transcutaneous vagus nerve stimulation (t-VNS), applied at the left auricle, in schizophrenia.
- Trial name
- 02VNS2009 (NCT01176721)
- Testing
- t-VNS verum
- Where
- 2 sites in Germany
- Volunteers
- 20 people
- Sponsor
- cerbomed GmbH
Metastases, Colorectal Neoplasms
Evaluation of the Efficacy of Xaliproden (SR57746A) in Preventing the Neurotoxicity of Oxaliplatin / 5FU/LV Chemotherapy.
Primary Objective : Compare the risk of occurrence of Grade3-4 cumulative peripheral sensory neuropathy (PSN) relative to cumulative dose of oxaliplatin between treatment group and placebo group.
- Conditions
- Metastases, Colorectal Neoplasms, Colorectal Carcinoma
- Trial name
- NCT00305188
- Testing
- Xaliproden (SR57746A), Oxaliplatin, 5-Fluorouracil
- Where
- 13 sites in United States, Argentina and 11 more
- Volunteers
- 879 people
- Sponsor
- Sanofi