Rett SyndromePhase 2PCTDMRTTNCT01520363

Placebo Controlled Trial of Dextromethorphan in Rett Syndrome

A Phase 2 study testing dextromethorphan in people with Rett Syndrome, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. 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

Dr. Sakkubai Naidu, Principal Investigator, is initiating a double blinded placebo controlled clinical drug trial using dextromethorphan (DM) in Rett Syndrome (RTT), at the Pediatric Clinical Research Unit (PCRU) of the Johns Hopkins Hospital/Kennedy Krieger Institute. Read more about this study

Who is it for?: Ages 1 year to 10 years
Conditions the study is for: Rett Syndrome
What is being tested?: dextromethorphan
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 57 participants
Where: 1 siteUnited States
Study dates: Mar 2012to 26 Oct 2016
Phase: Phase 2
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 1 year to 10 years
All sexes
No healthy volunteers
Child

Who may be able to join

males and females who have classic or atypical RTT with a proven mutation in the MECP2 gene;
subjects must be between one year - 10 years of age.

Who cannot join

those without an established mutation in the MECP2 gene;
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;
those on medications that could interact with DM, e.g. MAO inhibitors, SSRI, sibutramine etc. to avoid a serotonin syndrome; quinidine and drugs metabolized by the CYP450 isoform CYP2D6 (e.g. amiodarone, haloperidol, propafenone, thioridazine);
those proven to be intermediate or slow metabolizers of DM;
those with reported adverse reactions to DM;
those whose pregnancy test is positive;
those showing poor compliance with any aspect of the study;
foster children.

Trial locations and contacts

1 site in 1 country.

United States1 site

The Johns Hopkins Institute for Clinical and Translational Research
Baltimore, Maryland, 21287

Other trials in United States

About this study

It has been shown that receptors for a certain brain chemical called glutamate, in particular the NMDA type, are increased in the brain of young RTT patients (<10 years of age). This chemical and its receptors, when in excess, cause harmful over-stimulation of nerve cells in the brain, contributing in part to the seizures, behavioral problems, and learning disabilities in RTT.

The investigators propose to initiate a specific treatment using DM to counter/block the effects of this brain chemical and its excessive receptors to improve the ill effects of increased glutamate/NMDA receptors, because of DM's identified ability to block NMDA receptors. DM is available for human consumption. Infants and children with respiratory infections and cough, as well as non-ketotic hyperglycinemia, are treated with DM, which has been well tolerated.

Read the detailed description

The study will last for 3 months and will be limited to MECP2 mutation-positive children, one year - 9.99 years of age. This clinical trial, which is a placebo-controlled study, will randomize patients to the drug or placebo to determine the benefits of DM vs placebo on cognition, behavior, or seizures if present.

Your child will stay twice in the Pediatric Clinical Research Unit (PCRU) at Johns Hopkins ICTR, for 3 days during each admission. The first hospital stay will be for 3 days, before she starts the DM or placebo. The follow-up 3-day hospital stay will be 3 months after she starts taking DM or placebo. There will also be two interim follow up evaluations at 2 weeks and 1 month after she starts taking the DM or placebo consisting of a neurological evaluation, EKG, and blood work, which can take place at your local doctor's office or at Johns Hopkins, and will be paid for by this study. Our research nurse or research associate will contact you at least weekly during the first month, and at least monthly thereafter until the end of the 3-month study.

Conditions: Rett Syndrome
Being tested: dextromethorphan, placebo
Keywords: Rett syndrome, RTT, MECP2, dextromethorphan, DM
Medical subject headings: Rett Syndrome

What participants receive

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

dextromethorphanDrug
Also called Delsym
The DM group will take 5mg/kg/day orally in 2 divided doses 12 hours apart for the 3 month period of the study. The pharmacists will dispense the DM to the study participants.
placeboDrug
The placebo will be dispensed to equal the volume of DM of 5mg/kg/day. It is taken orally in 2 divided doses 12 hours apart during the study period of 3 months. The Research pharmacist will dispense the placebo to the participants.

