Arm A (Basimglurant to Placebo) for Sclerosis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Sclerosis+2 More
Eligibility
< 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether basimglurant is an effective seizure control medication for children and adolescents with Tuberous Sclerosis Complex.

Eligible Conditions
  • Sclerosis
  • Tuberous Sclerosis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Sclerosis

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 82 weeks

30 weeks
Change in seriousness of disease as assessed by Most Impactful Symptoms Scale in Periods 2 (weeks 13 to 16) and Period 4 (weeks 27 to 30) compared to baseline.
Change in the severity of symptoms of TSCas measured by Caregiver Global Impression of Change (CGIC) score during maintenance dosing in Period 2 (Weeks 13 to 16) and Period 4 (Weeks 27-30) compared to Baseline.
Changes in the Sheehan Disability Scale during maintenance dosing in Period 2 (Weeks 13 to 16) and Period 4 (Weeks 27-30) compared to baseline.
Frequency of seizures detected by the wearable device evaluated as the change from Baseline compared to study treatment in Period 1 (weeks 13 to 16) and Period 4 (weeks 27 to 30).
Intensity of seizures detected by the wearable device evaluated as the change from Baseline compared to study treatment Periods 1 and 4.
Longest seizure free interval (i.e., seizure free days).
Mean percentage change from baseline of seizure frequency during the maintenance dosing in Period 2 (Weeks 13 to 16) and Period 4 (Weeks 27-30).
Number of patients considered treatment responders.
82 weeks
Safety of the study drug in children and adolescents with seizures associated with TSC.

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Sclerosis

Trial Design

2 Treatment Groups

Arm A (Basimglurant to Placebo)
1 of 2
Arm B (Placebo to Basimglurant)
1 of 2
Experimental Treatment
Non-Treatment Group

54 Total Participants · 2 Treatment Groups

Primary Treatment: Arm A (Basimglurant to Placebo) · Has Placebo Group · Phase 2

Arm A (Basimglurant to Placebo)
Drug
Experimental Group · 1 Intervention: Basimglurant with crossover to Placebo · Intervention Types: Drug
Arm B (Placebo to Basimglurant)
Drug
PlaceboComparator Group · 1 Intervention: Placebo with crossover to Basimglurant · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 82 weeks

Who is running the clinical trial?

Noema Pharma AGLead Sponsor
2 Previous Clinical Trials
267 Total Patients Enrolled
Renata Lazarova, MDStudy DirectorNoema Pharma AG

Eligibility Criteria

Age < 65 · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are able to give informed assent or written consent or consent from their legal representative.
You are able to understand and communicate in the language of the study staff.
You are currently receiving one or more anti-epileptic drugs (AEDs).
You are willing to undergo serum or urinary pregnancy testing at screening and during the trial period.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 3rd, 2021

Last Reviewed: October 2nd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.