Adrenocortical AdenomaPhase 2NCT02150213

Medical Safety Follow-up Study for Patients Who Received More Than 28 Days of Total Exposure to BGG492

A Phase 2 study testing MRI, CT or ultrasound was permitted if MRI was contraindicated, Dexamethasone Supression Test and Sonogram in people with Adrenocortical Adenoma and Endometrial Stromal Sarcomas, run by Novartis Pharmaceuticals at 20 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To provide medical follow-up to patients exposed to BGG492 for more than 28 days in study CBGG492A2207 (NCT 01147003) and/or CBGG492A2212 (NCT 01338805). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Adrenocortical Adenoma, Endometrial Stromal Sarcomas
What is being tested?: MRI, CT or ultrasound was permitted if MRI was contraindicated, Dexamethasone Supression Test and Sonogram
Type of treatment: Pill or oral medicine, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 59 participants
Where: 20 sitesin 6 countries
Study dates: Aug 2014to Sep 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Written informed consent had to be obtained before any assessment was performed;
Patients had to be cooperative, willing to participate in the study assessments, and be able to report AEs (adverse events) themselves or have a caregiver who can record and report the events;
Total exposure to BGG492 treatment in Study BGG492A2207 and/or BGG492A2212 had to have been greater than 28 days
At least 1 year had to have elapsed since the patient received his or her last dose of BGG492.

Who cannot join

There were no exclusion criteria for this study. All patients meeting the inclusion criteria were eligible to participate in the follow-up safety assessments

Trial locations and contacts

20 sites in 6 countries.

Country

City, postcode or hospital

20 sites in 6 countries

Germany5 sites

Novartis Investigative Site
Bernau, 16321
Novartis Investigative Site
Bielefeld, 33617
Novartis Investigative Site
Bonn, 53105
Novartis Investigative Site
Kehl-Kork, 77694
Novartis Investigative Site
Ulm, 89081

Other trials in Germany

United States4 sites

Novartis Investigative Site
Baltimore, Maryland, 21287
Novartis Investigative Site
Dallas, Texas, 75230
Novartis Investigative Site
Hoffman, New Jersey, 08831
Novartis Investigative Site
Tallahassee, Florida, 32308

Other trials in United States

Hungary3 sites

Novartis Investigative Site
Budapest, H-1097
Novartis Investigative Site
Kecskemét, 6000
Novartis Investigative Site
Szombathely, 9700

Other trials in Hungary

Slovakia3 sites

Novartis Investigative Site
Banská Bystrica, Slovakia, 97517
Novartis Investigative Site
Hlohovec, Slovak Republic, 92001
Novartis Investigative Site
Košice, Slovak Republic, 041 90

Other trials in Slovakia

South Korea3 sites

Novartis Investigative Site
Seoul, Korea, 03080
Novartis Investigative Site
Seoul, Korea, 05505
Novartis Investigative Site
Seoul, Korea, 06351

Other trials in South Korea

Italy2 sites

Novartis Investigative Site
Florence, FI, 50143
Novartis Investigative Site
Milan, MI, 20142

Other trials in Italy

About this study

Official title: A Multicenter Medical Safety Follow-up Study for Patients With Partial Onset Seizures Who Received More Than 28 Days of Total Exposure to BGG492 in Studies CBGG492A2207 and/or CBGG492A2212

To provide medical follow-up to patients exposed to BGG492 for more than 28 days in study CBGG492A2207 (NCT 01147003) and/or CBGG492A2212 (NCT 01338805).

Read the detailed description

The purpose of the study was to provide medical follow-up to patients exposed to BGG492 for more than 28 days in study CBGG492A2207 (NCT 01147003) and/or CBGG492A2212 (NCT 01338805). Data from study CBGG492A2216 was used to support the clinical safety assessment of BGG492 regarding the observance of uterine endometrial stromal tumors and adrenal cortical adenomas at least one year after the completion of BGG492 treatment.

Conditions: Adrenocortical Adenoma, Endometrial Stromal Sarcomas
Being tested: MRI, CT or ultrasound was permitted if MRI was contraindicated, Dexamethasone Supression Test, Sonogram, Biopsy, BGG492
Keywords: Adrenocortical Adenoma,, Endometrial Stromal sarcomas, BGG492
Medical subject headings: Adrenocortical Adenoma, Sarcoma, Endometrial Stromal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MRI, CT or ultrasound was permitted if MRI was contraindicatedProcedure or surgery
Also called Magnetic Resonance Imaging Computed tomography
MRI/CT/ultrasound of abdomen
Dexamethasone Supression TestProcedure or surgery
Low dose of dexamethasone is administered in the evening; the next morning, a blood sample is collected to measure cortisol
SonogramProcedure or surgery
Also called Sonogram ultrasound
Sonogram of the uterus (females only)
BiopsyProcedure or surgery
Also called Uterine Biopsy
Uterine endometrial biopsy (females only)
BGG492Drug
Also called Selurampanel
No study-drug was administered in this study

Study groups in NCT02150213
Study group	Role	What they receive
BGG492	Experimental	This was a follow-up safety study where study treatment was not administered. Patients came from BGG492 studies where patients were previously exposed to > 28 days of BGG492 50 mg, 100 mg or 150 mg given orally three times a day Receives: Procedure: MRI, CT or ultrasound was permitted if MRI was contraindicated; Procedure: Dexamethasone Supression Test; Procedure: Sonogram; Procedure: Biopsy; Drug: BGG492

