Trial record 1 of 1 for:
bp41316
A 12-Week Placebo-Controlled Study to Investigate the Efficacy, Safety, and Tolerability of RO7017773 in Participants Aged 15-45 Years With Autism Spectrum Disorder (ASD)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04299464 |
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Recruitment Status :
Active, not recruiting
First Posted : March 6, 2020
Last Update Posted : March 29, 2024
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
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Brief Summary:
This study will investigate the efficacy, safety, tolerability, and pharmacokinetics of RO7017773 in participants aged 15-45 years who have been diagnosed with ASD with a score of >/=50 on the Wechsler Abreviated Scale of Intelligence (WASI-II).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Autism Spectrum Disorder (ASD) | Drug: Placebo Drug: RO7017773 | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 103 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase II Multicenter, Randomized, Double-Blind, 12-Week Treatment, 3-Arm, Parallel-Group, Placebo-Controlled Study to Investigate the Efficacy, Safety, and Tolerability of RO7017773 in Participants Aged 15-45 Years With Autism Spectrum Disorder (ASD) |
| Actual Study Start Date : | March 31, 2021 |
| Estimated Primary Completion Date : | May 17, 2024 |
| Estimated Study Completion Date : | May 17, 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Autism spectrum disorder
MedlinePlus related topics:
Autism Spectrum Disorder
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo
Participants will receive placebo matched to RO7017773 for approximately 12 weeks.
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Drug: Placebo
Participants will receive oral placebo for approximately 12 weeks. |
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Experimental: RO7017773 Low Dose
Participants will receive a fixed low dose of RO7017773 for approximately 12 weeks.
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Drug: RO7017773
Participants will receive oral RO7017773 for approximately 12 weeks. |
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Experimental: RO7017773 High Dose
Participants will receive a fixed high dose of RO7017773 for approximately 12 weeks.
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Drug: RO7017773
Participants will receive oral RO7017773 for approximately 12 weeks. |
Primary Outcome Measures :
- Change from Baseline to Week 12 in the Adaptive Behavior Composite score of the Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) [ Time Frame: Week 12 ]
Secondary Outcome Measures :
- Percentage of Participants with Adverse Events (AEs) [ Time Frame: Up to Week 18 ]
- Percentage of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up to Week 18 ]
- Percentage of Participants Discontinuing Treatment due to AEs [ Time Frame: From Baseline up to Week 12 ]
- Change from Baseline Over Time in Suicide Risk Using the Columbia-Suicide-Severity Rating Scale (C-SSRS) [ Time Frame: Days 14, 42, 84, 98, 126 ]
- Change from Baseline to Week 12 in Behavior/Symptoms as Measured by all Domains of the Repetitive Behavior Scale-Revised (RBS-R) [ Time Frame: Week 12 ]
- Change from Baseline to Week 12 on the Vineland-3 Socialization Domain [ Time Frame: Week 12 ]
- Change from baseline to Week 12 on the Vineland-3 Communication domains [ Time Frame: Week 12 ]
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| Ages Eligible for Study: | 15 Years to 45 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria
- Male and female participants with Autism Spectrum Disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
- Wechsler Abbreviated Scale of Intelligence (WASI-II) >/= 50 at screening or within the last 12 months prior to screening
- ASD or Autism diagnosis confirmed by Autism Diagnostic Observation Schedule (ADOS-2)
- Body mass index within the range of 18.5 to 40 kg/m2
- Female Participants: is eligible if she is not pregnant, not breastfeeding, and women of childbearing potential (WOCBP), who agree to remain abstinent or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 28 days after the last dose of study drug
- Language, hearing, and vision compatible with the study measurements as judged by the Investigator
- Allowed existing treatment regimens should be stable for 8 weeks prior to screening. Investigator expects stability of these treatments and behavioral interventions for the duration of the study
- In the Investigator's opinion, able to participate and deemed appropriate for participation in the study, capable of following the study SoA and able to comply with the study restrictions
- In the Investigator's opinion, participation in the study or discontinuation of prohibited medication will not pose undue risks
Exclusion Criteria
Neurologic/Psychiatric Conditions:
- Non-verbal individuals
- Presence of chromosome 15q11.2 q13.1 duplication syndrome (Dup15q syndrome), known "syndromic" forms of ASD (confirmed per genetic results available at screening): fragile X syndrome, Prader Willi syndrome, Rett's syndrome, tuberous sclerosis, and Angelman syndrome, as well as genetic alterations strongly associated with ASD per genetic results available at screening affecting the following genes: CHD8, ANDP, SHANK3
- Medical history of alcohol and/or substance abuse/dependence in the last 12 months or positive test for drugs of abuse at screening
- Initiation of a major change in psychosocial intervention within 6 weeks prior to screening. Minor changes in ongoing treatment are not considered major changes
- Clinically significant psychiatric and/or neurological disorder that may interfere with the safety or efficacy endpoints
- Risk of suicidal behavior in the opinion of a certified clinician or as evidenced by a "yes" to questions 4 and/or 5 of Columbia-Suicide-Severity Rating Scale (C-SSRS) taken at screening and baseline with respect to the last 12 months, or any suicide attempt in the past 5 years
- Unstable epilepsy/seizure disorder within the past 6 months or changes in anticonvulsive therapy within the last 6 months
Other Conditions:
- Medical history of malignancy if not considered cured or if occurred within the last 3 years with the exception of fully excised non-melanoma skin cancers or in-situ carcinoma of the cervix that has been successfully treated
- Concomitant disease, condition or treatment which would either interfere with the conduct of the study or pose an unacceptable risk to the participant in the opinion of the Investigator Prior/Concomitant Therapy
- Use of prohibited medications or herbal remedies within 6 weeks or 5 half-lives (t1/2) prior to randomization
Prior/Concurrent Clinical Study Experience:
- Donation or loss of blood over 500 mL in adults and 250 mL in adolescents within 3 months prior to randomization
- Participation in an investigational drug study within 1 month or 5 times the t1/2 of the investigational molecule prior to randomization or participation in a study testing an investigational medical device within 1 month prior to randomization or if the device is still active Diagnostic Assessments
- Confirmed clinically significant abnormality in hematological, chemistry or coagulation laboratory parameters
- Positive test result at screening for hepatitis B surface antigen, hepatitis C virus (HCV, untreated), or human immunodeficiency virus (HIV)-1 and -2. HCV participants who have been successfully treated and who test negative for HCV RNA, may be considered eligible for entry into the study
Other Exculsions:
- Uncorrected hypokalemia or hypomagnesaemia
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04299464
Locations
Show 27 study locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT04299464 |
| Other Study ID Numbers: |
BP41316 2019-003524-20 ( EudraCT Number ) |
| First Posted: | March 6, 2020 Key Record Dates |
| Last Update Posted: | March 29, 2024 |
| Last Verified: | March 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm). |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive Neurodevelopmental Disorders Mental Disorders |