Study groups in NCT01520363
Study group	Role	What they receive
Study drug-dextromethorphan (DM)	Active comparator	MECP2 mutation positive subjects randomized to receive DM Receives: Drug: dextromethorphan
Placebo group	Placebo comparator	MECP2 positive subjects randomized to the placebo compound Receives: Drug: placebo

What is being measured

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

Change in Mullen; Visual Reception Sub-scale Scores, Pre- and Post-Intervention
The Mullen Scales of Early Learning (MULLEN) Visual reception subscale raw scores range from Minimum=0 to Maximum=50. A higher score is a better outcome. Age equivalents from 1 month to 70 months can be computed for each subscale separately.
Measured: Initial evaluation and at the end of the 3 month trial
Change in Mullen; Fine Motor Sub-scale Scores, Pre- and Post-Intervention
The Mullen Scales of Early Learning (MULLEN) Fine motor scale raw scores range from Minimum=0 to Maximum=49. A higher score is a better outcome. Age equivalents from 1 month to 70 months can be computed for each subscale separately.
Measured: Baseline and 3 months
Change in Mullen; Receptive Language Subscale Scores, Pre- and Post-Intervention
The Mullen Scales of Early Learning (MULLEN) Receptive Language scale raw scores range from Minimum=0 to Maximum=50. A higher score is a better outcome. Age equivalents from 1 month to 70 months can be computed for each subscale separately.
Measured: Baseline and 3 months
Change in Mullen, Expressive Language Sub-scale Scores, Pre- and Post-Intervention
The Mullen Scales of Early Learning (MULLEN) Expressive Language scale raw scores range from Minimum=0 to Maximum=50. A higher score is a better outcome. Age equivalents from 1 month to 70 months can be computed for each subscale separately.
Measured: Baseline and 3 months

Secondary outcomes (6)

Change in VABS: Motor Skills Domain Scores, Pre- and Post-Intervention
Vineland Adaptive Behavior Scales-II (VABS): Motor Skills Domain Scores individual items are scored on a Likert scale from 2=Usually, 1=Sometimes or Partially, 0= Seldom or Never. Motor Skills Domain raw scores range from: Minimum=0 to Maximum=100. A higher score is a better outcome.
Measured: Baseline evaluation and at the end of the 3 month study
Change in VABS:Daily Living Skills Domain Scores, Pre- and Post-Intervention
Vineland Adaptive Behavior Scales-II (VABS): Daily Living Skills Domain individual items are scored on a Likert scale from 2=Usually, 1=Sometimes or Partially, 0= Seldom or Never. The Daily Living Skills Domain measures personal behavior as well as domestic and community interaction skills. Daily Living Skills Domain raw scores range from Minimum=0 to Maximum=218.
Measured: Baseline and at the end of the 3 month trial
Change in VABS: Socialization Domain Scores, Pre- and Post-Intervention
Vineland Adaptive Behavior Scales-II (VABS): Socialization Domain. Critical behaviors are scored on a Likert scale from 2=Usually, 1=Sometimes or Partially, 0= Seldom or Never. Socialization Domain raw scores range from: Minimum=0 to Maximum=152. A higher score is a better outcome.
Measured: Baseline and at the end of the 3 month trial
Change in VABS:Communication Domain Scores, Pre- and Post-Intervention
Vineland Adaptive Behavior Scales (VABS)-II Communication Domain Scores. The Communication Domain evaluates the receptive, expressive, and written communication skills of the child. Critical behaviors in each Subdomain item are rated as 2=Usually, 1=Sometimes or Partially, 0= Seldom or Never. Communication Domain raw scores range from: Minimum=0 to Maximum=198. A higher score is a better outcome.
Measured: Baseline and at the end of the 3 month trial
Change in Ghuman-Folstein Screen for Social Interaction (SSI) Score, Pre- and Post-Intervention.
The Ghuman-Folstein Screen for Social Interaction (SSI) assesses the change in behavior and temperament dysregulation as a total score.
The score ranges from 0-162, with 0 being most Impaired /has the strongest autism features and 162 having no impairment/no autism features.
Measured: Initial evaluation and at the end of the 3 month study. The test lasts 45 minutes
Change in Rett Syndrome Behavior Questionnaire Score, Pre- and Post-Intervention
The Rett Syndrome Behavior Questionnaire (RSBQ) total score was assessed. The total score ranges from 0 to 90, with 0 exhibiting no Rett syndrome related symptoms and 90 showing the greatest amount of symptoms (worse outcome).
Measured: Initial evaluation and at the end of the 3 month study

Timeline

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

Mar 201226 Oct 2016

First posted27 Jan 2012 (estimated)
Study startMar 2012
Primary completion26 Oct 2016
Study completion26 Oct 2016

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.
Other trials for Rett SyndromeStudies of the same condition, open and under way.
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: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01520363
Sponsor's protocol ID: FD-004247-01
Acronym: PCTDMRTT
Status last verified: Nov 2018
First submitted: 25 Jan 2012
Last updated: 4 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

