Clinical trial NCT04200352: A Study to Test if TEV-50717 is Safe and Effective in Relieving Abnormal Involuntary Movements in Cerebral Palsy
Official title: An Open-Label, Long-Term Safety, Tolerability, and Efficacy Study of TEV-50717 (Deutetrabenazine) for the Treatment of Dyskinesia in Cerebral Palsy in Children and Adolescents (Open RECLAIM-DCP)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Cerebral Palsy, Dyskinetic
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2019-12-16
Enrollment: 44
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study TV50717-CNS-30081 is a 55-week study in which participants who have successfully completed the parent study (Study TV50717-CNS-30080) may be eligible to enroll in this study.

The primary objective of this study is to evaluate the safety and tolerability of long-term therapy with TEV-50717 in children and adolescents with DCP.

The secondary objective of this study is to evaluate the efficacy of long-term therapy with TEV-50717 in reducing the severity of DCP.


Eligibility criteria: Inclusion Criteria:

* Participant has completed parent Study TV50717-CNS-30080.
* Participant weighs at least 12 kg (26 lb) on day 1 of this study.
* Participant is able to swallow TEV-50717 whole. NOTE- Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

* Participant has clinically significant depression at screening or day 1 of this study. Note: Participants receiving antidepressant therapy may be enrolled if on a stable dose for at least 6 weeks before screening or day 1 (whichever comes first) and anticipated to remain stable (dose and frequency) within the study duration.
* Participant has a history of suicidal intent or related behaviors based on medical or psychiatric history or the C-SSRS at screening visit, if performed, or at the day 1 visit, as applicable according to the participant's age:

  * intent to act on suicidal ideation with a specific plan, irrespective of level of ambivalence, at the time of suicidal thought
  * suicidal preparatory acts or behavior.
* Participant has a history of a previous actual, interrupted, or aborted suicide attempt.
* Participant has a first-degree relative who has completed suicide.
* Participant has received any of the following concomitant Participant has received any of the following concomitant medications within the specified exclusionary windows from screening or day 1 (whichever comes first) of this study:

  * within 30 days: tetrabenazine or valbenazine
  * within 21 days: reserpine
  * within 14 days: levodopa, dopamine agonists, and monoamine oxidase inhibitors
* Participant has received treatment with stem cells, deep brain stimulation, transmagnetic stimulation, or transcranial direct current stimulation for treatment of abnormal movements or CP since the week 15 visit of Study TV50717-CNS-30080, or the participant is not in a stable clinical condition.
* Participants with a history of torsade de pointes, congenital long QT syndrome, bradyarrhythmias, other cardiac arrhythmias, or uncompensated heart failure.
* Participant has a known allergy to any of the components of TEV-50717.
* Participant has participated in an investigational drug or device study other than Study TV50717-CNS-30080 and received IMP/intervention within 30 days or 5 drug half-lives of day 1 of this study, whichever is longer.
* Participant is pregnant or breastfeeding. NOTE- Additional criteria apply, please contact the investigator for more information

