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DReAMzz- Dronabinol and Acetazolamide Medication for Sleep Apnea (ZZ). Dose Confirmation Crossover Study for IHL-42X in Subjects With Obstructive Sleep Apnea. (DReAMzz)

2026年9月13日 更新者：Incannex Healthcare Ltd

Phase II, Randomized, Double-Blind, Multidose Crossover Clinical Trial to Determine the Safety and Efficacy of IHL-42X in Subjects With Obstructive Sleep Apnea

The goal of this randomized, double-blind, multi-dose crossover clinical trial is to determine the safety and efficacy of IHL-42X in subjects with obstructive sleep apnea.

The primary endpoint is: Change in AHI4 at the end of each treatment period compared to baseline (each treatment period is 28 days).

The study will consist of three separate four-way crossover dose-comparison studies each comparing three dose strengths of IHL-42X to placebo. The double-blind four-way crossover will be conducted according to a Williams design. Each of the crossover studies will test different doses of dronabinol in combination with a distinct, set dose of acetazolamide. In total, nine different combinations of dronabinol and acetazolamide formulated as IHL-42X will be tested in the study. The optimal dose strength will be selected based on safety and efficacy over a 4-week treatment period.

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

120

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • アメリカ
    • California
      • Chula Vista、California、アメリカ、91910
        • まだ募集していません
        • Exalt Clinical Research
        • コンタクト：
        • 主任研究者：
          • David Bortz
    • Florida
      • Brandon、Florida、アメリカ、33511
        • 募集
        • Teradan Clinical Trials LLC
        • 主任研究者：
          • Daniel Lorch
        • コンタクト：
      • Jacksonville、Florida、アメリカ、32256
        • まだ募集していません
        • CNS Healthcare - Jacksonville
        • 主任研究者：
          • Mark Joyce
        • コンタクト：
      • Orlando、Florida、アメリカ、32801
        • 募集
        • CNS Healthcare Orlando
        • コンタクト：
        • 副調査官：
          • Felipe Suplicy
      • West Palm Beach、Florida、アメリカ、33409
        • 募集
        • Palm Beach Research Center
        • 主任研究者：
          • Mira Baron
        • コンタクト：
      • Winter Park、Florida、アメリカ、32789
        • 引きこもった
        • Conquest Research/Neurotrials
    • Louisiana
      • Marrero、Louisiana、アメリカ、70072
        • まだ募集していません
        • Tandem Clinical Research
        • 主任研究者：
          • Angela Traylor
        • コンタクト：
    • Maryland
      • Rockville、Maryland、アメリカ、20854
        • 募集
        • Velocity Clinical Research, Rockville
        • 主任研究者：
          • Asefa Mekonnen
        • コンタクト：
    • Ohio
      • Cincinnati、Ohio、アメリカ、45212
        • 募集
        • CTI Clinical Research Center
        • コンタクト：
        • 主任研究者：
          • Robert Wagner
      • Cincinnati、Ohio、アメリカ、45245
        • 募集
        • Intrepid Research
        • 主任研究者：
          • Bruce Corser
        • コンタクト：
    • South Carolina
      • Anderson、South Carolina、アメリカ、29621
        • 募集
        • Velocity Clinical Research, Anderson
        • 主任研究者：
          • Charles Thompson
        • コンタクト：
    • Tennessee
      • Memphis、Tennessee、アメリカ、38119
        • 募集
        • CNS Healthcare - Memphis
        • 主任研究者：
          • Lora McGill
        • コンタクト：
    • Texas
      • Dallas、Texas、アメリカ、75251
        • まだ募集していません
        • FutureSearch Trials of Dallas
        • 主任研究者：
          • Michael Downing
        • コンタクト：
      • San Antonio、Texas、アメリカ、78229
        • 募集
        • Sleep Therapy & Research Center
        • コンタクト：
        • 主任研究者：
          • James Andry

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria

Participants must satisfy all the following criteria at screening unless otherwise stated:

  1. Aged ≥18 and ≤65 years of age at the time of consent.

  2. Two screening PSG findings confirmed on central over-read that both must meet the below criteria:

    1. AHI4 ≥5
    2. ≤25% central or mixed apneas out of total AHI
    3. no Cheyne-Stokes respiration
    4. total sleep time ≥ 4 hours in each PSG
    5. < 30 periodic leg movement disorder arousals per hour.
  3. A difference in AHI4 of ≤15 between screening PSG 1 and screening PSG 2.
  4. A PROMIS-SRI 8a score of >16.

  5. Intolerant or non-compliant to PAP, or has refused PAP after physician recommendation. Participants will be identified as intolerant or non-compliant to PAP devices by the following criteria (NB: OSA diagnosis must be entered in participant medical history):

    1. Participants are regarded as PAP-non-compliant if they do not use PAP for ≥ 4 hours for at least 63 nights during consecutive 90-day period based on data collected from the PAP device (e.g., SD storage cards) and/or a cloud-based repository of PAP device data.
    2. Participants are regarded as PAP-intolerant if they are former PAP users, i.e., a PAP device that they have not used for >90 days, have tried PAP and not continued to use it or refusal of PAP after prior positive sleep study or prior refusal of provider recommended sleep study due to unwillingness to consider PAP.

    NB: Participants will have the benefits and risks of PAP explained at screening, including that PAP is standard of care for OSA. Participants also have the option to withdraw from the study at any time if he/she elects to be treated with PAP or other alternative therapy such as an oral appliance or surgery.

  6. Must agree not to take any form of cannabis or cannabinoid with the exception of the IP, or any other illicit or recreational drug while participating in this study.

  7. A female participant of childbearing potential must agree to at least one approved highly effective method of contraception. Approved methods of contraception include the following:

    1. Intra-uterine device in place for at least 3 months prior to Day 1 through to 10 days following the last dose of the study drug.

    2. Stable hormonal contraceptive which includes oral, intravaginal, intrauterine, transdermal, injectable, or implantable methods of hormonal contraception for at least 3 months prior to Day 1 through to 10 days after the last dose of the study drug.

      NB: Barrier method (condom or diaphragm) is not considered 'highly effective' for the purpose of this study and should be used in combination with one of the approved highly effective methods listed above.

      A female will not be considered of childbearing potential if:

    3. 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels > 40 mIU/ml.
    4. Undergone bilateral tubal ligation, hysterectomy, or bilateral oophorectomy at least 6 months prior to Day 1.

  8. A male participant must agree to use at least 1 approved method of contraception (or as required by local regulations) while engaging in sexual activity from study Day -1 through EOS follow-up and/or up to 10 days following the last administration of the study drug. Male participants must not donate sperm during this same period. Approved methods of contraception include the following:

    1. Barrier method (condom) from date of consent through to 10 days after the final dose of the study drug.
    2. Surgical sterilization (vasectomy) at least 6 months prior to Day 1 with proof of azoospermia.
  9. Voluntarily written consent to participate in the study and be willing and able to participate in all scheduled visits, treatment plans, tests, and other study procedures according to the protocol.

Exclusion Criteria:

Participants will be excluded from the study if they satisfy any of the following criteria at screening, unless otherwise stated:

  1. Body mass index (BMI) >40 kg/m2 (men) and >42 kg/m2 (women).
  2. Diagnosed obesity hypoventilation syndrome or hypercapnia.
  3. PAP-compliant, defined by use of PAP for ≥4 hours for at least 63 nights during the consecutive 90-day period.
  4. Current use of custom-made oral appliances (mandibular advancement device, tongue retaining device, or mouth guard) or hypoglossal nerve stimulation devices. Devices must not be used for the duration of the study.
  5. Maxillomandibular advancement, upper airway, or bariatric surgery within the last 6 months prior to first administration of the study drug; or participants who are planning surgical treatment.
  6. Have commenced glucagon-like peptide-1 receptor agonist therapy within the last 6 months.
  7. Use of benzodiazepines, sedative-hypnotics or stimulants (Anatomical Therapeutic Chemical [ATC] N06B, N05C, N05BA, N03AE, and N01AF categories) to treat insomnia, OSA, and other sleep disorders, or other disorders that require the drug to be taken prior to sleep.
  8. Use of other prescription medications to treat insomnia.
  9. Pierre Robin, Treacher Collins, or other craniofacial malformation syndrome, or grade ≥3 tonsillar hypertrophy.
  10. Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator.
  11. Known allergic or other severe reaction to cannabis products with previous use.
  12. Known allergic reaction to sesame oil.
  13. Known allergic reaction to acetazolamide.
  14. Pregnant or breastfeeding.

