Panic DisorderPhase 1NCT04592536

A Trial of the Effect of CVL-865 on Panic Symptoms Induced by Carbon Dioxide Inhalation in Healthy Subjects

A Phase 1 study testing CVL-865 High dose, Alprazolam 1mg XR and CVL-865 low dose in people with Panic Disorder, run by Cerevel Therapeutics, LLC at 1 site in Netherlands.

Completed

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

Official record

Search all trials

Trial summary

The purpose of this study is to determine anxiolytic effect of multiple doses of CVL-865 using an experimental medicine model of carbon dioxide (CO2) inhalation in healthy volunteers. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Panic Disorder
What is being tested?: CVL-865 High dose, Alprazolam 1mg XR and CVL-865 low dose
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 56 participants
Where: 1 siteNetherlands
Study dates: 6 Oct 2020to 13 Dec 2021
Phase: Phase 1
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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male and female subjects, ages 18 to 55 years, inclusive, at the time of signing the ICF. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and heart rate measurement, 12-lead ECG, and clinical laboratory tests, as evaluated by the investigator.
Body mass index of 18.5 to 30.0 kg/m2, inclusive, and a total body weight >50 kg (110 lbs)
A female subject of childbearing potential who is sexually active with a nonsterilized male partner must agree to use a highly effective method of contraception from signing of informed consent and for 30 days post last dose. A male subject with a pregnant or a nonpregnant partner of childbearing potential must agree to use condom during treatment and until the end of relevant systemic exposure in the male subject for 94 days following the last dose with IMP.
Capable of giving signed informed consent
Ability, in the opinion of the investigator, to understand the nature of the trial and comply with protocol requirements, including the prescribed dosage regimens, scheduled visits, laboratory tests, and other trial procedures.
Defined as sensitive to the anxiogenic effects of double-breath CO2 inhalation

Who cannot join

Subjects with a current history of clinically significant cardiovascular pulmonary, gastrointestinal, renal, hepatic, metabolic, hematological, immunological, or neurological disease.
Subjects with a current or past history of clinically significant respiratory conditions
Subject with a personal or family history of sickle cell anemia
Subject with a personal or family history of cerebral aneurysm
Subjects with a clinically significant current or past personal or family history of any psychiatric disorder as classified by DSM-4 or DSM-5 criteria
Subjects with epilepsy or a history of seizures except for a single seizure episode

Show all 36Show fewer

Subjects with a history of substance or alcohol-use disorder (DSM-5 criteria)
Subjects who answer "Yes" on the C-SSRS Suicidal Ideation Item 4, 5 and whose most recent episode meeting criteria for this C-SSRS Item 4, 5 occurred within the last 6 months
Subjects who, in the opinion of the investigator, present a serious risk of suicide
Subjects with human immunodeficiency virus seropositive status or acquired immunodeficiency syndrome, chronic hepatitis B or C (defined as positive serology and aspartate aminotransferase or alanine aminotransferase elevated to >2 × ULN)
Subject with a positive drug screen for illicit drugs
Subjects with a 12-lead ECG demonstrating either of the following:
QT interval corrected for heart rate using Fridericia's formula >450 msec (average of 3 ECGs obtained at the Screening Visit)
QRS interval >120 msec at the Screening Visit
Subjects with any of the following abnormalities in clinical laboratory tests at the Screening Visit, as assessed by the local laboratory and confirmed by a single repeat measurement, if deemed necessary:
AST or ALT ≥2 × ULN
Total bilirubin ≥1.5 × ULN. Subjects with a history of Gilbert's syndrome may be eligible provided the direct bilirubin is <ULN
Females: Hemoglobin <11 g/dL; Males: hemoglobin <12 g/dL
White blood cell count <3.0 × 109/L
Neutrophil count <2.0 × 109/L
Platelet count <150 × 109/L
Subjects with other abnormal laboratory test results, vital sign results, or ECG findings unless, based on the investigator's judgment, the findings are not medically significant
Systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg at Screening or Day -1
Subjects taking prohibited medication or who would be likely to require prohibited concomitant therapy
Subject has a current or past history of BZD abuse and/or dependence
Female subjects who are breastfeeding and/or who have a positive pregnancy test result prior to receiving IMP
Subjects who currently use or have used tobacco or nicotine-containing products within 30 days prior to signing the ICF. Subjects who test positive for urine cotinine
Subjects who has a history of consuming foods or beverages containing >8 units of methylxanthines per day and refuses to abstain from consumption of methylxanthine containing food and beverages while in the clinic.
Subjects with any condition possibly affecting drug absorption
Subjects with difficulty swallowing
Subjects who are known to be allergic or hypersensitive to the IMP or any of its components
Subjects with a known sensitivity or contraindication to alprazolam
Subjects who have participated in any clinical trial within 90 days prior to signing the ICF.
Subjects who have demonstrated a non-response to 35% CO2 double inhalation challenge in a previous trial.
Any subject who, in the opinion of the sponsor, investigator, or medical monitor, should not participate in the trial
Subjects with a positive SARS-CoV-2 quantitative PCR test result at Day -1, Period 1 are excluded. Results from subjects reporting a positive SARS-CoV-2 quantitative PCR test result prior to Day -1, Period need to be discussed with the sponsor/medical monitor prior to enrolment of the subject into the trial

