Early Phase 1
N=34
Efficacy and Safety of Topiramate in the Treatment of Sleep-Related Eating Disorder
Sleep-Related Eating Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00606411 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Change in Frequency of Sleep-related Eating Episodes (Time Frame: Comparing Final Study Visit to Baseline) — -41.2; -20.0 change in % of nights eating per week
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Topiramate or Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Frequency of Sleep-related Eating Episodes (Time Frame: Comparing Final Study Visit to Baseline) |
-41.2; -20.0 | — |
| PRIMARY The Clinician Global Impression (CGI) Scale |
71.4; 26.7 | — |
| SECONDARY Body Weight |
-8.5; 1.0 | — |
| SECONDARY HbA1c (%) |
0; -0.2 | — |
| SECONDARY Average Total Sleep Time (Hours) |
0.4; 0.4 | — |
| SECONDARY Sleep Quality (Visual Analogue Scale or VAS) |
3.0; -1.0 | — |
| SECONDARY The Patient Global Impression (PGI) Scale |
75; 16.7 | — |
Summary
The purpose of the study is to learn about the safety and effectiveness of oral (taken by mouth) topiramate in treating Sleep-Related Eating Disorder (SRED).
Eligibility Criteria
Inclusion Criteria
- Adults 18-65
- Diagnosis of SRED
- Must be able to swallow capsules and follow instructions
Exclusion Criteria
- Women who are pregnant or lactating
- Other sleep disorders
- Kidney or Liver disease
- Night shift workers
- Previous history of Topiramate or Topamax use for any condition
Data sourced from ClinicalTrials.gov (NCT00606411). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.