A Study to Assess the Efficacy and Safety of CD-008-0045 in Patients With Generalized Anxiety Disorder

NCT04598867 | Unknown Phase 3

• 1 other identifier: CNS-CD0080045-06
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multicenter, randomized, double-blind, placebo- and active-controlled study to assess the efficacy and safety of CD-008-0045 in patients with generalized anxiety disorder (GAD). Each patient will participate in the study for the period of approximately 37 weeks: Screening and Run-in period: 1 week; Study Treatment period: 32 weeks; Follow-up period: 4 weeks.

Conditions

Anxiety Disorder Generalized

Outcome Measures

Primary Outcomes (1)

• Change in total score of the Hamilton Anxiety Rating Scale structured interview (SIGH-A) at Week 8 from baseline.

  Mean change of the Hamilton Anxiety Rating Scale structured interview (SIGH-A) score \[the values from 0 to 56; the higher scores mean a worse outcome\] \[score\]

  Baseline to Week 8

Secondary Outcomes (18)

• The frequency of decrease in total score of the Hamilton Anxiety Rating Scale structured interview (SIGH-A) by 50% or more at week 8 from baseline

  Baseline to Week 8

• Change in total score and sum of scores of the subscales for assessment of the mental and somatic anxiety of the Hamilton Anxiety Rating Scale (SIGH-A) structured interview for each parameter at Week 2, Week 4, Week 8, Week 16, Week 24 and Week 32

  Baseline to Week 2, Week 4, Week 8, Week 16, Week 24 and Week 32

• Change of score of items 1 (Anxious mood) and 2 (Tension) of the Hamilton Anxiety Rating Scale structured interview (SIGH-A) from baseline at Week 2, Week 4, Week 8, Week 16, Week 24 and Week 32

  Baseline to Week 2, Week 4, Week 8, Week 16, Week 24 and Week 32

• Proportion of patients who reached a medically induced remission (the sum of scores of the SIGH-A ≤ 7) at Week 8 and Week32

  Baseline to Week 8 and Week 32

• Changes in the sum of scores of the Montgomery-Asberg Depression Rating Scale (MADRS) at Week 2, Week 4, Week 8, Week 16, Week 24 and Week 32 from baseline

  Baseline to Week 2, Week 4, Week 8, Week 16, Week 24 and Week 32

Study Arms (3)

CD-008-0045 40 mg/day

EXPERIMENTAL

Patients assigned to the CD-008-0045 40 mg/day group will receive 1 capsule of CD-008-0045 (20 mg) before breakfast and before dinner for 32 weeks.

Drug: CD-008-0045

Placebo

PLACEBO COMPARATOR

Patients assigned to the Placebo group will receive 1 placebo capsule before breakfast, and dinner for 8 weeks.

Drug: Placebo

Afobazol 30 mg/day

ACTIVE COMPARATOR

Patients assigned to the Afobazol 30 mg/day group will receive 1 tablet of Afobazol (10 mg) before breakfast, before lunch and before dinner for 8 weeks.

Drug: Afobazol

Interventions

CD-008-0045 DRUG

CD-008-0045 20 mg capsules

CD-008-0045 40 mg/day

Placebo DRUG

Placebo capsules

Placebo

Afobazol DRUG

Afobazol 10 mg tabletes

Also known as: Fabomotizole

Afobazol 30 mg/day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent Form;
• Age ≥18 years old;
• Generalized anxiety disorder diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria and International Classification of Diseases (ICD-10);
• Scores of the Hamilton Anxiety Rating Scale (SIGH-A) structured interview at Screening and Randomization Visits (Week 0):
• Total score ≥20;
• Item 1 (Anxious mood) and item 2 (Tension) scores ≥2 points;
• Condition according to the CGI-S ≥4 (moderate severity and higher) at Screening and Randomization Visits (Week 0);
• Consent of patients to use adequate contraception methods throughout the study. Adequate contraception methods include:
• Condoms with spermicide for males;
• For females (at their discretion):
• oral contraceptives,
• condoms with spermicide (for the partner),
• diaphragm with spermicide,
• cervical cap with spermicide,
• intrauterine device (IUD);

You may not qualify if:

• Pregnant or lactating women, or women planning to get pregnant during the clinical study; women of childbearing potential (including those without history of surgical sterilization and women with \<2 years of post-menopause) not using adequate contraception methods;
• Total score \>13 of the Montgomery-Åsberg Depression Rating Scale (MADRS) structured interview.
• Confirmed diagnosis of depressive episode, recurrent depressive disorder, bipolar affective disorder in history or at Screening;
• Confirmed diagnosis of schizophrenia in history or at Screening;
• Confirmed diagnosis of panic disorder in history or at Screening;
• Phobic anxiety disorders (agoraphobia, social phobia, unspecified phobic anxiety disorder) in history or at Screening;
• Disorders of personality or behavior in history or at Screening;
• Post-traumatic stress disorder diagnosed within 12 months prior to Screening;
• Eating disorders diagnosed within 12 months prior to Screening;
• Obsessive-compulsive disorder in history or at Screening;
• Epilepsy, seizures, head trauma with loss of consciousness, tumors, inflammatory, or demyelinating diseases of the central nervous system, stroke in history;
• Pheochromocytoma;
• Malignancies diagnosed within the last 5 years (except for the cured basal cell carcinoma);
• Significant cardiovascular diseases at present or within 12 months prior to Screening, including: Chronic class III or IV heart failure (according to the New York Heart Association classification), severe arrhythmia requiring treatment with class Ia, Ib, Ic or III antiarrhythmic drugs, unstable angina, myocardial infarction, heart and coronary artery surgery, significant valvular heart disease, uncontrolled hypertension with systolic blood pressure \>180 mm Hg and diastolic blood pressure \>110 mm Hg, pulmonary embolism or deep vein thrombosis;
• Nephrotic syndrome, moderate to severe chronic renal failure or significant renal impairment with Creatinine level \>1.5 mg/dL in men and \>1.4 mg/dL in women or glomerular filtration rate (GFR) \<60 ml/min;

Sponsors & Collaborators

• ChemRar Research and Development Institute, LLC: lead

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

2-((2-morpholino)ethylthio)-5-ethoxybenzimidazole

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Margarita A Morozova, MD,PhD,Prof

  "Research Center for Mental Health" Scientific Institution

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ludmila Mefodieva

CONTACT

+7 (999) 915-94-00; mlg@chemrar.ru

Dmitry Gorchakov, MD, PharmD

CONTACT

+7 (926) 902-00-75; dgor@ipharma.ru

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double (Participant, Investigator) Dose blinding will be performed using Placebo. Patient will receive 2 vials labeled for study drug administration as follows: 1 capsule in the morning, and evening. Package numbers were assigned via IWRS. Thus, during the Study Treatment period, neither the patient nor the Investigator knew the group to which the patient was allocated. Single blinding was performed during the Placebo Run-in and Follow-up periods.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a multicenter, randomized, double-blind, placebo- and active-controlled study to assess the efficacy and safety of CD-008-0045 in patients with GAD. The primary study objective is To assess the efficacy of CD-008-0045 at a dose 20 mg BID vs Placebo and Afobazol based on the change of the total score of the Hamilton Anxiety Rating Scale (SIGH-A) structured interview at Week 8 from baseline. Treatment response is considered the difference between group CD-008-0045 and Placebo is 5.5 points decrease of the Hamilton Anxiety Rating Scale (HARS) total score from baseline.

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 22, 2020
• Study Start: December 1, 2020
• Primary Completion: May 1, 2023
• Study Completion: June 1, 2023
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share