  15. Current illicit drug abuse (within the last 6 months prior to screening); "abuse" has some subsets that are objective and some that require investigator judgement; questions should be discussed with the medical monitor or with the sponsor

    1. An objective subset includes consumption of substances that are "illicit", i.e., not legal per local laws
    2. Investigator judgement is expected for legally marketed products ingested for other than the approved indication(s)
    3. Participants who test positive to THC should be screen failed and can be considered for rescreening after a >6-week washout period. Participants can only be rescreened once. Positive test results for all other substances shall be reviewed by the investigator and participants shall only be screen failed if the investigator believes the use of the substance may be clinically significant with regards to the participant's safe participation in this study or may confound this study's findings.
  16. Severe depression, defined as a score of ≥30 on the Major Depression Inventory (MDI) questionnaire.
  17. Severe anxiety, defined as score of >15 on the General Anxiety Disorder-7 (GAD-7) questionnaire.

  18. Any of the following co-morbid conditions (NB: clarification on co-morbidities and inclusion/exclusion criteria may be discussed with the medical monitor and/or sponsor):

    1. Severe psychiatric disorder that might be aggravated or exacerbated by dronabinol's potential to cause anxiety/nervousness, depersonalization, hallucination, etc.
    2. Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator.
    3. Cardiac dysfunction and/or its treatment that might augment dronabinol's potential to cause tachycardia or vasodilation.
    4. Marked hepatic dysfunction as defined by elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 × the upper limit of normal (ULN), that would reduce dronabinol metabolism.

    i. One retest per participant is permitted at the discretion of the investigator; the participant may continue if BOTH repeat transaminase levels are within acceptable range (i.e., less than 3 × ULN).

    e. Current or history of encephalopathy or cirrhosis Child-Pugh category B or C (see Appendix 8) since acetazolamide can increase blood ammonia levels precipitating a bout of hepatic encephalopathy.

    f. Marked renal dysfunction that would reduce acetazolamide excretion, including eGFR <60 mL/min/1.73 m2, as determined using the National Kidney Foundation calculator (https://www.kidney.org/professionals /kdoqi/gfr_calculator) and instructions in Appendix 9.

    g. Hypokalemia (low blood potassium), hyponatremia (low blood sodium), hyperchloremic acidosis, and/or adrenal insufficiency that might be aggravated or exacerbated by acetazolamide's activity as a carbonic anhydrase inhibitor.

  19. Known CYP2C9 poor metabolizers (NB: this is based on medical history and does not need to be tested genetically).
  20. Other ongoing condition(s) that the investigator considers may be clinically significant with regards to the participant's safe participation in this study or may confound this study's findings; any consideration should be discussed with the medical monitor or with the sponsor (such as known alcohol abuse).
  21. Shift workers whose shift pattern has the potential to disrupt sleep patterns.
  22. Participation in any other interventional studies involving investigational or marketed products within 30 days or 5.5 half-lives, whichever is longer, prior to screening.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：クロスオーバー割り当て
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的：IHL-42X: 2.5 mg dronabinol + 125 mg acetazolamide
IHL-42X (2.5 mg dronabinol + 125 mg acetazolamide), self-administered once daily every night approximately 1 hour prior to bed for 4 weeks.
薬：IHL-42X: 2.5 mg dronabinol + 125 mg acetazolamide
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 1
実験的：IHL-42X: 5 mg dronabinol + 125 mg acetazolamide
IHL-42X (5 mg dronabinol + 125 mg acetazolamide), self-administered once daily every night approximately 1 hour prior to bed for 4 weeks.
薬：IHL-42X: 5 mg dronabinol + 125 mg acetazolamide
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 2
実験的：IHL-42X: 7.5 mg dronabinol + 125 mg acetazolamide
IHL-42X (7.5 mg dronabinol + 125 mg acetazolamide), self-administered once daily every night approximately 1 hour prior to bed for 4 weeks.
薬：IHL-42X: 7.5 mg dronabinol + 125 mg acetazolamide
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 3
実験的：IHL-42X: 2.5 mg dronabinol + 250 mg acetazolamide
IHL-42X (2.5 mg dronabinol + 250 mg acetazolamide), self-administered once daily every night approximately 1 hour prior to bed for 4 weeks.
薬：IHL-42X: 2.5 mg dronabinol + 250 mg acetazolamide
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 4
実験的：IHL-42X: 5 mg dronabinol + 250 mg acetazolamide
IHL-42X (5 mg dronabinol + 250 mg acetazolamide), self-administered once daily every night approximately 1 hour prior to bed for 4 weeks.
薬：IHL-42X: 5 mg dronabinol + 250 mg acetazolamide
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 5
実験的：IHL-42X: 7.5 mg dronabinol + 250 mg acetazolamide
IHL-42X (7.5 mg dronabinol + 250 mg acetazolamide), self-administered once daily every night approximately 1 hour prior to bed for 4 weeks.
薬：IHL-42X: 7.5 mg dronabinol + 250 mg acetazolamide
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 6
実験的：IHL-42X: 2.5 mg dronabinol + 375 mg acetazolamide
IHL-42X (2.5 mg dronabinol + 375 mg acetazolamide), self-administered once daily every night approximately 1 hour prior to bed for 4 weeks.
薬：IHL-42X: 2.5 mg dronabinol + 375 mg acetazolamide
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 7
実験的：IHL-42X: 5 mg dronabinol + 375 mg acetazolamide
IHL-42X (5 mg dronabinol + 375 mg acetazolamide), self-administered once daily every night approximately 1 hour prior to bed for 4 weeks.
薬：IHL-42X: 5 mg dronabinol + 375 mg acetazolamide
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 8
実験的：IHL-42X: 7.5 mg dronabinol + 375 mg acetazolamide
IHL-42X (7.5 mg dronabinol + 375 mg acetazolamide), self-administered once daily every night approximately 1 hour prior to bed for 4 weeks.
薬：IHL-42X: 7.5 mg dronabinol + 375 mg acetazolamide
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 9
プラセボコンパレーター：Placebo: Negative control
One capsule self-administered once daily every night approximately 1 hour prior to bed for 4 weeks
薬：Placebo: Negative control
DReAMzz Phase 2 Placebo

