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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).
This is a single center, 13-week, outpatient, randomized, double-blind, placebo-controlled, parallel group, pilot study of topiramate in subjects with Sleep-Related Eating Disorder (SRED). The primary objective of this study is to investigate the efficacy and safety of topiramate compared to placebo in the treatment of Sleep-Related Eating Disorder. SRED is a disorder that consists of out of control eating during the night with little or no awareness of the events. In this study we are comparing topiramate to placebo. A placebo is a pill that looks exactly like the study drug, but it does not have any active drug in it. Topamax (topiramate) is approved by the U.S. Food and Drug Administration (FDA) as a therapy for epilepsy, but topiramate has not been approved by the FDA for SRED.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topiramate | Active Comparator | Study medication arm, 25-300mg of Topiramate |
|
| Placebo | Placebo Comparator | Placebo arm of study, 25-300mg of sugar pill |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topiramate or Placebo | Drug | 25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Frequency of Sleep-related Eating Episodes (Time Frame: Comparing Final Study Visit to Baseline) | 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. | every 2 weeks for 10 weeks |
| The Clinician Global Impression (CGI) Scale | 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." | Day 1 (First Study Visit) to Day 63 (Final Study Visit) (assessed at last study visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight | The change in body weight in the study participants was calculated comparing the participant's last study visit to their baseline weight. | every other week for 10 weeks |
| HbA1c (%) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John W Winkelman, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32227216 | Derived | Winkelman JW, Wipper B, Purks J, Mei L, Schoerning L. Topiramate reduces nocturnal eating in sleep-related eating disorder. Sleep. 2020 Sep 14;43(9):zsaa060. doi: 10.1093/sleep/zsaa060. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Topiramate | Study medication arm, 25-300mg of Topiramate Topiramate or Placebo: 25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules |
| FG001 | Placebo | Placebo arm of study, 25-300mg of sugar pill Topiramate or Placebo: 25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Topiramate | Study medication arm, 25-300mg of Topiramate Topiramate or Placebo: 25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Frequency of Sleep-related Eating Episodes (Time Frame: Comparing Final Study Visit to Baseline) | 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. | 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. | Posted | Mean | 95% Confidence Interval | change in % of nights eating per week | every 2 weeks for 10 weeks |
|
AE data collected over the course of 9-week titration period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Topiramate | Study medication arm, 25-300mg of Topiramate Topiramate or Placebo: 25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Paresthesia | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John W. Winkelman | Massachusetts General Hospital | 617-643-9101 | jwwinkelman@partners.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 8, 2016 | Jan 19, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077236 | Topiramate |
| ID | Term |
|---|---|
| D005632 | Fructose |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 |
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Change in HbA1c levels from randomization to the end of follow-up.
| Day 1 (First Study Visit) to Day 63 (Final Study Visit) |
| Average Total Sleep Time (Hours) | Average sleep time over the course of the previous two weeks, comparing end results to baseline. | Day 1 (First Study Visit) to Day 63 (Final Study Visit) |
| Sleep Quality (Visual Analogue Scale or VAS) | 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). | Day 1 (First Study Visit) to Day 63 (Final Study Visit) |
| The Patient Global Impression (PGI) Scale | A participant with a score of 1 or 2 on the Patient Global Impression scale was considered a "responder." | Day 1 (First Study Visit) to Day 63 (Final Study Visit) (assessed at last study visit) |
| Lack of Efficacy |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Move out of state |
|
Placebo arm of study, 25-300mg of sugar pill
Topiramate or Placebo: 25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Number of nights eating per week | Mean | Standard Deviation | percent of nights per week |
|
| Weight | Mean | Standard Deviation | lbs |
|
| HbA1c | Mean | Standard Deviation | percent glycohemoglobin/total hemoglobin |
|
| Average nightly total sleep time | Mean | Standard Deviation | hours |
|
| OG001 | Placebo | Placebo arm of study, 25-300mg of sugar pill Topiramate or Placebo: 25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules |
|
|
| Primary | The Clinician Global Impression (CGI) Scale | 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." | 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. | Posted | Number | percentage responders | Day 1 (First Study Visit) to Day 63 (Final Study Visit) (assessed at last study visit) |
|
|
|
| Secondary | Body Weight | The change in body weight in the study participants was calculated comparing the participant's last study visit to their baseline weight. | 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. | Posted | Mean | Standard Deviation | pounds | every other week for 10 weeks |
|
|
|
| Secondary | HbA1c (%) | Change in HbA1c levels from randomization to the end of follow-up. | 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. | Posted | Mean | 95% Confidence Interval | Change in percent HbA1c | Day 1 (First Study Visit) to Day 63 (Final Study Visit) |
|
|
|
| Secondary | Average Total Sleep Time (Hours) | Average sleep time over the course of the previous two weeks, comparing end results to baseline. | 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. | Posted | Mean | 95% Confidence Interval | hours | Day 1 (First Study Visit) to Day 63 (Final Study Visit) |
|
|
|
| Secondary | Sleep Quality (Visual Analogue Scale or VAS) | 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). | 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. | Posted | Mean | Standard Deviation | change in points on VAS (BL to day 63) | Day 1 (First Study Visit) to Day 63 (Final Study Visit) |
|
|
|
| Secondary | The Patient Global Impression (PGI) Scale | A participant with a score of 1 or 2 on the Patient Global Impression scale was considered a "responder." | 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. | Posted | Number | % Responders | Day 1 (First Study Visit) to Day 63 (Final Study Visit) (assessed at last study visit) |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 13 |
| 16 |
| EG001 | Placebo | Placebo arm of study, 25-300mg of sugar pill Topiramate or Placebo: 25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules | 0 | 18 | 0 | 18 | 5 | 18 |
| Dysgeusia | Nervous system disorders | Systematic Assessment |
|
| Cognitive Dysfunction | General disorders | Systematic Assessment |
|
| Daytime Tiredness | General disorders | Systematic Assessment |
|
| Decreased Daytime Apetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Dry Mouth | General disorders | Systematic Assessment |
|
| Nausea | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
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| Carbohydrates |
| D007661 | Ketoses |