Trial of Dextromethorphan in Rett Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00593957
• Date of registration: 04/01/2008
• Prospective Registration: No
• Primary sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
• Public title: Trial of Dextromethorphan in Rett Syndrome
• Scientific title: Trial of Dextromethorphan in Rett Syndrome
• Date of first enrolment: August 2004
• Target sample size: 38
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00593957
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: SakkuBai Naidu, MD
• Affiliation: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Key inclusion & exclusion criteria

Inclusion Criteria:

1. those who have classic or atypical RTT with a proven mutation in the MeCP2 gene;

2. those with documented EEG evidence of spike activity who may or may not have clinical
seizures;

3. subjects must be between 2years -14.99 years of age.

Exclusion Criteria:

1. those without an established mutation in the MeCP2 gene;

2. those who do not have EEG evidence of spike activity;

3. those with mutations in the MeCP2 gene but who have had brain resection or surgical
intervention; for example, tumor, hydrocephalus, severe head trauma; or, an associated
severe medical illnesses such as vasculopathies, malignancies, diabetes, thyroid
dysfunction, etc;

4. those on medications that could interact with DM, e.g. monoamine oxidase (MAO)
inhibitors, selective serotonin reuptake inhibitor (SSRI), sibutramine etc. to avoid a
serotonin syndrome; quinidine and drugs metabolized by the Cytochrome P450 (CYP450)
isoform cytochrome P450 2D6 (CYP2D6) (e.g. amiodarone, haloperidol, propafenone,
thioridazine);

5. those proven to be intermediate or slow metabolizers of DM;

6. those with reported adverse reactions to DM;

7. those whose pregnancy test is positive; and,

8. those showing poor compliance with any aspect of the study;

9. foster children



Age minimum: 2 Years
Age maximum: 15 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rett Syndrome

Intervention(s)

Drug: Dextromethorphan

Primary Outcome(s)

Difference in EEG Spike Counts at Six Months Compared to Baseline for Each Treatment Arm. [Time Frame: Initial and 6-month post-treatment]

Secondary Outcome(s)

Improvement in Receptive Language as Measured by the Mullen Scale. [Time Frame: Change in mean between Initial and 6-month follow-up]

Mean SSI Score for Total Subjects at Baseline and 6 Months [Time Frame: 0-6 months]

Difference in SSI Mean Score at Six Months Compared to Baseline for Each Treatment Arm. [Time Frame: Initial and 6 month followup]

Secondary ID(s)

FD2408

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 23/04/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00593957