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Pasireotide Therapy in Patients With Nelson's Syndrome
Plain-language guide to NCT01617733: phase 2 interventional trial of Pasireotide, 8 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01617733
- Phase
- phase 2
- Status
- terminated early
- Start
- 2011-03
- Completion (planned or actual)
- 2015-08
- Participants
- 8 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Nelson Syndrome
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 2 trial, researchers set out to test Pasireotide.
Plasma Adrenocorticotrophic hormone (ACTH) levels in these patients remain high, they are characteristically deeply pigmented, and may experience neurological effects as a consequence of the tumour.
It is not known whether the tumour growth is due to the lack of cortisol feedback after adrenalectomy or whether the pituitary cells were preprogrammed to develop into a tumour.
It had 1 arm (groups): Pasireotide (experimental).
The registry classes the interventions as drug.
Who Took Part
The registry lists 8 actual participants took part.
It was open to people of any sex aged from 18 years up to 80 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: To be verified at Visit one and confirmed at Visit two. Male or female patients aged 18-80 years. Signs and symptoms consistent with Nelson's Syndrome. Negative pregnancy test where applicable.
The full record lists 5 inclusion and 13 exclusion criteria; among the exclusions: received any prior or current treatment with a pasireotide or other somatostatin analogue; patients with symptomatic cholelithiasis; QTcF interval as measured by ECG \>480msecs.
How the Study Was Run
Design: single-group and open-label.
Being open-label, the Pasireotide study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2011-03 with completion listed for 2015-08.
It ran at 4 sites in United Kingdom (4).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Serum ACTH levels in patients with Nelson's syndrome (time frame: 0, 2, 4, 8, 12, 16, 20, 24, 28 weeks).
It also tracked 3 secondary outcomes, for example Tumour volume in patients with Nelson's syndrome and Does tumour volume correlate with somatostatin receptor expression?.
What This Means in Plain Language
Put simply, this is a phase 2 trial of Pasireotide in 8 people.
Its size is small, so on its own it can only give an early look.
It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Pasireotide compound page, all human trials.
Our Notes on the Compound
Pasireotide: An FDA-approved multi-receptor somatostatin analog for Cushing's disease and acromegaly; high blood sugar is a common side effect.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.