| CTRI Number |
CTRI/2012/01/002344 [Registered on: 17/01/2012] Trial Registered Prospectively |
| Last Modified On: |
17/11/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study to Evaluate the Safety and Effectiveness of USL255 in Patients With Refractory Partial-onset Seizures (a type of epilepsy of fits). |
|
Scientific Title of Study
|
A Randomized, Multicenter, Double-Blind, Placebo–Controlled, Parallel-Group, Phase 3 Study to Evaluate the Efficacy and Safety of USL255 as Adjunctive Therapy in Patients with Refractory Partial-Onset Seizures. |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT01142193 |
ClinicalTrials.gov |
| P09-004 (Version date 22 Feb 2010) |
Protocol Number |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
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| Affiliation |
|
| Address |
|
| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Arun Sundriyal |
| Designation |
Associate Director, Clinical Management |
| Affiliation |
PPD Pharmaceutical Development India Pvt. Ltd. |
| Address |
PPD Pharmaceutical Development India Pvt Ltd., Vatika City Point, 11th floor
Sector 25, Mehrauli Gurgaon Road,India
Gurgaon
HARYANA
122002
India |
| Phone |
911244739903 |
| Fax |
911244739999 |
| Email |
Arun.Sundriyal@ppdi.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Arun Sundriyal |
| Designation |
Associate Director - Clinical Management |
| Affiliation |
PPD Pharmaceutical Development India Pvt. Ltd. |
| Address |
PPD Pharmaceutical Development India Pvt Ltd., Vatika City Point, 11th floor
Sector 25, Mehrauli Gurgaon Road,India
Gurgaon
HARYANA
122002
India |
| Phone |
911244739903 |
| Fax |
911244739999 |
| Email |
Arun.Sundriyal@ppdi.com |
|
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Source of Monetary or Material Support
|
| Upsher-Smith Laboratories, Inc. 6701 Evenstad Drive
Maple Grove, MN 55369, USA |
|
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Primary Sponsor
|
| Name |
UpsherSmith Laboratories Inc |
| Address |
6701 Evenstad Drive Maple Grove, MN 55369, USA |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
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Details of Secondary Sponsor
|
| Name |
Address |
| PPD Pharmaceutical Development India Pvt Ltd |
01-Dynasty B-Wing (Kanakia Spaces)
Andheri-Kurla Road, Andheri East,
Mumbai-400059, India |
|
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Countries of Recruitment
|
Argentina
Australia
Belgium
Canada
Chile
Germany
Greece
India
Israel
New Zealand
Poland
Russian Federation
South Africa
Spain
United States of America
Hungary |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jagaralpudi Murali Krishna Murthy |
Care Hospital, |
Department of Neurology, Room No 327, 3rd Floor, Nampally, Opp Exhibition Road, Hyderabad 500001, India
Hyderabad
ANDHRA PRADESH |
919848012983
914066835559
jmkmurthy@satyam.net.in |
| Dr Deepak Goel |
Himalayan Institute of Medical Sciences, |
HIHT University, Department of Neurology, Swami Ram Nagar, P.O.-Doiwala, Dehradun-248140, Uttarakhand
India
Dehradun
UTTARANCHAL |
91941173059
91135247111
goeld007in@yahoo.co.in |
| Dr Joy Dinkerray Desai |
Jaslok Hospital And Research Centre |
Department of Neurology, Room No:224, 2nd Floor, 15, Dr. G. Deshmukh Marg, Mumbai - 400026, India
Mumbai
MAHARASHTRA |
912266573365
912223526282
desaijoy@gmail.com |
| Dr Sita Jayalakshmi Sattaluri |
Krishna Institute of Medical Sciences |
Department of Neurology, #1-8-31/1,Minister Road, Secunderabad Hyderabad - 500003, India
Hyderabad
ANDHRA PRADESH |
914023300833
914023300833
sita_js@hotmail.com |
| Dr Srinivasa R |
M. S. Ramaiah Medical College and Hospitals |
M. S. Ramaiah Medical College and Hospitals, MSRIT Post, New BEL Road, Bangalore – 560054, Karnataka, India.
And
M.S. Ramaiah Clinical Research Centre,
M.S.Ramaiah Medical College and Hospitals
First Floor, M.S. Ramaiah Advanced Learning Centre, Gate No. 4, Gnanagangothri Campus,
MSRIT Post, New BEL Road -560054,India.
