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Lamivudine as a Novel Clinical Effort for Rett Syndrome (LANCE)

6. června 2026 aktualizováno: Maria Denise Fernandes Carvalho de Andrade

Lamivudine in Individuals With Rett Syndrome: Clinical, Biochemical, and Cellular Evaluation

Rett syndrome (RTT) is a rare genetic neurodevelopmental disorder caused primarily by mutations in the MECP2 gene, leading to progressive impairments in motor function, communication, and behavior following an initial period of apparently typical development. Currently, there are no treatments that change the course of the disease, and clinical care is largely focused on managing symptoms. Loss of MeCP2 function has been associated with increased activity of the LINE-1 (L1) retroelement, which may contribute to neuroinflammation and cellular stress in the brain. Lamivudine, a nucleoside reverse transcriptase inhibitor widely used in antiviral therapy, can inhibit L1 reverse transcription and has shown beneficial effects in preclinical models of RTT, including reductions in inflammatory and oxidative stress markers and improvements in neurological and behavioral outcomes. This study aims to evaluate the safety and potential clinical and biological effects of lamivudine in individuals with Rett syndrome using a before-and-after treatment design. Participants will receive oral lamivudine and will undergo clinical assessments and laboratory testing before and after the treatment period to evaluate changes in symptom severity, functional status, quality of life, seizure activity, and biomarkers related to inflammation and neurodevelopment. Biological samples will also be collected to support translational laboratory studies aimed at improving understanding of disease mechanisms and treatment response in RTT. Results from this study may help determine whether lamivudine is a safe and promising therapeutic option and may guide future clinical research in this population.

Přehled studie

Postavení

Zápis na pozvánku

Podmínky

Intervence / Léčba

Detailní popis

Rett syndrome (RTT) is a rare genetic neurodevelopmental disorder caused primarily by loss-of-function mutations in the MECP2 gene, leading to progressive impairments in motor, cognitive, and communicative function after an initial period of apparently typical development. Currently, there are no medications that change the course of the disease, and treatment is mainly focused on managing symptoms.

Functional MeCP2 represses the activity of the LINE-1 (L1) retroelement, and loss of this repression may result in increased L1 accumulation in glial cells in the brain, promoting genomic instability, oxidative stress, and neuroinflammation associated with RTT pathophysiology.

Lamivudine inhibits L1 reverse transcription and has shown beneficial effects in preclinical neuronal culture and MeCP2-deficient mouse models, including reduced inflammatory and oxidative stress markers, improved neurological and behavioral outcomes, and increased survival. In this study, each participant is evaluated before and after receiving treatment, allowing changes to be assessed within the same individual over time. Following screening and baseline assessments, participants enter a treatment phase during which oral lamivudine is administered for a defined period. Longitudinal clinical, laboratory, and safety evaluations are conducted at scheduled visits, followed by a post-treatment follow-up period to assess the persistence of effects.

A 24-week intervention period was selected as a feasible and acceptable duration for participants and caregivers and as an appropriate timeframe for an initial open-label evaluation of therapeutic potential. This duration is expected to provide sufficient exposure to lamivudine to allow detection of short-term clinical and biological changes suggested by preclinical studies, while also enabling systematic assessment of safety and tolerability in this population.

Participants may continue their usual medical treatments, including medications for seizures and other supportive therapies, as long as these treatments remain stable during the study, unless a change is medically necessary.

Caregivers receive standardized instructions on medication administration, and adherence is monitored throughout the treatment phase through caregiver reporting and visit-based verification to ensure accurate assessment of treatment exposure.

Clinical assessments employ validated clinician and caregiver-reported instruments to evaluate symptom severity, functional status, quality of life, and seizure activity, capturing changes across motor, behavioral, and daily functioning domains relevant to RTT. Safety is monitored continuously through adverse event surveillance, routine clinical evaluations, and laboratory testing, with predefined criteria for treatment interruption if clinically indicated. Venous blood samples are collected at baseline and during treatment to evaluate systemic biomarkers related to oxidative stress, inflammation, and neurodevelopment. These measures complement clinical outcomes and explore potential mechanistic effects of lamivudine treatment.

