Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00337285
Status:
COMPLETED
Last Update Posted:
2012-08-20
First Post:
2006-06-09
Brief Title:
An Open-label Study of NRP104 in Adults With Attention Deficit Hyperactivity Disorder ADHD
Sponsor:
New River Pharmaceuticals
Organization:
New River Pharmaceuticals
Study Overview
Official Title:
A Long-Term Open-Label and Single-Arm Study of NRP104 30 mg 50 mg or 70 mg Per Day in Adults With Attention Deficit Hyperactivity Disorder ADHD
Status:
COMPLETED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the long-term safety and efficacy of three NRP104 doses of 30 mg 50 mg or 70 mg administered at the same time daily in the treatment of adults with ADHD
Detailed Description:
This is a multi-center open-label and single-arm study to assess the safety of three NRP104 doses 30 mg 50 mg or 70 mg per day for up to one 1 year in the treatment of adults with ADHD Subjects who were randomized and met all inclusionexclusion criteria in Protocol NRP104303 are eligible for participation in this protocol The study will consist of three periods a screeningbaseline period a 4-week dose titration and a long-term maintenance of up to 11 months There are three possibilities for subjects that rollover from the NRP104303 protocol They are
Subjects that rollover at the final visit of the NRP104303 study on the same day
The screening and baseline procedures from this open label study will coincide with the final study visit of Protocol NRP104303 Subject data from final study visit will be transferred and utilized for the open label study On this same day the subject will be consented for NRP104304 inclusionexclusion criteria will be assessed the subject will be enrolled and study medication will be dispensed
Subjects that rollover not on the same day but within seven days of the NRP104303 study
If the subject returns to enroll into the NRP104304 study within seven days of the final NRP104303 study visit and has not taken any excluded medications for which a washout is required the final study visit procedures and data from the NRP104303 study will be transferred and utilized for the screening and baseline visit procedures of this study where applicable When the subject returns to the site they will be consented inclusion and exclusion criteria will be assessed the subject will be enrolled and study medication will be dispensed
Subjects will require a full screening visit if more than 7 days have elapsed since they completed the NRP104303 study
After screening results have been received by the site the site personnel will contact the subject via telephone to inform them of continued study eligibility During this call the subject will be instructed to stop all medications for the treatment of ADHD if any This call starts the washout of all psychoactive medications which should last 7 2 days During the Washout Phone Contact the visit dates for the Baseline visit Visit 01 and Visits 02 through 05 should be scheduled at 7-day intervals as calculated from Baseline After the washout is complete subjects will return to the clinic for the baseline visit Visit 01 to have the baseline procedures performed and to receive study medication
Dose Titration
All subjects will initiate treatment at NRP104 30 mg for the 1st week At the subsequent 4 weekly visits Visits 02 03 04 and 05 the subjects daily dose of NRP104 may be increased or decreased by 20 mg at weekly intervals to achieve the optimal efficacy and tolerability if deemed appropriate by the Investigator In this study the maximum daily dose of NRP104 that can be received by the subject is 70 mg and the minimum daily dose of NRP104 the subject must take to continue the treatment is 30 mg
Monthly Maintenance
At the end of the initial 4-week dose titration Visit 05 subjects will enter the long-term maintenance of up to 11 months Monthly visits starting with Visit 06 will have a window of 4 days All visits will be scheduled relative to the Baseline Visit date The last scheduled visit of the protocol is Visit 16 at Month 12 During the long-term maintenance the subjects dose may be increased or decreased by 20 mg at any visit if deemed appropriate by the Investigator to maintain optimal treatment in terms of efficacy and tolerability All reasons for dose changes should be well documented by the investigator during the maintenance period Subjects who cannot maintain the minimum daily dose of NRP 30 mg due to intolerance will be withdrawn from the study
Safety and Efficacy Assessments
ADHD Rating Scale ADHD-RS performed using adult prompts and Clinical Global Impression CGI will be assessed by the Investigator The Pittsburgh Sleep Quality Index PSQI will be assessed once every three months following baseline
Adverse events and concomitant medications will be recorded at each visit starting from the baseline visit Vital signs will be measured at each visit from the screening visit Physical exam and clinical laboratory tests including pregnancy tests will be assessed at Screening Visit 10 and the final visit Weight will be measured at the screening visit baseline visit and every month thereafter Height will be measured at the screening visit and final visit ECG parameters will be assessed at the screening visit baseline visit and every 3 months thereafter
Subjects that rollover at the final visit of the NRP104303 study on the same day
The screening and baseline procedures from this open label study will coincide with the final study visit of Protocol NRP104303 Subject data from final study visit will be transferred and utilized for the open label study On this same day the subject will be consented for NRP104304 inclusionexclusion criteria will be assessed the subject will be enrolled and study medication will be dispensed
Subjects that rollover not on the same day but within seven days of the NRP104303 study
If the subject returns to enroll into the NRP104304 study within seven days of the final NRP104303 study visit and has not taken any excluded medications for which a washout is required the final study visit procedures and data from the NRP104303 study will be transferred and utilized for the screening and baseline visit procedures of this study where applicable When the subject returns to the site they will be consented inclusion and exclusion criteria will be assessed the subject will be enrolled and study medication will be dispensed
Subjects will require a full screening visit if more than 7 days have elapsed since they completed the NRP104303 study
After screening results have been received by the site the site personnel will contact the subject via telephone to inform them of continued study eligibility During this call the subject will be instructed to stop all medications for the treatment of ADHD if any This call starts the washout of all psychoactive medications which should last 7 2 days During the Washout Phone Contact the visit dates for the Baseline visit Visit 01 and Visits 02 through 05 should be scheduled at 7-day intervals as calculated from Baseline After the washout is complete subjects will return to the clinic for the baseline visit Visit 01 to have the baseline procedures performed and to receive study medication
Dose Titration
All subjects will initiate treatment at NRP104 30 mg for the 1st week At the subsequent 4 weekly visits Visits 02 03 04 and 05 the subjects daily dose of NRP104 may be increased or decreased by 20 mg at weekly intervals to achieve the optimal efficacy and tolerability if deemed appropriate by the Investigator In this study the maximum daily dose of NRP104 that can be received by the subject is 70 mg and the minimum daily dose of NRP104 the subject must take to continue the treatment is 30 mg
Monthly Maintenance
At the end of the initial 4-week dose titration Visit 05 subjects will enter the long-term maintenance of up to 11 months Monthly visits starting with Visit 06 will have a window of 4 days All visits will be scheduled relative to the Baseline Visit date The last scheduled visit of the protocol is Visit 16 at Month 12 During the long-term maintenance the subjects dose may be increased or decreased by 20 mg at any visit if deemed appropriate by the Investigator to maintain optimal treatment in terms of efficacy and tolerability All reasons for dose changes should be well documented by the investigator during the maintenance period Subjects who cannot maintain the minimum daily dose of NRP 30 mg due to intolerance will be withdrawn from the study
Safety and Efficacy Assessments
ADHD Rating Scale ADHD-RS performed using adult prompts and Clinical Global Impression CGI will be assessed by the Investigator The Pittsburgh Sleep Quality Index PSQI will be assessed once every three months following baseline
Adverse events and concomitant medications will be recorded at each visit starting from the baseline visit Vital signs will be measured at each visit from the screening visit Physical exam and clinical laboratory tests including pregnancy tests will be assessed at Screening Visit 10 and the final visit Weight will be measured at the screening visit baseline visit and every month thereafter Height will be measured at the screening visit and final visit ECG parameters will be assessed at the screening visit baseline visit and every 3 months thereafter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None