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NCT01303835 · ClinicalTrials.gov registry record · Phase 2
Low Dose Naltrexone for Glioma Patients
A Phase 2 study, sponsored by Katy Peters.
- Completed
- Registry status
- Phase 2
- Development phase
- 110
- Enrollment target
NCT01303835: Completed Phase 2 study, sponsored by Katy Peters.
NCT01303835 is a Phase 2 study that has completed, run by Katy Peters. The registered enrollment target is 110 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01303835, a Phase 2 study, has completed, sponsored by Katy Peters.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 110 participants
- Enrollment target
Study Summary
To compare the effects of low dose naltrexone (LDN) versus placebo on quality of life in high grade glioma patients undergoing standard chemoradiation
Primary Outcome
The difference in QoL scores between the 3rd QoL measurement (approximately 16 weeks from initial assessment) and the initial baseline assessment are reported. QoL instruments included are listed below. Higher scores indicate more favorable outcomes unless otherwise indicated. * Functional Assessment of Cancer Therapy-Brain (FACT-Br) measures general QoL reflecting symptoms associated with brain malignancies (range 0-132) * Functional Assessment of Chronic Illness Therapy (FACIT-F) measures lev
Interventions
- DRUG Placebo
- DRUG LDN
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2011-05 |
| Est. Completion | 2015-05 |
| Phase | Phase 2 |
What the finished NCT01303835 record still lists
NCT01303835 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01303835 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01303835 about?
NCT01303835 is a clinical study titled "Low Dose Naltrexone for Glioma Patients". To compare the effects of low dose naltrexone (LDN) versus placebo on quality of life in high grade glioma patients undergoing standard chemoradiation
What is the current status of trial NCT01303835?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 110 participants. The study started on 2011-05. Estimated completion is 2015-05.
What interventions are being tested in trial NCT01303835?
The interventions under investigation include: Placebo (DRUG), LDN (DRUG).
Who is sponsoring clinical trial NCT01303835?
This trial is sponsored by Katy Peters, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01303835's enrollment target sits among peer trials
110 632nd of 2000 higher than 1,361 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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