- |||||||||| Synacthen Depot (cosyntropin) / Novartis, Mallinckrodt, Alliance
Journal: PITUITARY FUNCTIONS AFTER RECOVERY FROM COVID-19. (Pubmed Central) - Feb 15, 2024
Basal pituitary hormone levels and HPA axes were found to be preserved and competently functioning in patients who experienced mild/moderate COVID-19. However, symptoms observed after COVID-19 episode were evident in substantial amount of patients in this study and these symptoms were not associated with changes in pituitary gland function.
- |||||||||| Synacthen Depot (cosyntropin) / Novartis, Mallinckrodt, Alliance
Enrollment change, Trial completion date, Trial termination: Evaluation of the Effectiveness and Tolerance of Tetracosactide Synacthen (clinicaltrials.gov) - Nov 18, 2023
P2, N=46, Terminated,
This approach resulted in a marked reduction in aldosterone concentrations and a complete biochemical cure of PA over the observation period. N=88 --> 46 | Trial completion date: Dec 2023 --> Nov 2022 | Recruiting --> Terminated; Interim analysis and decision of the independent committee, investigators and sponsor (futility) (2023/10/05)
- |||||||||| Synacthen Depot (cosyntropin) / Novartis, Mallinckrodt, Alliance, Ovidrel (choriogonadotropin alfa) / EMD Serono
Trial completion date, Trial primary completion date: Relative Contributions of Predictors of Hyperandrogenism in Older vs. Young Women With PCOS (clinicaltrials.gov) - Nov 3, 2023
P1, N=144, Recruiting,
This should be considered as a rare potential complication of ACTH stimulation testing. Trial completion date: May 2024 --> May 2026 | Trial primary completion date: Apr 2024 --> Apr 2026
- |||||||||| Synacthen Depot (cosyntropin) / Novartis, Mallinckrodt, Alliance
Enrollment closed, Trial completion date, Trial primary completion date: Evaluation of Adrenal Androgens in Normal and Obese Girls After Suppression and Stimulation (clinicaltrials.gov) - Oct 27, 2023
P=N/A, N=84, Active, not recruiting,
High ACTH reduced PDL2 and leptin levels in a glucocorticoid-independent manner but the overall effect on biomarker profiles was small. Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Aug 2023 --> Aug 2024
- |||||||||| Synacthen Depot (cosyntropin) / Novartis, Mallinckrodt, Alliance, H.P. Acthar Gel (repository corticotropin injection) / Mallinckrodt
Review, Journal: Treatment modalities for infantile spasms: current considerations and evolving strategies in clinical practice. (Pubmed Central) - Sep 22, 2023
There is no universally accepted mainstay of treatment for this condition, but some options include synthetic adrenocorticotropic hormone (ACTH), repository corticotropin injection (RCI/Acthar Gel), corticosteroids, valproic acid, vigabatrin, and surgery...Vigabatrin and valproic acid are both anti-seizure medications that work by increasing GABA concentrations in the CNS and decreasing excitatory activity. Acthar Gel has been shown to have superior efficacy and a diminished side effect profile when compared with other treatment modalities.
- |||||||||| Synacthen Depot (cosyntropin) / Novartis, Mallinckrodt, Alliance
Enrollment open, Trial completion date, Trial primary completion date: NeSST2: The Development of a Noninvasive Short Synacthen Test (clinicaltrials.gov) - Sep 7, 2023
P2, N=12, Recruiting,
Acthar Gel has been shown to have superior efficacy and a diminished side effect profile when compared with other treatment modalities. Suspended --> Recruiting | Trial completion date: Dec 2023 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2025
- |||||||||| Synacthen Depot (cosyntropin) / Novartis, Mallinckrodt, Alliance
Post Dural Puncture Headache with Associated Auditory Impairment Resolved by Epidural Blood Patch (South: Hall F) - Aug 23, 2023 - Abstract #ASA2023ASA_5837;
PDPH improved while supine, but worsening auditory impairment (like hearing underwater) prompted patient consent for blood patch on PPD4, resulting in complete auditory symptom resolution within 2 hours. Hearing loss after spinal anesthesia is a rare complication and should be considered and treated in parturients after post-dural puncture.
- |||||||||| Synacthen Depot (cosyntropin) / Novartis, Mallinckrodt, Alliance
SLC35A2-CDG related early onset epileptic encephalopathy: Clinical features and treatment of epilepsy (Foyer 3B, 3rd Floor) - May 29, 2023 - Abstract #EPNS2023EPNS_767;
Moreover, increased frequency of epileptic seizures was observed probably due to reduction in serum ketone levels. Although seizure control was partially achieved (>50%) with the ketogenic diet, she did not benefit from oral galactose supplementation, which can be considered as a precision medicine for SLC35A2-CDG in the literature.
