Clinical trials: Delivery Systems
Migraine Headache
Safety and Tolerability of POD-DHE (INP104) in Migraine (STOP 301)
This study consists of a 4-week screening period, a 24-week treatment period for all participants, followed by a 28-week treatment period extension (to 52 weeks in total) for a subset of at least 60 and up to 80 participants, and…
- Trial name
- NCT03557333
- Testing
- INP104
- Where
- 36 sites in United States
- Volunteers
- 360 people
- Sponsor
- Impel Pharmaceuticals
Spinal Muscular Atrophy
Pre-Symptomatic Study of Intravenous Onasemnogene Abeparvovec-xioi in Spinal Muscular Atrophy (SMA) for Patients With Multiple Copies of SMN2
To evaluate the safety and efficacy of intravenous onasemnogene abeparvovec-xioi in pre-symptomatic patients with SMA and 2 or 3 copies SMN2
- Trial name
- SPR1NT (NCT03505099)
- Testing
- onasemnogene abeparvovec-xioi
- Where
- 16 sites in United States, Australia and 4 more
- Volunteers
- 30 people
- Sponsor
- Novartis Gene Therapies
Aortic Dissection
Study to Evaluate the Clinical Performance of the Valiant Thoracic Stent Graft With the Captivia Delivery System (Valiant Captivia) for the Treatment of Acute, Complicated Type B Aortic Dissections
The purpose of this study is to determine if the Valiant stent graft is safe and effective in treating patients who have a thoracic dissection.
- Trial name
- NCT01114724
- Testing
- Valiant Thoracic Stent Graft with the Captivia Delivery System
- Where
- 17 sites in United States
- Volunteers
- 50 people
- Sponsor
- Medtronic Cardiovascular
Infertility
Comparison of Alternative Embryo Culture Systems
This study will compare two alternative embryo culture systems. Embryos from each patient will be randomly assigned to one of two systems. One group will be cultured conventionally in oil-covered droplets in dishes.
- Trial name
- NCT02028897
- Testing
- Conventional embryo culture, Enclosed embryo culture
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Bruce Shapiro M.D.
Healthy
AG200-15 Transdermal Contraceptive Delivery System (TCDS) of Levonorgestrel and Ethinyl Estradiol
Pharmacokinetics and safety of AG200-15 over two consecutive cycles of therapy will be evaluated.
- Trial name
- NCT01243580
- Testing
- Ortho-Cyclen, AG200-15
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Agile Therapeutics
Endovascular Repair of Infrarenal Abdominal Aortic Aneurysm Using Endovascular Stent Graft
Post-market European & Asian Registry to Evaluate the Minos™ Stent-Graft and Delivery System in Abdominal Aortic Aneurysm Treatment
The Minos™ Abdominal Aortic Stent-Graft and Delivery System is a medical device designed to treat abdominal aortic aneurysms using a minimally invasive procedure.
- Trial name
- PEARL (NCT07674173)
- Testing
- Implantation with Minos Stent graft
- Where
- 16 sites in China, Germany and 4 more
- Volunteers
- 200 people
- Sponsor
- Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd
Cancers, Chronic Pain
The Clinical Evaluation of Implantable Pump System For Safety And Delivery Accuracy In Patients Requiring Intrathecal Administration Of Morphine Sulfate For Chronic Pain
The objectives of this study are to confirm the medication delivery accuracy of the Infusion System, LLC Implantable Drug Delivery System (IDDS) with Patient Controlled Analgesia for intrathecal delivery of morphine sulfate for…
- Trial name
- NCT01185470
- Testing
- Implantation of Morphine Sulfate delivering programmable pump
- Where
- 9 sites in United States
- Volunteers
- 75 people
- Sponsor
- Medallion Therapeutics, Inc.
Parkinson's Disease
Therapeutic Potential for Intranasal Levodopa in Parkinson's Disease -Off Reversal
A Phase IIa, Randomized, Double Blind, Placebo Controlled, Single Dose, Safety and Pharmacokinetic/Pharmacodynamic Study of INP103 (POD L-dopa) Administered in the Presence of Decarboxylase Inhibitor to L-dopa Responsive…
- Trial name
- THOR201 (NCT03541356)
- Testing
- L-dopa 35 mg, L-dopa 70mg, L-dopa 140 mg
- Where
- 5 sites in Australia
- Volunteers
- 32 people
- Sponsor
- Impel Pharmaceuticals
Anal Neoplasm
VGX-3100 Delivered Intramuscularly (IM) Followed by Electroporation (EP) for the Treatment of HPV-16 and/or HPV-18 Related Anal or Anal/Peri-Anal, High Grade Squamous Intraepithelial Lesion (HSIL) in Individuals Seronegative for Human Immunodeficiency Virus (HIV)-1/2
This is a phase 2, open-label efficacy study of VGX-3100 administered by intramuscular (IM) injection followed by electroporation (EP) in adult men and women who are human immunodeficiency virus (HIV) negative with histologically…
- Trial name
- NCT03499795
- Testing
- VGX-3100, CELLECTRA™ 5PSP
- Where
- 3 sites in United States, Canada
- Volunteers
- 23 people
- Sponsor
- Inovio Pharmaceuticals
Asthma
A Study to Compare the Efficacy and Safety of Different Dosings of Olodaterol Administered With the Respimat® Inhaler in Patients With Moderate to Severe Asthma
This study will compare efficacy and safety of different regimens of olodaterol administration in asthma (once daily, twice daily) with placebo in a complete cross-over design each within one of the two daily dose groups (medium…
- Trial name
- NCT01311661
- Testing
- Olodaterol low daily dose twice daily, Olodaterol medium daily dose twice daily
- Where
- 36 sites in United States, Austria and 4 more
- Volunteers
- 206 people
- Sponsor
- Boehringer Ingelheim
Aortic Stenosis Treated With TAVI, Aortic Diseases
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
The objective of this pivotal study is to compare the safety and effectiveness of the F2 CPC (Treatment group) to a Control group (no embolic protection) in participants undergoing transfemoral (TF) TAVR with commercially…
- Trial name
- SHIELD (NCT06689839)
- Testing
- F2 Filter and Delivery System, Transcatheter Aortic Valve Replacement (TAVR)
- Where
- 10 sites in United States, Australia
- Volunteers
- 500 people
- Sponsor
- EnCompass Technologies, Inc.