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Centre for Human Drug Research
Leiden, Zernikedreef 8, 2333 CL

Other trials in Netherlands

About this study

Official title: A Randomized, Double-blind, Placebo- and Active Comparator-controlled, Crossover Trial to Examine the Effect of Multiple Doses of CVL-865 on Panic Symptoms Induced by Carbon Dioxide Inhalation in Healthy Subject

The purpose of this study is to determine anxiolytic effect of multiple doses of CVL-865 using an experimental medicine model of carbon dioxide (CO2) inhalation in healthy volunteers.

Conditions: Panic Disorder
Being tested: CVL-865 High dose, Alprazolam 1mg XR, Placebo, CVL-865 low dose
Keywords: Anxiety, Panic, CVL-865, PF-06372865, Hypercapnia, CO2 challenge, Healthy Subjects
Medical subject headings: Panic Disorder, Anxiety Disorders, Hypercapnia

What participants receive

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

CVL-865 High doseDrug
High dose CVL-865: Will be administered as 5mg BID for 2 days followed by 12.5mg BID for another 2 days during the Titration Phase. 25mg will be administered during the Maintenance Phase (3 days of BID and morning dose only on the 4th day)
Alprazolam 1mg XRDrug
Alprazolam 1mg XR will be administered for 8 days BID (morning dose only on 8th day)
PlaceboDrug
Placebo, oral tablet/capsule will be administered for 8 days BID (morning dose only on 8th day)
CVL-865 low doseDrug
Low dose CVL-865, oral tablets. Will be administered as 2.5mg BID for 2 days followed by 5mg BID for another 2 days during the Titration Phase. 7.5mg BID will be administered during the Maintenance Phase (3 days of BID and morning dose only on 4th day)

Study groups in NCT04592536
Study group	Role	What they receive
CVL-865	Experimental	High dose CVL-865 (25mg) Low dose CVL-865 (7.5mg) Receives: Drug: CVL-865 High dose; Drug: CVL-865 low dose
Alprazolam	Active comparator	Active Comparator Alprazolam with extended release oral tablets; 1 tablet BID Receives: Drug: Alprazolam 1mg XR
Placebo	Placebo comparator	Placebo Comparator matching oral tablets for CVL-865, capsule for Alprazolam Receives: Drug: Placebo

What is being measured

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

PSL-IV score
Change in Panic Symptom List -IV (PSL-IV), a questionnaire including 13 symptoms, each with intensity rating from 0 (not at all) to 4 (very intense), from pre-CO2 to Post CO2 challenge value
Measured: up to Day 8

