Clinical trials: Hypothalamic Diseases
Acromegaly
Efficacy/Safety of Octreotide Acetate in Patients With Uncontrolled Acromegaly
This study evaluated the safety and efficacy of an increased frequency of octreotide acetate injections or an increase in dose in partially responsive acromegalic patients with persistently uncontrolled disease.
- Trial name
- NCT00372697
- Testing
- Octreotide acetate 30 mg suspension
- Where
- Italy
- Volunteers
- 28 people
- Sponsor
- Novartis Pharmaceuticals
Obesity
Pediatric Hypothalamic Obesity
This trial is being conducted in pediatric patients with Hypothalamic Obesity. This generally occurs in people who have had an injury to or tumor in their hypothalamus (gland or organ that secretes hormones).
- Trial name
- NCT00076362
- Testing
- Sandostatin LAR
- Where
- 15 sites in United States
- Volunteers
- 60 people
- Sponsor
- Novartis Pharmaceuticals
Growth Hormone Deficiency
Safety and Efficacy Study of MOD-4023 to Treat Children With Growth Hormone Deficiency
Treatment of children with growth failure due to growth hormone deficiency (GHD). Primary • To evaluate the efficacy and safety of weekly MOD-4023 administration compared to daily Genotropin® administration in Japanese…
- Trial name
- NCT03874013
- Testing
- MOD-4023, Genotropin
- Where
- 46 sites in Japan
- Volunteers
- 44 people
- Sponsor
- OPKO Health, Inc.
Growth Hormone Deficiency
Patient Perception of Treatment Burden in Weekly Versus Daily Growth Hormone Injections in Children With GHD
This is an open label randomized 24 week crossover trial assessing the treatment burden of a weekly growth hormone injection regimen (somatrogon) compared to a daily growth hormone injection regimen (Genotropin).
- Trial name
- NCT03831880
- Testing
- Genotropin, somatrogon
- Where
- 32 sites in United States, Bulgaria and 3 more
- Volunteers
- 87 people
- Sponsor
- Pfizer
Anovulation, Oligo-ovulation
Trial to Assess the Clinical Efficacy and Safety of MSJ-0011 in Inducing Ovulation in Anovulatory or Oligo-ovulatory Japanese Women
This is an open-label, parallel-group, randomized, multicenter Phase III trial to compare the efficacy and safety of a single 250 microgram (mcg) subcutaneous dose of MSJ-0011 to a single 5,000 international units (IU)…
- Conditions
- Anovulation, Oligo-ovulation, Hypothalamic-pituitary Dysfunction, Polycystic Ovarian Syndrome
- Trial name
- NCT01653743
- Testing
- MSJ-0011, urinary hCG (u-hCG), Follitropin alpha
- Where
- 6 sites in Japan
- Volunteers
- 81 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Growth Hormone Disorder, Adult Growth Hormone Deficiency
Observational Study of the Safety and Efficacy of Norditropin® in Adult Patients With Growth Hormone Deficiency
This study is conducted in Japan. The aim of this observational study is to collect information about the safety and efficacy of Norditropin® long-term treatment of growth hormone deficiency in adults.
- Trial name
- NCT01109017
- Testing
- somatropin
- Where
- Japan
- Volunteers
- 387 people
- Sponsor
- Novo Nordisk A/S
Bardet-Biedl Syndrome, POMC Deficiency
Phase 3 Crossover Trial of Two Formulations of Setmelanotide in Participants With Specific Gene Defects in the MC4R Pathway
A trial to compare the weekly and daily formulations of setmelanotide in participants with genetic defects in the melanocortin-4 receptor pathway.
- Trial name
- NCT05194124
- Testing
- Setmelanotide 2 mg, Setmelanotide 2.5 mg, Setmelanotide 3 mg
- Where
- 7 sites in United States, Canada and 4 more
- Volunteers
- 19 people
- Sponsor
- Rhythm Pharmaceuticals, Inc.
Acromegaly
Long-term Safety and Efficacy Study of Octreotide Implant in Patients With Acromegaly
This is a long term study to evaluate the safety, tolerability and efficacy of an Octreotide Implant in patients that were previously treated with an Octreotide implant.
- Trial name
- NCT01295060
- Testing
- Octreotide
- Where
- 6 sites in United States
- Volunteers
- 12 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Bardet-Biedl Syndrome, POMC Deficiency Obesity
Setmelanotide in Pediatric Participants With Rare Genetic Diseases of Obesity
This is a phase 3 open-label, clinical study to evaluate the efficacy, safety and tolerability of setmelanotide over 1 year of treatment, in pediatric participants aged 2 to <6 years with obesity due to either biallelic variants…
- Conditions
- Bardet-Biedl Syndrome, POMC Deficiency Obesity, PCSK1 Deficiency Obesity, LEPR Deficiency Obesity
- Trial name
- NCT04966741
- Testing
- Setmelanotide
- Where
- 6 sites in United States, Australia and 2 more
- Volunteers
- 12 people
- Sponsor
- Rhythm Pharmaceuticals, Inc.
