Amphetamine Extended-Release Tablets in the Treatment of Adults With ADHD
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|ClinicalTrials.gov Identifier: NCT03834766|
Recruitment Status : Completed
First Posted : February 8, 2019
Last Update Posted : December 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|ADHD||Drug: AMPH ER Tab 5, 10, 15 and 20 mg Drug: AMPH ER Tab Matching Placebo 5, 10, 15 and 20 mg||Phase 3|
This is a randomized, double-blind (DB), placebo-controlled, parallel, study to assess the efficacy and safety of AMPH ER TAB compared to placebo for the treatment of ADHD in adults aged 18 to 60 years.
After Screening and Baseline evaluations are complete, eligible subjects will be randomized in the study to take DB AMPH ER TAB or matching placebo orally once daily in the morning beginning the day after the Baseline visit for 5 weeks. Dose will be titrated on a weekly basis to reach 20 mg per day.Subjects who cannot tolerate the study drug will be discontinued from the study.
A Math Test placement test will be done at Screening or at Baseline. At Visit 5, efficacy assessments will include the administration of serial Math Tests at pre-dose and at 0.5, 1, 2, 4, 8, 10, 12, 13, and 14 hours post-dose.
Adult Investigator Symptom Rating Scale (AISRS) and Clinical Global Impression Scale Severity (CGI-S) will be conducted at Baseline and Visits 1 to 5. Digit Symbol Substitution Test (DSST) will be administered at Baseline and Visit 5.
Safety assessments will include treatment-emergent adverse events, physical examination, vital signs, body weight, Columbia Suicide Severity Rating Scale (C-SSRS), and direct questioning to assess for sleep, appetite, mood and psychotic events.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is a randomized, double-blind (DB), placebo-controlled, parallel study|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||AMPH ER Tab 5, 10, 15 & 20 mg Vs. Matching Placebo|
|Official Title:||Amphetamine Extended-Release Tablets in the Treatment of Adults With ADHD|
|Actual Study Start Date :||February 6, 2019|
|Actual Primary Completion Date :||October 19, 2019|
|Actual Study Completion Date :||October 19, 2019|
Active Comparator: AMPH ER Tab
Amphetamine Extended Release Tablets 5, 10, 15 and 20 mg
Drug: AMPH ER Tab 5, 10, 15 and 20 mg
Other Name: Amphetamine Extended Release Tablets
Placebo Comparator: Matching Placebo
Matching Placebo Tablets 5, 10, 15 and 20 mg
Drug: AMPH ER Tab Matching Placebo 5, 10, 15 and 20 mg
Other Name: Amphetamine Extended Release Tablets Matching Placebo
- Math Test score over all post-dose time points assessed during the administration of serial Math Tests at Visit 5 [ Time Frame: 6 monts ]The primary efficacy endpoint will be assessed using a linear Mixed Model Repeated Measures (MMRM) analysis using SAS® PROC MIXED. The model will include treatment, time and treatment by time as fixed effects and subject as a random effect. Pre-dose Math Test score will be included as a covariate. The difference between AMPH ER TAB and placebo will be assessed at the alpha = 0.05 level of significance.
- Onset of clinical effect [ Time Frame: 6 months ]Defined as the first time point post-dose when treatment effect of AMPH ER TAB versus placebo, evaluated using Math Test scores (attempted + correct) is significant.
- Duration of clinical effect [ Time Frame: 6 months ]Defined as the time between last time point to the first time point post-dose with significant treatment effect of AMPH ER TAB versus placebo evaluated using Math Test scores (attempted + correct).
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): NCT03834766
|United States, Florida|
|Bradenton, Florida, United States, 344201|
|Meridien Research, Inc.|
|Maitland, Florida, United States, 32751|
|United States, Nevada|
|Center for Psychiatry and Behavioral Medicine|
|Las Vegas, Nevada, United States, 89128|
|Principal Investigator:||Andrew J. Cutler, MD||Meridien Research Inc.|