Secondary outcomes (7)

VAS Fear score
Change in Visual Analog Scale (VAS) value for fear, consisting of a horizontal line 100 mm in length with 0 corresponding to "no fear" and 100 corresponding to "the most fear possible", from pre-CO2 to Post CO2 challenge
Measured: up to Day 8
CO2 challenge
Change from pre-CO2 to post-CO2 challenge values in Finapres NanoCore Physiological Measurements
Measured: Screening, Day 1, Day 8
Treatment-emergent AEs
Treatment-emergent AEs
Measured: From screening to Follow-up Visit
Suicidality assessed using Columbia - Suicide Severity Rating Scale (C-SSRS)
Suicidality assessed using Columbia - Suicide Severity Rating Scale (C-SSRS) with no/yes (0/1) to each interview question on the occurrence of suicide events or ideation.
Measured: Screening, Day -1, Day 8
CVL-865 (and alprazolam, if appropriate) concentrations
Measured: Day 8
Change From Baseline in NeuroCart test battery Score
Psychodynamic effects of CVL-865 will be assessed by means of the NeuroCart test battery (including saccadic eye movements, adaptive tracking, body sway, Quantitative EEG)
Measured: Screening, Day 1, Day 8
Change from Baseline in Bond & Lader Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS) is made up of 16 pairs of alternative descriptors of mood and attention at either end. The Bond-Lader of a 10 cm line. Participants will rate their feelings at the time of assessment by indicating the point on the line which best represent their mood. Each item is scored by measuring the position relative to the left hand end of the line and levels of anxiety, sedation, and dysphoria are then calculated from the combined scores of selected items. The score ranges from 0 to 100, with a high score reflecting a high level of anxiety, sedation or dysphoria.
Measured: Day 1, Day 8

Timeline

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

6 Oct 202013 Dec 2021

First posted19 Oct 2020
Study start6 Oct 2020
Primary completion14 Nov 2021
Study completion13 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (25)Papers the sponsor has linked to this study.
Other trials for Panic DisorderStudies 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04592536
Sponsor's protocol ID: CVL-865-HV-001
Status last verified: Jan 2022
First submitted: 29 Sep 2020
Last updated: 11 Jan 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Atack JR. GABAA receptor alpha2/alpha3 subtype-selective modulators as potential nonsedating anxiolytics. Curr Top Behav Neurosci. 2010;2:331-60. doi: 10.1007/7854_2009_30.
PubMed 21309116
Atack JR, Hallett DJ, Tye S, Wafford KA, Ryan C, Sanabria-Bohorquez SM, Eng WS, Gibson RE, Burns HD, Dawson GR, Carling RW, Street LJ, Pike A, De Lepeleire I, Van Laere K, Bormans G, de Hoon JN, Van Hecken A, McKernan RM, Murphy MG, Hargreaves RJ. Preclinical and clinical pharmacology of TPA023B, a GABAA receptor α2/α3 subtype-selective partial agonist. J Psychopharmacol. 2011 Mar;25(3):329-44. doi: 10.1177/0269881109354928. Epub 2010 Feb 15.
PubMed 20156926
Atack JR, Hutson PH, Collinson N, Marshall G, Bentley G, Moyes C, Cook SM, Collins I, Wafford K, McKernan RM, Dawson GR. Anxiogenic properties of an inverse agonist selective for alpha3 subunit-containing GABA A receptors. Br J Pharmacol. 2005 Feb;144(3):357-66. doi: 10.1038/sj.bjp.0706056.
PubMed 15655523
Atack JR, Wafford KA, Tye SJ, Cook SM, Sohal B, Pike A, Sur C, Melillo D, Bristow L, Bromidge F, Ragan I, Kerby J, Street L, Carling R, Castro JL, Whiting P, Dawson GR, McKernan RM. TPA023 [7-(1,1-dimethylethyl)-6-(2-ethyl-2H-1,2,4-triazol-3-ylmethoxy)-3-(2-fluorophenyl)-1,2,4-triazolo[4,3-b]pyridazine], an agonist selective for alpha2- and alpha3-containing GABAA receptors, is a nonsedating anxiolytic in rodents and primates. J Pharmacol Exp Ther. 2006 Jan;316(1):410-22. doi: 10.1124/jpet.105.089920. Epub 2005 Sep 23.
PubMed 16183706
Bailey JE, Dawson GR, Dourish CT, Nutt DJ. Validating the inhalation of 7.5% CO(2) in healthy volunteers as a human experimental medicine: a model of generalized anxiety disorder (GAD). J Psychopharmacol. 2011 Sep;25(9):1192-8. doi: 10.1177/0269881111408455.
PubMed 21994314
Bandelow B, Zohar J, Hollander E, Kasper S, Moller HJ; WFSBP Task Force on Treatment Guidelines for Anxiety, Obsessive-Compulsive and Post-Traumatic Stress Disoders; Zohar J, Hollander E, Kasper S, Moller HJ, Bandelow B, Allgulander C, Ayuso-Gutierrez J, Baldwin DS, Buenvicius R, Cassano G, Fineberg N, Gabriels L, Hindmarch I, Kaiya H, Klein DF, Lader M, Lecrubier Y, Lepine JP, Liebowitz MR, Lopez-Ibor JJ, Marazziti D, Miguel EC, Oh KS, Preter M, Rupprecht R, Sato M, Starcevic V, Stein DJ, van Ameringen M, Vega J. World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for the pharmacological treatment of anxiety, obsessive-compulsive and post-traumatic stress disorders - first revision. World J Biol Psychiatry. 2008;9(4):248-312. doi: 10.1080/15622970802465807.
PubMed 18949648
Bond A, Lader M. The use of analogue scales in rating subjective feelings. Br J Med Psychol. 1974;47:211-8
Borland RG, Nicholson AN. Visual motor co-ordination and dynamic visual acuity. Br J Clin Pharmacol. 1984;18 Suppl 1(Suppl 1):69S-72S. doi: 10.1111/j.1365-2125.1984.tb02583.x.
PubMed 6525331
Borland RG, Nicholson AN. Comparison of the residual effects of two benzodiazepines (nitrazepam and flurazepam hydrochloride) and pentobarbitone sodium on human performance. Br J Clin Pharmacol. 1975 Feb;2(1):9-17. doi: 10.1111/j.1365-2125.1975.tb00465.x.
PubMed 10941
Dias R, Sheppard WF, Fradley RL, Garrett EM, Stanley JL, Tye SJ, Goodacre S, Lincoln RJ, Cook SM, Conley R, Hallett D, Humphries AC, Thompson SA, Wafford KA, Street LJ, Castro JL, Whiting PJ, Rosahl TW, Atack JR, McKernan RM, Dawson GR, Reynolds DS. Evidence for a significant role of alpha 3-containing GABAA receptors in mediating the anxiolytic effects of benzodiazepines. J Neurosci. 2005 Nov 16;25(46):10682-8. doi: 10.1523/JNEUROSCI.1166-05.2005.
PubMed 16291941
Hidalgo RB, Davidson JR. Generalized anxiety disorder. An important clinical concern. Med Clin North Am. 2001 May;85(3):691-710. doi: 10.1016/s0025-7125(05)70336-9.
PubMed 11349480
Leibold NK, van den Hove DL, Viechtbauer W, Buchanan GF, Goossens L, Lange I, Knuts I, Lesch KP, Steinbusch HW, Schruers KR. CO2 exposure as translational cross-species experimental model for panic. Transl Psychiatry. 2016 Sep 6;6(9):e885. doi: 10.1038/tp.2016.162.
PubMed 27598969
Low K, Crestani F, Keist R, Benke D, Brunig I, Benson JA, Fritschy JM, Rulicke T, Bluethmann H, Mohler H, Rudolph U. Molecular and neuronal substrate for the selective attenuation of anxiety. Science. 2000 Oct 6;290(5489):131-4. doi: 10.1126/science.290.5489.131.
PubMed 11021797
Morris HV, Dawson GR, Reynolds DS, Atack JR, Stephens DN. Both alpha2 and alpha3 GABAA receptor subtypes mediate the anxiolytic properties of benzodiazepine site ligands in the conditioned emotional response paradigm. Eur J Neurosci. 2006 May;23(9):2495-504. doi: 10.1111/j.1460-9568.2006.04775.x.
PubMed 16706856
Nickolls SA, Gurrell R, van Amerongen G, Kammonen J, Cao L, Brown AR, Stead C, Mead A, Watson C, Hsu C, Owen RM, Pike A, Fish RL, Chen L, Qiu R, Morris ED, Feng G, Whitlock M, Gorman D, van Gerven J, Reynolds DS, Dua P, Butt RP. Pharmacology in translation: the preclinical and early clinical profile of the novel alpha2/3 functionally selective GABAA receptor positive allosteric modulator PF-06372865. Br J Pharmacol. 2018 Feb;175(4):708-725. doi: 10.1111/bph.14119. Epub 2018 Jan 18.
PubMed 29214652

