Clinical trials: HPA
Stress
Study to Assess the Effect of Multi-herb Formulae and an Ashwagandha Root Formula on the Modulation of the Stress and Related Symptoms
Two unique proprietary formulations of adaptogens VL-G-E12 formulation and an herbal blend containing VL-G-A57 is one of the most well-known adaptogens that has been used for years to enhance positive mood states, deepen sleep…
- Trial name
- NCT05602389
- Testing
- VL-G-A57, VL-G-E12
- Where
- 5 sites in India
- Volunteers
- 186 people, healthy volunteers welcome
- Sponsor
- Vedic Lifesciences Pvt. Ltd.
Phenylketonuria (PKU) and Hyperphenylalaninemia, Brain Diseases, Metabolic, Inborn
Market Research of a Slow Release Protein Substitute for the Dietary Management of PKU
XPhePiccosMR is a prospective, single-arm, open label, observational study that aims to evaluate the acceptability and tolerability of XPhe Piccos, a slow-release, phenylalanine-free protein substitute in the form of tiny…
- Conditions
- Phenylketonuria (PKU) and Hyperphenylalaninemia, Brain Diseases, Metabolic, Inborn, Brain Disorder, Metabolic, Brain Diseases
- Trial name
- XPhePiccosMR (NCT07802366)
- Testing
- Slow release, phenylalanine-free protein substitute tablets
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- metaX Institut fuer Diatetik GmbH
Asthma
Study of the Effect of Mometasone Furoate/Formoterol (MF/F), Montelukast and Beclomethasone Dipropionate (BDP) on Plasma Cortisol Levels of Children 5-11 Years Old With Persistent Asthma (P05574)
The purpose of this study is to assess the effect of one of five possible study medications used in the treatment of asthma on blood plasma cortisol levels in children aged 5-11 years with persistent asthma.
- Trial name
- NCT01615874
- Testing
- MF/F Metered Dose Inhaler (MDI) 25/5 mcg, MF/F MDI 50/5 mcg, MF/F MDI 100/5 mcg
- Sponsor
- Organon and Co
Phenylketonuria
Response to Kuvan® in Subjects With Phenylketonuria (PKU) in a 4 Weeks Testing Period
The primary objective of the study is to evaluate the proportion of responders (that is, greater than or equal to [>=] 30 percent reduction from Baseline in blood phenylalanine [Phe] level) to treatment with Kuvan® (sapropterin…
- Trial name
- ENDURE (NCT01082328)
- Testing
- Kuvan®
- Where
- Norway
- Volunteers
- 59 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Tetrahydrobiopterin Deficiencies, Hyperphenylalaninemia, Non-Phenylketonuric
Safety and Efficacy Study of Phenoptin in Subjects With Hyperphenylalaninemia Due to BH4 Deficiency
The purpose of this study is to evaluate the ability of Phenoptin to control blood phenylalanine levels in subjects who have hyperphenylalaninemia due to a primary BH4 deficiency and to evaluate the safety of Phenoptin in this…
- Trial name
- NCT00355264
- Testing
- Phenoptin
- Where
- 10 sites in United States, Germany
- Volunteers
- 12 people
- Sponsor
- BioMarin Pharmaceutical
Phenylketonurias, Hyperphenylalaninaemia, Type I
Evaluating the Efficacy of PKU Synergy in Patients Expressing Phenylketonuria or Hyperphenylalaninemia
This study centres around a new one-a-day phenylalanine-free protein substitute for phenylketonuria patients. Fifty eligible adults (≥ 16 years) with proven phenylketonuria or hyperphenylalaninemia will be recruited and randomly…
- Trial name
- NCT03167697
- Testing
- Synergy, Routine
- Where
- 6 sites in United Kingdom
- Volunteers
- 14 people
- Sponsor
- Nutricia UK Ltd
Phenylketonurias, Hyperphenylalaninaemia
Acceptability and Tolerance of a Ready-to-use Protein Substitute in Tablet Form for the Dietary Management of Phenylketonuria
The purpose of this prospective, observational study is to evaluate the tolerability and acceptability of phenylalanine-free protein substitute tablets for young children with PKU aged of 7 years or older.
