Clinical trials: Adverse Reaction
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
Asthma, Aspirin-Induced
Oral Ifetroban to Treat Aspirin Exacerbated Respiratory Disease (AERD)
The purpose of this phase 2 study is to assess the safety and efficacy of oral ifetroban for the treatment of aspirin-exacerbated respiratory disease (AERD).
- Trial name
- NCT03028350
- Testing
- Ifetroban Oral Capsule
- Where
- 16 sites in United States
- Volunteers
- 54 people
- Sponsor
- Cumberland Pharmaceuticals
Carcinoid Syndrome
Telotristat Etiprate for Carcinoid Syndrome Therapy
The purpose of the study is to evaluate the effect of telotristat etiprate versus placebo on the incidence of treatment-emergent adverse events and on 5-hydroxyindoleacetic acid (5-HIAA) levels.
- Trial name
- TELECAST (NCT02063659)
- Testing
- Telotristat etiprate
- Where
- 50 sites in United States, Australia and 9 more
- Volunteers
- 76 people
- Sponsor
- Lexicon Pharmaceuticals
Hypercholesterolemia, Atherosclerosis
Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) as Add-on to Ezetimibe Therapy in Patients With Elevated LDL-C (CLEAR Tranquility)
The purpose of this study is to determine if bempedoic acid (ETC-1002) added-on to ezetimibe therapy is effective and safe versus placebo in patients with elevated LDL cholesterol.
- Conditions
- Hypercholesterolemia, Atherosclerosis, Statin Adverse Reaction
- Trial name
- NCT03001076
- Testing
- Bempedoic acid, Ezetimibe
- Where
- United States
- Volunteers
- 269 people
- Sponsor
- Esperion Therapeutics, Inc.
Acromegaly, Neuroendocrine Tumors
Phase II Study of Subcutaneous Inj. Depot of Octreotide in Patients With Acromegaly and Neuroendocrine Tumours (NETs)
This is a Phase II, open-label multicentre, randomised study to assess the PK, PD, efficacy, and safety of two dosing regimens of CAM2029 in adult patients with acromegaly or a functional, well-differentiated NET, with carcinoid…
- Trial name
- NCT02299089
- Testing
- octreotide FluidCrystal® injection depot
- Where
- 10 sites in France, Germany and 2 more
- Volunteers
- 12 people
- Sponsor
- Camurus AB
Echocardiography
A Prospective Surveillance Trial to Evaluate the Safety of Optison in Clinical Practice.
This prospective surveillance trial will gather safety information for Optison when it is used in routine practice.
- Trial name
- OSSAR (NCT00730964)
- Testing
- Perflutren Protein-Type A Microspheres Injectable Suspension, United States Pharmacopeia (USP)
- Where
- United States
- Volunteers
- 1,039 people
- Sponsor
- GE Healthcare
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
Drug-Related Side Effects and Adverse Reactions
A Positron Emission Tomography (PET) Imaging Study to Investigate the Biodistribution and Clearance of an Albumin Binding Domain Antibody (AlbudAb) GSK3128349 in Healthy Male Subjects
GSK3128349 is a small protein molecule (biopharmaceutical) that binds to albumin in the body, and by itself, has no pharmacological action.
- Trial name
- NCT02829307
- Testing
- 89Zr-GSK3128349 1 mg
- Where
- Netherlands
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Adverse Drug Events, Adverse Drug Reactions
Pharmacogenetic Testing Among Home Health Patients
Patients meeting eligibility criteria will be randomized into two groups, one receiving pharmacogenetic testing and the other not receiving pharmacogenetic testing.
- Conditions
- Adverse Drug Events, Adverse Drug Reactions, Drug Interaction Potentiation, Drug Metabolism, Poor, CYP2D6-RELATED
- Trial name
- NCT02378220
- Testing
- Pharmacogenetic testing
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Genelex Corporation
Hypercholesterolemia, Atherosclerotic Cardiovascular Disease
Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia and Statin Intolerant
The purpose of this study is to determine if bempedoic acid (ETC-1002) is effective and safe versus placebo in patients with elevated LDL cholesterol and who are statin-intolerant.
- Conditions
- Hypercholesterolemia, Atherosclerotic Cardiovascular Disease, Statin Adverse Reaction
- Trial name
- CLEAR Serenity (NCT02988115)
- Testing
- bempedoic acid
- Where
- 67 sites in United States, Canada
- Volunteers
- 345 people
- Sponsor
- Esperion Therapeutics, Inc.
