Trial Outcomes & Findings for Efficacy and Safety of Topiramate in the Treatment of Sleep-Related Eating Disorder (NCT NCT00606411)

Last Updated: 2024-04-19

Results Overview

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.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

34 participants

Primary outcome timeframe

every 2 weeks for 10 weeks

Results posted on

2024-04-19

Participant Flow

Participant milestones

Participant milestones
Measure	Topiramate Study medication arm, 25-300mg of Topiramate Topiramate or Placebo: 25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules	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
Overall Study STARTED	16	18
Overall Study COMPLETED	10	11
Overall Study NOT COMPLETED	6	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Topiramate Study medication arm, 25-300mg of Topiramate Topiramate or Placebo: 25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules	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
Overall Study Adverse Event	1	2
Overall Study Lack of Adherence	1	1
Overall Study Lack of Efficacy	1	1
Overall Study Withdrawal by Subject	2	0
Overall Study Lost to Follow-up	1	2
Overall Study Move out of state	0	1

Baseline Characteristics

Efficacy and Safety of Topiramate in the Treatment of Sleep-Related Eating Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Topiramate n=16 Participants Study medication arm, 25-300mg of Topiramate Topiramate or Placebo: 25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules	Placebo n=18 Participants 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	Total n=34 Participants Total of all reporting groups
Age, Continuous	40.0 years STANDARD_DEVIATION 12 • n=5 Participants	39.4 years STANDARD_DEVIATION 12.1 • n=7 Participants	39.5 years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Number of nights eating per week	74.7 percent of nights per week STANDARD_DEVIATION 17.3 • n=5 Participants	77 percent of nights per week STANDARD_DEVIATION 17.2 • n=7 Participants	75.2 percent of nights per week STANDARD_DEVIATION 17.4 • n=5 Participants
Weight	181.8 lbs STANDARD_DEVIATION 38.5 • n=5 Participants	188.2 lbs STANDARD_DEVIATION 42.3 • n=7 Participants	185.3 lbs STANDARD_DEVIATION 40.1 • n=5 Participants
HbA1c	5.4 percent glycohemoglobin/total hemoglobin STANDARD_DEVIATION 0.2 • n=5 Participants	5.3 percent glycohemoglobin/total hemoglobin STANDARD_DEVIATION 0.5 • n=7 Participants	5.3 percent glycohemoglobin/total hemoglobin STANDARD_DEVIATION 0.4 • n=5 Participants
Average nightly total sleep time	7.0 hours STANDARD_DEVIATION 1.0 • n=5 Participants	7.0 hours STANDARD_DEVIATION 1.1 • n=7 Participants	7.0 hours STANDARD_DEVIATION 1.0 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Topiramate n=15 Participants Study medication arm, 25-300mg of Topiramate Topiramate or Placebo: 25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules	Placebo n=17 Participants 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
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 Interval -71.9 to -10.5	-20.0 change in % of nights eating per week Interval -43.5 to 3.5

PRIMARY outcome

Timeframe: 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.

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."

Outcome measures

Outcome measures
Measure	Topiramate n=14 Participants Study medication arm, 25-300mg of Topiramate Topiramate or Placebo: 25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules	Placebo n=15 Participants 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
The Clinician Global Impression (CGI) Scale	71.4 percentage responders	26.7 percentage responders

SECONDARY outcome

Timeframe: 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.

The change in body weight in the study participants was calculated comparing the participant's last study visit to their baseline weight.

Outcome measures

Outcome measures
Measure	Topiramate n=14 Participants Study medication arm, 25-300mg of Topiramate Topiramate or Placebo: 25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules	Placebo n=14 Participants 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
Body Weight	-8.5 pounds Standard Deviation 8.2	1.0 pounds Standard Deviation 5.3

SECONDARY outcome

Timeframe: 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.

Change in HbA1c levels from randomization to the end of follow-up.

Outcome measures

Outcome measures
Measure	Topiramate n=12 Participants Study medication arm, 25-300mg of Topiramate Topiramate or Placebo: 25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules	Placebo n=8 Participants 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
HbA1c (%)	0 Change in percent HbA1c Interval -0.1 to 0.1	-0.2 Change in percent HbA1c Interval -0.4 to 0.0

SECONDARY outcome

Timeframe: 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.

Average sleep time over the course of the previous two weeks, comparing end results to baseline.

Outcome measures

Outcome measures
Measure	Topiramate n=12 Participants Study medication arm, 25-300mg of Topiramate Topiramate or Placebo: 25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules	Placebo n=17 Participants 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
Average Total Sleep Time (Hours)	0.4 hours Interval -0.3 to 1.1	0.4 hours Interval -0.7 to 1.5

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Topiramate n=14 Participants Study medication arm, 25-300mg of Topiramate Topiramate or Placebo: 25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules	Placebo n=16 Participants 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
Sleep Quality (Visual Analogue Scale or VAS)	3.0 change in points on VAS (BL to day 63) Standard Deviation 14.6	-1.0 change in points on VAS (BL to day 63) Standard Deviation 17.0

SECONDARY outcome

Timeframe: 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.

A participant with a score of 1 or 2 on the Patient Global Impression scale was considered a "responder."

Outcome measures

Outcome measures
Measure	Topiramate n=12 Participants Study medication arm, 25-300mg of Topiramate Topiramate or Placebo: 25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules	Placebo n=12 Participants 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
The Patient Global Impression (PGI) Scale	75 % Responders	16.7 % Responders

Adverse Events

Topiramate

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Topiramate n=16 participants at risk Study medication arm, 25-300mg of Topiramate Topiramate or Placebo: 25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules	Placebo n=18 participants at risk 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
Nervous system disorders Paresthesia	56.2% 9/16 • AE data collected over the course of 9-week titration period.	0.00% 0/18 • AE data collected over the course of 9-week titration period.
Nervous system disorders Dysgeusia	31.2% 5/16 • AE data collected over the course of 9-week titration period.	0.00% 0/18 • AE data collected over the course of 9-week titration period.
General disorders Cognitive Dysfunction	31.2% 5/16 • AE data collected over the course of 9-week titration period.	5.6% 1/18 • AE data collected over the course of 9-week titration period.
General disorders Daytime Tiredness	31.2% 5/16 • AE data collected over the course of 9-week titration period.	16.7% 3/18 • AE data collected over the course of 9-week titration period.
Metabolism and nutrition disorders Decreased Daytime Apetite	18.8% 3/16 • AE data collected over the course of 9-week titration period.	5.6% 1/18 • AE data collected over the course of 9-week titration period.
General disorders Dry Mouth	18.8% 3/16 • AE data collected over the course of 9-week titration period.	0.00% 0/18 • AE data collected over the course of 9-week titration period.
General disorders Nausea	6.2% 1/16 • AE data collected over the course of 9-week titration period.	0.00% 0/18 • AE data collected over the course of 9-week titration period.
General disorders Headache	12.5% 2/16 • AE data collected over the course of 9-week titration period.	5.6% 1/18 • AE data collected over the course of 9-week titration period.

Additional Information

Dr. John W. Winkelman

Massachusetts General Hospital

Phone: 617-643-9101

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place