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?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo- and Active Comparator-controlled, Crossover Trial to Examine the Effect of Multiple Doses of CVL-865 on Panic Symptoms Induced by Carbon Dioxide Inhalation in Healthy Subject
ClinicalTrials.gov ID: NCT04592536
Acronym / sponsor ID: CVL-865-HV-001
Conditions: Panic Disorder
Keywords: Anxiety, Panic, CVL-865, PF-06372865, Hypercapnia, CO2 challenge, Healthy Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: Cerevel Therapeutics, LLCIndustry (pharma, biotech, devices)
Study start: 6 Oct 2020 (actual)
Primary completion: 14 Nov 2021 (actual)
Study completion: 13 Dec 2021 (actual)
First posted: 19 Oct 2020 (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 purpose of this study is to determine anxiolytic effect of multiple doses of CVL-865 using an experimental medicine model of carbon dioxide (CO2) inhalation in healthy volunteers.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
CVL-865	Experimental	Drug: CVL-865 High dose, Drug: CVL-865 low doseHigh dose CVL-865 (25mg) Low dose CVL-865 (7.5mg)
Alprazolam	Active comparator	Drug: Alprazolam 1mg XRActive Comparator Alprazolam with extended release oral tablets; 1 tablet BID
Placebo	Placebo comparator	Drug: PlaceboPlacebo Comparator matching oral tablets for CVL-865, capsule for Alprazolam

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Healthy male and female subjects, ages 18 to 55 years, inclusive, at the time of signing the ICF. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and heart rate measurement, 12-lead ECG, and clinical laboratory tests, as evaluated by the investigator.
Body mass index of 18.5 to 30.0 kg/m2, inclusive, and a total body weight >50 kg (110 lbs)
A female subject of childbearing potential who is sexually active with a nonsterilized male partner must agree to use a highly effective method of contraception from signing of informed consent and for 30 days post last dose. A male subject with a pregnant or a nonpregnant partner of childbearing potential must agree to use condom during treatment and until the end of relevant systemic exposure in the male subject for 94 days following the last dose with IMP.
Capable of giving signed informed consent
Ability, in the opinion of the investigator, to understand the nature of the trial and comply with protocol requirements, including the prescribed dosage regimens, scheduled visits, laboratory tests, and other trial procedures.