Hepatitis B
To Evaluate Immunogenicity & Safety of GSK Bio's DTPa-HBV-IPV/Hib (Mixed Vaccine) and DTPa-IPV/Hib + HBV Vaccines
This study assessed the immunogenicity and safety of two vaccination regimens that employed either GSK Biologicals' combined DTPa-HBV-IPV/Hib vaccine or DTPa-IPV/Hib vaccine.
- Trial name
- NCT00366366
- Testing
- Infanrix-Hexa
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
HIV Infections, HIV Seronegativity
Safety and Effects of Giving a New HIV Vaccine (GENEVAX-HIV) to HIV-Negative Volunteers
The purpose of this study is to see if it is safe to give GENEVAX-HIV, a new HIV vaccine, to HIV-negative volunteers. This study will also look at how this vaccine affects the immune system of these volunteers.
- Trial name
- NCT00002231
- Testing
- APL 400-003
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Wyeth-Lederle Vaccines
Asthma
Efficacy and Safety of 4 Weeks of Treatment With Inhaled BI 1744 CL in Patients With Asthma
The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL inhalation solution delivered by the Respimat® inhaler for four weeks in patients with asthma.
- Trial name
- NCT00467740
- Testing
- BI 1744 CL
- Where
- 37 sites in United States, Canada and 2 more
- Volunteers
- 296 people
- Sponsor
- Boehringer Ingelheim
Pulmonary Arterial Hypertension
Pilot Study Evaluating the Safety and Performance of the GeNO NITROsyl Delivery System for Inhaled Nitric Oxide
This is an open label phase 2 pilot study designed to evaluate the safety, tolerability and device performance of the GeNO nitrosyl delivery system during right heart catheterization (RHC) in participants with pulmonary arterial…
- Trial name
- PILOT (NCT01092559)
- Testing
- Nitric Oxide generated by the GeNO nitrosyl delivery system
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- Geno LLC
Asthma
To Investigate the Effects of Altering the Time of Day of Dosing (Morning or Evening) With Fluticasone Furoate 100 Micrograms Once Daily Administered Via a Dry Powder Inhaler in Subjects With Asthma
This study will investigate the effects of altering the time of day of dosing (morning or evening) with Fluticasone Furoate 100 (FF 100) micrograms (mcg) once daily administered via a dry powder inhaler (DPI) in subjects with…
- Trial name
- NCT01808339
- Testing
- Fluticasone Furoate (FF)
- Where
- Australia
- Volunteers
- 28 people
- Sponsor
- GlaxoSmithKline
Chronic Obstructive Pulmonary Disease (COPD), Asthma
Two-part Pharmacokinetic and Pharmacodynamic Study of LAS190792 in Patients With Asthma and COPD
The purpose of this study is to assess the safety and tolerability of single doses of LAS190792 administered by inhalation to patients with mild persistent asthma and moderate to severe chronic obstructive pulmonary disease…
- Trial name
- NCT02059434
- Testing
- LAS190792 Dose 1, LAS190792 Dose 2, LAS190792 Dose 3
- Where
- 2 sites in United Kingdom
- Volunteers
- 55 people
- Sponsor
- AstraZeneca
Rett Syndrome
Safety and Preliminary Efficacy of TSHA-102 Gene Therapy in Pediatric Females Aged >2 to <4 Years With Rett Syndrome
The primary objectives of this study are to evaluate the safety, tolerability and preliminary efficacy of a single intrathecal (IT) dose of TSHA-102 in pediatric females with typical Rett syndrome.
- Trial name
- ASPIRE (NCT07480564)
- Testing
- TSHA-102
- Where
- 3 sites in United States
- Volunteers
- 4 people
- Sponsor
- Taysha Gene Therapies, Inc.
Pneumonia
Safety, Tolerability and Pharmacokinetics of Aerosolized Amikacin in Intubated and Mechanically-ventilated Patients With Nosocomial Pneumonia
This study is to understand how the inhaled form of amikacin is spread throughout the human body and how it is eliminated from the body and to make sure that giving an inhaled form of Amikacin to patients is safe and well…
- Trial name
- NCT01021436
- Testing
- Amikacin inhalation solution (BAY41-6551)
- Where
- 6 sites in United States, France
- Volunteers
- 30 people
- Sponsor
- Bayer
Preterm Infant
Growth and Safety of a Two-stage Feeding System in Preterm Infants
This study evaluates the safety and suitability of the two-stage feeding system in preterm infants.
- Trial name
- NCT03728764
- Testing
- Preterm infant formula
- Where
- 4 sites in Czechia, Poland and 1 more
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)