Partial Corticotrope InsufficiencyPhase 4CSMünchen01NCT01089075
Neuropsychological Effects of Hydrocortisone in Patients With Partial Adrenal Insufficiency
A Phase 4 study testing Hydrocortisone in people with Partial Corticotrope Insufficiency, run by Max-Planck-Institute of Psychiatry at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate the efficacy of hydrocortisone replacement therapy in patients with partial cortisol deficiency after traumatic brain injury or subarachnoid hemorrhage on cognitive function. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Partial Corticotrope Insufficiency
- What is being tested?
- Hydrocortisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2010to Mar 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (male and female) between 18 and 75 years
- 1 -12 month after TBI or SAH before prescreening
- Cortisol level 100-180 ng/ml after stimulation with ACTH
- Written informed consent by patient or a legally accepted representative
Who cannot join
- Pregnancy and lactation period (during study treatment)
- Concomitant or previous high-dose therapy with glucocorticoids; previous treatment with glucocorticoids will be accepted, if it has been low dose (i.e. lower than the Cushing threshold) and has been stopped at least 3 months before study participation
- Suspected or known hypersensitivity to hydrocortisone or any of its components
- Albumine less than 2,5 g/dl
- Suspected or known drug or alcohol abuse
- Planned treatment for thyroid dysfunction or a planned change in established thyroid treatment
Show all 14Show fewer
- Any condition which in the opinion of the investigator makes the patient unsuitable for inclusion.
- Participation in another clinical trial with investigational new drugs
- Severe medical or psychiatric disease
- Change of dosage of any other drug which might influence the corticotrope axis or cognitive function (e.g. antidepressive treatment) during the last 3 weeks
- Oral contraceptives
- Severe disturbances in articulation, visual faculty or hearing
- Any elective surgery or medical treatment planned in the observation period
- Intensive Care treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IV Study to Evaluate the Neuropsychological Effects of Hydrocortisone Substitution in Patients With Partial Adrenal Insufficiency After Traumatic Brain Injury or Subarachnoidal Haemorrhage
The purpose of this study is to evaluate the efficacy of hydrocortisone replacement therapy in patients with partial cortisol deficiency after traumatic brain injury or subarachnoid hemorrhage on cognitive function.
Read the detailed description
This is a controlled, randomized, double-blind, placebo-controlled, crossover, interventional study. The benefit of replacement in partial corticotropic failure on brain function (cognition), especially in cases with borderline low cortisol levels after stimulation is unknown.
Moreover, since glucocorticoids might affect hGH secretion, the effect of hydrocortisone on hGH secretion reflected by IGF-1 levels will be assessed. If IGF-1 is below 2 SD at the end of the study, hGH secretion will additionally be determined by a GHRH-arginine-test.
An improved cognition in TBI and SAH patients with partial corticotropic insufficiency would give a new treatment option in this population which may lead to better quality of life and an enhanced rehabilitation process.
- Conditions
- Partial Corticotrope Insufficiency
- Being tested
- Hydrocortisone, Placebo
- Keywords
- neuropsychological effects of hydrocortisone replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrocortisoneDrug
Also called Hydrocortison GALEN 20 mg
20 mg po for 7 days (2 tablets)
PlaceboDrug
Also called P-Tabletten 7 mm Lichtenstein
2 tablets po
| Study group | Role | What they receive |
|---|---|---|
| placebo/20 mg hydrocortisone | Placebo comparator | Order of study treatment: 7 days placebo followed by 7 days 20 mg hydrocortisone Receives: Drug: Hydrocortisone; Drug: Placebo |
| 20 mg hydrocortisone/placebo | Active comparator | Order of study treatment: 7 days 20 mg hydrocortisone followed by 7 days placebo Receives: Drug: Hydrocortisone; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in score of alertness test (TAP)- interindividual differences
Measured: day -5 to - 0 (before start of study treatment), day 7 (after 7 days treatment with Hydrocortisone or Placebo, day 14 (after 7 days treatment with Hydrocortisone or Placebo)
Secondary outcomes (1)
Changes in score of Alertness Test (TAP) - intraindividual differences
Measured: day -5 to - 0 (before start of study treatment), day 7 (after 7 days treatment with Hydrocortisone or Placebo, day 14 (after 7 days treatment with Hydrocortisone or Placebo)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionMar 2015
- Study completionMar 2015
Why it stopped: Insufficient recruitment of suitable patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial Corticotrope InsufficiencyStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Max-Planck-Institute of Psychiatry
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Sponsor
- Investigators
- Günter K. Stalla, Prof. Dr., Study director, Max-Planck-Institute, Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01089075
- Sponsor's protocol ID
- 2009-014909-14
- Other IDs
- 2009
- Acronym
- CSMünchen01
- Status last verified
- Apr 2015
- First submitted
- 2 Feb 2010
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study to Evaluate the Neuropsychological Effects of Hydrocortisone Substitution in Patients With Partial Adrenal Insufficiency After Traumatic Brain Injury or Subarachnoidal Haemorrhage
- ClinicalTrials.gov ID
- NCT01089075
- Acronym / sponsor ID
- CSMünchen01 / 2009-014909-14
- Conditions
- Partial Corticotrope Insufficiency
- Keywords
- neuropsychological effects of hydrocortisone replacement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment of suitable patients.
