Ketamine-Induced NeurotoxicityNCT05648526
Neuroprotective Effects of ACTH4-10PRO8-GLY9-PRO10
A study testing ACTH4-10Pro8-Gly9-Pro10 and Ketamine in people with Ketamine-Induced Neurotoxicity, run by Universitas Sumatera Utara at 1 site in Indonesia.
Trial summary
The compound ACTH4-10Pro8-Gly9-Pro10 is a synthetic analog molecule of an adrenocorticotropic hormone (ACTH) short fragment. That is free from hormonal effects and has neuromodulatory effects. Read more about this study
- Who is it for?
- Ages 7 to 7 days, men only
- Conditions the study is for
- Ketamine-Induced Neurotoxicity
- What is being tested?
- ACTH4-10Pro8-Gly9-Pro10 and Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Aug 2021to 30 Oct 2021
- Phase
- Interventional
- 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 7 to 7 days
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Rattus norvegicus rats
- Male, seven days old, weighing 15-20 grams
- Spraque-Dawley strain, obtained from the Experimental Animal Care Unit
Who cannot join
- Animals that behave aggressively in observation by attacking other groups
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Faculty of Medicine Universitas Sumatera Utara
Medan, North Sumatra, 20155
About this study
Official title: Neuroprotective Effects of ACTH4-10PRO8-GLY9-PRO10 on The Ketamine-Induced Neurotoxicity In Neonatal Rats: Increased BDNF Expression And BDNF Serum Concentrations
The compound ACTH4-10Pro8-Gly9-Pro10 is a synthetic analog molecule of an adrenocorticotropic hormone (ACTH) short fragment. That is free from hormonal effects and has neuromodulatory effects. We investigate the neuroprotective effects of ACTH4-10Pro8-Gly9-Pro10 can lessen neurotoxicity against ketamine in neonatal rats by looking at BDNF expression in the cortex and hippocampus tissue as well as BDNF blood levels.
Read the detailed description
The compound ACTH4-10Pro8-Gly9-Pro10 is a synthetic analog molecule of a short fragment of adrenocorticotropic hormone (ACTH). It is free from hormonal effects and has neuromodulatory effects. The immune-modulating and neurotrophic activity of the drug were shown to balance the state of anti-inflammatory and trophic factors (IL-IO, TNF-a, TGF-Pl, BDNF, NGF) over proinflammatory factors (IL-Ip, IL-8, CRP, LE) to increase the anti-apoptotic defense (Bcl-2 elevation), as well as to reduce the peroxidation process (increased SOD activity).
ACTH4-10Pro8-Gly9-Pro10 also has neuromodulator characteristics to function as a neuroprotector in inhibiting the apoptotic process. Modulation by ACTH4-10Pro8-Gly9-Pro10 will increase the levels of BDNF thereby inhibiting the process of apoptosis. Based on research by Gusev and Skvortsova, ischemic stroke patients who were given ACTH4-10Pro8-Gly9-Pro10 showed increased levels of BDNF, decreased mortality, and reduced length of stay. Based on the description above, the researcher was interested in analyzing the effect of the administration of ACTH4-10Pro8-Gly9-Pro10 on ketamine neurotoxicity in neonatal rats by assessing the level of BDNF.
- Conditions
- Ketamine-Induced Neurotoxicity
- Being tested
- ACTH4-10Pro8-Gly9-Pro10, Ketamine
- Keywords
- ACTH4-10Pro8-Gly9-Pro10, BDNF, ketamine-induced neurotoxicity, apoptosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTH4-10Pro8-Gly9-Pro10Drug
ACTH4-10Pro8-Gly9-Pro10 also has neuromodulator characteristics to function as a neuroprotector in inhibiting the apoptotic process. Modulation by ACTH4-10Pro8-Gly9-Pro10 will increase the levels of BDNF thereby inhibiting the process of apoptosis
KetamineDrug
negative-positive control (ketamine 40 mg/kg BW subcutaneously)
| Study group | Role | What they receive |
|---|---|---|
| ACTH4-10PRO8-GLY9-PRO10 | Experimental | The compound ACTH4-10Pro8-Gly9-Pro10 is a synthetic analog molecule of a short fragment of adrenocorticotropic hormone (ACTH). It is free from hormonal effects and has neuromodulatory effects. Receives: Drug: ACTH4-10Pro8-Gly9-Pro10 |
| ketamine 40 mg/kg BW subcutaneously | Active comparator | ketamine results in impaired brain function associated with neuroapoptosis injury in the immature brain. Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
BDNF Expression
a protein that, in humans, is encoded by the BDNF gene
Measured: On 6 hours after the study drug dose
BDNF Serum Concentrations
a protein that, in humans, is encoded by the BDNF gene
Measured: On 6 hours after the study drug dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start1 Aug 2021
- Primary completion30 Sep 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ketamine-Induced NeurotoxicityStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Sumatera Utara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raka Jati Prasetya, Universitas Sumatera Utara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05648526
- Sponsor's protocol ID
- Intervention
- Status last verified
- Dec 2022
- First submitted
- 5 Dec 2022
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ing C, DiMaggio C, Whitehouse A, Hegarty MK, Brady J, von Ungern-Sternberg BS, Davidson A, Wood AJ, Li G, Sun LS. Long-term differences in language and cognitive function after childhood exposure to anesthesia. Pediatrics. 2012 Sep;130(3):e476-85. doi: 10.1542/peds.2011-3822. Epub 2012 Aug 20.
