Clinical trials: Long Term
Migraine
A Trial to Test if Fremanezumab is Effective in Preventing Migraine in Children and Adolescents
The primary objective of the study is to evaluate the long-term safety and tolerability of subcutaneous fremanezumab in the preventive treatment of migraine in pediatric participants 6 to 17 years of age (inclusive at enrollment…
- Trial name
- NCT04530110
- Testing
- Fremanezumab
- Where
- 70 sites in United States, Canada and 7 more
- Volunteers
- 499 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D LLC
Atopic Dermatitis (AD)
A Phase 3 Study of MH004 Ointment in Patients With Mild to Moderate Atopic Dermatitis
This is a multicenter, randomized, double-blind, vehicle-controlled phase III study of MH004 Ointment with a 44-week open-label long-term safety extension period.
- Trial name
- NCT07185282
- Testing
- MH004 Ointment, Vehicle Ointment
- Where
- China
- Volunteers
- 375 people
- Sponsor
- Minghui Pharmaceutical (Hangzhou) Ltd
Asthma
FASENRA SCEI for Long-term Use
The purpose of the investigation is to confirm the safety and efficacy under the post-marketing actual long-term use of FASENRA Subcutaneous Injection 30 mg Syringe.
- Trial name
- NCT03588546
- Where
- 29 sites in Japan
- Volunteers
- 653 people
- Sponsor
- AstraZeneca
Urea Cycle Disorder
Observational Study That Will Collect Information on Patients With Urea Cycle Disorders (UCDs)
THRIVE is an observational study that will collect information on patients with UCDs. THRIVE will follow enrolled participants for up to 10 years.
- Trial name
- THRIVE (NCT01948427)
- Where
- United States
- Volunteers
- 203 people
- Sponsor
- Amgen
Lower Limb and Combined Lower Limb and Upper Limb Spasticity Due to Cerebral Palsy
Long-term Open-label Study of Botulinumtoxin Type A to Treat Spasticity of Leg(s) or Leg(s) and Arm in Cerebral Palsy
The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg(s) or of leg(s) and one arm are safe in treating children/adolescents (age 2-17 years) long-term with increased muscle…
- Trial name
- NCT01905683
- Testing
- IncobotulinumtoxinA (16-20 Units per kg body weight)
- Where
- 43 sites in Austria, Czechia and 10 more
- Volunteers
- 370 people
- Sponsor
- Merz Pharmaceuticals GmbH
Prader-Willi Syndrome
Open-Label Extension Study of DCCR in PWS Followed by Double-Blind, Placebo-Controlled, Randomized Withdrawal Period
This is a multi-center, multi-period study with an open-label period followed by a double-blind, placebo-controlled, randomized withdrawal period evaluating the safety and efficacy of DCCR treatment.
- Trial name
- NCT03714373
- Testing
- DCCR
- Where
- 28 sites in United States, United Kingdom
- Volunteers
- 115 people
- Sponsor
- Soleno Therapeutics, Inc.
Hypercholesterolemia, Familial Hypercholesterolemia
Long Term Post Marketing Specified Drug Use Result Survey for Evolocumab in Japan
The purpose of this post-marketing survey is to obtain real-world information on the safety and effectiveness of evolocumab in Japan.
- Trial name
- NCT02808403
- Testing
- No intervention
- Where
- 138 sites in Japan
- Volunteers
- 6,000 people
- Sponsor
- Amgen
Cystic Fibrosis
A Study Evaluating the Long-Term Safety of Elexacaftor Combination Therapy
This study evaluate the long-term safety and tolerability of elexacaftor (ELX)/tezacaftor (TEZ)/ ivacaftor (IVA) triple combination (TC) in participants with cystic fibrosis (CF) who are homozygous for F508del.
- Trial name
- NCT04362761
- Testing
- ELX/TEZ/IVA, IVA
- Where
- 29 sites in Australia, Belgium and 2 more
- Volunteers
- 172 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Congenital Adrenal Hyperplasia, Classic Congenital Adrenal Hyperplasia
A Study in Pediatric Participants With Congenital Adrenal Hyperplasia (Balance-CAH)
The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of atumelnant treatment in pediatric participants with classic congenital adrenal hyperplasia (CAH).
- Trial name
- NCT07159841
- Testing
- Atumelnant
- Where
- 52 sites in United States, Argentina and 11 more
- Volunteers
- 153 people
- Sponsor
- Crinetics Pharmaceuticals Inc.
Epilepsies, Partial
Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures
To evaluate the long-term safety and tolerability of cenobamate in Japanese epilepsy patients with partial seizures
- Trial name
- NCT06590896
- Testing
- Cenobamate
- Where
- 29 sites in Japan
- Volunteers
- 100 people
- Sponsor
- Ono Pharmaceutical Co., Ltd.
Type 2 Diabetes Mellitus
Specified Drug-Use Survey of Trelagliptin Tablets "Survey on Long-term Use in Type 2 Diabetes Mellitus Patients With Severe Renal Impairment or End-stage Renal Disease"
The purpose of this study is to evaluate the long-term safety of trelagliptin tablets in patients with type 2 diabetes mellitus complicated by severe renal impairment or end-stage renal failure in the routine clinical setting.
