Sleep-Related Eating DisorderEarly Phase 1NCT00606411

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

A Early Phase 1 study of Sleep-Related Eating Disorder, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Sleep-Related Eating Disorder
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 34 participants
Where: 1 siteUnited States
Study dates: Jan 2008to 29 Nov 2018
Phase: Early Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adults 18-65
Diagnosis of SRED
Must be able to swallow capsules and follow instructions

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine the Efficacy and Safety of Topiramate in the Treatment of Sleep-Related Eating Disorder

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).

Read the 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.

Conditions: Sleep-Related Eating Disorder
Being tested: Topiramate or Placebo
Keywords: Sleep-Related Eating Disorder, Topiramate, Parasomnia
Medical subject headings: Parasomnias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Topiramate or PlaceboDrug
Also called Brand Name: Topamax
25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules

Study groups in NCT00606411
Study group	Role	What they receive
Topiramate	Active comparator	Study medication arm, 25-300mg of Topiramate Receives: Drug: Topiramate or Placebo
Placebo	Placebo comparator	Placebo arm of study, 25-300mg of sugar pill Receives: Drug: Topiramate or Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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."
Measured: Day 1 (First Study Visit) to Day 63 (Final Study Visit) (assessed at last study visit)

Secondary outcomes (5)

Body Weight
The change in body weight in the study participants was calculated comparing the participant's last study visit to their baseline weight.
Measured: every other week for 10 weeks
HbA1c (%)
Change in HbA1c levels from randomization to the end of follow-up.
Measured: 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.
Measured: 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).
Measured: 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."
Measured: Day 1 (First Study Visit) to Day 63 (Final Study Visit) (assessed at last study visit)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 200829 Nov 2018

First posted4 Feb 2008 (estimated)
Study startJan 2008
Primary completion29 Nov 2018
Study completion29 Nov 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Sleep-Related Eating DisorderStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00606411
Sponsor's protocol ID: MGH-2008P000662
Status last verified: Apr 2024
First submitted: 22 Jan 2008
Last updated: 19 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 32227216

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine the Efficacy and Safety of Topiramate in the Treatment of Sleep-Related Eating Disorder
ClinicalTrials.gov ID: NCT00606411
Acronym / sponsor ID: MGH-2008P000662
Conditions: Sleep-Related Eating Disorder
Keywords: Sleep-Related Eating Disorder, Topiramate, Parasomnia
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Study start: Jan 2008 (actual)
Primary completion: 29 Nov 2018 (actual)
Study completion: 29 Nov 2018 (actual)
First posted: 4 Feb 2008 (estimated)
Results: Posted 19 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Topiramate	Active comparator	Drug: Topiramate or PlaceboStudy medication arm, 25-300mg of Topiramate
Placebo	Placebo comparator	Drug: Topiramate or PlaceboPlacebo arm of study, 25-300mg of sugar pill

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Adults 18-65
Diagnosis of SRED
Must be able to swallow capsules and follow instructions

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Topiramate or PlaceboAlso: Brand Name: Topamax25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules	Drug	Placebo, Topiramate

Primary outcome

Change in Frequency of Sleep-related Eating Episodes (Time Frame: Comparing Final Study Visit to Baseline)
Time frame: 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
Time frame: 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."

5 secondary outcomes

Body Weight
Time frame: every other week for 10 weeks
HbA1c (%)
Time frame: Day 1 (First Study Visit) to Day 63 (Final Study Visit)
Average Total Sleep Time (Hours)
Time frame: Day 1 (First Study Visit) to Day 63 (Final Study Visit)
Sleep Quality (Visual Analogue Scale or VAS)
Time frame: Day 1 (First Study Visit) to Day 63 (Final Study Visit)
The Patient Global Impression (PGI) Scale
Time frame: Day 1 (First Study Visit) to Day 63 (Final Study Visit) (assessed at last study visit)

Results and safety

Results posted to the registry on 19 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Topiramate	16	10
Placebo	18	11

Primary outcome: Change in Frequency of Sleep-related Eating Episodes (Time Frame: Comparing Final Study Visit to Baseline)

Time frame: every 2 weeks for 10 weeks. Mean (95% Confidence Interval). Unit: change in % of nights eating per week

Measure	Topiramate n = 15	Placebo n = 17
Value	-41.2 (-71.9 to -10.5)	-20.0 (-43.5 to 3.5)

Population analysed: 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.

Primary outcome: The Clinician Global Impression (CGI) Scale

Time frame: Day 1 (First Study Visit) to Day 63 (Final Study Visit) (assessed at last study visit). Number. Unit: percentage responders

Measure	Topiramate n = 14	Placebo n = 15
Value	71.4	26.7

Population analysed: 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.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: AE data collected over the course of 9-week titration period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Topiramate	0 of 16 (0%)	13 of 16 (81.3%)	0 of 16
Placebo	0 of 18 (0%)	5 of 18 (27.8%)	0 of 18

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32227216Winkelman 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John W Winkelman, MD, PhD principal investigator

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study of Sleep-Related Eating Disorder, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Frequency of Sleep-related Eating Episodes (Time Frame: Comparing Final Study Visit to Baseline) (time frame: every 2 weeks for 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00606411, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.