PubMed 22908104Flick RP, Katusic SK, Colligan RC, Wilder RT, Voigt RG, Olson MD, Sprung J, Weaver AL, Schroeder DR, Warner DO. Cognitive and behavioral outcomes after early exposure to anesthesia and surgery. Pediatrics. 2011 Nov;128(5):e1053-61. doi: 10.1542/peds.2011-0351. Epub 2011 Oct 3.
PubMed 21969289
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroprotective Effects of ACTH4-10PRO8-GLY9-PRO10 on The Ketamine-Induced Neurotoxicity In Neonatal Rats: Increased BDNF Expression And BDNF Serum Concentrations
- ClinicalTrials.gov ID
- NCT05648526
- Acronym / sponsor ID
- Intervention
- Conditions
- Ketamine-Induced Neurotoxicity
- Keywords
- ACTH4-10Pro8-Gly9-Pro10, BDNF, ketamine-induced neurotoxicity, apoptosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Universitas Sumatera UtaraUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 13 Dec 2022 (actual)
- 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 compound ACTH4-10Pro8-Gly9-Pro10 is a synthetic analog molecule of an adrenocorticotropic hormone (ACTH) short fragment. That is free from hormonal effects and has neuromodulatory effects. We investigate the neuroprotective effects of ACTH4-10Pro8-Gly9-Pro10 can lessen neurotoxicity against ketamine in neonatal rats by looking at BDNF expression in the cortex and hippocampus tissue as well as BDNF blood levels.
Detailed description
The compound ACTH4-10Pro8-Gly9-Pro10 is a synthetic analog molecule of a short fragment of adrenocorticotropic hormone (ACTH). It is free from hormonal effects and has neuromodulatory effects. The immune-modulating and neurotrophic activity of the drug were shown to balance the state of anti-inflammatory and trophic factors (IL-IO, TNF-a, TGF-Pl, BDNF, NGF) over proinflammatory factors (IL-Ip, IL-8, CRP, LE) to increase the anti-apoptotic defense (Bcl-2 elevation), as well as to reduce the peroxidation process (increased SOD activity).
ACTH4-10Pro8-Gly9-Pro10 also has neuromodulator characteristics to function as a neuroprotector in inhibiting the apoptotic process. Modulation by ACTH4-10Pro8-Gly9-Pro10 will increase the levels of BDNF thereby inhibiting the process of apoptosis. Based on research by Gusev and Skvortsova, ischemic stroke patients who were given ACTH4-10Pro8-Gly9-Pro10 showed increased levels of BDNF, decreased mortality, and reduced length of stay. Based on the description above, the researcher was interested in analyzing the effect of the administration of ACTH4-10Pro8-Gly9-Pro10 on ketamine neurotoxicity in neonatal rats by assessing the level of BDNF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACTH4-10PRO8-GLY9-PRO10 | Experimental | Drug: ACTH4-10Pro8-Gly9-Pro10The compound ACTH4-10Pro8-Gly9-Pro10 is a synthetic analog molecule of a short fragment of adrenocorticotropic hormone (ACTH). It is free from hormonal effects and has neuromodulatory effects. |
| ketamine 40 mg/kg BW subcutaneously | Active comparator | Drug: Ketamineketamine results in impaired brain function associated with neuroapoptosis injury in the immature brain. |
Who may qualify
- Ages
- 7 to 7 days
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Rattus norvegicus rats
- Male, seven days old, weighing 15-20 grams
- Spraque-Dawley strain, obtained from the Experimental Animal Care Unit
Key exclusion criteria (1 listed)
- Animals that behave aggressively in observation by attacking other groups
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 |
|---|---|---|
| ACTH4-10Pro8-Gly9-Pro10ACTH4-10Pro8-Gly9-Pro10 also has neuromodulator characteristics to function as a neuroprotector in inhibiting the apoptotic process. Modulation by ACTH4-10Pro8-Gly9-Pro10 will increase the levels of BDNF thereby inhibiting the process of apoptosis | Drug | ACTH4-10PRO8-GLY9-PRO10 |
| Ketaminenegative-positive control (ketamine 40 mg/kg BW subcutaneously) | Drug | ketamine 40 mg/kg BW subcutaneously |
Primary outcome
BDNF Expression
Time frame: On 6 hours after the study drug dose
a protein that, in humans, is encoded by the BDNF gene
BDNF Serum Concentrations
Time frame: On 6 hours after the study drug dose
a protein that, in humans, is encoded by the BDNF gene
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
- Background: PubMed 22908104Ing C, DiMaggio C, Whitehouse A, Hegarty MK, Brady J, von Ungern-Sternberg BS, Davidson A, Wood AJ, Li G, Sun LS. Long-term differences in language and cognitive function after childhood exposure to anesthesia. Pediatrics. 2012 Sep;130(3):e476-85. doi: 10.1542/peds.2011-3822. Epub 2012 Aug 20.
- Results publication: PubMed 21969289Flick RP, Katusic SK, Colligan RC, Wilder RT, Voigt RG, Olson MD, Sprung J, Weaver AL, Schroeder DR, Warner DO. Cognitive and behavioral outcomes after early exposure to anesthesia and surgery. Pediatrics. 2011 Nov;128(5):e1053-61. doi: 10.1542/peds.2011-0351. Epub 2011 Oct 3.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACTH4-10Pro8-Gly9-Pro10 and Ketamine in people with Ketamine-Induced Neurotoxicity, run by Universitas Sumatera Utara at 1 site in Indonesia.
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 3 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 13 Dec 2022. 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 Indonesia. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
BDNF Expression (time frame: On 6 hours after the study drug dose). 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 NCT05648526, which also lists 2 linked publications.
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 13 Dec 2022.