Key exclusion criteria (36 listed)

Subjects with a current history of clinically significant cardiovascular pulmonary, gastrointestinal, renal, hepatic, metabolic, hematological, immunological, or neurological disease.
Subjects with a current or past history of clinically significant respiratory conditions
Subject with a personal or family history of sickle cell anemia
Subject with a personal or family history of cerebral aneurysm
Subjects with a clinically significant current or past personal or family history of any psychiatric disorder as classified by DSM-4 or DSM-5 criteria

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
CVL-865 High doseHigh dose CVL-865: Will be administered as 5mg BID for 2 days followed by 12.5mg BID for another 2 days during the Titration Phase. 25mg will be administered during the Maintenance Phase (3 days of BID and morning dose only on the 4th day)	Drug	CVL-865
Alprazolam 1mg XRAlprazolam 1mg XR will be administered for 8 days BID (morning dose only on 8th day)	Drug	Alprazolam
PlaceboPlacebo, oral tablet/capsule will be administered for 8 days BID (morning dose only on 8th day)	Drug	Placebo
CVL-865 low doseLow dose CVL-865, oral tablets. Will be administered as 2.5mg BID for 2 days followed by 5mg BID for another 2 days during the Titration Phase. 7.5mg BID will be administered during the Maintenance Phase (3 days of BID and morning dose only on 4th day)	Drug	CVL-865

Primary outcome

PSL-IV score
Time frame: up to Day 8
Change in Panic Symptom List -IV (PSL-IV), a questionnaire including 13 symptoms, each with intensity rating from 0 (not at all) to 4 (very intense), from pre-CO2 to Post CO2 challenge value

7 secondary outcomes

VAS Fear score
Time frame: up to Day 8
CO2 challenge
Time frame: Screening, Day 1, Day 8
Treatment-emergent AEs
Time frame: From screening to Follow-up Visit
Suicidality assessed using Columbia - Suicide Severity Rating Scale (C-SSRS)
Time frame: Screening, Day -1, Day 8
CVL-865 (and alprazolam, if appropriate) concentrations
Time frame: Day 8
Change From Baseline in NeuroCart test battery Score
Time frame: Screening, Day 1, Day 8
Change from Baseline in Bond & Lader Visual Analogue Scale (VAS)
Time frame: Day 1, Day 8