- |||||||||| Synacthen Depot (cosyntropin) / Novartis, Mallinckrodt, Alliance, Ovidrel (choriogonadotropin alfa) / EMD Serono
Trial completion date, Trial primary completion date: Relative Contributions of Predictors of Hyperandrogenism in Older vs. Young Women With PCOS (clinicaltrials.gov) - Mar 2, 2023
P1, N=144, Recruiting,
Our findings can aid future theoretical studies of daily rhythm and evaluations of challenging and/or disturbing situations that result in changes in behaviour or hormonal cascades of these changes in ex situ populations of owls. Trial completion date: Dec 2023 --> May 2024 | Trial primary completion date: Dec 2023 --> Apr 2024
- |||||||||| Trial completion date: Hormonal Mechanisms of Sleep Restriction - Axis Study (clinicaltrials.gov) - Jan 26, 2023
P1, N=80, Active, not recruiting,
Trial completion date: Dec 2023 --> May 2024 | Trial primary completion date: Dec 2023 --> Apr 2024 Trial completion date: Dec 2022 --> Dec 2023
- |||||||||| Synacthen Depot (cosyntropin) / Novartis, Mallinckrodt, Alliance
Journal: Assessment of a compounded synthetic adrenocorticotropic hormone product in 17 healthy dogs. (Pubmed Central) - Jan 4, 2023
With hormone monotherapy, either prednisolone or tetracosactide depot may be recommended for infantile epileptic spasms syndrome. In healthy dogs, cortisol concentrations were in agreement after compounded tetracosactide compared to commercial tetracosactide, Synacthen®.
- |||||||||| Synacthen Depot (cosyntropin) / Novartis, Mallinckrodt, Alliance
Journal: Deazaflavin cofactor boosts earthworms Henlea bioluminescence. (Pubmed Central) - Dec 20, 2022
The synthetic ActH was identical to the natural one and activated Henlea sp...We propose that ActH and the novel sulfated deazariboflavin ActS either emit the light of the Henlea sp. bioluminescence and/or accept hydride(s) donor upon luciferin oxidation.
- |||||||||| Enrollment closed, Enrollment change, Trial completion date: Hormonal Mechanisms of Sleep Restriction - Axis Study in Older Men and Postmenopausal Women (clinicaltrials.gov) - Oct 27, 2022
P1, N=5, Active, not recruiting,
Clinicians must be diligent in investigating adrenal function in patients undergoing alloHCT on azole antifungals who present with symptoms of AI. Recruiting --> Active, not recruiting | N=40 --> 5 | Trial completion date: Jul 2023 --> Jul 2024
- |||||||||| Synacthen Depot (cosyntropin) / Novartis, Mallinckrodt, Alliance
INHALED CORTICOSTEROIDS: AN OVERLOOKED CAUSE OF ADRENAL INSUFFICIENCY (Convention Center Exhibit Hall: Rapid Area 3C) - Sep 11, 2022 - Abstract #CHEST2022CHEST_4217;
The risk of AI associated with ICS is admittedly less compared to oral steroids. This case report highlights the need for recognizing AI and screening patients on higher ICS doses.
- |||||||||| Synacthen Depot (cosyntropin) / Novartis, Mallinckrodt, Alliance
Trial completion date, Trial primary completion date: NeSST2: The Development of a Noninvasive Short Synacthen Test (clinicaltrials.gov) - Sep 9, 2022
P2, N=12, Suspended,
This case report highlights the need for recognizing AI and screening patients on higher ICS doses. Trial completion date: Dec 2020 --> Dec 2023 | Trial primary completion date: Dec 2020 --> Dec 2023
- |||||||||| Synacthen Depot (cosyntropin) / Novartis, Mallinckrodt, Alliance
Consyntropin As Prophylaxis For Post-dural Puncture Headache In Surgical Patients (Hall C) - Aug 15, 2022 - Abstract #ASA2022ASA_1055;
Both patients received IV cosyntropin intraoperatively as prophylaxis, and neither patient developed any subsequent PDPH symptoms. Accordingly, these outcomes offer support for further research in evaluating IV cosyntropin as a prophylactic strategy for PDPH in surgical patients.
- |||||||||| Synacthen Depot (cosyntropin) / Novartis, Mallinckrodt, Alliance
Trial completion date, Trial primary completion date: Evaluation of Adrenal Androgens in Normal and Obese Girls After Suppression and Stimulation (clinicaltrials.gov) - Jul 29, 2022
P=N/A, N=84, Recruiting,
Accordingly, these outcomes offer support for further research in evaluating IV cosyntropin as a prophylactic strategy for PDPH in surgical patients. Trial completion date: Mar 2022 --> Dec 2023 | Trial primary completion date: Aug 2021 --> Aug 2023
- |||||||||| Synacthen Depot (cosyntropin) / Novartis, Mallinckrodt, Alliance
Trial completion date: Stress and the Nervous System (clinicaltrials.gov) - Jul 25, 2022
P=N/A, N=23, Active, not recruiting,
Trial completion date: Mar 2022 --> Dec 2023 | Trial primary completion date: Aug 2021 --> Aug 2023 Trial completion date: Dec 2021 --> Dec 2023
- |||||||||| Synacthen Depot (cosyntropin) / Novartis, Mallinckrodt, Alliance
Retrospective data, Journal: Retrospective Echocardiographic Analysis of West Syndrome During Adrenocorticotropic Hormone Therapy. (Pubmed Central) - May 29, 2022
The therapy protocol involved administering tetracosactide acetate 0.01-0.0125 mg/kg via intramuscular injection once a day for weeks 1-2, then gradually tapering off...Cardiac function, including ventricular wall thickness and diastolic function, should be monitored during ACTH therapy. E/E' and DcT are useful in evaluating diastolic function.