In addition to the biomarkers reported as outcome measures, a panel of exploratory, hypothesis-generating biomarkers will be analyzed, including markers of oxidative stress, neuroinflammation and neurodevelopment, mitochondrial and energy metabolism, and nutritional and micronutrient status. These analyses are not considered clinical endpoints and are not reported as outcome measures.

As a translational research component, skin punch biopsies from a subset of participants are used to establish a dermal fibroblast biobank, enabling the generation of patient-derived induced pluripotent stem cells and brain organoids. These models will be used in exploratory laboratory studies to investigate cellular and molecular mechanisms in RTT and responses to lamivudine, without being considered clinical endpoints. Based on preclinical evidence and the proposed mechanism of action, lamivudine treatment is expected to be safe and well-tolerated in individuals with Rett syndrome. Clinically, it may lead to improvements in motor function, social engagement, and overall symptom severity, while reducing seizure frequency and enhancing quality of life. Biologically, lamivudine is anticipated to modulate oxidative stress and inflammatory pathways, potentially restoring a more balanced neurodevelopmental environment. The combined clinical and laboratory observations from this study will provide critical insights into the therapeutic potential of lamivudine and inform future research directions in RTT.

Typ studie

Intervenční

Zápis (Odhadovaný)

10

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Brazílie
    • Ceará
      • Fortaleza, Ceará, Brazílie
        • GenClinics

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě
  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

  • Clinical and molecular diagnosis of Rett syndrome;
  • Age 2 years or older at the time of enrollment;
  • Ability to swallow liquid medication;
  • Stable clinical condition, as determined by the study investigator;
  • Availability of a parent or legal guardian able to provide informed consent and comply with study procedures;
  • Willingness of the participant and/or legal guardian to comply with study visits and assessments.

Exclusion Criteria:

  • Known hypersensitivity or contraindication to lamivudine;
  • Severe hepatic or renal impairment that, in the investigator's judgment, would preclude safe participation;
  • Use of investigational drugs or participation in another clinical trial within a defined washout period before enrollment;
  • Presence of any medical condition or acute illness that could interfere with study participation or outcome assessment, as determined by the investigator;
  • Inability to undergo blood collection or skin biopsy procedures required for the study;
  • Any condition that, in the opinion of the investigator, would place the participant at undue risk or compromise adherence to the study protocol.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Lamivudine Treatment
Approximately 10 participants aged ≥2 years with a confirmed clinical and molecular diagnosis of Rett syndrome will receive oral lamivudine using weight-based dosing for 24 weeks following baseline clinical and laboratory assessments. Participants will undergo regular monitoring for safety, tolerability, and efficacy, including clinical evaluations, laboratory testing, and assessment of neurological and functional outcomes. Dose adjustments or discontinuation may occur in response to adverse events. Blood samples will be collected for biomarker analyses, with an optional skin biopsy in a subset of participants for exploratory research.
Lék: Lamivudine
Lamivudine will be given orally to participants with Rett syndrome using weight-based dosing after baseline clinical and laboratory assessments. Children <14 kg will receive oral solution at 4 mg/kg twice daily (max 300 mg/day). Participants ≥14 kg will receive tablets by weight: 14-20 kg, 150 mg/day; 20-25 kg, 225 mg/day; >25 kg, 300 mg/day. Medication may be taken with or without food. Tablets should not be crushed unless swallowing is difficult. If needed, they may be crushed and mixed with liquid or soft food and taken immediately, or oral solution may be used. Caregivers will be instructed on dosing and concomitant medications. Treatment lasts 24 weeks with weekly safety, tolerability, and efficacy monitoring. Dose adjustment or discontinuation may occur if significant adverse events arise.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Rett Syndrome Symptom Severity (RARS)
Časové okno: Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)

Change in Rett syndrome symptom severity assessed using the Rett Assessment Rating Scale (RARS), comparing total scores obtained at baseline with scores obtained after treatment with lamivudine and at post-treatment follow-up. Total scores range from 0 to 128, with higher scores indicating greater symptom severity. A reduction in total score will be interpreted as clinical improvement.