Cushing Syndrome
Pharmacokinetic (PK), Pharmacodynamic (PD) and Tolerability of Osilodrostat in Pediatric Patients With Cushing's Syndrome
Multicenter, open-label, non-comparative study to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of osilodrostat in children and adolescent patients with Cushing's syndrome.
- Trial name
- NCT03708900
- Testing
- LCI699
- Where
- 15 sites in United States, Belgium and 5 more
- Volunteers
- 12 people
- Sponsor
- RECORDATI GROUP
Acromegaly
Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients
To evaluate the long-term efficacy and safety of repeated injections of lanreotide Autogel given in doses titrated to effect in acromegalic patients previously treated or not with somatostatin analogues.
- Trial name
- NCT00210457
- Testing
- Lanreotide (Autogel formulation)
- Where
- 17 sites in France, Switzerland
- Volunteers
- 63 people
- Sponsor
- Ipsen
Growth Hormone Disorder, Adult Growth Hormone Deficiency
French National Registry of Adults With Growth Hormone Deficiency Treated With Somatropin
This study is conducted in Europe. The aim of this study is to extract data from the French National Registry holding information about patients having initiated growth hormone therapy with the objective to describe patients…
- Trial name
- NCT01580605
- Testing
- somatropin
- Where
- France
- Volunteers
- 331 people
- Sponsor
- Novo Nordisk A/S
Allergic Rhinitis
Hypothalamic-Pituitary-Adrenal (HPA)-Axis Study in Pediatric Subjects With Perennial Allergic Rhinitis (PAR)
The purpose of this study is to compare the effect of 6 weeks of treatment with beclomethasone dipropionate (BDP) nasal aerosol versus placebo on HPA-axis function, as assessed by 24-hour serum cortisol weighted mean, and to…
- Trial name
- NCT01697956
- Testing
- BDP
- Where
- 6 sites in United States
- Volunteers
- 99 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Cushing's Disease
A Trial of Lu AG13909 in Adult Participants With Cushing's Disease
This trial will evaluate the effects of Lu AG13909 in adult participants with Cushing's disease (CD). CD is a rare and serious disorder where the body makes too much of a hormone called cortisol.
- Trial name
- BalanCeD (NCT06471829)
- Testing
- Lu AG13909
- Where
- 27 sites in United States, France and 7 more
- Volunteers
- 16 people
- Sponsor
- H. Lundbeck A/S
GHD
A Study to Investigate the Safety and Efficacy of Once-weekly PEG-somatropin (GenSci004) in Children With Growth Hormone Deficiency
The purpose of this Phase 3 study is to evaluate the safety and efficacy of once-weekly GenSci004 over 108 weeks in children with GHD aged from 6 months to 17 years old, inclusive.
- Trial name
- ESCALATE (NCT06024967)
- Testing
- PEG-somatropin
- Volunteers
- 180 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Acromegaly
Efficacy and Safety Study of Varying Doses of Lanreotide Autogel in Patients With Acromegaly
The purpose of this study is to compare the effectiveness of lanreotide autogel to placebo after a single injection. Effectiveness and safety were then also assessed following four fixed-dose injections and after one year of…
- Trial name
- NCT00234572
- Testing
- Lanreotide (Autogel formulation)
- Where
- 29 sites in United States, Czechia and 6 more
- Volunteers
- 108 people
- Sponsor
- Ipsen
Cushing's Disease
Mifepristone in Children With Refractory Cushing's Disease
Study objectives are to obtain safety, pharmacokinetic, and pharmacodynamic data on the effect of mifepristone on glucose metabolism, body weight and the growth-hormone-IGF in children with refractory Cushing's disease.
- Trial name
- NCT01925092
- Testing
- mifepristone
- Where
- United States
- Sponsor
- Corcept Therapeutics
Cushing Syndrome, Cushing Disease
Open-label Treatment in Cushing's Syndrome
This is a long-term, open-label extension study of levoketoconazole in participants with endogenous Cushing's Syndrome.
- Trial name
- OPTICS (NCT03621280)
- Testing
- Levoketoconazole
- Where
- 30 sites in United States, Bulgaria and 9 more
- Volunteers
- 51 people
- Sponsor
- Cortendo AB
Cushings Disease
Long Term Safety and Efficacy of Pasireotide s.c. in Patients With Cushing's Disease
This is a non-interventional, multinational, multi-center post-marketing study, to further document the safety and efficacy of pasireotide s.c. administered in routine clinical practice in patients with Cushing's disease.
- Trial name
- NCT02310269
- Testing
- Pasireotide
- Where
- 54 sites in United States, Canada and 9 more
- Volunteers
- 152 people
- Sponsor
- RECORDATI GROUP
Adult Growth Hormone Deficiency
A Clinical Study in AGHD to Assess Safety, Tolerability and Efficacy of GX-H9
This is a randomized, active-controlled, open-label, sequential dose group, Phase 1b/2 study designed to assess the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of weekly and every other week doses of…
- Trial name
- NCT02946606
- Testing
- GX-H9, Genotropin
- Where
- South Korea
- Volunteers
- 45 people
- Sponsor
- Genexine, Inc.