- Trial name
- NCT04285983
- Testing
- Trelagliptin
- Where
- Japan
- Volunteers
- 89 people
- Sponsor
- Takeda
Infections, Meningococcal
The Long-term Antibody Persistence of GSK Biologicals' Meningococcal Vaccine GSK134612 in Healthy Toddlers
In this study, the concentration of antibody to the vaccine one year, three and five years after vaccination in subjects who were vaccinated with GSK Biologicals' meningococcal vaccine GSK134612 in a previous study (whose…
- Trial name
- NCT00718666
- Testing
- Meningococcal vaccine GSK134612
- Where
- 14 sites in United States
- Volunteers
- 387 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hemophilia a, Hemophilia B
The Long-term Safety and Efficacy of SerpinPC in Subjects with Hemophilia Who Completed a Sponsored SerpinPC Clinical Trial
The purpose of the study is to evaluate the efficacy, safety, tolerability and pharmacokinetic (PK) profile of prophylactic SerpinPC in participants with hemophilia
- Conditions
- Hemophilia a, Hemophilia B, Hemophilia a with Inhibitor, Hemophilia B with Inhibitor
- Trial name
- PRESent-6 (NCT06568302)
- Testing
- SerpinPC
- Where
- 2 sites in Georgia, Moldova
- Volunteers
- 15 people
- Sponsor
- ApcinteX Ltd
Dental Restoration, Permanent, Dental Restorations
Clinical Investigation Measuring the Long Term Clinical Performance and Safety of Biodentine™ XP in Patients Treated for Coronal Restorative or Endodontic Dental Indications.
The aim of this present study is to collect additional data for the post-marketing follow-up of Biodentine™ XP and measure long-term (up to 10 years) performance and safety of the biomaterial in all its indications.
- Conditions
- Dental Restoration, Permanent, Dental Restorations, Endodontic Treatment
- Trial name
- BIOD XP (NCT06955429)
- Testing
- Dental restorative or endodontic treatment requiring Biodentine XP use
- Where
- 8 sites in Belgium, France
- Volunteers
- 275 people
- Sponsor
- Septodont
Leukemia, T-Cell
Repeat-Dose of Forodesine Hydrochloride (BCX-1777) Infusion in Patients With Advanced T-Cell Leukemia
BCX-1777 may stop the growth of cancer cells by blocking the enzymes necessary for their growth. The Phase II trial is designed to study the effectiveness of BCX-1777 in treating patients who have recurrent or refractory advanced…
- Trial name
- NCT00095381
- Testing
- forodesine hydrochloride (BCX-1777)
- Where
- 24 sites in United States, Georgia
- Volunteers
- 20 people
- Sponsor
- BioCryst Pharmaceuticals
Cystic Fibrosis
Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor
Study 110 is a Phase 3, multicenter study in subjects aged 6 years and older with cystic fibrosis (CF) who are homozygous for the F508del-CF transmembrane conductance regulator (CFTR) mutation and who participated in Study 109…
- Trial name
- NCT02544451
- Testing
- LUM/IVA
- Where
- 60 sites in United States, Australia and 7 more
- Volunteers
- 246 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Neurofibromatosis
A Long-term Study of NPC-12G Gel in Neurofibromatosis Type I
The purpose of this tria is to evaluate the safety and efficacy of long-term treatment with NPC-12G gel to patients with neurofibromatosis type I.
- Trial name
- NCT04461886
- Testing
- NPC-12G gel
- Where
- 4 sites in Japan
- Volunteers
- 100 people
- Sponsor
- Nobelpharma
Retinitis Pigmentosa (RP), Usher Syndrome Type 2
Study to Evaluate the Long-Term Safety of Ultevursen in Participants With Retinitis Pigmentosa (RP) Due to Mutations in Exon 13 of the USH2A Gene
The purpose of this Phase 2 Open-label study is to evaluate the long-term safety and tolerability of Ultevursen administered via intravitreal injection (IVT) in participants with Retinitis Pigmentosa due to mutations in exon 13…
- Conditions
- Retinitis Pigmentosa (RP), Usher Syndrome Type 2, Deaf Blind, Retinal Disease
- Trial name
- CAPELLA (NCT07796646)
- Testing
- No intervention, will not receive any active study intervention, Intravitreal Injection of Ultevursen
- Volunteers
- 81 people
- Sponsor
- Laboratoires Thea
Sickle Cell Disease
GBT021601-022: A Study of GBT021601 in Participants With Sickle Cell Disease (SCD)
An Open-label Extension Study of GBT021601 in Participants with Sickle Cell Disease
- Trial name
- NCT05632354
- Testing
- Osivelotor
- Where
- 9 sites in United States, Nigeria
- Volunteers
- 47 people
- Sponsor
- Pfizer
Juvenile Idiopathic Arthritis
Long-Term Safety Study Of Tofacitinib In Patients With Juvenile Idiopathic Arthritis
Evaluate long-term safety and tolerability of tofacitinib in patients with JIA, who have previously participated in tofacitinib JIA studies.
- Trial name
- NCT01500551
- Testing
- Tofacitinib
- Where
- 104 sites in United States, Argentina and 17 more
- Volunteers
- 302 people
- Sponsor
- Pfizer
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