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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All Rett Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Placebo Controlled Trial of Dextromethorphan in Rett Syndrome
ClinicalTrials.gov ID: NCT01520363
Acronym / sponsor ID: PCTDMRTT / FD-004247-01
Conditions: Rett Syndrome
Keywords: Rett syndrome, RTT, MECP2, dextromethorphan, DM
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 57 participants (actual)
Lead sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.University, hospital or other
Collaborators: The Johns Hopkins Institute for Clinical and Translational Research (ICTR)
Study start: Mar 2012 (actual)
Primary completion: 26 Oct 2016 (actual)
Study completion: 26 Oct 2016 (actual)
First posted: 27 Jan 2012 (estimated)
Results: Posted 23 Oct 2018

Clinical summary

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

Detailed description

Study design

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

Arm	Type	Receives
Study drug-dextromethorphan (DM)	Active comparator	Drug: dextromethorphanMECP2 mutation positive subjects randomized to receive DM
Placebo group	Placebo comparator	Drug: placeboMECP2 positive subjects randomized to the placebo compound

Who may qualify

Ages: 1 year to 10 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

males and females who have classic or atypical RTT with a proven mutation in the MECP2 gene;
subjects must be between one year - 10 years of age.

Key exclusion criteria (8 listed)

those without an established mutation in the MECP2 gene;
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;
those on medications that could interact with DM, e.g. MAO inhibitors, SSRI, sibutramine etc. to avoid a serotonin syndrome; quinidine and drugs metabolized by the CYP450 isoform CYP2D6 (e.g. amiodarone, haloperidol, propafenone, thioridazine);
those proven to be intermediate or slow metabolizers of DM;
those with reported adverse reactions to DM;

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
dextromethorphanAlso: DelsymThe DM group will take 5mg/kg/day orally in 2 divided doses 12 hours apart for the 3 month period of the study. The pharmacists will dispense the DM to the study participants.	Drug	Study drug-dextromethorphan (DM)
placeboThe placebo will be dispensed to equal the volume of DM of 5mg/kg/day. It is taken orally in 2 divided doses 12 hours apart during the study period of 3 months. The Research pharmacist will dispense the placebo to the participants.	Drug	Placebo group

Primary outcome

Change in Mullen; Visual Reception Sub-scale Scores, Pre- and Post-Intervention
Time frame: Initial evaluation and at the end of the 3 month trial
The Mullen Scales of Early Learning (MULLEN) Visual reception subscale raw scores range from Minimum=0 to Maximum=50. A higher score is a better outcome. Age equivalents from 1 month to 70 months can be computed for each subscale separately.
Change in Mullen; Fine Motor Sub-scale Scores, Pre- and Post-Intervention
Time frame: Baseline and 3 months
The Mullen Scales of Early Learning (MULLEN) Fine motor scale raw scores range from Minimum=0 to Maximum=49. A higher score is a better outcome. Age equivalents from 1 month to 70 months can be computed for each subscale separately.
Change in Mullen; Receptive Language Subscale Scores, Pre- and Post-Intervention
Time frame: Baseline and 3 months
The Mullen Scales of Early Learning (MULLEN) Receptive Language scale raw scores range from Minimum=0 to Maximum=50. A higher score is a better outcome. Age equivalents from 1 month to 70 months can be computed for each subscale separately.
Change in Mullen, Expressive Language Sub-scale Scores, Pre- and Post-Intervention
Time frame: Baseline and 3 months
The Mullen Scales of Early Learning (MULLEN) Expressive Language scale raw scores range from Minimum=0 to Maximum=50. A higher score is a better outcome. Age equivalents from 1 month to 70 months can be computed for each subscale separately.

6 secondary outcomes

Change in VABS: Motor Skills Domain Scores, Pre- and Post-Intervention
Time frame: Baseline evaluation and at the end of the 3 month study
Change in VABS:Daily Living Skills Domain Scores, Pre- and Post-Intervention
Time frame: Baseline and at the end of the 3 month trial
Change in VABS: Socialization Domain Scores, Pre- and Post-Intervention
Time frame: Baseline and at the end of the 3 month trial
Change in VABS:Communication Domain Scores, Pre- and Post-Intervention
Time frame: Baseline and at the end of the 3 month trial
Change in Ghuman-Folstein Screen for Social Interaction (SSI) Score, Pre- and Post-Intervention.
Time frame: Initial evaluation and at the end of the 3 month study. The test lasts 45 minutes
Change in Rett Syndrome Behavior Questionnaire Score, Pre- and Post-Intervention
Time frame: Initial evaluation and at the end of the 3 month study

