Clinical trials: Neurobehavioral Manifestation
Prader-Willi Syndrome
A Study of Pitolisant in Participants With Prader-Willi Syndrome
The purpose of this study is to assess safety of pitolisant in eligible participants with Prader-Willi syndrome (PWS) who completed the End of Treatment (EOT) visit in a parent study (HBS-101-CL-002 [Open Label Extension (OLE)]…
- Trial name
- NCT07219485
- Testing
- Pitolisant
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Harmony Biosciences Management, Inc.
Pain, Post-operative
Placebo-Controlled Evaluation of Intranasal Dexmedetomidine for Postoperative Analgesia Following Bunionectomy Surgery
The primary objective of this study is to evaluate the analgesic efficacy, on Post-Operative Day (POD) 1, of DEX-IN compared with placebo, using the summed pain intensity difference over the first 48 hours (SPID48) in subjects…
- Trial name
- NCT02284243
- Testing
- Intranasal Dexmedetomidine
- Where
- 3 sites in United States
- Volunteers
- 168 people
- Sponsor
- Baudax Bio
Aggressive Behavior in Fragile X Syndome
Inhibition of Aggressive Behavior in Participants With Fragile X Syndrome
The goal of this clinical trial is to learn if drug SRX246 works to treat irritability, agitation, aggression and self-injury (IAAS) behaviors in adult males with Fragile X Syndrome (FXS).
- Trial name
- NCT07328529
- Testing
- SRX246
- Where
- 3 sites in United States
- Volunteers
- 80 people
- Sponsor
- Azevan Pharmaceuticals
Mucopolysaccharidosis II
An Extension Study of the Long-Term Safety, Tolerability, and Efficacy of Tividenofusp Alfa (DNL310) in Participants With Mucopolysaccharidosis Type II (MPS II) From Study DNLI-E-0002 or Study DNLI-E-0007
This is a multiregional open-label extension (OLE) to assess the safety, tolerability, and efficacy of long-term treatment with tividenofusp alfa (DNL310), an investigational central nervous system (CNS)-penetrant intravenous…
- Trial name
- NCT06075537
- Testing
- tividenofusp alfa
- Where
- 30 sites in United States, Argentina and 12 more
- Volunteers
- 99 people
- Sponsor
- Denali Therapeutics Inc.
Other Acute Postoperative Pain, Prolonged Endotracheal Intubation
Pharmacokinetics, Safety, and Efficacy of Intravenous Dosing of Buprenorphine in Pediatric Patients Who Require Opioid Analgesia for Acute Moderate to Severe Pain
The purpose of this study is to characterize the safety, pharmacokinetics (PK), and efficacy of intravenous (IV) buprenorphine in pediatric patients.
- Trial name
- NCT01324544
- Testing
- Buprenorphine IV
- Sponsor
- Purdue Pharma LP
Pain, Analgesia, Patient-Controlled
A Study to Compare Patient-controlled Pain Medications Delivered Either Through the Skin or Intravenously
The purpose of this study is to evaluate the effectiveness and safety of a patient-controlled system to deliver fentanyl compared with a patient-controlled intravenous system to deliver morphine in the management of postoperative…
- Conditions
- Pain, Analgesia, Patient-Controlled, Pain, Postoperative
- Trial name
- EuroTrans (NCT00996177)
- Testing
- IONSYS (fentanyl HCl) Iontophoretic TransdermalSystem, IV Morphine Patient-Controlled Analgesia (IV PCA)
- Where
- 44 sites in Austria, Belgium and 8 more
- Volunteers
- 657 people
- Sponsor
- Janssen-Cilag International NV
Pain, Post-operative
Placebo-Controlled Evaluation of N1539 Following Bunionectomy Surgery
The primary objective of this study is to evaluate the safety of N1539 in subjects with acute moderate to severe pain following unilateral bunionectomy.
- Trial name
- NCT02540265
- Testing
- N1539
- Where
- United States
- Volunteers
- 59 people
- Sponsor
- Baudax Bio
Low Mood
Effect of a Nutritional Supplement on Mental Wellness in Adults
Trillions of microbes reside in human gut and constitute "gut microbiota". Composition of these microbes and substances produced by them play an important role in human health and wellness.
- Trial name
- NCT06058364
- Testing
- Intervention 1 - Triglyceride
- Where
- United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Pharmavite LLC
Delirium
Hip Fracture Surgery in Elderly Patients
The objective of this study is to evaluate the incidence of Post-Operative Delirium (POD), diagnosed with the Confusion Assessment Method (CAM), in elderly patients undergoing hip fracture surgery under general anaesthesia with…
- Trial name
- HIPELD (NCT01199276)
- Testing
- Xenon, Sevoflurane
- Where
- 13 sites in Belgium, France and 4 more
- Volunteers
- 256 people
- Sponsor
- Air Liquide Santé International
Rett Syndrome
A Safety Study of NNZ-2566 in Patients With Rett Syndrome
The purpose of this study is to determine whether NNZ-2566 is safe and well tolerated in the treatment of Rett Syndrome in adolescent and adult females.