Bangalore
KARNATAKA |
918022183125
918040528402
drrsrinivasa@hotmail.com |
| Dr Shankara Nellikunja |
Mallikatta Neuro Research Centre, |
Opposite Mallikatta Circle,
Kadri, Mangalore - 575002, Karnataka, India
Udupi
KARNATAKA |
918242444933
918244255925
shankarmnl@hotmail.com |
| Dr Anshu Rohatgi |
Sir Ganga Ram Hospital, |
Department of Neurology, 4th Floor, Sir Ganga Ram Hospital Marg, Rajinder Nagar
New Delhi-110060, India
New Delhi
DELHI |
911142251450
911145041726
rohatgianshu@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Ethical Review Board - M S Ramaiah Medical College And Hospitals, Bangalore (Dr R Srinivasa) |
Approved |
| Ethics Committee - HIHT University, Dehradun (Dr Deepak Goel - HIHT University) |
Approved |
| Ethics Committee - Jaslok Hospital & Research Centre, Mumbai (Dr. Joy Desai - Jaslok Hospital) |
Approved |
| Ethics Committee - Krishna Institute of Medical Sciences, Hyderabad (Dr. Sita Sattaluri) |
Approved |
| Ethics Committee, Sir Ganga Ram Hospital, New Delhi (Dr. Anshu Rohatgi) |
Approved |
| Institutional Ethical Committee - CARE Hospital, Hyderabad (Dr JMK Murthy - CARE Hospital) |
Approved |
| Mallikatta Ethical Committee, Mangalore (Dr Shankara Nellikunja - Mallikatta Neuro Centre) |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Refractory Partial-Onset Seizures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Drug: Placebo |
15 Weeks |
| Intervention |
Drug: USL255 |
From 50mg QD increased upto 200mg QD (15 Weeks) |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Subject has a confirmed diagnosis of partial-onset seizures with or without secondary generalization for at least 12 months prior to Visit 1.
2. Currently on a stable dosing regimen of 1 to 3 AEDs for at least 4-weeks prior to Visit 1 (12 weeks for phenobarbital and primidone).
3. Have a minimum of 8 partial-onset seizures and no more than 21 consecutive seizure free days, during the 8-week baseline.
|
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| ExclusionCriteria |
| Details |
1. Have a history of seizure episodes lasting less than 30 minutes in which several seizures occur with such frequency that the initiation and completion of each individual seizure cannot be distinguished, within 3 months prior to Visit 1.
2. Have a history of pseudoseizures, or status epilepticus, within 3 months prior to Visit 1.
3. Have a history of metabolic acidosis, nephrolithiasis, ureterolithiasis, or narrow angle glaucoma.
4. Have a history of suicidal attempts, suicidal ideation, or uncontrolled psychiatric illness within 2 years of Visit 1.
5. Currently taking, or have taken felbamate within the past 18 months, or have taken vigabatrin in the past.
6. Have taken topiramate within the past 6 months.
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
|
Centralized |
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Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
Percent reduction from baseline in weekly (7 day) partial-onset seizure frequency during the titration plus maintenance phase.
|
Weekly (7 day)
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of subjects with greater than or equal 50 percent reduction (responder rate) in weekly (7 day) partial-onset seizure frequency during the titration plus maintenance phase compared to baseline. |
Weekly |
| Proportions of subjects with greater than or equal 50 percent reduction (responder rate) in weekly (7 day) partial-onset seizure frequency during the titration and maintenance phases, separately. |
Weekly |
| Percent reductions from baseline in weekly (7 day) partial-onset seizure frequency during the titration and maintenance phases, separately. |
Weekly |
| Percent reduction from baseline in weekly (7 day) all seizure frequency during the titration plus maintenance phase. |
Weekly |
| Proportions of subjects with greater than or equal 25 percent, greater than or equal 75 percent, and 100 percent reduction in weekly (7 day) partial-onset seizure frequency during the titration, maintenance and titration plus maintenance phases, separately. |
Weekly |
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Target Sample Size
Modification(s)
|
Total Sample Size="270"
Sample Size from India="34"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
15/06/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
11/08/2010 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
This is a Phase 3, randomized, multi-national, multicenter, double-blind, placebo–controlled, parallel group study designed to evaluate the efficacy and safety of USL255 as adjunctive therapy in subjects with refractory partial-onset seizures with or without secondary generalization. |