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in AHI4 at the end of each treatment period compared to baseline
時間枠：Each treatment period (28 days)
To assess the change in efficacy at the end of each dosing period compared with baseline.
Each treatment period (28 days)

二次結果の測定

結果測定
メジャーの説明
時間枠
Percent change in AHI4 at the end of each treatment period compared to baseline
時間枠：Each treatment period (28 days)
Each treatment period (28 days)
Change in Functional Outcomes of Sleep Questionnaire 10-items (FOSQ-10) at the end of each treatment period compared to baseline
時間枠：Each treatment period (28 days)
Each treatment period (28 days)
Change in Patient-reported outcome measurement information system (PROMIS)-Fatigue 7a at the end of each treatment period compared to baseline
時間枠：Each treatment period (28 days)
Each treatment period (28 days)
Change in Patient-reported outcome measurement information system - Sleep Related Impairment (PROMIS-SRI) 8a at the end of each treatment period compared to baseline
時間枠：Each treatment period (28 days)
Each treatment period (28 days)
Change in Patient Global Impression of Severity (PGI-S) the end of each treatment period compared to baseline
時間枠：Each treatment period (28 days)
Each treatment period (28 days)
Patient Global Impression of Change (PGI-C) score at the end of each treatment period compared to baseline
時間枠：Each treatment period (28 days)
Each treatment period (28 days)
Change in Patient-reported Longitudinal Assessment Tool for OSA-11 item (PLATO) at the end of each treatment period compared to baseline
時間枠：Each treatment period (28 days)
Each treatment period (28 days)
Change in Epworth Sleepiness Scale (ESS) at the end of each treatment period compared to baseline
時間枠：Each treatment period (28 days)
Each treatment period (28 days)
Change in Oxygen Desaturation Index (ODI) (from PSG) at the end of each treatment period compared to baseline
時間枠：Each treatment period (28 days)
Each treatment period (28 days)
Change in hypoxic burden at the end of each treatment period compared to baseline
時間枠：Each treatment period (28 days)
Each treatment period (28 days)
Percent of participants whose OSA severity reduces by one or more levels with severe OSA AHI4 ≥30, moderate OSA AHI4 15-30, mild OSA AHI4 <15
時間枠：140 days
140 days
Percent of participants with ≥50% reduction in AHI4
時間枠：140 days
140 days
Percent of participants with AHI4 <5
時間枠：140 days
140 days
Adverse events and treatment-emergent adverse events (TEAEs), clinically significant out of range values or findings from clinical laboratory test results, electrocardiogram (ECG), vital signs, and physical examinations
時間枠：140 days
To evaluate the safety and tolerability of IHL-42X
140 days

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Incannex Healthcare Ltd

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年7月21日

一次修了 (推定)

2027年4月1日

研究の完了 (推定)

2027年5月1日

試験登録日

最初に提出

2026年6月3日

QC基準を満たした最初の提出物

2026年6月3日

最初の投稿 (実際)

2026年6月9日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月15日

QC基準を満たした最後の更新が送信されました

2026年9月13日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • IHL42XOSAP2X

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

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