Carcinoid Syndrome
Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome
The purpose of the study is to evaluate the safety and tolerability of orally administered telotristat etiprate (LX1606) in participants with symptomatic carcinoid syndrome.
- Trial name
- NCT01104415
- Testing
- Telotristat etiprate
- Where
- 10 sites in Germany, United Kingdom
- Volunteers
- 15 people
- Sponsor
- Lexicon Pharmaceuticals
Smallpox Vaccine Adverse Reaction
VA-006 Vaccinia Vaccine (ACAM2000) for the Production of VIGIV
The purpose of this study is to vaccinate plasma donors with ACAM2000 smallpox vaccine for collection of plasma to be used in the manufacturing of Vaccinia Immune Globulin Intravenous (VIGIV).
- Trial name
- NCT01158157
- Testing
- ACAM2000
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Adverse Effect of Contact Lens Solution
Comparative Performance of a Bausch & Lomb Multipurpose Solution and Alcon OptiFree Replenish Multipurpose Solution
To evaluate the product performance of a Bausch \& Lomb Multipurpose solution when compared to Alcon OptiFree Replenish Multipurpose Solution
- Trial name
- NCT00636194
- Testing
- Bausch & Lomb Multipurpose Solution, Alcon OptiFree Replenish Multipurpose Solution
- Where
- Malaysia
- Volunteers
- 361 people
- Sponsor
- Bausch & Lomb Incorporated
Graft vs Host Disease, Congenital Aniridia
Safety and Performance Study of the ARGOS-IO System in Patients Undergoing Boston Keratoprosthesis Implantation
The ARGOS-IO pressure sensor is intended to be implanted in the human eye in combination with Boston Keratoprosthesis (BKPro) surgery and to remain in place indefinitely.
- Conditions
- Graft vs Host Disease, Congenital Aniridia, Chemical Burns, Stevens-Johnson Syndrome
- Trial name
- NCT02945176
- Testing
- ARGOS-IO system
- Where
- 2 sites in Germany
- Volunteers
- 13 people
- Sponsor
- Implandata Ophthalmic Products GmbH
Carcinoid Syndrome
Telotristat Etiprate - Expanded Treatment for Patients With Carcinoid Syndrome Symptoms
The primary objective of this study is to evaluate the long-term safety and tolerability of orally administered telotristat etiprate.
- Trial name
- TELEPATH (NCT02026063)
- Testing
- Telotristat etiprate
- Where
- 43 sites in United States, Australia and 10 more
- Volunteers
- 124 people
- Sponsor
- Lexicon Pharmaceuticals
Infections, Respiratory, Virus Diseases
A Trial Investigating the Safety and Effects of Four BNT162 Vaccines Against COVID-19 in Healthy and Immunocompromised Adults
Originally, the study was planned to include two parts, i.e., Part A and Part B, however Part B was cancelled due to changes in the overall clinical development plan.
- Conditions
- Infections, Respiratory, Virus Diseases, Infection Viral, Vaccine Adverse Reaction
- Trial name
- NCT04380701
- Testing
- BNT162a1, BNT162b1, BNT162b2
- Where
- 5 sites in Germany
- Volunteers
- 512 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Adverse Effect of MRI on an Implanted Pacemaker Lead, Adverse Effect of MRI on an Implanted Pacemaker
Safety and Efficacy of the Accent Magnetic Resonance Imaging™ (MRI) Pacemaker and Tendril MRI™ Lead
The MRI Study is a prospective, multi-center, clinical study designed to evaluate the safety and efficacy of the Accent MRI™ System in a patient population indicated for implant of a pacemaker within and outside of the MRI…
- Trial name
- NCT01576016
- Testing
- Accent MRI system (lead safety), Accent MRI system (with MRI scan)
- Where
- 70 sites in United States, Australia and 3 more
- Volunteers
- 950 people
- Sponsor
- Abbott Medical Devices
Injection Site Reaction
Prospective Study to Assess Tissue Responses After Injection With Biostimulatory Products
The objective of this study is to identify and assess in vivo tissue responses after injection with various biostimulatory products at various timepoints.
- Trial name
- NCT06093815
- Testing
- Injection
- Where
- Spain
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Merz North America, Inc.
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
Smallpox Vaccine Adverse Reaction
VA-008 ACAM2000® Vaccination of Plasma Donors for the Production of VIGIV
Objectives: To vaccinate plasma donors with the ACAM2000 smallpox vaccine thereby inducing an immune response resulting in high anti-vaccinia antibody titers.
- Trial name
- NCT02443623
- Testing
- Vaccination with ACAM2000
- Where
- Canada
- Volunteers
- 3,032 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions