Trial · NCT00606411
Efficacy and Safety of Topiramate in the Treatment of Sleep-Related Eating Disorder
NCT00606411, Early phase 1, Completed, Massachusetts General Hospital; results first posted 2024-04-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Topiramate in the Treatment of Sleep-Related Eating Disorder. Trials, record NCT00606411. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00606411
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Topiramate in the Treatment of Sleep-Related Eating Disorder
- NCT number
- NCT00606411
- Status
- Completed
- Phases
- Early phase 1
- Enrollment
- 34 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Sleep-Related Eating Disorder
- Interventions
- Topiramate or Placebo
- First posted
- 2008-02-04
- Last updated
- 2024-04-19
- Results first posted
- 2024-04-19
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Frequency of Sleep-related Eating Episodes (Time Frame: Comparing Final Study Visit to Baseline) | every 2 weeks for 10 weeks | Frequency of sleep-related eating episodes was measured as the number of nights a participant had an episode within the previous two weeks. The change was measured by comparing the last study visit (by the participant) from to the baseline results. |
| Primary | The Clinician Global Impression (CGI) Scale | Day 1 (First Study Visit) to Day 63 (Final Study Visit) (assessed at last study visit) | The Clinician Global Impression (CGI) Scale is used by healthcare professionals to assess the overall severity of illness and change in a patient's condition over time. The scale ranges from 1 to 7, 1 being Very much improved and 7 being Very much worse. A participant with a score of 1 or 2 on the Clinician Global Impression scale was considered a "responder." |
| Secondary | Body Weight | every other week for 10 weeks | The change in body weight in the study participants was calculated comparing the participant's last study visit to their baseline weight. |
| Secondary | HbA1c (%) | Day 1 (First Study Visit) to Day 63 (Final Study Visit) | Change in HbA1c levels from randomization to the end of follow-up. |
| Secondary | Average Total Sleep Time (Hours) | Day 1 (First Study Visit) to Day 63 (Final Study Visit) | Average sleep time over the course of the previous two weeks, comparing end results to baseline. |
| Secondary | Sleep Quality (Visual Analogue Scale or VAS) | Day 1 (First Study Visit) to Day 63 (Final Study Visit) | Measured on visual analogue scale (VAS). VAS ranges were as follows: Sleep Quality; 0 = "Poorly" to 100 = "Great," Wakefulness; 0 = "Asleep/Not Awake" to 100 = "Fully Awake," Control; 0 = "No Control Over Eating" to 100 = "Full Control Over Eating," Memory; 0 = "No Memory of Eating" to 100 = "Fully Remember Eating". The change was calculated from baseline to the final study visit (day 63). |
| Secondary | The Patient Global Impression (PGI) Scale | Day 1 (First Study Visit) to Day 63 (Final Study Visit) (assessed at last study visit) | A participant with a score of 1 or 2 on the Patient Global Impression scale was considered a "responder." |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Frequency of Sleep-related Eating Episodes (Time Frame: Comparing Final Study Visit to Baseline) | every 2 weeks for 10 weeks | One participant in the Topiramate group and one participant in the Placebo group were not analyzed due to being removed or withdrawing from the study prior to the collection of post-randomization data. | change in % of nights eating per week | MEAN |
| PRIMARY | The Clinician Global Impression (CGI) Scale | Day 1 (First Study Visit) to Day 63 (Final Study Visit) (assessed at last study visit) | Two participants in the Topiramate group and three participants in the Placebo group were not analyzed due to being removed or withdrawing from the study prior to the end of treatment visit, where CGI is determined. | percentage responders | NUMBER |
| SECONDARY | Body Weight | every other week for 10 weeks | Two participants in the Topiramate group and four participants in the Placebo group were excluded from the analysis due to being removed or withdrawing from the study prior to the collection of this end-of-treatment datapoint. | pounds | MEAN |
| SECONDARY | HbA1c (%) | Day 1 (First Study Visit) to Day 63 (Final Study Visit) | Four participants in the Topiramate group and ten participants in the Placebo group were excluded from this analysis due to being removed or withdrawing from the study prior to the collection of this end of treatment data point. | Change in percent HbA1c | MEAN |
| SECONDARY | Average Total Sleep Time (Hours) | Day 1 (First Study Visit) to Day 63 (Final Study Visit) | Four participants in the Topiramate group and one participant in the Placebo group were excluded from the analysis due to being removed or withdrawing from the study prior to the collection of this end-of-treatment datapoint. | hours | MEAN |
| SECONDARY | Sleep Quality (Visual Analogue Scale or VAS) | Day 1 (First Study Visit) to Day 63 (Final Study Visit) | Two participants in the Topiramate group and two participants in the Placebo group were excluded from the analysis due to being removed or withdrawing from the study prior to the collection of this end-of-treatment datapoint. | change in points on VAS (BL to day 63) | MEAN |
| SECONDARY | The Patient Global Impression (PGI) Scale | Day 1 (First Study Visit) to Day 63 (Final Study Visit) (assessed at last study visit) | Four participants in the Topiramate group and six participants in the Placebo group were excluded from the analysis due to being removed or withdrawing from the study prior to the collection of this end-of-treatment datapoint. | % Responders | NUMBER |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Frequency of Sleep-related Eating Episodes (Time Frame: Comparing Final Study Visit to Baseline) | Topiramate | -41.2 | 95% Confidence Interval -71.9 to -10.5 | change in % of nights eating per week | |
| Change in Frequency of Sleep-related Eating Episodes (Time Frame: Comparing Final Study Visit to Baseline) | Placebo | -20.0 | 95% Confidence Interval -43.5 to 3.5 | change in % of nights eating per week | |
| The Clinician Global Impression (CGI) Scale | Topiramate | 71.4 | percentage responders | ||
| The Clinician Global Impression (CGI) Scale | Placebo | 26.7 | percentage responders | ||
| Body Weight | Topiramate | -8.5 | Standard Deviation 8.2 | pounds | |
| Body Weight | Placebo | 1.0 | Standard Deviation 5.3 | pounds | |
| HbA1c (%) | Topiramate | 0 | 95% Confidence Interval -0.1 to 0.1 | Change in percent HbA1c | |
| HbA1c (%) | Placebo | -0.2 | 95% Confidence Interval -0.4 to 0 | Change in percent HbA1c | |
| Average Total Sleep Time (Hours) | Topiramate | 0.4 | 95% Confidence Interval -0.3 to 1.1 | hours | |
| Average Total Sleep Time (Hours) | Placebo | 0.4 | 95% Confidence Interval -0.7 to 1.5 | hours |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Topiramate | 16 | |
| Overall Study | STARTED | Placebo | 18 | |
| Overall Study | COMPLETED | Topiramate | 10 | |
| Overall Study | COMPLETED | Placebo | 11 | |
| Overall Study | NOT COMPLETED | Topiramate | 6 | |
| Overall Study | NOT COMPLETED | Placebo | 7 |
Source ClinicalTrials.gov
Adverse events16
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Paresthesia | Nervous system disorders | Topiramate | 9 | 16 | |
| other | Paresthesia | Nervous system disorders | Placebo | 0 | 18 | |
| other | Dysgeusia | Nervous system disorders | Topiramate | 5 | 16 | |
| other | Dysgeusia | Nervous system disorders | Placebo | 0 | 18 | |
| other | Cognitive Dysfunction | General disorders | Topiramate | 5 | 16 | |
| other | Cognitive Dysfunction | General disorders | Placebo | 1 | 18 | |
| other | Daytime Tiredness | General disorders | Topiramate | 5 | 16 | |
| other | Daytime Tiredness | General disorders | Placebo | 3 | 18 | |
| other | Decreased Daytime Apetite | Metabolism and nutrition disorders | Topiramate | 3 | 16 | |
| other | Decreased Daytime Apetite | Metabolism and nutrition disorders | Placebo | 1 | 18 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Topiramate | 0 | 16 |
| Total, all-cause mortality | Placebo | 0 | 18 |
| Total, other adverse events | Topiramate | 13 | 16 |
| Total, other adverse events | Placebo | 5 | 18 |
| Total, serious adverse events | Topiramate | 0 | 16 |
| Total, serious adverse events | Placebo | 0 | 18 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32227216 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Topiramate vs Placebo: deaths from any cause | Trial comparisons |
| Topiramate vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00606411
GET https://conductscience.org/api/trials/v1/NCT00606411/registered