- Conditions
- Phenylketonurias, Hyperphenylalaninaemia, Tetrahydrobiopterin Deficiency
- Trial name
- NCT04375592
- Testing
- Phenylalanine-free protein substitute in tablet form (XPhe minis)
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- metaX Institut fuer Diatetik GmbH
Psoriasis
A Safety and Pharmacokinetics Study of IDP-118 Lotion in Pediatric Participants With Plaque Psoriasis
This study is to evaluate the safety, the systemic exposure, and the hypothalamic-pituitary-adrenal (HPA) axis suppression potential for topically applied IDP-118 lotion in pediatric participants with moderate to severe plaque…
- Trial name
- NCT03988439
- Testing
- IDP-118 Lotion
- Where
- 9 sites in United States, Dominican Republic and 1 more
- Volunteers
- 16 people
- Sponsor
- Bausch Health Americas, Inc.
Phenylketonuria (PKU) and Hyperphenylalaninemia
PheCheck™ Validation Study
The goal of this observational study is to evaluate the performance of the PheCheck™ test for the rapid detection of phenylalanine (Phe) from a fingerstick sample, in patients 1 year or older with phenylketonuria (PKU) or…
- Trial name
- NCT07551921
- Testing
- PheCheck, Dried Blood Spot Cards.
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Aptatek BioSciences, Inc
Psoriasis
A Safety and Pharmacokinetics Study of IDP-122 Lotion in Pediatric Participants With Plaque Psoriasis
This study is to evaluate the safety, the systemic exposure of halobetasol propionate (HP), and the hypothalamic-pituitary-adrenal (HPA) axis suppression potential for topically applied IDP-122 lotion in pediatric participants…
- Trial name
- NCT03987763
- Testing
- IDP-122 Lotion
- Where
- 9 sites in United States, Dominican Republic and 1 more
- Volunteers
- 45 people
- Sponsor
- Bausch Health Americas, Inc.
Atopic Dermatitis
Clobetasol Topical Oil for Children With Moderate to Severe Atopic Dermatitis
Open-Label Study designed to evaluate the HPA axis suppression potential of Clobetasol Topical Oil and pharmacokinetic safety / systemic exposure to clobetasol when Clobetasol Topical Oil is applied to pediatric subjects with…
- Trial name
- NCT03847389
- Testing
- Clobetasol propionate 0.05% Topical Oil
- Where
- 6 sites in United States
- Volunteers
- 8 people
- Sponsor
- Hill Dermaceuticals, Inc.
Psoriasis, Atopic Dermatitis
Study to Evaluate Effect of Pandel Cream 0.1% on HPA Axis in Pediatric and Adult Population
The purpose of this study is to determine the effect of Pandel® (hydrocortisone probutate cream) Cream 0.1% on the Hypothalamic Pituitary Adrenal (HPA) axis in pediatric and adult subjects with either psoriasis or atopic…
- Trial name
- NCT01137032
- Testing
- Pandel Cream 0.1%
- Where
- 3 sites in United States
- Volunteers
- 19 people
- Sponsor
- Fougera Pharmaceuticals Inc.
Hyperphenylalaninemia (HPA) Due to Phenylketonuria (PKU) or Tetrahydrobiopterin (BH4) Deficiency
Observational Study on the Long Term Safety of Kuvan® Treatment in Patients With Hyperphenylalaninemia (HPA) Due to Phenylketonuria (PKU) or BH4 Deficiency
Kuvan® is a synthetic copy of a body's own substance called tetrahydrobiopterin (BH4). BH4 is required by the body to use an amino acid called phenylalanine in order to build another substance called tyrosine.