- Trial name
- NCT01703533
- Testing
- NNZ-2566
- Where
- 3 sites in United States
- Volunteers
- 67 people
- Sponsor
- Neuren Pharmaceuticals Limited
Low Mood, Depressive Symptoms
The Effects of Bifidobacterium Longum 1714® in a Population With Low Mood
A randomised, double-blind, placebo-controlled clinical trial to evaluate the effect of 8 weeks of supplementation with Bifidobacterium longum 1714® strain on Beck's Depression Inventory-II Score in adults who experience low mood.
- Trial name
- NCT04925440
- Testing
- Bifidobacterium longum 1714® strain
- Where
- Ireland
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- PrecisionBiotics Group Ltd.
PARKINSON DISEASE (Disorder), Apathy
Safety and Tolerability of IRL757 in Participants With Parkinson's Disease and Apathy
This clinical trial's goal is to evaluate if the IRL757 is safe and has a good tolerability in participants with Parkinson's disease and experiencing apathy (a lack of interest or motivation).
- Conditions
- PARKINSON DISEASE (Disorder), Apathy, Safety
- Trial name
- LIFT-PD (NCT07461220)
- Testing
- IRL757
- Where
- 14 sites in Bulgaria, Germany and 2 more
- Volunteers
- 75 people
- Sponsor
- Integrative Research Laboratories AB
Delirium
Ceribell Delirium Data Collection Study
This study is designed as a prospective, non-randomized, observational clinical study. The study will collect clinical and rrEEG (Ceribell EEG) data when monitoring subjects for delirium subtypes.
- Trial name
- NCT04962815
- Testing
- Electroencephalogram (EEG) Test
- Where
- 7 sites in United States
- Volunteers
- 200 people
- Sponsor
- Ceribell Inc.
Bipolar Disorder
An Outpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder in Children and Adolescents
The purpose of this study is to determine the safety and effectiveness of Depakote ER (Divalproex Sodium Extended-Release Tablets) compared to placebo in the treatment of bipolar disorder, manic or mixed type in children and…
- Trial name
- NCT00067262
- Testing
- Divalproex Sodium Extended-Release Tablets
- Where
- 16 sites in United States
- Volunteers
- 150 people
- Sponsor
- Abbott
Bipolar Disorder
Study Evaluating Cariprazine (RGH-188) in the Treatment of Patients With Acute Mania
This is a study designed to evaluate the efficacy, safety, and tolerability of RGH-188 monotherapy in the treatment of acute mania.
- Trial name
- NCT00488618
- Testing
- Cariprazine (RGH-188)
- Where
- United States
- Volunteers
- 238 people
- Sponsor
- Forest Laboratories
Obesity, Over-weight
An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Prader-Willi Syndrome
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics for certain doses of beloranib in obese subjects with Prader-Willi Syndrome.
- Conditions
- Obesity, Over-weight, Prader-Willi Syndrome
- Trial name
- NCT01818921
- Testing
- ZGN-440 sterile diluent, 1.2 mg ZGN-440 for injectable suspension, 1.8 mg ZGN-440 for injectable suspension
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Zafgen, Inc.
Pain, Diabetic Neuropathies
Safety and Efficacy of GRT6005 in Pain Due to Diabetic Polyneuropathy
The purpose of this trial is to investigate the efficacy and safety of GRT6005 in patients with painful diabetic neuropathy.
- Trial name
- NCT01347671
- Testing
- GRT6005
- Where
- 22 sites in Bulgaria, Germany and 1 more
- Volunteers
- 189 people
- Sponsor
- Tris Pharma, Inc.
Mucopolysaccharidosis II
A Study of JR-141 in Patients With Mucopolysaccharidosis Type II
The purpose of this study in patients with mucopolysaccharidosis type II (MPS II) is below, to collect the safety information of JR-141 to evaluate the plasma pharmacokinetics of JR-141 to explore the efficacy of JR-141 on MPS…
- Trial name
- NCT03128593
- Testing
- JR-141
- Where
- 8 sites in Japan
- Volunteers
- 14 people
- Sponsor
- JCR Pharmaceuticals Co., Ltd.
Down Syndrome, Edwards Syndrome
Non-Invasive Screening for Fetal Aneuploidy
The purpose of this study is to detect whole chromosome abnormalities in maternal blood.
- Trial name
- NCT02317965
- Testing
- Maternal Blood Draw
- Where
- 10 sites in United States
- Volunteers
- 340 people
- Sponsor
- Progenity, Inc.
Agitation in Patients With Dementia of the Alzheimer's Type
Assessment of the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo, for the treatment of agitation in participants with dementia of the Alzheimer's type.
- Trial name
- NCT03393520
- Testing
- AVP-786
- Where
- 211 sites in United States, Australia and 9 more
- Volunteers
- 601 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.