Unit of Measure: Units on a scale (0-128)
Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)
Change in Rett Syndrome Behavioral Symptoms
Časové okno: Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)

Change in Rett syndrome behavioral symptoms assessed using the Rett Syndrome Behaviour Questionnaire (RSBQ), comparing total scores obtained at baseline with scores obtained at the end of treatment with lamivudine and at post-treatment follow-up. The RSBQ is a Rett syndrome-specific instrument used to assess behavioral, autonomic, and functional manifestations associated with Rett syndrome, including breathing abnormalities, irritability, anxiety, mood, repetitive hand movements, communication, and social interaction.

The RSBQ consists of 45 items scored from 0 to 2, where 0 indicates "not true," 1 indicates "somewhat or sometimes true," and 2 indicates "often true" or "very true." Total scores range from 0 to 90, with higher scores indicating greater frequency or severity of behavioral symptoms and worse clinical status. A reduction in total score after treatment will be interpreted as improvement in Rett syndrome behavioral symptoms.

Unit of Measure: Units on a scale (0-90)
Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)
Safety of Lamivudine: Occurrence of Adverse Events
Časové okno: Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)

Safety assessed by the number and proportion of participants experiencing at least one adverse event (serious or non-serious) during treatment with lamivudine, based on clinical assessment and laboratory monitoring.

Unit of Measure: Number and proportion of participants with adverse events
Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Causality of Adverse Events (LCAT)
Časové okno: Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)

Causality of adverse events related to lamivudine assessed using the Liverpool Adverse Drug Reaction Causality Assessment Tool (LCAT). The tool classifies the causal relationship between the drug and each adverse event as unlikely, possible, probable, or definite. Higher categories indicate a greater likelihood of a causal relationship between the adverse event and lamivudine.

Unit of Measure: Number and proportion of adverse events in each causality category
Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)
Change in Health-Related Quality of Life: Pediatric Participants (PedsQL Neuromuscular Module)
Časové okno: Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)

Change in health-related quality of life assessed primarily by the PedsQL 3.0 Neuromuscular Module (PedsQL NMM), caregiver-report adapted version, comparing baseline scores with scores at the end of treatment and at follow-up. The PedsQL NMM yields transformed scores from 0 to 100; higher scores indicate better health-related quality of life and lower symptom impact. An increase after treatment is interpreted as improvement.

Unit of Measure: Units on a scale (0-100)
Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)
Change in Health-Related Quality of Life - Adult participants (SF-36)
Časové okno: Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)

Change in health-related quality of life assessed by the Short Form (36) Health Survey (SF-36) in adult participants, comparing baseline scores with scores at the end of treatment and follow-up. SF-36 domain scores range from 0 to 100, with higher scores indicating better quality of life. An increase in score after treatment is interpreted as improvement.

Unit of Measure: Units on a scale (0-100)
Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)
Change in Adaptive Behavior (Vineland Adaptive Behavior Scales - Adaptive Behavior Composite)
Časové okno: Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)

Change in adaptive behavior assessed using the Vineland Adaptive Behavior Scales, reported as the Adaptive Behavior Composite standard score, comparing baseline with end-of-treatment and follow-up values. Standard scores have a mean of 100 and a standard deviation of 15, higher scores indicate better adaptive functioning.

Unit of Measure: Standard score
Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)
Presence of Epileptic Seizures
Časové okno: Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)

Presence of epileptic seizures during treatment with lamivudine, assessed by the number of participants experiencing at least one epileptic seizure after the start of the intervention. Data obtained from caregiver records and clinical assessment by the research team.