- Trial name
- KAMPER (NCT01016392)
- Where
- 69 sites in Austria, France and 7 more
- Volunteers
- 627 people
- Sponsor
- BioMarin Pharmaceutical
Atopic Dermatitis
Cutivate Lotion HPA Axis Pediatric Study
A multi-center, open-label, Phase IV, unblinded study using Cutivate (fluticasone propionate, 0.05%)lotion and it's possible effects on the HPA axis of infants diagnosed with atopic dermatitis.
- Trial name
- NCT00546000
- Testing
- Fluticasone propionate 0.05% lotion
- Where
- 10 sites in United States
- Volunteers
- 56 people
- Sponsor
- Fougera Pharmaceuticals Inc.
Phenylketonurias, Hyperphenylalaninaemia
PKU Low Calorie Drink Study
This study will evaluate the compliance, acceptability, gastrointestinal (GI) tolerance and safety of a lower calorie amino acid based liquid protein substitute for patients with Phenylketonuria (PKU) or hyperphenylalaninemia…
- Trial name
- NCT04272736
- Testing
- Low calorie protein substitute
- Sponsor
- Nutricia UK Ltd
Scalp Psoriasis
Safety and Efficacy of LEO 80185 Topical Suspension in Adolescent Subjects (Aged 12 to 17) With Scalp Psoriasis
The purpose of the study is to evaluate the safety and efficacy of once daily use of LEO 80185 topical suspension in adolescent subjects (aged 12 to 17 years) with scalp psoriasis.
- Trial name
- NCT01083758
- Testing
- LEO 80185 (Taclonex® Scalp topical suspension/Xamiol® gel)
- Where
- 6 sites in United States
- Volunteers
- 31 people
- Sponsor
- LEO Pharma
Asthma
Safety Study of the Effects of Inhaled Fluticasone Furoate/GW642444 on the Hypothalamic-Pituitary-Adrenal (HPA) Axis
The purpose of this study is to assess the effect of six weeks' treatment with two once-daily strengths of Fluticasone Furoate/GW642444 Inhalation Powder on the HPA axis system
- Trial name
- NCT01086410
- Testing
- Fluticasone Furoate/GW642444 Inhalation Powder, Prednisolone Oral Capsule
- Where
- 17 sites in United States, Germany and 1 more
- Volunteers
- 185 people
- Sponsor
- GlaxoSmithKline
Multiple Myeloma
SST0001 (Roneparstat) in Advanced Multiple Myeloma
Heparanase cleaves heparan sulfate (HS) chains, a natural substrate for heparanase, and participates in degradation and remodelling of the extra-cellular matrix (ECM) facilitating, among other activities, cell invasion associated…
- Trial name
- NCT01764880
- Testing
- SST0001 (Roneparstat)
- Where
- 5 sites in Germany, Israel and 1 more
- Volunteers
- 19 people
- Sponsor
- Sigma Tau Research Switzerland SA
Asthma
Effect of Fluticasone Furoate Inhalation Powder on the Hypothalamic-pituitary-adrenocortical Axis of Children Aged 5-11 Years With Asthma
Inhaled corticosteroids (ICS) have a number of known class effects including hypothalamic-pituitary-adrenocortical (HPA) axis suppression.
- Trial name
- NCT02483975
- Testing
- FF, Montelukast, Albuterol/Salbutamol
- Where
- 17 sites in United States, South Africa
- Volunteers
- 111 people
- Sponsor
- GlaxoSmithKline
Major Depressive Disorder
Evaluation of the Potential Effects of SSR149415 on the Hypothalamic-pituitary-adrenal Axis in Outpatients With Major Depressive Disorder
Primary Objective: To evaluate the effects of two fixed doses of SSR149415 (250 mg bid and 100 mg bid) on hypothalamic-pituitary-adrenal axis function in patients with major depressive disorder.
- Trial name
- NAPA (NCT01606384)
- Testing
- VASOPRESSIN V1B RECEPTOR ANTAGONIST (SSR149415)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Sanofi