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 11 Jan 2022.
Background: PubMed 21309116Atack JR. GABAA receptor alpha2/alpha3 subtype-selective modulators as potential nonsedating anxiolytics. Curr Top Behav Neurosci. 2010;2:331-60. doi: 10.1007/7854_2009_30.
Background: PubMed 20156926Atack JR, Hallett DJ, Tye S, Wafford KA, Ryan C, Sanabria-Bohorquez SM, Eng WS, Gibson RE, Burns HD, Dawson GR, Carling RW, Street LJ, Pike A, De Lepeleire I, Van Laere K, Bormans G, de Hoon JN, Van Hecken A, McKernan RM, Murphy MG, Hargreaves RJ. Preclinical and clinical pharmacology of TPA023B, a GABAA receptor α2/α3 subtype-selective partial agonist. J Psychopharmacol. 2011 Mar;25(3):329-44. doi: 10.1177/0269881109354928. Epub 2010 Feb 15.
Background: PubMed 15655523Atack JR, Hutson PH, Collinson N, Marshall G, Bentley G, Moyes C, Cook SM, Collins I, Wafford K, McKernan RM, Dawson GR. Anxiogenic properties of an inverse agonist selective for alpha3 subunit-containing GABA A receptors. Br J Pharmacol. 2005 Feb;144(3):357-66. doi: 10.1038/sj.bjp.0706056.
Background: PubMed 16183706Atack JR, Wafford KA, Tye SJ, Cook SM, Sohal B, Pike A, Sur C, Melillo D, Bristow L, Bromidge F, Ragan I, Kerby J, Street L, Carling R, Castro JL, Whiting P, Dawson GR, McKernan RM. TPA023 [7-(1,1-dimethylethyl)-6-(2-ethyl-2H-1,2,4-triazol-3-ylmethoxy)-3-(2-fluorophenyl)-1,2,4-triazolo[4,3-b]pyridazine], an agonist selective for alpha2- and alpha3-containing GABAA receptors, is a nonsedating anxiolytic in rodents and primates. J Pharmacol Exp Ther. 2006 Jan;316(1):410-22. doi: 10.1124/jpet.105.089920. Epub 2005 Sep 23.
Background: PubMed 21994314Bailey JE, Dawson GR, Dourish CT, Nutt DJ. Validating the inhalation of 7.5% CO(2) in healthy volunteers as a human experimental medicine: a model of generalized anxiety disorder (GAD). J Psychopharmacol. 2011 Sep;25(9):1192-8. doi: 10.1177/0269881111408455.
Background: PubMed 18949648Bandelow B, Zohar J, Hollander E, Kasper S, Moller HJ; WFSBP Task Force on Treatment Guidelines for Anxiety, Obsessive-Compulsive and Post-Traumatic Stress Disoders; Zohar J, Hollander E, Kasper S, Moller HJ, Bandelow B, Allgulander C, Ayuso-Gutierrez J, Baldwin DS, Buenvicius R, Cassano G, Fineberg N, Gabriels L, Hindmarch I, Kaiya H, Klein DF, Lader M, Lecrubier Y, Lepine JP, Liebowitz MR, Lopez-Ibor JJ, Marazziti D, Miguel EC, Oh KS, Preter M, Rupprecht R, Sato M, Starcevic V, Stein DJ, van Ameringen M, Vega J. World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for the pharmacological treatment of anxiety, obsessive-compulsive and post-traumatic stress disorders - first revision. World J Biol Psychiatry. 2008;9(4):248-312. doi: 10.1080/15622970802465807.
BackgroundBond A, Lader M. The use of analogue scales in rating subjective feelings. Br J Med Psychol. 1974;47:211-8
Background: PubMed 6525331Borland RG, Nicholson AN. Visual motor co-ordination and dynamic visual acuity. Br J Clin Pharmacol. 1984;18 Suppl 1(Suppl 1):69S-72S. doi: 10.1111/j.1365-2125.1984.tb02583.x.
Background: PubMed 10941Borland RG, Nicholson AN. Comparison of the residual effects of two benzodiazepines (nitrazepam and flurazepam hydrochloride) and pentobarbitone sodium on human performance. Br J Clin Pharmacol. 1975 Feb;2(1):9-17. doi: 10.1111/j.1365-2125.1975.tb00465.x.
Background: PubMed 16291941Dias R, Sheppard WF, Fradley RL, Garrett EM, Stanley JL, Tye SJ, Goodacre S, Lincoln RJ, Cook SM, Conley R, Hallett D, Humphries AC, Thompson SA, Wafford KA, Street LJ, Castro JL, Whiting PJ, Rosahl TW, Atack JR, McKernan RM, Dawson GR, Reynolds DS. Evidence for a significant role of alpha 3-containing GABAA receptors in mediating the anxiolytic effects of benzodiazepines. J Neurosci. 2005 Nov 16;25(46):10682-8. doi: 10.1523/JNEUROSCI.1166-05.2005.
Background: PubMed 11349480Hidalgo RB, Davidson JR. Generalized anxiety disorder. An important clinical concern. Med Clin North Am. 2001 May;85(3):691-710. doi: 10.1016/s0025-7125(05)70336-9.
Background: PubMed 27598969Leibold NK, van den Hove DL, Viechtbauer W, Buchanan GF, Goossens L, Lange I, Knuts I, Lesch KP, Steinbusch HW, Schruers KR. CO2 exposure as translational cross-species experimental model for panic. Transl Psychiatry. 2016 Sep 6;6(9):e885. doi: 10.1038/tp.2016.162.

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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.

Gabriel Etienne Jacobs, PhD, MD principal investigator

Centre for Human Drug Research

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CVL-865 High dose, Alprazolam 1mg XR and CVL-865 low dose in people with Panic Disorder, run by Cerevel Therapeutics, LLC at 1 site in Netherlands.

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 6 inclusion and 36 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 11 Jan 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 Netherlands. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 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?

PSL-IV score (time frame: up to Day 8). 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 NCT04592536, which also lists 25 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 11 Jan 2022.