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Adrenal Cortical Adenomas
Incidence of adrenal cortical adenomas as assessed by non-contrast MRI of the abdomen (CT or ultrasound of the abdomen was permitted if MRI was contraindication)
Measured: Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212
Incidence of Uterine Endometrial Stromal Sarcomas
Incidence of uterine endometrial stromal sarcomas as assessed by sonogram/biopsy (females)
Measured: Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2014Sep 2015

First posted29 May 2014 (estimated)
Study startAug 2014
Primary completionSep 2015
Study completionSep 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Adrenocortical AdenomaStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 59 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02150213
Sponsor's protocol ID: CBGG492A2216
Other IDs: 2013-003431-29
Status last verified: Oct 2016
First submitted: 15 May 2014
Last updated: 5 Dec 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Adrenocortical Adenoma trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter Medical Safety Follow-up Study for Patients With Partial Onset Seizures Who Received More Than 28 Days of Total Exposure to BGG492 in Studies CBGG492A2207 and/or CBGG492A2212
ClinicalTrials.gov ID: NCT02150213
Acronym / sponsor ID: CBGG492A2216
Conditions: Adrenocortical Adenoma, Endometrial Stromal Sarcomas
Keywords: Adrenocortical Adenoma,, Endometrial Stromal sarcomas, BGG492
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 59 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Aug 2014
Primary completion: Sep 2015 (actual)
Study completion: Sep 2015 (actual)
First posted: 29 May 2014 (estimated)
Results: Posted 25 Jul 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To provide medical follow-up to patients exposed to BGG492 for more than 28 days in study CBGG492A2207 (NCT 01147003) and/or CBGG492A2212 (NCT 01338805).

Detailed description

Study design

Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
BGG492	Experimental	Procedure: MRI, CT or ultrasound was permitted if MRI was contraindicated, Procedure: Dexamethasone Supression Test, Procedure: Sonogram, Procedure: Biopsy, Drug: BGG492This was a follow-up safety study where study treatment was not administered. Patients came from BGG492 studies where patients were previously exposed to > 28 days of BGG492 50 mg, 100 mg or 150 mg given orally three times a day

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Written informed consent had to be obtained before any assessment was performed;
Patients had to be cooperative, willing to participate in the study assessments, and be able to report AEs (adverse events) themselves or have a caregiver who can record and report the events;
Total exposure to BGG492 treatment in Study BGG492A2207 and/or BGG492A2212 had to have been greater than 28 days
At least 1 year had to have elapsed since the patient received his or her last dose of BGG492.

Key exclusion criteria (1 listed)

There were no exclusion criteria for this study. All patients meeting the inclusion criteria were eligible to participate in the follow-up safety assessments

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MRI, CT or ultrasound was permitted if MRI was contraindicatedAlso: Magnetic Resonance Imaging Computed tomographyMRI/CT/ultrasound of abdomen	Procedure or surgery	BGG492
Dexamethasone Supression TestLow dose of dexamethasone is administered in the evening; the next morning, a blood sample is collected to measure cortisol	Procedure or surgery	BGG492
SonogramAlso: Sonogram ultrasoundSonogram of the uterus (females only)	Procedure or surgery	BGG492
BiopsyAlso: Uterine BiopsyUterine endometrial biopsy (females only)	Procedure or surgery	BGG492
BGG492Also: SelurampanelNo study-drug was administered in this study	Drug	BGG492

Primary outcome

Incidence of Adrenal Cortical Adenomas
Time frame: Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212
Incidence of adrenal cortical adenomas as assessed by non-contrast MRI of the abdomen (CT or ultrasound of the abdomen was permitted if MRI was contraindication)
Incidence of Uterine Endometrial Stromal Sarcomas
Time frame: Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212
Incidence of uterine endometrial stromal sarcomas as assessed by sonogram/biopsy (females)

Results and safety

Results posted to the registry on 25 Jul 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BGG492	59	57

Primary outcome: Incidence of Adrenal Cortical Adenomas

Time frame: Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212. Number. Unit: Particpants

Measure	BGG492 n = 59
Value	3

Population analysed: Full analysis Set: included all patients who signed informed consent to enter the study

Primary outcome: Incidence of Uterine Endometrial Stromal Sarcomas

Time frame: Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212. Number. Unit: Participants

Measure	BGG492 n = 29
Value	0

Population analysed: Full Analysis Set (FAS):included all patients who signed informed consent to enter the study, but this assessment was only done on female patients. Of the 31 female patients, two had a hysterectomy and were not evaluated (N=29)

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BGG492	5 of 59 (8.5%)	3 of 59 (5.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Adrenocortical Adenoma

Recruiting
Trial of Aldosterone-hybrid SteRoid for Guiding curablE Treatment of Primary Aldosteronism (TARGET-PA)
Hyperaldosteronism; Primary, Primary Aldosteronism Due to Aldosterone Producing Adenoma
RecruitingObservational study
Adrenal Diseases in the Population of Modena: A Clinical-Epidemiological Database of Patients Referred to the Adrenal Disorders Outpatient Clinic of the Clinical Unit of Endocrinology at the Modena University Hospital (AOU Modena)
Cushing s Syndrome, Cushing Disease
Active, not recruitingPhase 2
Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome
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RecruitingObservational study
Clinical and Molecular Characteristics of Primary Aldosteronism in Blacks
Adrenal Gland Neoplasm, Hypertension
RecruitingPhase 4
Isturisa Treatment in Mild Autonomous Cortisol Secretion( MACS)
Mild Autonomous Cortisol Secretion (MACS)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

20 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Germany, United States, Hungary, Slovakia, South Korea and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adrenal Cortical Adenomas (time frame: Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02150213.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2016.