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Immunomodulator

Copaxone for Rett Syndrome

Phase 2
Waitlist Available
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and final week of treatment (week 32)
Awards & highlights

Study Summary

A phase 2 open label trial to test a potential drug treatment for Rett syndrome, the leading known genetic cause of severe neurological impairment in girls. The drug, Copaxone (generic name - Glatiramer acetate) is medication FDA approved for the treatment of multiple sclerosis. Copaxone's high safety profile has been documented in large cohorts of patients for more than 12 years.

Eligible Conditions
  • Rett Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and final week of treatment (week 32)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and final week of treatment (week 32) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Gait Velocity as Measured by GAITRite System
Secondary outcome measures
Breath Hold Index (Number of Breath Holds Per Hour; Assessed in the Sleep Monitoring Lab)
Breath Hold Time (Assessed in the Sleep Monitoring Lab)
Eye
+2 more

Side effects data

From 2011 Phase 3 trial • 1417 Patients • NCT00451451
31%
FLUSHING
29%
MULTIPLE SCLEROSIS RELAPSE
17%
NASOPHARYNGITIS
14%
URINARY TRACT INFECTION
14%
HEADACHE
13%
DIARRHEA
11%
NAUSEA
10%
ABDOMINAL PAIN UPPER
10%
UPPER RESPIRATORY TRACT INFECTION
10%
FATIGUE
9%
BACK PAIN
8%
PROTEINURIA
7%
ABDOMINAL PAIN
7%
DEPRESSION
7%
VOMITING
7%
RASH
6%
PRURITIS
6%
PAIN IN EXTREMITY
6%
INFLUENZA
6%
ARTHRALGIA
6%
ALBUMIN URINE PRESENT
6%
PARAESTHESIA
5%
SINUSITIS
5%
HOT FLUSH
5%
PROTEIN URINE PRESENT
4%
COUGH
4%
ERYTHEMA
4%
BRONCHITIS
4%
MUSCLE SPASMS
4%
INSOMNIA
4%
MICROALBUMINURIA
4%
ALANINE AMINOTRANSFERASE INCREASED
3%
OROPHARYNGEAL PAIN
3%
DYSPEPSIA
3%
VERTIGO
3%
PYREXIA
3%
HYPOAESTHESIA
1%
CELLULITIS
1%
GASTROENTERITIS
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
BG00012 240 mg Twice Daily (BID)
BG00012 240 mg 3 Times Daily (TID)
Total BG00012
Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)

Trial Design

1Treatment groups
Experimental Treatment
Group I: CopaxoneExperimental Treatment1 Intervention
Dose escalation: Study drug will be administered once a week for 4 weeks, twice a week for 4 weeks and daily for 24 weeks. Drug is administered as a subcutaneous injection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Glatiramer
FDA approved

Find a Location

Who is running the clinical trial?

Montefiore Medical CenterLead Sponsor
445 Previous Clinical Trials
582,616 Total Patients Enrolled
2 Trials studying Rett Syndrome
3,020 Patients Enrolled for Rett Syndrome
Rett Syndrome Research TrustOTHER
7 Previous Clinical Trials
5,378 Total Patients Enrolled
7 Trials studying Rett Syndrome
5,378 Patients Enrolled for Rett Syndrome

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Pharmacological Treatment of Rett Syndrome With Glatiramer Acetate (Copaxone)
Aleksandra Djukic 2013. "Pharmacological Treatment of Rett Syndrome With Glatiramer Acetate (Copaxone)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02153723.
~1 spots leftby May 2025
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