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Max-Planck-Institute of PsychiatryUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- Feb 2010
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 18 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy of hydrocortisone replacement therapy in patients with partial cortisol deficiency after traumatic brain injury or subarachnoid hemorrhage on cognitive function.
Detailed description
This is a controlled, randomized, double-blind, placebo-controlled, crossover, interventional study. The benefit of replacement in partial corticotropic failure on brain function (cognition), especially in cases with borderline low cortisol levels after stimulation is unknown.
Moreover, since glucocorticoids might affect hGH secretion, the effect of hydrocortisone on hGH secretion reflected by IGF-1 levels will be assessed. If IGF-1 is below 2 SD at the end of the study, hGH secretion will additionally be determined by a GHRH-arginine-test.
An improved cognition in TBI and SAH patients with partial corticotropic insufficiency would give a new treatment option in this population which may lead to better quality of life and an enhanced rehabilitation process.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo/20 mg hydrocortisone | Placebo comparator | Drug: Hydrocortisone, Drug: PlaceboOrder of study treatment: 7 days placebo followed by 7 days 20 mg hydrocortisone |
| 20 mg hydrocortisone/placebo | Active comparator | Drug: Hydrocortisone, Drug: PlaceboOrder of study treatment: 7 days 20 mg hydrocortisone followed by 7 days placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (male and female) between 18 and 75 years
- 1 -12 month after TBI or SAH before prescreening
- Cortisol level 100-180 ng/ml after stimulation with ACTH
- Written informed consent by patient or a legally accepted representative
Key exclusion criteria (14 listed)
- Pregnancy and lactation period (during study treatment)
- Concomitant or previous high-dose therapy with glucocorticoids; previous treatment with glucocorticoids will be accepted, if it has been low dose (i.e. lower than the Cushing threshold) and has been stopped at least 3 months before study participation
- Suspected or known hypersensitivity to hydrocortisone or any of its components
- Albumine less than 2,5 g/dl
- Suspected or known drug or alcohol abuse
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 |
|---|---|---|
| HydrocortisoneAlso: Hydrocortison GALEN 20 mg20 mg po for 7 days (2 tablets) | Drug | 20 mg hydrocortisone/placebo, placebo/20 mg hydrocortisone |
| PlaceboAlso: P-Tabletten 7 mm Lichtenstein2 tablets po | Drug | 20 mg hydrocortisone/placebo, placebo/20 mg hydrocortisone |
Primary outcome
Changes in score of alertness test (TAP)- interindividual differences
Time frame: day -5 to - 0 (before start of study treatment), day 7 (after 7 days treatment with Hydrocortisone or Placebo, day 14 (after 7 days treatment with Hydrocortisone or Placebo)
1 secondary outcome
Changes in score of Alertness Test (TAP) - intraindividual differences
Time frame: day -5 to - 0 (before start of study treatment), day 7 (after 7 days treatment with Hydrocortisone or Placebo, day 14 (after 7 days treatment with Hydrocortisone or Placebo)
Results and safety
The study was stopped early (reason given: Insufficient recruitment of suitable patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
- Click here for more information about endocrinological diseasesLink provided by the sponsor.
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.
Günter K. Stalla, Prof. Dr. study director
Max-Planck-Institute, Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydrocortisone in people with Partial Corticotrope Insufficiency, run by Max-Planck-Institute of Psychiatry at 1 site in Germany.
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 14 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: stopped early, as of the sponsor's last update on 8 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Insufficient recruitment of suitable patients.). Results are not available in the source record.
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?
Changes in score of alertness test (TAP)- interindividual differences (time frame: day -5 to - 0 (before start of study treatment), day 7 (after 7 days treatment with Hydrocortisone or Placebo, day 14 (after 7 days treatment with Hydrocortisone or Placebo)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2015.