Results and safety

Results posted to the registry on 23 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Study Drug-dextromethorphan (DM)	26	24
Placebo Group	26	26

Primary outcome: Change in Mullen; Visual Reception Sub-scale Scores, Pre- and Post-Intervention

Time frame: Initial evaluation and at the end of the 3 month trial. Mean (Standard Deviation). Unit: score on a scale

Measure	Study Drug-dextromethorphan (DM) n = 24	Placebo Group n = 26	Study Drug Group at 3 Months n = 22	Placebo at 3 Months n = 25
Value	5.45 (3.419)	6.61 (6.308)	6.64 (7.135)	6.57 (5.008)

Study Drug-dextromethorphan (DM) vs Study Drug Group at 3 Months: Mean Difference (Net): -1.182 (95% CI -3.086 to .722), p = .211, t-test, 2 sided
Placebo Group vs Placebo at 3 Months: Median Difference (Final Values): .043 (95% CI -1.345 to 1.432), p = .949, t-test, 2 sided

Population analysed: Mutation positive participants who are fast metabolizers at baseline. 2 were noncompliant and removed from the study drug group. At 3 months 22 were analyzed in the study drug group and 25 in the placebo group due to incomplete data.

Primary outcome: Change in Mullen; Fine Motor Sub-scale Scores, Pre- and Post-Intervention

Time frame: Baseline and 3 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Study Drug-dextromethorphan (DM) n = 24	Placebo Group n = 26	Study Drug Group at 3 Months n = 22	Placebo at 3 Months n = 25
Value	5.38 (5.5)	7.00 (6.474)	5.05 (6.103)	7.04 (6.564)

Study Drug-dextromethorphan (DM) vs Study Drug Group at 3 Months: Mean Difference (Final Values): 0.333 (95% CI -0.785 to 1.451), p = .541, t-test, 2 sided
Placebo Group vs Placebo at 3 Months: Mean Difference (Net): -.042 (95% CI -1.290 to 1.206), p = .946, t-test, 2 sided

Primary outcome: Change in Mullen; Receptive Language Subscale Scores, Pre- and Post-Intervention

Time frame: Baseline and 3 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Study Drug-dextromethorphan (DM) n = 24	Placebo Group n = 26	Study Drug Group at 3 Months n = 22	Placebo at 3 Months n = 25
Value	6.45 (5.307)	6.95 (5.269)	6.68 (5.472)	6.55 (6.085)

Study Drug-dextromethorphan (DM) vs Study Drug Group at 3 Months: Mean Difference (Net): -0.227 (95% CI -1.609 to 1.154), p = .736, t-test, 2 sided
Placebo Group vs Placebo at 3 Months: Mean Difference (Net): 0.409 (95% CI -1.143 to 1.961), p = .589, t-test, 2 sided

Primary outcome: Change in Mullen, Expressive Language Sub-scale Scores, Pre- and Post-Intervention

Time frame: Baseline and 3 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Study Drug-dextromethorphan (DM) n = 24	Placebo Group n = 26	Study Drug Group at 3 Months n = 22	Placebo at 3 Months n = 25
Value	5.33 (3.665)	6.73 (3.8)	6.76 (5.504)	7.29 (7.123)

Study Drug-dextromethorphan (DM) vs Study Drug Group at 3 Months: Mean Difference (Net): -1.429 (95% CI -2.886 to 0.029), p = .05, t-test, 2 sided
Placebo Group vs Placebo at 3 Months: Mean Difference (Net): 0.042 (95% CI -1.589 to 1.672), p = 0.958, t-test, 2 sided

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Study Drug-dextromethorphan (DM)	0 of 26 (0%)	0 of 26 (0%)	0 of 26
Placebo Group	0 of 26 (0%)	0 of 26 (0%)	0 of 26
Study Drug Group at 3 Months	0 of 24 (0%)	18 of 24 (75%)	0 of 24
Placebo at 3 Months	0 of 26 (0%)	22 of 26 (84.6%)	0 of 26

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Sakkubai R Naidu, MD principal investigator

The Kennedy Krieger Institute and Johns Hopkins SOM

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing dextromethorphan in people with Rett Syndrome, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. 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 2 inclusion and 8 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 4 Dec 2018. 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?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 23 Oct 2018). 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 Mullen; Visual Reception Sub-scale Scores, Pre- and Post-Intervention (time frame: Initial evaluation and at the end of the 3 month trial). The study lists 4 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 NCT01520363.

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 4 Dec 2018; AzTrials last refreshed its copy on 7 Nov 2026.