Trial · NCT00593957
Trial of Dextromethorphan in Rett Syndrome
NCT00593957, Phase 2, Terminated, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.; results first posted 2014-04-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial of Dextromethorphan in Rett Syndrome. Trials, record NCT00593957. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00593957
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Dextromethorphan in Rett Syndrome
- NCT number
- NCT00593957
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 38 participants, actual
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Conditions
- Rett Syndrome
- Interventions
- Dextromethorphan, Dextromethorphan
- First posted
- 2008-01-15
- Last updated
- 2014-04-23
- Results first posted
- 2014-04-23
- Limitations and caveats
The trial was terminated due to the FDA requiring a placebo controlled trial instead of the ongoing open label trial. As recruitment was delayed,the total number of participants was also less than anticipated.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Difference in EEG Spike Counts at Six Months Compared to Baseline for Each Treatment Arm. | Initial and 6-month post-treatment | Difference in EEG spike count means pre and 6 months post-treatment in each of three treatment groups. |
| Secondary | Improvement in Receptive Language as Measured by the Mullen Scale. | Change in mean between Initial and 6-month follow-up | The Mullen Receptive language scale pre and 6 months post DM, measured as a change in the mean score of language, by age in months. |
| Secondary | Difference in SSI Mean Score at Six Months Compared to Baseline for Each Treatment Arm. | Initial and 6 month followup | The Screen for Social Interaction (SSI) is a 54-item parent/caregiver-report screening instrument that emphasizes reciprocal social interaction including joint attention skills. The items are positive (prosocial) and are scored on a four-point frequency scale (child displays the behavior "almost never" = 0 to "almost all the time" = 3). Thus lower scores reflect a slower or delayed development, and higher scores reflect more normative development. SSI total scores range from 0-162. There are no subscales. Difference in Screen for Social Interaction (SSI) mean scores between baseline and 6 months post-treatment for each treatment arm are reported. |
| Secondary | Mean SSI Score for Total Subjects at Baseline and 6 Months | 0-6 months | Analysis of Difference in Mean Screen for Social Interaction (SSI) Score between 0-6 months for total sample (n=19). |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Difference in EEG Spike Counts at Six Months Compared to Baseline for Each Treatment Arm. | Initial and 6-month post-treatment | 33/35 participants who completed the protocol with two epochs of 5 mins of non-Rapid eye movement (REM)sleep during which spikes could be counted pre and post DM intake. | EEG spike counts per minute | MEAN |
| SECONDARY | Improvement in Receptive Language as Measured by the Mullen Scale. | Change in mean between Initial and 6-month follow-up | 25/35 enrolled participants completed the receptive language scale of the Mullen and underwent the analysis. | age in months | MEAN |
| SECONDARY | Difference in SSI Mean Score at Six Months Compared to Baseline for Each Treatment Arm. | Initial and 6 month followup | Those who provided complete information only were included. Others did not provide adequate or complete information for analysis. | scores on a scale | MEAN |
| SECONDARY | Mean SSI Score for Total Subjects at Baseline and 6 Months | 0-6 months | 19 subjects (total sample) for whom complete data was available | scores on a scale | MEAN |
Source ClinicalTrials.gov
Results by group17
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Difference in EEG Spike Counts at Six Months Compared to Baseline for Each Treatment Arm. | Dextromethorphan (DM)1 EEG Spike Counts at Baseline | 44.22 | Standard Deviation 23.77 | EEG spike counts per minute | |
| Difference in EEG Spike Counts at Six Months Compared to Baseline for Each Treatment Arm. | DM2 EEG Spike Counts at Baseline | 25.44 | Standard Deviation 18.6 | EEG spike counts per minute | |
| Difference in EEG Spike Counts at Six Months Compared to Baseline for Each Treatment Arm. | DM3 EEG Spike Counts at Baseline | 40.67 | Standard Deviation 27.83 | EEG spike counts per minute | |
| Difference in EEG Spike Counts at Six Months Compared to Baseline for Each Treatment Arm. | DM1 EEG Spike Count at 6 Months | 38.29 | Standard Deviation 30.24 | EEG spike counts per minute | |
| Difference in EEG Spike Counts at Six Months Compared to Baseline for Each Treatment Arm. | DM2 EEG Spike Counts at 6 Months | 27.58 | Standard Deviation 19.52 | EEG spike counts per minute | |
| Difference in EEG Spike Counts at Six Months Compared to Baseline for Each Treatment Arm. | DM3 EEG Spike Counts at 6 Months | 36.01 | Standard Deviation 23.29 | EEG spike counts per minute | |
| Improvement in Receptive Language as Measured by the Mullen Scale. | DM1( 0.25 mg/kg /Day) | 0 | Standard Deviation 2.94 | age in months | |
| Improvement in Receptive Language as Measured by the Mullen Scale. | DM2 (2.5 mg/kg/Day) | -0.44 | Standard Deviation 2.96 | age in months | |
| Improvement in Receptive Language as Measured by the Mullen Scale. | DM3 (5mg/kg/Day) | 03 | Standard Deviation 2.45 | age in months | |
| Difference in SSI Mean Score at Six Months Compared to Baseline for Each Treatment Arm. | DM1( 0.25 mg/kg /Day) SSI Baseline | 40.25 | Standard Deviation 18.59 | scores on a scale |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | DM1( 0.25 mg/kg /Day) | 13 | |
| Overall Study | STARTED | DM2 (2.5 mg/kg/Day) | 13 | |
| Overall Study | STARTED | DM3 (5mg/kg/Day) | 12 | |
| Overall Study | COMPLETED | DM1( 0.25 mg/kg /Day) | 13 | |
| Overall Study | COMPLETED | DM2 (2.5 mg/kg/Day) | 12 | |
| Overall Study | COMPLETED | DM3 (5mg/kg/Day) | 10 | |
| Overall Study | NOT COMPLETED | DM1( 0.25 mg/kg /Day) | 0 | |
| Overall Study | NOT COMPLETED | DM2 (2.5 mg/kg/Day) | 1 | |
| Overall Study | NOT COMPLETED | DM3 (5mg/kg/Day) | 2 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DM1( 0.25 mg/kg /Day) | ||
| Total, all-cause mortality | DM2 (2.5 mg/kg/Day) | ||
| Total, all-cause mortality | DM3 (5mg/kg/Day) | ||
| Total, other adverse events | DM1( 0.25 mg/kg /Day) | 0 | 13 |
| Total, other adverse events | DM2 (2.5 mg/kg/Day) | 0 | 12 |
| Total, other adverse events | DM3 (5mg/kg/Day) | 0 | 10 |
| Total, serious adverse events | DM1( 0.25 mg/kg /Day) | 0 | 13 |
| Total, serious adverse events | DM2 (2.5 mg/kg/Day) | 0 | 12 |
| Total, serious adverse events | DM3 (5mg/kg/Day) | 0 | 10 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00593957
GET https://conductscience.org/api/trials/v1/NCT00593957/registered