Unit of Measure: Participants
Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)
Frequency of Epileptic Seizures
Časové okno: Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)

Change in the frequency of epileptic seizures, comparing the mean number of seizures per participant at baseline with the mean number recorded during treatment with lamivudine. Information obtained from a caregiver-completed seizure diary, confirmed at follow-up visits.

Unit of Measure: Number of seizures per month
Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)
Need for Medical Intervention Related to Epileptic Seizures
Časové okno: Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)

Need for medical intervention related to epileptic seizures during treatment with lamivudine, assessed by the number of participants requiring emergency care, hospitalization, or rescue medication due to an epileptic seizure.

Unit of Measure: Participants
Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)
Change in Caregiver Burden (Zarit Burden Interview, ZBI-22)
Časové okno: Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)

Change in caregiver burden assessed using the Zarit Burden Interview (ZBI-22), comparing baseline scores with scores at the end of treatment and at follow-up. Total scores range from 0 to 88, with higher scores indicating greater caregiver burden. A reduction in total score after treatment is interpreted as improvement.

Unit of Measure: Units on a scale (0-88)
Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)
Change in Global Clinical Severity (CGI-S)
Časové okno: Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)

Change in global clinical severity assessed by the Clinical Global Impression Severity (CGI-S) scale, comparing the score at baseline with the score at the end of treatment. The CGI-S is a 7-point clinician-rated scale ranging from 1 to 7, where 1 = normal (not at all ill) and 7 = among the most extremely ill patients. Higher scores indicate greater global clinical severity. A reduction after treatment is interpreted as clinical improvement.

Unit of Measure: Units on a scale (1-7)
Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)
Global Clinical Improvement (CGI-I)
Časové okno: Week 24 and Week 52

Global clinical improvement assessed using the Clinical Global Impression-Improvement scale (CGI-I) at the end of lamivudine treatment and during post-treatment follow-up. Scores range from 1 ("very much improved") to 7 ("very much worse"), with lower scores indicating greater improvement.

Unit of Measure: Units on a scale (1-7)
Week 24 and Week 52
Change in serum C-reactive protein (CRP)
Časové okno: Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)

Change in serum C-reactive protein (CRP) concentrations, comparing values at baseline with values at the end of treatment and at follow-up.

Unit of Measure: mg/L
Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)
Change in serum Monocyte chemoattractant protein-1 (MCP-1)
Časové okno: Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)

Change in serum Monocyte chemoattractant protein-1 (MCP-1), comparing values at baseline with values at the end of treatment and at follow-up.

Unit of Measure: pg/mL
Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)
Change in serum Ferritin
Časové okno: Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)

Change in serum Ferritin, comparing values at baseline with values at the end of treatment and at follow-up.

Unit of Measure: ng/mL
Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)
Change in serum Interleukin-1 beta (IL-1β)
Časové okno: Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)

Change in serum Interleukin-1 beta (IL-1β), comparing values at baseline with values at the end of treatment and at follow-up.

Unit of Measure: pg/mL
Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)
Change in serum Interleukin-6 (IL-6)
Časové okno: Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)

Change in serum Interleukin-6 (IL-6), comparing values at baseline with values at the end of treatment and at follow-up.

Unit of Measure: pg/mL
Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)
Change in serum Interleukin-8 (IL-8)
Časové okno: Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)

Change in serum Interleukin-8 (IL-8), comparing values at baseline with values at the end of treatment and at follow-up.

Unit of Measure: pg/mL
Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)
Change in serum Interleukin-10 (IL-10)
Časové okno: Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)

Change in serum Interleukin-10 (IL-10), comparing values at baseline with values at the end of treatment and at follow-up.

Unit of Measure: pg/mL
Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)
Change in serum Tumor Necrosis Factor alpha (TNF-α)
Časové okno: Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)

Change in serum Tumor Necrosis Factor alpha (TNF-α), comparing values at baseline with values at the end of treatment and at follow-up.

Unit of Measure: pg/mL
Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)
Change in serum Aspartate aminotransferase (AST/TGO)
Časové okno: Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)

Change in serum Aspartate aminotransferase (AST/TGO) levels comparing values at baseline with values at the end of treatment and at follow-up.

Unit of Measure: U/L
Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)
Change in serum Alanine aminotransferase (ALT/TGP)
Časové okno: Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)

Change in serum Alanine aminotransferase (ALT/TGP) levels comparing values at baseline with values at the end of treatment and at follow-up.

Unit of Measure: U/L
Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)
Change in serum Alkaline phosphatase
Časové okno: Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)

Change in serum Alkaline phosphatase levels comparing values at baseline with values at the end of treatment and at follow-up.

Unit of Measure: U/L
Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)
Change in serum Urea
Časové okno: Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)

Change in serum Urea levels comparing values at baseline with values at the end of treatment and at follow-up.

Unit of Measure: mg/dL
Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)
Change in serum Creatinine
Časové okno: Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)

Change in serum Creatinine levels comparing values at baseline with values at the end of treatment and at follow-up.

Unit of Measure: mg/dL
Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)
Change in serum Glucose
Časové okno: Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)

Change in serum Glucose levels comparing values at baseline with values at the end of treatment and at follow-up.

Unit of Measure: mg/dL
Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)
Change in serum Uric acid
Časové okno: Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)

Change in serum Uric acid levels comparing values at baseline with values at the end of treatment and at follow-up.

Unit of Measure: mg/dL
Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)
Change in serum Total bilirubin
Časové okno: Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)

Change in serum total bilirubin levels comparing values at baseline with values at the end of treatment and at follow-up.

Unit of Measure: mg/dL
Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)
Change in serum Direct bilirubin
Časové okno: Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)

Change in serum direct bilirubin levels comparing values at baseline with values at the end of treatment and at follow-up.

Unit of Measure: mg/dL
Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)
Change in serum Albumin
Časové okno: Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)

Change in serum albumin levels comparing values at baseline with values at the end of treatment and at follow-up.

Unit of Measure: g/dL
Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)
Change in Hemoglobin
Časové okno: Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)

Change in hemoglobin comparing values at baseline with values at the end of treatment and at follow-up.

Unit of Measure: g/dL
Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)
Change in Hematocrit
Časové okno: Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)

Change in hematocrit comparing values at baseline with values at the end of treatment and at follow-up.

Unit of Measure: %
Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)
Change in Leukocyte count
Časové okno: Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)

Change in leukocyte count comparing values at baseline with values at the end of treatment and at follow-up.

Unit of Measure: cells/µL
Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)
Change in Platelet count
Časové okno: Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)

Change in platelet count comparing values at baseline with values at the end of treatment and at follow-up.

Unit of Measure: cells/µL
Baseline (Week 0), Week 24 (end of treatment), and Week 52 (post-treatment follow-up)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Maria Denise Fernandes Carvalho de Andrade

Spolupracovníci

University of California, San Diego

Vyšetřovatelé

  • Vrchní vyšetřovatel: Maria Denise Fernandes Carvalho de Andrade, MD, PhD, Universidade Estadual do Ceara

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

  • Martins AMA, Nakashima H, Macia A, et al. Dormant viral pathways underlie space-induced neural senescence: a neuroprotective strategy for spaceflight and neurological diseases. bioRxiv. 2025. doi:10.1101/2025.11.02.686043

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

5. listopadu 2025

Primární dokončení (Odhadovaný)

1. června 2027

Dokončení studie (Odhadovaný)

1. prosince 2027

Termíny zápisu do studia

První předloženo

12. května 2026

První předloženo, které splnilo kritéria kontroly kvality

6. června 2026

První zveřejněno (Aktuální)

10. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

10. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

6. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 88455225.8.0000.5534

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

produkt vyrobený a vyvážený z USA

Ano

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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