A Study to Evaluate Effects on Sleep and Safety of RE03 in PTSD Patients With Sleep Disturbances

NCT06685965 | Recruiting Phase 2

• 1 other identifier: RL004
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Post-traumatic stress disorder (PTSD) affects many people who have experienced traumatic events. A common issue with PTSD is severe sleep disturbances, such as nightmares. Current treatments often do not provide sufficient relief, especially for sleep problems. This study aims to determine whether dexmedetomidine - a medication already used in intensive care - can improve sleep quality in PTSD patients.

Conditions

Posttraumatic Stress Disorder (PTSD); Sleep Disturbances and Insomnia

Keywords

Phase 2; Proof of Concept; Target Engagement; Cross-over; placebo-controlled; randomized; Sleep Disturbances; PTSD

Outcome Measures

Primary Outcomes (1)

• Time spent in sleep stages N2 + N3

  The total duration (in minutes) of sleep stages N2+N3, as measured by polysomnography (PSG) on the night following administration of each treatment \[minutes spent in N2 + N3\].

  0.5 hours after each substance administration for 9 hours or until terminal morning awakening

Secondary Outcomes (1)

• REM fragmentation index

  0.5 hours after each substance administration for 9 hours or until terminal morning awakening

Study Arms (3)

Low dose

EXPERIMENTAL

low dose of RE03

Drug: RE03

High dose

EXPERIMENTAL

High dose of RE03

Drug: RE03

Placebo control

PLACEBO COMPARATOR

Matching Placebo

Drug: Placebo

Interventions

RE03 DRUG

Buccal Dexmedetomidine

High dose; Low dose

Placebo DRUG

Matching Placebo

Placebo control

Eligibility Criteria

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

You may qualify if:

• Male or female, aged ≥18 and ≤64 years (inclusive)
• Diagnosis of PTSD according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) for more than 6 months
• PTSD diagnosis assessed with CAPS-5 (life-time) severity ≥ 2
• Sleep disturbance, e.g., difficulty falling or staying asleep, or restless sleep (Criterion E6 of the DSM-5 criteria for PTSD) is present for at least a month prior to screening and causes clinically significant distress or impairment in social, occupational, or other important areas of functioning
• Sleep disturbance assessed with the PSQI; severity ≥ 5
• Ability (verified by investigator) and willingness to provide informed consent as documented by dated signature

You may not qualify if:

• Inability to comply with sleep-wake schedule related study requirements, e.g. due to crossing of time zones (≥ 2), extreme chronotypes, shift working within 2 weeks prior to the screening visit, or planned shift work during the study, self-reported usual daytime napping ≥1 hour per day, and ≥3 days per week
• Inability to follow the procedures of the study, e.g. due to insufficient understanding of the German language used in the study as evaluated by the investigator or anticipated problems with overnight stays at the sleep laboratory
• Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dose; administration of a biological product (e.g. vaccines, blood components, gene therapies, tissues, etc.) in the context of a clinical research study within 90 days prior to the first dose; or concomitant participation in an investigational study involving drug or device administration
• Females of childbearing potential who are sexually active with a non-sterile male partner (sterile male partners are defined as men vasectomised at least 6 months prior to the first study drug administration) not willing to use one of the following acceptable contraceptive methods throughout the study and for at least 3 months after the last study drug administration:
• ○ Simultaneous use of condom and hormonal contraceptive (e.g., oral, patch, depot injection, implant, vaginal ring, intrauterine device) or non-hormonal intrauterine device used for at least 4 weeks prior to sexual intercourse for the female partner;
• Females of non-childbearing potential who are neither:
• Post-menopausal (status defined as an absence of menses for at least 12 months prior to the first study drug administration); or
• Surgically sterilized (complete hysterectomy or bilateral oophorectomy at least 3 months prior to the first study drug administration)
• Male participants who are not vasectomised for at least 6 months prior to dosing and who are sexually active with a female partner of childbearing potential not willing to use one of the following acceptable contraceptive methods from the first dose and for 3 months after the last dose:
• ○ Use of condom and/or hormonal contraceptive (e.g., oral, patch, depot injection, implant, vaginal ring, intrauterine device) or non-hormonal intrauterine device used for at least 4 weeks prior to sexual intercourse for the female partner;
• Male participants (including men who have had a vasectomy) with a pregnant partner not willing to use a condom from the first dose and for 3 months after the last dose.
• Male participants not willing to abstain from sperm donation for 3 months after the last dose
• Body Mass Index lower than 17.5 kg/m2 or higher than 35 kg/m2
• History of any clinically significant cardiovascular disorder, including:
• Clinically significant atrioventricular conduction disturbance (e.g. higher grade AV block \>grade 1), cardiac arrhythmias, sick sinus syndrome, or accessory bypass tract (e.g. Wolff-Parkinson-White)

Sponsors & Collaborators

• Reconnect Labs: lead
• University of Zurich: collaborator

Study Sites (1)

Human Sleep Pharmacology, University of Zurich

Zurich, Canton of Zurich, 8057, Switzerland

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Parasomnias; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Sleep Wake Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• Andres Ort, MD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robin von Rotz, MSc

CONTACT

+41797990831; robin@reconnect-labs.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Cross-over assignment: low dose, high dose and a placebo in randomized order

Study Record Dates

• First Submitted: November 8, 2024
• First Posted: November 13, 2024
• Study Start: September 10, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

CH (1)