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Baseline up to Week 55
measure: Number of Participants (Aged ≥12 Years) With Columbia-Suicide Severity Rating Scale (C-SSRS) Outcomes (Worst Overall Finding)
timeFrame: Baseline to Week 54
measure: Change From Baseline in Extrapyramidal Symptom Rating Scale (ESRS) Subscale I Total Score at Week 54
timeFrame: Baseline, Week 54
measure: Change From Baseline in ESRS Subscale II Total Score at Week 54
timeFrame: Baseline, Week 54
measure: Change From Baseline in Child Behavior Checklist (CBCL) Competence Total Score at Week 53
timeFrame: Baseline, Week 53
measure: Change From Baseline in CBCL Syndrome Total Score at Week 53
timeFrame: Baseline, Week 53
measure: Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 54
timeFrame: Baseline, Week 54
Secondary outcomes:
measure: Change From Baseline in the Movement Disorder-Childhood Rating Scale (MD-CRS) Part I Total Score (General Assessment, Centrally Read)
timeFrame: Baseline, Week 53, Week 54
measure: Change From Baseline in the MD-CRS Part II Total Score (Movement Disorder Severity, Centrally Read)
timeFrame: Baseline, Week 53, Week 54
measure: Change From Baseline in the MD-CRS Part I Total Score (General Assessment, Physician Rated)
timeFrame: Baseline, Week 53, Week 54
measure: Change From Baseline in the MD-CRS Part II Total Score (General Assessment, Physician Rated)
timeFrame: Baseline, Week 53, Week 54
measure: Change From Baseline in MD-CRS Global Index Score (Calculated From MD-CRS Parts I and II Total Scores, Physician Rated)
timeFrame: Baseline, Week 53, Week 54
measure: Change From Baseline in MD-CRS Global Index Score (Calculated From MD-CRS Parts I and II Total Scores, Centrally Read)
timeFrame: Baseline, Week 53, Week 54
measure: Change From Baseline in Caregiver Global Impression of Improvement (CaGI-I) Scale Score (Global, Caregiver Rated) at Week 54
timeFrame: Baseline, Week 54
measure: Change From Baseline in Clinical Global Impression of Improvement (CGI-I) Scale Score (Global, Physician Rated) at Week 54
timeFrame: Baseline, Week 54
measure: Change From Baseline in Clinical Global Impression of Severity (CGI-S) Scale Score (Global, Physician Rated) at Week 54
timeFrame: Baseline, Week 54
measure: Change From Baseline in Pediatric Evaluation Disability Inventory-Computer Adapted Test (PEDI-CAT) Score (Activities of Daily Living [ADL], Caregiver Completed, Content-Balanced Version) at Week 53
timeFrame: Baseline, Week 53
measure: Change From Baseline in Unified Huntington's Disease Rating Scale-Total Maximal Chorea (UHDRS-TMC) Score (Centrally Read) at Week 53
timeFrame: Baseline, Week 53
measure: Change From Baseline in Unified Huntington's Disease Rating Scale-Total Maximal Dystonia (UHDRS-TMD) Score (Centrally Read) at Week 53
timeFrame: Baseline, Week 53
measure: Change From Baseline in Unified Huntington's Disease Rating Scale-Total Motor Score (UHDRS-TMS) Score (Physician Rated) at Week 53
timeFrame: Baseline, Week 53
measure: Change From Baseline in Unified Huntington's Disease Rating Scale-Total Maximal Chorea (UHDRS-TMC) Score (Physician Rated) at Week 53
timeFrame: Baseline, Week 53
measure: Change From Baseline in Unified Huntington's Disease Rating Scale-Total Maximal Dystonia (UHDRS-TMD) Score (Physician Rated) at Week 53
timeFrame: Baseline, Week 53
measure: Change From Baseline in Canadian Occupational Performance Measure (COPM) (Physician Rated) Score at Week 53
timeFrame: Baseline, Week 53
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Teva Investigational Site 14137
state: Alabama
city: San Diego
country: United States
facility: Teva Investigational Site 14295
state: California
city: Voorhees
country: United States
facility: Teva Investigational Site 14122
state: New Jersey
city: Charleston
country: United States
facility: Teva Investigational Site 14299
state: South Carolina
city: Nashville
country: United States
facility: Teva Investigational Site 14129
state: Tennessee
city: Blegdamsvej 9
country: Denmark
facility: Teva Investigational Site 39058
city: Tel-Aviv, Tel-Aviv District
country: Israel
facility: Teva Investigational Site 80146
city: Zerifin, Central District
country: Israel
facility: Teva Investigational Site 80147
city: Milan
country: Italy
facility: Teva Investigational Site 30214
city: Pisa
country: Italy
facility: Teva Investigational Site 30216
city: Gdansk, Pomerania Province
country: Poland
facility: Teva Investigational Site 53428
city: Gdansk
country: Poland
facility: Teva Investigational Site 53434
city: Krakow
country: Poland
facility: Teva Investigational Site 53427
city: Wiazowna, Mazovia Province
country: Poland
facility: Teva Investigational Site 53430
city: Kazan
country: Russian Federation
facility: Teva Investigational Site 50477
city: Khabarovsk, Khabarovsk Krai Region
country: Russian Federation
facility: Teva Investigational Site 50475
city: Moscow, Moscow Region
country: Russian Federation
facility: Teva Investigational Site 50470
city: Nizhniy Novgorod, Nizhny Novgorod Region
country: Russian Federation
facility: Teva Investigational Site 50485
city: Novosibirsk, Novosibirsk Region
country: Russian Federation
facility: Teva Investigational Site 50468
city: Smolensk, Smolensk Region
country: Russian Federation
facility: Teva Investigational Site 50469
city: Stavropol, Stavropol Krai Region
country: Russian Federation
facility: Teva Investigational Site 50478
city: Tyumen, Tyumen Region
country: Russian Federation
facility: Teva Investigational Site 50474
city: Valencia
country: Spain
facility: Teva Investigational Site 31254
city: Dnipro, Dnipropetrovsk Province
country: Ukraine
facility: Teva Investigational Site 58313
city: Kyiv, Kyiv Province
country: Ukraine
facility: Teva Investigational Site 58309
city: Odessa, Odessa Province
country: Ukraine
facility: Teva Investigational Site 58311
city: Vinnytsya, Vinnytsia Province
country: Ukraine
facility: Teva Investigational Site 58310
city: Edinburgh, Edinburgh
country: United Kingdom
facility: Teva Investigational Site 34245
city: London, Greater London
country: United Kingdom
facility: Teva Investigational Site 34243
city: Sheffield, South Yorkshire
country: United Kingdom
facility: Teva Investigational Site 34244
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References: