Sleep-Related Eating Disorder
Conditions
Keywords
Sleep-Related Eating Disorder, Topiramate, Parasomnia
Brief 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).
Detailed description
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.
Interventions
DRUGTopiramate or Placebo
25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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). |
| HbA1c (%) | Day 1 (First Study Visit) to Day 63 (Final Study Visit) | Change in HbA1c levels from randomization to the end of follow-up. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Topiramate Study medication arm, 25-300mg of Topiramate
Topiramate or Placebo: 25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules | 16 |
| 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 | 18 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 |
| Overall Study | Lack of Adherence | 1 | 1 |
| Overall Study | Lack of Efficacy | 1 | 1 |
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Move out of state | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Placebo | Total | Topiramate |
|---|---|---|---|
| Age, Continuous | 39.4 years STANDARD_DEVIATION 12.1 | 39.5 years STANDARD_DEVIATION 12.6 | 40.0 years STANDARD_DEVIATION 12 |
| Average nightly total sleep time | 7.0 hours STANDARD_DEVIATION 1.1 | 7.0 hours STANDARD_DEVIATION 1 | 7.0 hours STANDARD_DEVIATION 1 |
| HbA1c | 5.3 percent glycohemoglobin/total hemoglobin STANDARD_DEVIATION 0.5 | 5.3 percent glycohemoglobin/total hemoglobin STANDARD_DEVIATION 0.4 | 5.4 percent glycohemoglobin/total hemoglobin STANDARD_DEVIATION 0.2 |
| Number of nights eating per week | 77 percent of nights per week STANDARD_DEVIATION 17.2 | 75.2 percent of nights per week STANDARD_DEVIATION 17.4 | 74.7 percent of nights per week STANDARD_DEVIATION 17.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 29 Participants | 14 Participants |
| Sex: Female, Male Female | 12 Participants | 25 Participants | 13 Participants |
| Sex: Female, Male Male | 6 Participants | 9 Participants | 3 Participants |
| Weight | 188.2 lbs STANDARD_DEVIATION 42.3 | 185.3 lbs STANDARD_DEVIATION 40.1 | 181.8 lbs STANDARD_DEVIATION 38.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 18 |
| other Total, other adverse events | 13 / 16 | 5 / 18 |
| serious Total, serious adverse events | 0 / 16 | 0 / 18 |
Outcome results
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.
Time frame: every 2 weeks for 10 weeks
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Topiramate | Change in Frequency of Sleep-related Eating Episodes (Time Frame: Comparing Final Study Visit to Baseline) | -41.2 change in % of nights eating per week |
| Placebo | Change in Frequency of Sleep-related Eating Episodes (Time Frame: Comparing Final Study Visit to Baseline) | -20.0 change in % of nights eating per week |
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.
Time frame: Day 1 (First Study Visit) to Day 63 (Final Study Visit) (assessed at last study visit)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Topiramate | The Clinician Global Impression (CGI) Scale | 71.4 percentage responders |
| Placebo | The Clinician Global Impression (CGI) Scale | 26.7 percentage responders |
Secondary
Average Total Sleep Time (Hours)
Average sleep time over the course of the previous two weeks, comparing end results to baseline.
Time frame: Day 1 (First Study Visit) to Day 63 (Final Study Visit)
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Topiramate | Average Total Sleep Time (Hours) | 0.4 hours |
| Placebo | Average Total Sleep Time (Hours) | 0.4 hours |
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.
Time frame: every other week for 10 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topiramate | Body Weight | -8.5 pounds | Standard Deviation 8.2 |
| Placebo | Body Weight | 1.0 pounds | Standard Deviation 5.3 |
Secondary
HbA1c (%)
Change in HbA1c levels from randomization to the end of follow-up.
Time frame: Day 1 (First Study Visit) to Day 63 (Final Study Visit)
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Topiramate | HbA1c (%) | 0 Change in percent HbA1c |
| Placebo | HbA1c (%) | -0.2 Change in percent HbA1c |
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).
Time frame: Day 1 (First Study Visit) to Day 63 (Final Study Visit)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topiramate | Sleep Quality (Visual Analogue Scale or VAS) | 3.0 change in points on VAS (BL to day 63) | Standard Deviation 14.6 |
| Placebo | Sleep Quality (Visual Analogue Scale or VAS) | -1.0 change in points on VAS (BL to day 63) | Standard Deviation 17 |
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.
Time frame: Day 1 (First Study Visit) to Day 63 (Final Study Visit) (assessed at last study visit)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Topiramate | The Patient Global Impression (PGI) Scale | 75 % Responders |
| Placebo | The Patient Global Impression (PGI) Scale | 16.7 % Responders |