- |||||||||| Synacthen Depot (cosyntropin) / Novartis, Mallinckrodt, Alliance
Clinical, Journal, Combination therapy: Comparison of Cosyntropin, Vigabatrin, and Combination Therapy in New-Onset Infantile Spasms in a Prospective Randomized Trial. (Pubmed Central) - Apr 28, 2022
Adverse events were reported in all 3 treatment arms: 31 (86%) had an adverse event, 7 (19%) had a serious adverse event, and 15 (42%) had an adverse event of special interest with no difference between treatment arms. Significance: This randomized trial was underpowered because of incomplete enrollment, yet it demonstrated that cosyntropin was more effective for short-term outcomes than vigabatrin as initial treatment for infantile spasms.
- |||||||||| Synacthen Depot (cosyntropin) / Novartis, Mallinckrodt, Alliance
Journal: Determining the effectiveness of using dermal swabs to evaluate the stress physiology of laboratory cephalopods: a preliminary investigation. (Pubmed Central) - Mar 17, 2022
To better understand glucocorticoid production, we conducted an adrenocorticotropic hormone, using Cosyntropin (an adrenocorticotropin (ACTH) analogue) challenge with a saline control and swabbed their mantles at 15-minute intervals for 2 h...We were able to successfully measure 2-fold increase in immunoreactive corticosteroids which reacted with cortisol and corticosterone assays for all the species following ACTH injection, although not all individuals responded similarly. With further investigation, this technique can increase our understanding and management of cephalopods in captivity.
- |||||||||| Trial completion date: Hormonal Mechanisms of Sleep Restriction - Axis Study (clinicaltrials.gov) - Mar 15, 2022
P1, N=80, Active, not recruiting,
With further investigation, this technique can increase our understanding and management of cephalopods in captivity. Trial completion date: Sep 2022 --> Dec 2022
- |||||||||| Synacthen Depot (cosyntropin) / Novartis, Mallinckrodt, Alliance
Journal: Cortisol levels in blood and hair of unanesthetized grizzly bears (Ursus arctos) following intravenous cosyntropin injection. (Pubmed Central) - Mar 1, 2022
We conclude the cosyntropin-induced cortisol spike was likely insignificant when compared to the adrenocortical response that occurs in free-ranging bears when captured. We suggest further study with a larger sample of captive bears to evaluate the combined effects of anaesthesia and multiple doses of cosyntropin administered over several hours would better simulate the adrenocortical response of free-ranging grizzly bears during capture.
- |||||||||| Synacthen Depot (cosyntropin) / Novartis, Mallinckrodt, Alliance
Clinical, Journal: Effectiveness of ACTH in Patients with Infantile Spasms. (Pubmed Central) - Feb 26, 2022
(2) Aim of the study and The objective of our study was to examine short-term efficacy (during treatment schedule) and long-term outcome of intramuscular 0.02 mg/kg/day ACTH (tetracosactide) depot, used concomitantly with other antiepileptic drugs (AEDs) in patients with infantile spasms who did not achieve seizure cessation or relapse when taking only the AEDs...(4) Randomized controlled clinical trialswith long-term follow-up are needed to compare the effectiveness of ACTH in polytherapy and monotherapy. Dyskinesias as a potential side effect observed in our study group should be investigated in the following studies.
- |||||||||| Synacthen Depot (cosyntropin) / Novartis, Mallinckrodt, Alliance
Clinical, Review, Journal: Post-traumatic Neuroinflammation: Relevance to Pediatrics. (Pubmed Central) - Feb 24, 2022
Microglia, the brain-resident macrophages, have become central in these investigations as they serve a major surveillance function, have the ability to react swiftly to injury, recruit various cellular and chemical mediators, and monitor the reparative/degenerative processes. In this review we describe selected aspects of this burgeoning literature, describing the critical role of cytokines and chemokines, microglia, advances in neuroimaging, genetics and fractal morphology analysis, our research efforts in this area, and selected aspects of pediatric post-traumatic neuroinflammation.
- |||||||||| Synacthen Depot (cosyntropin) / Novartis, Mallinckrodt, Alliance
Journal: Intra-Lot and Inter-Lot Variability in Cosyntropin. (Pubmed Central) - Jan 18, 2022
One vial of 12 sampled from Sandoz Lot0200062 appeared 6.9 SDs from the center of the rest of the vials, and another was 4.3 SDs away. Spectra of 102 vials from 7 lots in the library clustered in two groups (p=0.02).
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